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CD007016

At present, there is insufficient RCT evidence to enable evaluation of the effect of TPD in patients with AKI. Well-designed and larger RCTs are required to better understand the risks and benefits of TPD for AKI.

Is peritoneal dialysis adequate for hypercatabolic acute renal failure in developing countries?

Peritoneal dialysis (PD) is a therapeutic option for acute renal failure (ARF) in developing countries, despite concerns about inadequacy. Shorter and more efficient tidal peritoneal dialysis (TPD) was compared with continuous equilibrating peritoneal dialysis (CEPD) therapy in ARF by using their adequacies as accepted standards and analyzing the solute reduction indices (SRI). A prospective, randomized crossover trial was performed in patients with mild to moderate hypercatabolic ARF who were assigned to CEPD and TPD therapy after an adequate washout period. Solute clearances (Kt/V, normalized creatinine clearances) were compared to NKF guidelines. Potassium and phosphate clearances, dextrose absorption, protein losses and costs were compared. Kt/V was compared to SRIdialysate, SRIKt/V. Eighty-seven patients with ARF received 236 sessions of dialysis (118 in each treatment). TPD resulted in higher clearances of solutes than CEPD (creatinine and urea clearances in mL/min of 9.94 +/- 2.93, 6.74 +/- 1.63 and 19.85 +/- 1.95, 10.63+/- 2.62, respectively, P=0.001). TPD and CEPD normalized creatinine clearances (L/week/1.73 m2 BSA) and Kt/V values were 68.5 +/- 4.43, 58.85 +/- 2.57 and 2.43 +/- 0.87, 1.80 +/- 0.32, respectively. CEPD did not meet standards of adequacy. TPD resulted in greater potassium and phosphate clearances, less dextrose absorption and was less expensive. CEPD resulted in less protein loss. Kt/V corresponded to SRIdialysate 0.88 +/- 0.12 (P=0.076). TPD produced higher solute clearances in less time with greater protein loss. CEPD just fell short to meet the dialysis adequacy standard. However, both TPD and CEPD are reasonable options for mild-moderate hypercatabolic ARF. Kt/V appropriately estimates solute removal in PD.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Phase II trial of alfimeprase, a novel-acting fibrin degradation agent, for occluded central venous access devices.

Alfimeprase is a recombinantly produced, genetically modified variant of the metalloproteinase, fibrolase. Alfimeprase proteolytically cleaves fibrin, independent of plasminogen activation to plasmin, and directly dissolves thrombi. Based on the direct fibrin degradation effect of alfimeprase, rapid activity in patients with occluded central venous access devices (CVADs) was hypothesized. We performed a phase II, randomized, double-blind, active-control, multicenter, dose-ranging study to compare the safety and efficacy of one or two instillations of three intraluminal doses of alfimeprase (0.3, 1.0, and 3.0 mg) and alteplase 2.0 mg in re-establishing patency to occluded CVADs in 55 adult patients. All three alfimeprase doses were more successful than alteplase during the first 15 and 30 minutes of treatment. The alfimeprase 3.0-mg dose resulted in 40%, 50%, and 60% patency restoration rates at 5, 15, and 30 minutes, respectively, compared with 0%, 0%, and 23% for alteplase. The difference at 15 minutes was highly significant (P = .0075). Alfimeprase 3.0 mg produced the highest patency rate at 120 minutes after the first (60%) and second (80%) doses. No major hemorrhagic or embolic events were reported. A single 1- or 3-mg dose of alfimeprase has the potential to restore function to occluded CVADs rapidly and safely, and to facilitate on-time infusion of vital therapies.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Dose-ranging trial with a recombinant urokinase (urokinase alfa) for occluded central venous catheters in oncology patients.

Recombinant urokinase (r-UK) is a high-molecular-weight urokinase produced in transfected, non-human, mammalian cells. A Phase II, randomized, double-blind, parallel, placebo-controlled, dose-ranging study was performed to compare the safety and efficacy of one or two instillations of three intraluminal concentrations of r-UK (5,000; 15,000; and 25,000 IU/mL) with a placebo for reestablishment of total function to occluded central venous access devices (CVADs). One-hundred eight patients with CVAD withdrawal or total occlusion were enrolled and randomized to treatment; 104 patients received at least one instillation of study drug and 101 patients completed treatment. All but one patient had cancer. All three concentrations of r-UK were significantly superior to placebo in restoring total CVAD function (patency of all occluded lumens) after one or two instillations of study medication (25,000 IU/mL r-UK, 68% vs. placebo, 28% [P =.007]; 15,000 IU/mL r-UK, 69% vs. placebo, 24% [P =.004]; 5,000 IU/mL r-UK, 70% vs. placebo, 28% [P =.003]). Comparisons of the three r-UK concentrations indicated no difference after one or two instillations with regards to patency restoration. Treatment-emergent hemorrhagic events occurring within 72 hours after study drug exposure were experienced by four patients (17%) in the 25,000 IU/mL r-UK group, two patients (7%) in the 15,000 IU/mL r-UK group, no patients in the 5,000 IU/mL r-UK group, and no patients in the placebo group. Efficacy and safety results of this study support further evaluation of a 5,000 IU/mL concentration of r-UK for treatment of occluded CVADs in adult and pediatric patients from 1 year of age.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: a double-blind placebo-controlled trial--the Cardiovascular Thrombolytic to Open Occluded Lines (COOL) efficacy trial.

Central venous access devices (CVADs) are a mainstay of current medical therapy but often become occluded by thrombus. Tissue plasminogen activator (alteplase), at a dose of 2 mg per 2 mL, has been shown to be effective in restoring flow to catheters proven by radiographic contrast injection to be occluded by thrombus. The purpose of this double-blind placebo-controlled multicenter trial was to determine the efficacy of alteplase in occluded catheters without earlier contrast injections or radiographic examinations. Patients were eligible for inclusion if blood could not be withdrawn from their catheter after a period of normal function of at least 48 hours. Single or multiple catheters, peripherally inserted central catheters, catheters with valves, and implanted ports were eligible; catheters used for hemodialysis were not included. Patients were randomly assigned to one of two groups. In one group, patients received a first dose of 2 mg alteplase followed, if needed, by a second dose of 2 mg alteplase and a third dose of placebo. The other group received placebo first followed by one 2-mg dose of alteplase and then a second, if needed. Each dose was allowed to dwell for 2 hours and ability to withdraw blood from the catheter was reassessed. The endpoint was restoration of the ability to withdraw and infuse through the catheter. One hundred forty-nine patients were randomized: 74 received placebo first, 75 received alteplase first. After the first 2-hour treatment, function was restored to 74% in the alteplase arm and 17% in the placebo arm (P <.0001 compared to placebo). After one or two treatments, function was restored in 90% of patients. There were no serious study-drug-related adverse events, no intracranial hemorrhage, no major hemorrhage, and no embolic events. Infusion of alteplase appeared to be safe and effective in restoring flow to occluded catheters without need for pretreatment radiographic evaluation.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Alteplase for central catheter clearance: 1 mg/mL versus 2 mg/2 mL.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Urokinase versus recombinant tissue plasminogen activator in thrombosed central venous catheters: a double-blinded, randomized trial.

Fifty dysfunctional central venous catheters proven radiographically to be occluded by thrombus were blindly randomized to be injected with either 2 mg recombinant tissue plasminogen activator (t-PA) or 10,000 units of urokinase (UK) and allowed to incubate for 2 h. A second dose was allowed if catheter function was not restored with the first injection. Repeat radiograph contrast injection was done when catheter function was restored or after 2 doses of study drug were administered, whichever occurred first. Thirteen of 22 catheters randomized to UK had full function restored compared to 25 of 28 randomized to t-PA (p = 0.013). Radiographic contrast injection showed 7 catheters randomized to UK had complete resolution of the thrombus compared to 17 randomized to t-PA (p = 0.042). Four catheters randomized to UK had complete resolution of the thrombus after a single dose compared to 13 randomized to t-PA (p = 0.036). A novel dose of 2 mg of t-PA restored catheter function more reliably and dissolved thrombi faster than twice the standard, FDA-approved dose of UK.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Recombinant urokinase for restoration of patency in occluded central venous access devices. A double-blind, placebo-controlled trial.

The interval occlusion of central venous access devices (CVADs) remains a significant clinical problem, often requiring re-intervention for catheter exchange or replacement. The purpose of this Phase 3, multi-center, double-blinded study was to test the hypothesis that instillation of recombinant urokinase (r-UK) 5000 IU/ml is superior to placebo in restoring total catheter patency to an unselected cohort of occluded CVADs. After obtaining informed consent, adult and pediatric patients with occluded, non-hemodialysis CVADs of any duration or type were randomized (2 : 1) to receive either r-UK 5000 IU/ml or placebo instilled into all occluded lumens of their catheter. Catheter function was assessed at 5, 15 and 30 min after the first instillation. If the catheter remained occluded after 30 min, a second dose was instilled with repeat assessments at 5, 15 and 30 min. The primary efficacy variable was the restoration of catheter function to all treated lumens (i.e., total catheter patency) after one or two instillations. Catheters that were not successfully recanalized after two instillations were allowed to receive up to two instillations of open-label r-UK administered in the same manner. The primary safety variable was the occurrence of hemorrhagic and non-hemorrhagic events within 72 hr after instillation. A total of 180 patients were enrolled at 43 sites in the United States and Canada. Most patients were adults, although 20% were </=18 years of age. CVAD types included totally implanted subcutaneous ports (45%), PICC lines (26%), non-tunneled percutaneous catheters (18%), and tunneled percutaneous catheters (10%). All CVADs were occluded by virtue of their inability to withdraw blood (withdrawal occlusion). Additionally, 32% of catheters were completely dysfunctional as blood could not be withdrawn and fluids could not be infused (total occlusion). Analysis of the results showed that r-UK was significantly better than placebo in restoring catheter function (54% versus 30%, p = 0.002). There were no major hemorrhagic events within 72 hr after up to four r-UK instillations, and the incidence of non-hemorrhagic events was similar among the r-UK and placebo groups. In conclusion, r-UK is superior to placebo in restoring total catheter patency to occluded CVADs. In patients with occluded CVADs, intra-catheter thrombolysis can restore patency and may obviate the need for catheter replacement.

CD007119

There is inadequate evidence to draw strong conclusions on the efficacy or safety of the drug interventions included in this review. There is some low quality evidence from a meta-analysis of two studies investigating urokinase (various strengths) and some very low evidence from two single studies investigating alteplase 2 mg/2 mL that suggest that these two drug interventions may be effective in treating withdrawal or total occlusion of CVC lumens caused by thrombosis. Further high quality, sufficiently powered research is still required to look at the efficacy and safety of urokinase, alteplase and other chemical, surgical and drug interventions for treating CVC lumen occlusion. Research studies which exclusively include child participants are especially warranted.

Low-dose urokinase infusions to treat fibrinous obstruction of venous access devices in cancer patients.

This study was undertaken to determine the role of low-dose urokinase infusions in treating fibrinous occlusions of venous access devices (VADs) in cancer patients. Forty-two patients with VAD occlusions refractory to routine urokinase instillations were documented by x-ray (cathetergram) to have fibrin sleeves at the catheter tips. They were randomized to receive infusions of either urokinase (40,000 U/h) or urokinase with heparin (320 U/h) through their catheters. After 1, 3, 6, and 12 hours of treatment, the function of the VADs was reassessed. Whenever the obstruction had been relieved, the infusion was stopped and a repeat cathetergram was performed. The status of the unoccluded catheters was followed to determine the longevity of the restored function. Twenty-one catheters were treated with urokinase alone and 21 with the combination of urokinase and heparin. In each group, 16 VADs opened within 12 hours of treatment and five did not. By actuarial analysis, the probability was only 0.28 that a reopened catheter would reocclude within 6 months. Low-dose urokinase infusions can restore function to the majority of catheters occluded by fibrin sleeves. Adding heparin to the urokinase does not enhance the efficacy of the infusions. The restored function often persists until the VADs are removed.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Improving access to geriatric mental health services: a randomized trial comparing treatment engagement with integrated versus enhanced referral care for depression, anxiety, and at-risk alcohol use.

The authors sought to determine whether integrated mental health services or enhanced referral to specialty mental health clinics results in greater engagement in mental health/substance abuse services by older primary care patients. This multisite randomized trial included 10 sites consisting of primary care and specialty mental health/substance abuse clinics. Primary care patients 65 years old or older (N=24,930) were screened. The final study group consisted of 2,022 patients (mean age=73.5 years; 26% female; 48% ethnic minority) with depression (N=1,390), anxiety (N=70), at-risk alcohol use (N=414), or dual diagnosis (N=148) who were randomly assigned to integrated care (mental health and substance abuse providers co-located in primary care; N=999) or enhanced referral to specialty mental health/substance abuse clinics (i.e., facilitated scheduling, transportation, payment; N=1,023). Seventy-one percent of patients engaged in treatment in the integrated model compared with 49% in the enhanced referral model. Integrated care was associated with more mental health and substance abuse visits per patient (mean=3.04) relative to enhanced referral (mean=1.91). Overall, greater engagement was predicted by integrated care and higher mental distress. For depression, greater engagement was predicted by integrated care and more severe depression. For at-risk alcohol users, greater engagement was predicted by integrated care and more severe problem drinking. For all conditions, greater engagement was associated with closer proximity of mental health/substance abuse services to primary care. Older primary care patients are more likely to accept collaborative mental health treatment within primary care than in mental health/substance abuse clinics. These results suggest that integrated service arrangements improve access to mental health and substance abuse services for older adults who underuse these services.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Randomized controlled trial of collaborative care management of depression among low-income patients with cancer.

To determine the effectiveness of the Alleviating Depression Among Patients With Cancer (ADAPt-C) collaborative care management for major depression or dysthymia. Study patients included 472 low-income, predominantly female Hispanic patients with cancer age >or= 18 years with major depression (49%), dysthymia (5%), or both (46%). Patients were randomly assigned to intervention (n = 242) or enhanced usual care (EUC; n = 230). Intervention patients had access for up to 12 months to a depression clinical specialist (supervised by a psychiatrist) who offered education, structured psychotherapy, and maintenance/relapse prevention support. The psychiatrist prescribed antidepressant medications for patients preferring or assessed to require medication. At 12 months, 63% of intervention patients had a 50% or greater reduction in depressive symptoms from baseline as assessed by the Patient Health Questionnaire-9 (PHQ-9) depression scale compared with 50% of EUC patients (odds ratio [OR] = 1.98; 95% CI, 1.16 to 3.38; P = .01). Improvement was also found for 5-point decrease in PHQ-9 score among 72.2% of intervention patients compared with 59.7% of EUC patients (OR = 1.99; 95% CI, 1.14 to 3.50; P = .02). Intervention patients also experienced greater rates of depression treatment (72.3% v 10.4% of EUC patients; P < .0001) and significantly better quality-of-life outcomes, including social/family (adjusted mean difference between groups, 2.7; 95% CI, 1.22 to 4.17; P < .001), emotional (adjusted mean difference, 1.29; 95% CI, 0.26 to 2.22; P = .01), functional (adjusted mean difference, 1.34; 95% CI, 0.08 to 2.59; P = .04), and physical well-being (adjusted mean difference, 2.79; 95% CI, 0.49 to 5.1; P = .02). ADAPt-C collaborative care is feasible and results in significant reduction in depressive symptoms, improvement in quality of life, and lower pain levels compared with EUC for patients with depressive disorders in a low-income, predominantly Hispanic population in public sector oncology clinics.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled trial.

Care of patients with depression in managed primary care settings often fails to meet guideline standards, but the long-term impact of quality improvement (QI) programs for depression care in such settings is unknown. To determine if QI programs in managed care practices for depressed primary care patients improve quality of care, health outcomes, and employment. Randomized controlled trial initiated from June 1996 to March 1997. Forty-six primary care clinics in 6 US managed care organizations. Of 27332 consecutively screened patients, 1356 with current depressive symptoms and either 12-month, lifetime, or no depressive disorder were enrolled. Matched clinics were randomized to usual care (mailing of practice guidelines) or to 1 of 2 QI programs that involved institutional commitment to QI, training local experts and nurse specialists to provide clinician and patient education, identification of a pool of potentially depressed patients, and either nurses for medication follow-up or access to trained psychotherapists. Process of care (use of antidepressant medication, mental health specialty counseling visits, medical visits for mental health problems, any medical visits), health outcomes (probable depression and health-related quality of life [HRQOL]), and employment at baseline and at 6- and 12-month follow-up. Patients in QI (n = 913) and control (n = 443) clinics did not differ significantly at baseline in service use, HRQOL, or employment after nonresponse weighting. At 6 months, 50.9% of QI patients and 39.7% of controls had counseling or used antidepressant medication at an appropriate dosage (P<.001), with a similar pattern at 12 months (59.2% vs 50.1%; P = .006). There were no differences in probability of having any medical visit at any point (each P > or = .21). At 6 months, 47.5% of QI patients and 36.6% of controls had a medical visit for mental health problems (P = .001), and QI patients were more likely to see a mental health specialist at 6 months (39.8% vs 27.2%; P<.001) and at 12 months (29.1% vs 22.7%; P = .03). At 6 months, 39.9% of QI patients and 49.9% of controls still met criteria for probable depressive disorder (P = .001), with a similar pattern at 12 months (41.6% vs 51.2%; P = .005). Initially employed QI patients were more likely to be working at 12 months relative to controls (P = .05). When these managed primary care practices implemented QI programs that improve opportunities for depression treatment without mandating it, quality of care, mental health outcomes, and retention of employment of depressed patients improved over a year, while medical visits did not increase overall.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A multifaceted intervention to improve treatment of depression in primary care.

This research study evaluates the effectiveness of a multifaceted intervention program to improve the management of depression in primary care. One hundred fifty-three primary care patients with current depression were entered into a randomized controlled trial. Intervention patients received a structured depression treatment program in the primary care setting that included both behavioral treatment to increase use of adaptive coping strategies and counseling to improve medication adherence. Control patients received "usual" care by their primary care physicians. Outcome measures included adherence to antidepressant medication, satisfaction with care of depression and with antidepressant treatment, and reduction of depressive symptoms over time. At 4-month follow-up, significantly more intervention patients with major and minor depression than usual care patients adhered to antidepressant medication and rated the quality of care they received for depression as good to excellent. Intervention patients with major depression demonstrated a significantly greater decrease in depression severity over time compared with usual care patients on all 4 outcome analyses. Intervention patients with minor depression were found to have a significant decrease over time in depression severity on only 1 of 4 study outcome analyses compared with usual care patients. A multifaceted primary care intervention improved adherence to antidepressant regimens and satisfaction with care in patients with major and minor depression. The intervention consistently resulted in more favorable depression outcomes among patients with major depression, while outcome effects were ambiguous among patients with minor depression.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomised controlled trial to test the feasibility of a collaborative care model for the management of depression in older people.

Depression is the most common mental health disorder in people aged over 65 years. Late-life depression is associated with chronic illness and disability. To investigate the feasibility of a collaborative care model for depression in older people in a primary care setting. Randomised controlled trial with 16-weeks follow up. A primary care trust in Manchester. Participants were 105 people aged 60 years or older who scored 5 or more on the Geriatric Depression Scale; 53 were randomly allocated to an intervention group and 52 to a usual care group. The intervention group received care managed by a community psychiatric nurse who delivered an intervention comprising a facilitated self-help programme with close liaison with primary care professionals and old-age psychiatry according to a defined protocol. The usual care group received usual GP care. A nested qualitative study explored the views of the health professionals and patients regarding the acceptability and effectiveness of the intervention. The main outcome measure was recovery from depression. Patients in the intervention group were less likely to suffer from major depressive disorder at follow up compared with usual care (0.32, 95% confidence = interval = 0.11 to 0.93, P = 0.036). The qualitative component of the study demonstrated the acceptability of the intervention to patients. A model of collaborative care for older people with depression, used in a primary care setting with a facilitated self-help intervention is more effective than usual GP care. This study demonstrates that the implementation of a collaborative care model is feasible in UK primary care and that the intervention is effective and acceptable to patients.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Systematic detection and multidisciplinary care of depression in older medical inpatients: a randomized trial.

Major depression is a frequent and serious disorder in older medical inpatients. Because the condition goes undetected and untreated in most of these patients, we conducted a randomized clinical trial to evaluate the effectiveness of a strategy of systematic detection and multidisciplinary treatment of depression in this population. Consecutive patients aged 65 years or more admitted to general medical services in a primary care hospital between October 1999 and November 2002 were screened for depression with the Diagnostic Interview Schedule (DIS) within 48 hours after admission. Patients found to have major depression were randomly allocated to receive the intervention or usual care. The intervention involved consultation and treatment by a psychiatrist and follow-up by a research nurse and the patient's family physician. Research assistants, blind to group allocation, collected data from the patients at enrollment and at 3 and 6 months later using the Hamilton Depression Rating Scale (HAMD), the Medical Outcomes 36-item Short Form (SF-36), the DIS, the Mini-Mental State Examination (MMSE), the Older Americans Resources and Services (OARS) questionnaire to assess basic and instrumental activities of daily living (OARS-ADL and OARS-IADL) and the Rating Scale for Side Effects. Data on the severity of illness, length of hospital stay, health services and medication use, mortality and process of care were also collected. The primary outcome measures were the HAMD and SF-36. Of 1500 eligible patients who were screened, 157 were found to have major depression and consented to participate (78 in the intervention group and 79 in the usual care group). At randomization, there were no clinically or statistically significant differences between the 2 groups. Sixty-four patients completed follow-up to 6 months, 57 withdrew, and 36 died. At 6 months, there were no clinically or statistically significant differences the 2 groups in HAMD or SF-36 scores or any of the secondary outcome measures. We were unable to demonstrate that systematic detection and multidisciplinary care of depression was more beneficial than usual care for elderly medical inpatients.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Implementing collaborative care for depression treatment in primary care: a cluster randomized evaluation of a quality improvement practice redesign.

Meta-analyses show collaborative care models (CCMs) with nurse care management are effective for improving primary care for depression. This study aimed to develop CCM approaches that could be sustained and spread within Veterans Affairs (VA). Evidence-based quality improvement (EBQI) uses QI approaches within a research/clinical partnership to redesign care. The study used EBQI methods for CCM redesign, tested the effectiveness of the locally adapted model as implemented, and assessed the contextual factors shaping intervention effectiveness. The study intervention is EBQI as applied to CCM implementation. The study uses a cluster randomized design as a formative evaluation tool to test and improve the effectiveness of the redesign process, with seven intervention and three non-intervention VA primary care practices in five different states. The primary study outcome is patient antidepressant use. The context evaluation is descriptive and uses subgroup analysis. The primary context evaluation measure is naturalistic primary care clinician (PCC) predilection to adopt CCM.For the randomized evaluation, trained telephone research interviewers enrolled consecutive primary care patients with major depression in the evaluation, referred enrolled patients in intervention practices to the implemented CCM, and re-surveyed at seven months. Interviewers enrolled 288 CCM site and 258 non-CCM site patients. Enrolled intervention site patients were more likely to receive appropriate antidepressant care (66% versus 43%, p = 0.01), but showed no significant difference in symptom improvement compared to usual care. In terms of context, only 40% of enrolled patients received complete care management per protocol. PCC predilection to adopt CCM had substantial effects on patient participation, with patients belonging to early adopter clinicians completing adequate care manager follow-up significantly more often than patients of clinicians with low predilection to adopt CCM (74% versus 48%%, p = 0.003). Depression CCM designed and implemented by primary care practices using EBQI improved antidepressant initiation. Combining QI methods with a randomized evaluation proved challenging, but enabled new insights into the process of translating research-based CCM into practice. Future research on the effects of PCC attitudes and skills on CCM results, as well as on enhancing the link between improved antidepressant use and symptom outcomes, is needed. ClinicalTrials.gov: NCT00105820.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

The pilot study of a telephone disease management program for depression.

Most depressed patients are seen and treated exclusively by primary care clinicians. However, primary care patients with depression are often not adequately treated. The aims of this pilot study were to measure the impact of a telephone disease management program on patient outcome and clinician adherence to practice guidelines, measure the relationship of clinician adherence to patient outcome, and explore the measurement of patient adherence to clinician recommendations and its impact on patient outcomes. Thirty-five primary care practices in the University of Pennsylvania Health System were randomized to telephone disease management (TDM) or "usual care" (UC). All patients received a baseline and a 16-week follow-up clinical evaluation performed over the telephone. Those from TDM practices also received follow-up contact at least every 3 weeks, with formal evaluations at weeks 6 and 12. These interval contacts were designed to facilitate patient and clinician adherence to a treatment algorithm based on the Agency for Health Research and Quality (AHRQ) practice guidelines. Depressive symptoms evaluated with the Community Epidemiologic Survey of Depression (CES-D) scale as well as guideline adherence were the primary outcome measures. Sixty-one patients were enrolled in this pilot project. The overall effect for CES-D scores over time was significant, (P <.001), indicating that those participating in the trial (both TDM and UC groups) showed significant improvement. The interaction between intervention condition and time was also significant (P <.05), indicating that TDM patients improved significantly more over time than did UC patients. A greater proportion of TDM patients had CES-D scores <16 by Week 16 (66.7 versus 33.3%; chi(2), P <.05). The improvement in depression outcome for the TDM group was related to its impact on improving clinician adherence to depression treatment algorithms. The TDM pilot did not show a statistically significant effect on improving patient adherence to clinician recommendations, however. This preliminary data suggests that TDM for depression improves both clinician guideline adherence and patient outcomes in the acute phase of depression. The effect on patient outcome is at least partially explained by the effect of TDM on clinician adherence to depression treatment algorithms.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Randomized trial of depression follow-up care by online messaging.

Quality of antidepressant treatment remains disturbingly poor. Rates of medication adherence and follow-up contact are especially low in primary care, where most depression treatment begins. Telephone care management programs can address these gaps, but reliance on live contact makes such programs less available, less timely, and more expensive. Evaluate the feasibility, acceptability, and effectiveness of a depression care management program delivered by online messaging through an electronic medical record. Randomized controlled trial comparing usual primary care treatment to primary care supported by online care management Nine primary care clinics of an integrated health system in Washington state Two hundred and eight patients starting antidepressant treatment for depression. Three online care management contacts with a trained psychiatric nurse. Each contact included a structured assessment (severity of depression, medication adherence, side effects), algorithm-based feedback to the patient and treating physician, and as-needed facilitation of follow-up care. All communication occurred through secure, asynchronous messages within an electronic medical record. An online survey approximately five months after randomization assessed the primary outcome (depression severity according to the Symptom Checklist scale) and satisfaction with care, a secondary outcome. Additional secondary outcomes (antidepressant adherence and use of health services) were assessed using computerized medical records. Patients offered the program had higher rates of antidepressant adherence (81% continued treatment more than 3 months vs. 61%, p = 0.001), lower Symptom Checklist depression scores after 5 months (0.95 vs. 1.17, p = 0.043), and greater satisfaction with depression treatment (53% "very satisfied" vs. 33%, p = 0.004). The trial was conducted in one integrated health care system with a single care management nurse. Results apply only to patients using online messaging. Our findings suggest that organized follow-up care for depression can be delivered effectively and efficiently through online messaging.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative care for depressed patients with chronic medical conditions: a randomized trial in Puerto Rico.

This study examined whether a collaborative care model for depression would improve clinical and functional outcomes for depressed patients with chronic general medical conditions in primary care practices in Puerto Rico. A total of 179 primary care patients with major depression and chronic general medical conditions were randomly assigned to receive collaborative care or usual care. The collaborative care intervention involved enhanced collaboration among physicians, mental health specialists, and care managers paired with depression-specific treatment guidelines, patient education, and follow-up. In usual care, study personnel informed the patient and provider of the diagnosis and encouraged patients to discuss treatment options with their provider. Depression severity was assessed with the Hopkins Symptom Checklist; social functioning was assessed with the 36-item Short Form. Compared with usual care, collaborative care significantly reduced depressive symptoms and improved social functioning in the six months after randomization. Integration of collaborative care in primary care practices considerably increased depressed patients' use of mental health services. Collaborative care significantly improved clinical symptoms and functional status of depressed patients with coexisting chronic general medical conditions receiving treatment for depression in primary care practices in Puerto Rico. These findings highlight the promise of the collaborative care model for strengthening the relationship between mental health and primary care services in Puerto Rico.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Stepped collaborative care for primary care patients with persistent symptoms of depression: a randomized trial.

Despite improvements in the accuracy of diagnosing depression and use of medications with fewer side effects, many patients treated with antidepressant medications by primary care physicians have persistent symptoms. A group of 228 patients recognized as depressed by their primary care physicians and given antidepressant medication who had either 4 or more persistent major depressive symptoms or a score of 1.5 or more on the Hopkins Symptom Checklist depression items at 6 to 8 weeks were randomized to a collaborative care intervention (n = 114) or usual care (n = 114) by the primary care physician. Patients in the intervention group received enhanced education and increased frequency of visits by a psychiatrist working with the primary care physician to improve pharmacologic treatment. Follow-up assessments were completed at 1, 3, and 6 months by a telephone survey team blinded to randomization status. Those in the intervention group had significantly greater adherence to adequate dosage of medication for 90 days or more and were more likely to rate the quality of care they received for depression as good to excellent compared with usual care controls. Intervention patients showed a significantly greater decrease compared with usual care controls in severity of depressive symptoms over time and were more likely to have fully recovered at 3 and 6 months. A multifaceted program targeted to patients whose depressive symptoms persisted 6 to 8 weeks after initiation of antidepressant medication by their primary care physician was found to significantly improve adherence to antidepressants, satisfaction with care, and depressive outcomes compared with usual care.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Managing depression in home health care: a randomized clinical trial.

A prospective randomized trial was conducted to examine the effectiveness, feasibility, and degree of implementation of home health care quality improvement interventions when implemented under usual conditions by usual care providers. A total of 311 older adults were randomized to enhanced usual care (EUC) that included routine depression screening and staff training in depression care management for older adults or to the intervention group (INT) that included antidepressants and/or psychotherapy treatment plus EUC. Implementing a routine screening protocol using the PHQ-9 and depression care management quality improvements is feasible in diverse home health care organizations and results in consistently better (but not statistically significant) depression outcomes in the INT group.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Treatment of postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile: a randomised controlled trial.

The optimum way to improve the recognition and treatment of postnatal depression in developing countries is uncertain. We compared the effectiveness of a multicomponent intervention with usual care to treat postnatal depression in low-income mothers in primary-care clinics in Santiago, Chile. 230 mothers with major depression attending postnatal clinics were randomly allocated to either a multicomponent intervention (n=114) or usual care (n=116). The multicomponent intervention involved a psychoeducational group, treatment adherence support, and pharmacotherapy if needed. Usual care included all services normally available in the clinics, including antidepressant drugs, brief psychotherapeutic interventions, medical consultations, or external referral for specialty treatment. The primary outcome measure was the Edinburgh postnatal depression scale (EPDS) score at 3 and 6 months after randomisation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00518830. 208 (90%) of women randomly assigned to treatment groups completed assessments. The crude mean EPDS score was lower for the multicomponent intervention group than for the usual care group at 3 months (8.5 [95% CI 7.2-9.7] vs 12.8 [11.3-14.1]). Although these differences between groups decreased by 6 months, EPDS score remained better in multicomponent intervention group than in usual care group (10.9 [9.6-12.2] vs 12.5 [11.1-13.8]). The adjusted difference in mean EPDS between the two groups at 3 months was -4.5 (95% CI -6.3 to -2.7; p<0.0001). The decrease in the number of women taking antidepressants after 3 months was greater in the intervention group than in the usual care group (multicomponent intervention from 60/101 [59%; 95% CI 49-69%] to 38/106 [36%; 27-46%]; usual care from 18/108 [17%; 10-25%] to 11/102 [11%; 6-19%]). Our findings suggest that low-income mothers with depression and who have newly born children could be effectively helped, even in low-income settings, through multicomponent interventions. Further refinements to this intervention are needed to ensure treatment compliance after the acute phase.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Management of depression for people with cancer (SMaRT oncology 1): a randomised trial.

Major depressive disorder severely impairs the quality of life of patients with medical disorders such as cancer, but evidence to guide its management is scarce. We aimed to assess the efficacy and cost of a nurse-delivered complex intervention that was designed to treat major depressive disorder in patients who have cancer. We did a randomised trial in a regional cancer centre in Scotland, UK. 200 outpatients who had cancer with a prognosis of greater than 6 months and major depressive disorder (identified by screening) were eligible and agreed to take part. Their mean age was 56.6 (SD 11.9) years, and 141 (71%) were women. We randomly assigned 99 of these participants to usual care, and 101 to usual care plus the intervention, with minimisation for sex, age, diagnosis, and extent of disease. The intervention was delivered by a cancer nurse at the centre over an average of seven sessions. The primary outcome was the difference in mean score on the self-reported Symptom Checklist-20 depression scale (range 0 to 4) at 3 months after randomisation. Analysis was by intention to treat. This trial is registered as ISRCTN84767225. Primary outcome data were missing for four patients. For 196 patients for whom we had data at 3 months, the adjusted difference in mean Symptom Checklist-20 depression score, between those who received the intervention and those who did not, was 0.34 (95% CI 0.13-0.55). This treatment effect was sustained at 6 and 12 months. The intervention also improved anxiety and fatigue but not pain or physical functioning. It cost an additional pound sterling 5278 (US$10 556) per quality-adjusted life-year gained. The intervention-Depression Care for People with Cancer-offers a model for the management of major depressive disorder in patients with cancer and other medical disorders who are attending specialist medical services that is feasible, acceptable, and potentially cost effective.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Stepped care treatment of postpartum depression: impact on treatment, health, and work outcomes.

The purpose of this study was to pilot a stepped collaborative care intervention for women with postpartum depression and evaluate health differences between self-diagnosed depressed and nondepressed women. Five hundred six mothers of infants from 7 clinics completed surveys at 0 to 1, 2, 4, 6, and 9 months postpartum and a Structured Clinical Interview for DSM-IV (SCID). SCID-positive depressed women were randomized to stepped collaborative care or usual care. Nine-month treatment, health, and work outcomes were evaluated for stepped care women (n = 19) versus control depressed women (n = 20), and self-diagnosed depressed women (n = 122) versus nondepressed women (n = 344). Forty-five women had SCID-positive depression whereas 122 had self-diagnosed depression. For SCID-positive depressed women, the stepped care intervention increased mothers' awareness of their depression diagnosis (100% vs 61%; P = .008) and their receipt of treatment (94% vs 56%; P = .019). Self-diagnosed depressed women (vs nondepressed women) had more depressive symptoms and acute care visits, worse general and mental health, and greater impact of health problems on regular activities. The stepped care intervention improved women's knowledge of their postpartum depression diagnosis and their receipt of treatment. However, our formal diagnostic procedures missed many women whose depressed mood interfered with their health and function.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Disease management for depression and at-risk drinking via telephone in an older population of veterans.

The purpose of this study was to explore the efficacy in a primary care setting of a telephone-based disease management program for the acute management of depression and/or at-risk drinking. Veterans (N= 97) with depression and/or at-risk drinking were identified by systematic screening and assessment. Eligible subjects received either telephone disease management (TDM) program or usual care based on random assignment of their clinician. The TDM program consisted of regular contacts with each subject by a behavioral health specialist (BHS) to assist in assessment, education, support, and treatment planning. Symptomatic outcomes were assessed at 4 months. Overall response rates favored those assigned to TDM compared with those assigned to usual care (39.1% responded vs. 17.6%, p= 0.022). Response rates within the separate diagnostic groups also favored TDM, but this was only significant for depressive disorders. Although the sample size was modest and the sample was limited to veterans, findings strongly suggest that a telephone-based disease management program can improve outcomes for patients with a behavioral health problem. Findings also suggest that a health specialist can focus and manage patients with different diagnoses, thus expanding the role beyond just depression care. TDM may be a viable, low-cost, model for primary care clinicians to deliver manual guideline-adherent behavioral health care, especially in a VA clinical setting.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized, controlled trial of disease management modules, including telepsychiatric care, for depression in rural primary care.

Introduction. Disease management modules (DMM), including education, tracking, support, and medical care, have improved health for patients with asthma and diabetes. For rural patients, novel ways of delivery are needed to access clinical expertise from urban or academic specialists. Telemedicine (telephone and televideo) could be instrumental in this process, though no randomized, controlled trials have assessed their effectiveness.Methods. Self-report and structured psychiatric interviews were used to screen potential depressed subjects. Subjects were randomized to: 1) usual care with a DMM using telephone and self-report questionnaires; or 2) a DMM using telephone, questionnaires, and monthly televideo psychiatric consultation emphasizing primary care physician (PCP) skill development. Subjects' depressive symptoms, health status, and satisfaction with care were tabulated at three, six, and 12 months after study entry.Results. There was significant clinical improvement for depression in both groups, with a trend toward significance in the more intensive module. Satisfaction and retention was superior in the more intensive group. There was no overall change in health functioning in either group.Conclusions. Intensive modules using telepsychiatric educational interventions toward PCPs may be superior, but the most critical ingredient may be administrative tracking of patients, prompted intervention by PCPs, and (when necessary) new ideas by a specialist.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial.

Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems-10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00-1·47; risk difference=12·1%, 95% CI 1·6%-22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02-2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74-1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. The Wellcome Trust. Copyright © 2010 Elsevier Ltd. All rights reserved.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care.

To compare collaborative care for treatment of depression in primary care with consult-liaison (CL) care. In collaborative care, a mental health team provided a treatment plan to the primary care provider, telephoned patients to support adherence to the plan, reviewed treatment results, and suggested modifications to the provider. In CL care, study clinicians informed the primary care provider of the diagnosis and facilitated referrals to psychiatry residents practicing in the primary care clinic. Patients were randomly assigned to treatment model by clinic firm. VA primary care clinic. One hundred sixty-eight collaborative care and 186 CL patients who met criteria for major depression and/or dysthymia. Hopkins Symptom Checklist (SCL-20), Short Form (SF)-36, Sheehan Disability Scale. Collaborative care produced greater improvement than CL in depressive symptomatology from baseline to 3 months (SCL-20 change scores), but at 9 months there was no significant difference. The intervention increased the proportion of patients receiving prescriptions and cognitive behavioral therapy. Collaborative care produced significantly greater improvement on the Sheehan at 3 months. A greater proportion of collaborative care patients exhibited an improvement in SF-36 Mental Component Score of 5 points or more from baseline to 9 months. Collaborative care resulted in more rapid improvement in depression symptomatology, and a more rapid and sustained improvement in mental health status compared to the more standard model. Mounting evidence indicates that collaboration between primary care providers and mental health specialists can improve depression treatment and supports the necessary changes in clinic structure and incentives.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Integrating type 2 diabetes mellitus and depression treatment among African Americans: a randomized controlled pilot trial.

The purpose of this study was to examine whether integrating depression treatment into care for type 2 diabetes mellitus among older African Americans improved medication adherence, glycemic control, and depression outcomes. Older African Americans prescribed pharmacotherapy for type 2 diabetes mellitus and depression from physicians at a large primary care practice in west Philadelphia were randomly assigned to an integrated care intervention or usual care. Adherence was assessed at baseline, 2, 4, and 6 weeks using the Medication Event Monitoring System to assess adherence. Outcomes assessed at baseline and 12 weeks included standard laboratory tests to measure glycemic control and the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression. In all, 58 participants aged 50 to 80 years participated. The proportion of participants who had 80% or greater adherence to an oral hypoglycemic (intervention 62.1% vs usual care 24.1%) and an antidepressant (intervention 62.1% vs usual care 10.3%) was greater in the intervention group in comparison with the usual care group at 6 weeks. Participants in the integrated care intervention had lower levels of glycosylated hemoglobin (intervention 6.7% vs usual care 7.9%) and fewer depressive symptoms (CES-D mean scores: intervention 9.6 vs usual care 16.6) compared with participants in the usual care group at 12 weeks. A pilot randomized controlled trial integrating type 2 diabetes mellitus treatment and depression was successful in improving outcomes among older African Americans. Integrated interventions may be more feasible and effective in real-world practices with competing demands for limited resources.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Generalist care managers for the treatment of depressed medicaid patients in North Carolina: a pilot study.

In most states, mental illness costs are an increasing share of Medicaid expenditures. Specialized depression care managers (CM) have consistently demonstrated improvements in patient outcomes relative to usual primary care (UC), but are costly and may not be fully utilized in smaller practices. A generalist care manager (GCM) could manage multiple chronic conditions and be more accepted and cost-effective than the specialist depression CM. We designed a pilot program to demonstrate the feasibility of training/deploying GCMs into primary care settings. We randomized depressed adult Medicaid patients in 2 primary care practices in Western North Carolina to a GCM intervention or to UC. GCMs, already providing services in diabetes and asthma in both study arms, were further trained to provide depression services including self-management, decision support, use of information systems, and care management. The following data were analyzed: baseline, 3- and 6-month Patient Health Questionnaire (PHQ9) scores; baseline and 6-month Short Form (SF) 12 scores; Medicaid claims data; questionnaire on patients' perceptions of treatment; GCM case notes; physician and office staff time study; and physician and office staff focus group discussions. Forty-five patients were enrolled, the majority with preexisting depression. Both groups improved; the GCM group did not demonstrate better clinical and functional outcomes than the UC group. Patients in the GCM group were more likely to have prescriptions of correct dosing by chart data. GCMs most often addressed comorbid conditions (36%), then social issues (27%) and appointment reminders (14%). GCMs recorded an average of 46 interactions per patient in the GCM arm. Focus group data demonstrated that physicians valued using GCMs. A time study documented that staff required no more time interacting with GCMs, whereas physicians spent an average of 4 minutes more per week. GCMs can be trained in care of depression and other chronic illnesses, are acceptable to practices and patients, and result in physicians prescribing guideline concordant care. GCMs appear to be a feasible intervention for community medical practices and to warrant a larger scale trial to test their appropriateness for Medicaid programs nationally.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A collaborative care depression management program for cardiac inpatients: depression characteristics and in-hospital outcomes.

Depression in cardiac patients is common, under-recognized, and independently associated with mortality. Our objectives in this initial report from a 6-month longitudinal trial were to determine whether a collaborative care program improves rates of depression treatment by discharge among patients hospitalized with acute cardiovascular disease, and to assess key clinical characteristics of depression in this cohort. This was a prospective, randomized trial comparing collaborative care and usual care interventions for depressed cardiac patients who were admitted to cardiac units in an urban academic medical center. For collaborative care subjects, the care manager performed a multi-component depression intervention in the hospital that included patient education and treatment coordination; usual care subjects' inpatient providers were informed of the depression diagnosis. The mean Patient Health Questionnaire-9 for subjects (N = 175) was 17.6 (SD 3.5; range 11-26), consistent with moderate-severe depression. The majority of subjects had depression for over one month (n = 134; 76.6%) and a prior depressive episode (n = 124; 70.8%); nearly one-half (n = 75; 42.9%) had thoughts that life was not worth living in the preceding 2 weeks. Collaborative care subjects were far more likely to receive adequate depression treatment by discharge (71.9% collaborative care vs. 9.5% usual care; p < 0.001). Depression identified by systematic screening in hospitalized cardiac patients appears was prolonged, and of substantial severity. A collaborative care depression management model appears to vastly increase rates of appropriate treatment by discharge. Copyright © 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized trial of telephonic counseling plus walking for depressed diabetes patients.

Patients with diabetes and depression often have self-management needs that require between-visit support. This study evaluated the impact of telephone-delivered cognitive behavioral therapy (CBT) targeting patients' management of depressive symptoms, physical activity levels, and diabetes-related outcomes. Two hundred ninety-one patients with type 2 diabetes and significant depressive symptoms (Beck Depression Inventory scores ≥ 14) were recruited from a community-based, university-based, and Veterans Affairs health care systems. A manualized telephone CBT program was delivered weekly by nurses for 12 weeks, followed by 9 monthly booster sessions. Sessions initially focused exclusively on patients' depression management and then added a pedometer-based walking program. The primary outcome was hemoglobin A1c levels measured at 12 months. Blood pressure was a secondary outcome; levels of physical activity were determined by pedometer readings; depression, coping, and health-related quality of life were measured using standardized scales. Baseline A1c levels were relatively good and there was no difference in A1c at follow-up. Intervention patients experienced a 4.26 mm Hg decrease in systolic blood pressure relative to controls (P=0.05). Intervention patients had significantly greater increases in step counts (mean difference, 1131 steps/d; P=0.0002) and greater reductions in depressive symptoms (58% remitted at 12 mo vs. 39%; P=0.002). Intervention patients also experienced relative improvements in coping and health-related quality of life. This program of telephone-delivered CBT combined with a pedometer-based walking program did not improve A1c values, but significantly decreased patients' blood pressure, increased physical activity, and decreased depressive symptoms. The intervention also improved patients' functioning and quality of life.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized trial of telemedicine-based collaborative care for depression.

Evidence-based practices designed for large urban clinics are not necessarily portable into smaller isolated clinics. Implementing practice-based collaborative care for depression in smaller primary care clinics presents unique challenges because it is often not feasible to employ on-site psychiatrists. The purpose of the Telemedicine Enhanced Antidepressant Management (TEAM) study was to evaluate a telemedicine-based collaborative care model adapted for small clinics without on-site psychiatrists. Matched sites were randomized to the intervention or usual care. Small VA Community-based outpatient clinics with no on-site psychiatrists, but access to telepsychiatrists. In 2003-2004, 395 primary care patients with PHQ9 depression severity scores > or = 12 were enrolled, and followed for 12 months. Patients with serious mental illness and current substance dependence were excluded. Medication adherence, treatment response, remission, health status, health-related quality of life, and treatment satisfaction. The sample comprised mostly elderly, white, males with substantial physical and behavioral health comorbidity. At baseline, subjects had moderate depression severity (Hopkins Symptom Checklist, SCL-20 = 1.8), 3.7 prior depression episodes, and 67% had received prior depression treatment. Multivariate analyses indicated that intervention patients were more likely to be adherent at both 6 (odds ratio [OR] = 2.1, p = .04) and 12 months (OR = 2.7, p = .01). Intervention patients were more likely to respond by 6 months (OR = 2.0, p = .02), and remit by 12 months (OR = 2.4, p = .02). Intervention patients reported larger gains in mental health status and health-related quality of life, and reported higher satisfaction. Collaborative care can be successfully adapted for primary care clinics without on-site psychiatrists using telemedicine technologies.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Treatment of depression improves physical functioning in older adults.

To determine the effect of collaborative care management for depression on physical functioning in older adults. Multisite randomized clinical trial. Eighteen primary care clinics from eight healthcare organizations. One thousand eight hundred one patients aged 60 and older with major depressive disorder. Patients were randomized to the Improving Mood: Promoting Access to Collaborative Treatment (IMPACT) intervention (n=906) or to a control group receiving usual care (n=895). Control patients had access to all health services available as part of usual care. Intervention patients had access for 12 months to a depression clinical specialist who coordinated depression care with their primary care physician. The 12-item short form Physical Component Summary (PCS) score (range 0-100) and instrumental activities of daily living (IADLs) (range 0-7). The mean patient age was 71.2, 65% were women, and 77% were white. At baseline, the mean PCS was 40.2, and the mean number of IADL dependencies was 0.7; 45% of participants rated their health as fair or poor. Intervention patients experienced significantly better physical functioning at 1 year than usual-care patients as measured using between-group differences on the PCS of 1.71 (95% confidence interval (CI)=0.96-2.46) and IADLs of -0.15 (95% CI=-0.29 to -0.01). Intervention patients were also less likely to rate their health as fair or poor (37.3% vs 52.4%, P<.001). Combining both study groups, patients whose depression improved were more likely to experience improvement in physical functioning. The IMPACT collaborative care model for late-life depression improves physical function more than usual care.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Effectiveness of collaborative care for depression in human immunodeficiency virus clinics.

Depression is common among persons with the human immunodeficiency virus (HIV) and is associated with unfavorable outcomes. A single-blind randomized controlled effectiveness trial at 3 Veterans Affairs HIV clinics (HIV Translating Initiatives for Depression Into Effective Solutions [HITIDES]). The HITIDES intervention consisted of an off-site HIV depression care team (a registered nurse depression care manager, pharmacist, and psychiatrist) that delivered up to 12 months of collaborative care backed by a Web-based decision support system. Participants who completed the baseline telephone interview were 249 HIV-infected patients with depression, of whom 123 were randomized to the intervention and 126 to usual care. Participant interview data were collected at baseline and at the 6- and 12-month follow-up visits. The primary outcome was depression severity measured using the 20-item Hopkins Symptom Checklist (SCL-20) and reported as treatment response (≥50% decrease in SCL-20 item score), remission (mean SCL-20 item score, <0.5), and depression-free days. Secondary outcomes were health-related quality of life, health status, HIV symptom severity, and antidepressant or HIV medication regimen adherence. Intervention participants were more likely to report treatment response (33.3% vs 17.5%) (odds ratio, 2.50; 95% confidence interval [CI], 1.37-4.56) and remission (22.0% vs 11.9%) (2.25; 1.11-4.54) at 6 months but not 12 months. Intervention participants reported more depression-free days during the 12 months (β = 19.3; 95% CI, 10.9-27.6; P < .001). Significant intervention effects were observed for lowering HIV symptom severity at 6 months (β = -2.6; 95% CI, -3.5 to -1.8; P < .001) and 12 months (β = -0.82; -1.6 to -0.07; P = .03). Intervention effects were not significant for other secondary outcomes. The HITIDES intervention improved depression and HIV symptom outcomes and may serve as a model for collaborative care interventions in HIV and other specialty physical health care settings where patients find their "medical home." clinicaltrials.gov Identifier: NCT00304915.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Randomized trial of pharmacist interventions to improve depression care and outcomes in primary care.

The impact of pharmacist interventions on the care and outcomes of patients with depression in a primary care setting was evaluated. Patients diagnosed with a new episode of depression and started on anti-depressant medications were randomized to enhanced care (EC) or usual care (UC) for one year. EC consisted of a pharmacist collaborating with primary care providers to facilitate patient education, the initiation and adjustment of antidepressant dosages, the monitoring of patient adherence to the regimen, the management of adverse reactions, and the prevention of relapse. The patients in the UC group served as controls. Outcomes were measured by the Hopkins Symptom Checklist, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depression, health-related quality of life, medication adherence, patient satisfaction, and use of depression-related health care services. An intent-to-treat analysis was used. Seventy-four patients were randomized to EC or UC. At baseline, the EC group included more patients diagnosed with major depression than did the UC group (p = 0.04). All analyses were adjusted for this difference. In both groups, mean scores significantly improved from baseline for symptoms of depression and quality of life at three months and were maintained for one year. There were no statistically significant differences between treatment groups in depression symptoms, quality of life, medication adherence, provider visits, or patient satisfaction. Frequent telephone contacts and interventions by pharmacists and UC in a primary care setting resulted in similar rates of adherence to antidepressant regimens and improvements in the outcomes of depression at one year.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Patient outcomes with education, drug therapy, and support: a study of venlafaxine ER-treated outpatients with major depressive disorder.

Dialogues Time to Talk (Dialogues) is a care management program that provides additional follow-up care and patient education for outpatients with major depressive disorder (MDD) starting venlafaxine extended release (ER) therapy. This study examined the effect of the Dialogues program on patient treatment satisfaction. In this 6-month, open-label study, primary care patients with MDD received usual care and were randomly assigned to venlafaxine ER (75 to 225 mg/d) either alone or in combination with the Dialogues program (venlafaxine ER + D). The primary outcome was patient treatment satisfaction on day 112, measured by the 10- point Satisfaction with Depression Care Scale (SDCS). Secondary efficacy outcomes included the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, response (≥50% decrease from baseline HAM-D17 score), and remission (HAM-D17 ≤ 7). The modified intent-to-treat population included 263 patients in the venlafaxine ER group and 257 in the venlafaxine ER+D group. The percentage of patients with an SDCS "very satisfied" score (≥8) at day 112 was not significantly different in the venlafaxine ER and venlafaxine ER+D groups (63% and 58%, respectively; P = 0.22). No significant differences were found on any secondary outcomes. Among primary care patients starting venlafaxine ER for MDD, participation in the Dialogues program did not have a statistically significant effect on patient treatment satisfaction.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Telephone-based cognitive-behavioral therapy for Latino patients living in rural areas: a randomized pilot study.

This pilot study tested the effectiveness of culturally tailored, telephone-based cognitive-behavioral therapy (CBT) for improving depression outcomes among Latino primary care patients living in rural settings. A total of 101 Latino patients at a rural family medical center who met criteria for probable major depression were randomly assigned to enhanced usual care or eight sessions of CBT delivered by phone by trained bilingual therapists from the community. Blinded study assistants assessed depression symptom severity, using the Hopkins Symptom Checklist (SCL) depression items and the Patient Health Questionnaire-9, and patient satisfaction after six weeks, three months, and six months. Mixed-effects models were used to estimate intervention effects over time. For cross-sectional analyses, attrition weights were used to account for missing data. In intent-to-treat analyses, patients who received CBT by phone were more likely to experience improvement in depression scores over the six-month follow-up period compared with patients who received enhanced usual care (β=-.41, t=-2.36, df=219, p=.018, for the SCL; and β=-3.51, t=-2.49, df=221, p=.013, for the PHQ-9). A greater proportion of patients in the CBT group than in the group that received enhanced usual care achieved treatment response at three months (p=.017), as indicated by a 50% improvement in SCL depression score or a score <.75, and reported high satisfaction with treatment (p=.013). Although limited by small sample size, pilot results suggest culturally tailored, telephone-based CBT has the potential to enhance access to psychotherapy in an underserved Latino population with little access to mental health services.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Effectiveness of collaborative care in addressing depression treatment preferences among low-income Latinos.

This study assessed treatment preferences among low-income Latino patients in public-sector primary care clinics and examined whether a collaborative care intervention that included patient education and allowed patients to choose between medication, therapy, or both would increase the likelihood that patients received preferred treatment. A total of 339 Latino patients with probable depressive disorders were recruited; participants completed a baseline conjoint analysis preference survey and were randomly assigned to receive the intervention or enhanced usual care. At 16 weeks, a patient survey assessed depression treatment received during the study period. Logistic regression models were constructed to estimate treatment preferences, examine patient characteristics associated with treatment preferences, and examine patient characteristics associated with a match between stated preference and actual treatment received. The conjoint analysis preference survey showed that patients preferred counseling or counseling plus medication over antidepressant medication alone and that they preferred treatment in primary care over specialty mental health care, but they showed no significant preference for individual versus group treatment. Patients also indicated that individual education sessions, telephone sessions, transportation assistance, and family involvement were barrier reduction strategies that would enhance their likelihood of accepting treatment. Compared with patients assigned to usual care, those in the intervention group were 21 times as likely to receive preferred treatment. Among all participants, women, unemployed persons, those who spoke English, and those referred by providers were more likely to receive preferred treatment. Collaborative care interventions that include psychotherapy can increase the likelihood that Latino patients receive preferred care; however, special efforts may be needed to address preferences of working persons, men, and Spanish-speaking patients.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial.

Both antidepressant medication and structured psychotherapy have been proven efficacious, but less than one third of people with depressive disorders receive effective levels of either treatment. To compare usual primary care for depression with 2 intervention programs: telephone care management and telephone care management plus telephone psychotherapy. Three-group randomized controlled trial with allocation concealment and blinded outcome assessment conducted between November 2000 and May 2002. A total of 600 patients beginning antidepressant treatment for depression were systematically sampled from 7 group-model primary care clinics; patients already receiving psychotherapy were excluded. Usual primary care; usual care plus a telephone care management program including at least 3 outreach calls, feedback to the treating physician, and care coordination; usual care plus care management integrated with a structured 8-session cognitive-behavioral psychotherapy program delivered by telephone. Blinded telephone interviews at 6 weeks, 3 months, and 6 months assessed depression severity (Hopkins Symptom Checklist Depression Scale and the Patient Health Questionnaire), patient-rated improvement, and satisfaction with treatment. Computerized administrative data examined use of antidepressant medication and outpatient visits. Treatment participation rates were 97% for telephone care management and 93% for telephone care management plus psychotherapy. Compared with usual care, the telephone psychotherapy intervention led to lower mean Hopkins Symptom Checklist Depression Scale depression scores (P =.02), a higher proportion of patients reporting that depression was "much improved" (80% vs 55%, P<.001), and a higher proportion of patients "very satisfied" with depression treatment (59% vs 29%, P<.001). The telephone care management program had smaller effects on patient-rated improvement (66% vs 55%, P =.04) and satisfaction (47% vs 29%, P =.001); effects on mean depression scores were not statistically significant. For primary care patients beginning antidepressant treatment, a telephone program integrating care management and structured cognitive-behavioral psychotherapy can significantly improve satisfaction and clinical outcomes. These findings suggest a new public health model of psychotherapy for depression including active outreach and vigorous efforts to improve access to and motivation for treatment.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Impact of a collaborative care model on depression in a primary care setting: a randomized controlled trial.

To measure the effects of a collaborative care model that emphasized the role of clinical pharmacists in providing drug therapy management and treatment follow-up to patients with depression, we conducted a randomized controlled trial at a staff model health maintenance organization. We compared the outcomes of subjects treated in this collaborative care model (75 patients, intervention group) with subjects receiving usual care (50 patients, control group). After 6 months, the intervention group demonstrated a significantly higher drug adherence rate than that of the control group (67% vs 48%, odds ratio 2.17, 95% confidence interval 1.04-4.51, p=0.038). Patient satisfaction was significantly greater among members randomly assigned to pharmacists' services than among controls, and provider satisfaction surveys revealed high approval rates as well. Changes in resource utilization were favorable for the intervention group, but differences from the control group did not achieve statistical significance. Clinical improvement was noted in both groups, but the difference was not significant. Clinical pharmacists had a favorable effect on multiple aspects of patient care. Future studies of this model in other health care settings appear warranted.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

The role of the practice nurse in the management of depression in general practice: treatment adherence to antidepressant medication.

This pilot study demonstrated the feasibility of providing practice nurse support as an adjunct to standard general practitioner treatment to patients with depressive disorders prescribed antidepressant medication. With respect to the measures used and pilot study objectives identified, there were no statistically significant differences between the study groups in treatment adherence to the prescription of antidepressant medication or in the incidence and severity of adverse events to medication. Large-scale randomized controlled trials are in progress to assess the effectiveness of practice nurse interventions in the management of depressive illness in general practice.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Effect of telecare management on pain and depression in patients with cancer: a randomized trial.

Pain and depression are 2 of the most prevalent and treatable cancer-related symptoms, yet they frequently go unrecognized, undertreated, or both. To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in patients with cancer. Randomized controlled trial conducted in 16 community-based urban and rural oncology practices involved in the Indiana Cancer Pain and Depression (INCPAD) trial. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The participating patients had depression (Patient Health Questionnaire-9 score > or = 10), cancer-related pain (Brief Pain Inventory [BPI] worst pain score > or = 6), or both. The 202 patients randomly assigned to receive the intervention and 203 to receive usual care were stratified by symptom type. Patients in the intervention group received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or Internet. Blinded assessment at baseline and at months 1, 3, 6, and 12 for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (BPI) severity. Of the 405 participants enrolled in the study, 131 had depression only, 96 had pain only, and 178 had both depression and pain. Of the 274 patients with pain, 137 patients in the intervention group had greater improvements in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (> or = 30% decrease in BPI) than the 137 patients in the usual-care group (P < .001 for both). Similarly, of the 309 patients with depression, the 154 patients in the intervention group had greater improvements in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical depression responder (> or = 50% decrease in HSCL) than the 155 patients in the usual care group (P < .001 for both). The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% confidence interval [CI], 0.33-1.02) and 0.39 (95% CI, 0.01-0.77) for pain, and 0.42 (95% CI, 0.16-0.69) and 0.41 (95% CI, 0.08-0.72) for depression. Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically dispersed urban and rural oncology practices. clinicaltrials.gov Identifier: NCT00313573.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Telephone depression care management for Latino Medicaid health plan members: a pilot randomized controlled trial.

The objective of this pilot study was to provide a preliminary test of feasibility, acceptability, and efficacy of telephone depression care management among Latino Medicaid health plan members. Thirty-eight depressed primary care patients were enrolled in a pilot randomized trial of telephone depression care management + treatment as usual (TAU) versus TAU only. Bilingual care managers conducted care management for 3 months following an antidepressant prescription. For 1 year, research staff attempted to contact 929 potentially eligible members and enrolled 38. Qualitative analyses suggested that, of the participants we interviewed, most expressed satisfaction with the program. Participants suggested ways to improve recruitment, such as face-to-face contact. When compared with the group receiving TAU, there was a trend for the intervention group to experience less depression in time. This pilot study suggests that this program may be promising; however, there is need to investigate ways to better reach those who might find the program helpful.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial.

Few depressed older adults receive effective treatment in primary care settings. To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment (IMPACT) collaborative care management program for late-life depression. Randomized controlled trial with recruitment from July 1999 to August 2001. Eighteen primary care clinics from 8 health care organizations in 5 states. A total of 1801 patients aged 60 years or older with major depression (17%), dysthymic disorder (30%), or both (53%). Patients were randomly assigned to the IMPACT intervention (n = 906) or to usual care (n = 895). Intervention patients had access for up to 12 months to a depression care manager who was supervised by a psychiatrist and a primary care expert and who offered education, care management, and support of antidepressant management by the patient's primary care physician or a brief psychotherapy for depression, Problem Solving Treatment in Primary Care. Assessments at baseline and at 3, 6, and 12 months for depression, depression treatments, satisfaction with care, functional impairment, and quality of life. At 12 months, 45% of intervention patients had a 50% or greater reduction in depressive symptoms from baseline compared with 19% of usual care participants (odds ratio [OR], 3.45; 95% confidence interval [CI], 2.71-4.38; P<.001). Intervention patients also experienced greater rates of depression treatment (OR, 2.98; 95% CI, 2.34-3.79; P<.001), more satisfaction with depression care (OR, 3.38; 95% CI, 2.66-4.30; P<.001), lower depression severity (range, 0-4; between-group difference, -0.4; 95% CI, -0.46 to -0.33; P<.001), less functional impairment (range, 0-10; between-group difference, -0.91; 95% CI, -1.19 to -0.64; P<.001), and greater quality of life (range, 0-10; between-group difference, 0.56; 95% CI, 0.32-0.79; P<.001) than participants assigned to the usual care group. The IMPACT collaborative care model appears to be feasible and significantly more effective than usual care for depression in a wide range of primary care practices.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized effectiveness trial of stepped collaborative care for acutely injured trauma survivors.

Although posttraumatic stress disorder (PTSD) and alcohol abuse frequently occur among acutely injured trauma survivors, few real-world interventions have targeted these disorders. We tested the effectiveness of a multifaceted collaborative care (CC) intervention for PTSD and alcohol abuse. Randomized effectiveness trial. We recruited a population-based sample of 120 male and female injured surgical inpatients 18 or older at a level I trauma center. Patients were randomly assigned to the CC intervention (n = 59) or the usual care (UC) control condition (n = 61). The CC patients received stepped care that consisted of (1) continuous postinjury case management, (2) motivational interviews targeting alcohol abuse/dependence, and (3) evidence-based pharmacotherapy and/or cognitive behavioral therapy for patients with persistent PTSD at 3 months after injury. We used the PTSD symptomatic criteria (PTSD Checklist) at baseline and 1, 3, 6, and 12 months after injury, and alcohol abuse/dependence (Composite International Diagnostic Interview) at baseline and 6 and 12 months after injury. Random-coefficient regression analyses demonstrated that over time, CC patients were significantly less symptomatic compared with UC patients with regard to PTSD (P =.01) and alcohol abuse/dependence (P =.048). The CC group demonstrated no difference (-0.07%; 95% confidence interval [CI], -4.2% to 4.3%) in the adjusted rates of change in PTSD from baseline to 12 months, whereas the UC group had a 6% increase (95% CI, 3.1%-9.3%) during the year. The CC group showed on average a decrease in the rate of alcohol abuse/dependence of -24.2% (95% CI, -19.9% to -28.6%), whereas the UC group had on average a 12.9% increase (95% CI, 8.2%-17.7%) during the year. Early mental health care interventions can be feasibly and effectively delivered from trauma centers. Future investigations that refine routine acute care treatment procedures may improve the quality of mental health care for Americans injured in the wake of individual and mass trauma.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative interventions for physically injured trauma survivors: a pilot randomized effectiveness trial.

Posttraumatic behavioral and emotional disturbances occur frequently among physically injured hospitalized trauma survivors. This investigation was a pilot randomized effectiveness trial of a 4-month collaborative care intervention for injured motor vehicle crash and assault victims. As surgical inpatients, intervention subjects (N=16) were assigned to a trauma support specialist who provided counseling, consulted with surgical and primary care providers, and attempted postdischarge care coordination. Control subjects (N=18) received usual posttraumatic care. For all participants, posttraumatic stress disorder (PTSD) and depressive symptoms, episodic alcohol intoxication, and functional limitations were evaluated during the hospitalization and 1 and 4 months postinjury. Study logs and field notes revealed that over 75% of intervention activity occurred in the first month after the trauma. One-month post-trauma intervention subjects when compared to controls demonstrated statistically significant decreases in PTSD symptoms as well as a reduction in depressive symptoms. However, at the 4-month assessment, intervention subjects evidenced no significant improvements in PTSD and depressive symptoms, episodic alcohol intoxication, or functional limitations. Future larger scale trials of stepped collaborative care interventions for physically injured trauma survivors are recommended.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Randomised trial of monitoring, feedback, and management of care by telephone to improve treatment of depression in primary care.

To test the effectiveness of two programmes to improve the treatment of acute depression in primary care. Randomised trial. Primary care clinics in Seattle. 613 patients starting antidepressant treatment. Patients were randomly assigned to continued usual care or one of two interventions: feedback only and feedback plus care management. Feedback only comprised feedback and algorithm based recommendations to doctors on the basis of data from computerised records of pharmacy and visits. Feedback plus care management included systematic follow up by telephone, sophisticated treatment recommendations, and practice support by a care manager. Blinded interviews by telephone 3 and 6 months after the initial prescription included a 20 item depression scale from the Hopkins symptom checklist and the structured clinical interview for the current DSM-IV depression module. Visits, antidepressant prescriptions, and overall use of health care were assessed from computerised records. Compared with usual care, feedback only had no significant effect on treatment received or patient outcomes. Patients receiving feedback plus care management had a higher probability of both receiving at least moderate doses of antidepressants (odds ratio 1.99, 95% confidence interval 1.23 to 3.22) and a 50% improvement in depression scores on the symptom checklist (2.22, 1.31 to 3.75), lower mean depression scores on the symptom checklist at follow up, and a lower probability of major depression at follow up (0.46, 0.24 to 0.86). The incremental cost of feedback plus care management was about $80 ( pound50) per patient. Monitoring and feedback to doctors yielded no significant benefits for patients in primary care starting antidepressant treatment. A programme of systematic follow up and care management by telephone, however, significantly improved outcomes at modest cost.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Understanding team-based quality improvement for depression in primary care.

To assess the impacts of the characteristics of quality improvement (QI) teams and their environments on team success in designing and implementing high quality, enduring depression care improvement programs in primary care (PC) practices. Two nonprofit managed care organizations sponsored five QI teams tasked with improving care for depression in large PC practices. Data on characteristics of the teams and their environments is from observer process notes, national expert ratings, administrative data, and interviews. Comparative formative evaluation of the quality and duration of implementation of the depression improvement programs developed by Central Teams (CTs) emphasizing expert design and Local Teams (LTs) emphasizing participatory local clinician design, and of the effects of additional team and environmental factors on each type of team. Both types of teams depended upon local clinicians for implementation. The CT intervention program designs were more evidence-based than those of LTs. Expert team leadership, support from local practice management, and support from local mental health specialists strongly influenced the development of successful team programs. The CTs and LTs were equally successful when these conditions could be met, but CTs were more successful than LTs in less supportive environments. The LT approach to QI for depression requires high local support and expertise from primary care and mental health clinicians. The CT approach is more likely to succeed than the LT approach when local practice conditions are not optimal.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Re-engineering systems for the treatment of depression in primary care: cluster randomised controlled trial.

To test the effectiveness of an evidence based model for management of depression in primary care with support from quality improvement resources. Cluster randomised controlled trial. Five healthcare organisations in the United States and 60 affiliated practices. 405 patients, aged > or = 18 years, starting or changing treatment for depression. Care provided by clinicians, with staff providing telephone support under supervision from a psychiatrist. Severity of depression at three and six months (Hopkins symptom checklist-20): response to treatment (> or = 50% decrease in scores) and remission (score of < 0.5). At six months, 60% (106 of 177) of patients in intervention practices had responded to treatment compared with 47% (68 of 146) of patients in usual care practices (P = 0.02). At six months, 37% of intervention patients showed remission compared with 27% for usual care patients (P = 0.014). 90% of intervention patients rated their depression care as good or excellent at six months compared with 75% of usual care patients (P = 0.0003). Resources such as quality improvement programmes can be used effectively in primary care to implement evidence based management of depression and improve outcomes for patients with depression.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Can collaborative care address the needs of low-income Latinas with comorbid depression and cancer? Results from a randomized pilot study.

In a pilot study, 55 low-income Latina patients with breast or cervical cancer and comorbid depression were randomly assigned to receive collaborative care as part of the Multifaceted Oncology Depression Program or usual care. Relative to patients in the usual care condition, patients receiving collaborative care were more likely to show>or=50% improvement in depressive symptoms as measured by the Personal Health Questionnaire (OR=4.51, 95% CI=1.07-18.93). Patients in the collaborative care program were also more likely to show improvement in emotional well-being (increase of 2.15) as measured by the Functional Assessment of Cancer Therapy Scale than were those receiving usual care (decrease of 0.50) (group difference=2.65, 95% CI: 0.18-5.12). Despite health system, provider, and patient barriers to care, these initial results suggest that patients in public sector oncology clinics can benefit from onsite depression treatment.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

An evaluation of practice nurses working with general practitioners to treat people with depression.

The diagnosis and treatment of depression constitutes a significant component of a general practitioner's workload. A pilot study has suggested that the practice nurse may have an important contribution to make in the care of patients with depression. To evaluate an extended role for practice nurses in improving the outcome of depression through two specially-designed interviews running in parallel. Two naturalistic, random allocation studies took place concurrently over four months. Study 1 evaluated the effectiveness of standardized psychiatric assessment by a practice nurse and feedback of information to the general practitioner (GP). Study 2 evaluated the above assessment and feedback combined with nurse-assisted follow-up care. Twenty general practices participating in the Medical Research Council General Practice Research Framework took part in the study. Subjects included general practice attenders identified as depressed by their GP. The main outcome measures were a change in Beck Depression Inventory (BDI) scores and in the proportion of patients fulfilling DSM-III criteria for major depression. A total of 577 patients were recruited; 516 [89% (95% CI = 86-92%)] were rated as depressed on the BDI and 474 [82% (95% CI = 79-85%)] met criteria for DSM-III major depression. Altogether, 524 (91%) patients completed follow-up at four months. All groups of patients showed improvement, but no difference in the rate of improvement was shown for the nurse intervention groups. BDI mean scores fell from 18.54 (95% CI = 17.53-20.06) to 11.53 (95% CI = 10.02-13.04) in Study 1, and from 21.01 (95% = CI 20.26-21.86) to 10.62 (95% CI = 9.73-11.51) in Study 2. The proportion of patients fulfilling criteria for DSM-III major depression in Study 1 fell from 80% (95% CI = 73-87%) to 30% (95% CI = 22-38%), and in Study 2 from 80% (95% CI = 76-84%) to 27% (95% CI = 23-31%). Prescription rates of antidepressant medication were higher than expected, ranging between 63% and 76% in the two studies. There was an increase in the rate of antidepressant prescription, but no additional benefit could be adduced for patients who received a nurse intervention.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

[A randomized trial of pharmacotherapy with telephone monitoring to improve treatment of depression in primary care in Santiago, Chile].

Depression is a public health problem, due to its high prevalence and its associated disability. To compare a pharmacological intervention for depression controlled by phone from a central level (TM) and the usual treatment (TH) in a randomized clinical trial. Three hundred and forty five women, aged 22 to 59 years were studied. They were randomly assigned to receive the usual therapy or a pharmacological intervention with periodical telephone contacts with medical collaboration personnel, to reinforce compliance with treatment and educate about the disease. Women were blindly evaluated at 3 and 6 months with the Hamilton depression rating score (HDRS) and the SF-36 to assess depressive symptoms and quality of life, respectively. In both evaluations, improvement was significantly greater in the TM group than the TH group. At 3 months, improvement was higher in the TM group in the subscales of physical function, pain, general health, energy, emotional role, mental health and standardized physical and psychic scales of SF-36. At 6 months, this significant difference in favour of TM was maintained for energy, mental health and the standardized psychic scale. A telephone reinforcement improves the outcomes of treatments for depression.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care.

Panic disorder and generalized anxiety disorder are prevalent in primary care, associated with poor functional outcomes, and are often unrecognized and ineffectively treated by primary care physicians. To examine whether telephone-based collaborative care for panic and generalized anxiety disorders improves clinical and functional outcomes more than the usual care provided by primary care physicians. Randomized controlled trial. Four Pittsburgh area primary care practices linked by a common electronic medical record system. Patients A total of 191 adults aged 18 to 64 years with panic and/or generalized anxiety disorder who were recruited from July 2000 to April 2002. Intervention Patients were randomly assigned to a telephone-based care management intervention (n = 116) or to notification alone of the anxiety disorder to patients and their physicians (usual care, n = 75). The intervention involved non-mental health professionals who provided patients with psychoeducation, assessed preferences for guideline-based care, monitored treatment responses, and informed physicians of their patients' care preferences and progress via an electronic medical record system under the direction of study investigators. Independent blinded assessments of anxiety and depressive symptoms, mental health-related quality of life, and employment status at baseline, 2-, 4-, 8-, and 12-month follow-up. At 12-month follow-up, intervention patients reported reduced anxiety (effect size [ES], 0.33-0.38; 95% confidence interval [CI], 0.04 to 0.67; P</=.02) and depressive symptoms (ES, 0.35; 95% CI, 0.25-0.46; P = .03); improved mental health-related quality of life (ES, 0.39; 95% CI, 0.10 to 0.68; P = .01); and larger improvements relative to baseline in hours worked per week (5.7; 95% CI, 0.1 to 11.3; P = .05) and fewer work days absent in the past month (-2.6; 95% CI, - 4.8 to -0.3; P = .03) than usual care patients. If working at baseline, more intervention patients than usual care patients remained working at 12-month follow-up (94% vs 79% [15% absolute difference, 0.7%-28.6%]; P = .04). Telephone-based collaborative care for panic disorder and generalized anxiety disorder is more effective than usual care at improving anxiety symptoms, health-related quality of life, and work-related outcomes.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Reducing suicidal ideation and depressive symptoms in depressed older primary care patients: a randomized controlled trial.

Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation. To determine the effect of a primary care intervention on suicidal ideation and depression in older patients. Randomized controlled trial known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001. Two-stage, age-stratified (60-74, > or =75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N = 598). Treatment guidelines tailored for the elderly with care management compared with usual care. Assessment of suicidal ideation and depression severity at baseline, 4 months, 8 months, and 12 months. Rates of suicidal ideation declined faster (P =.01) in intervention patients compared with usual care patients; at 4 months, in the intervention group, raw rates of suicidal ideation declined 12.9% points (29.4% to 16.5%) compared with 3.0% points (20.1% to 17.1% in usual care [P =.01]). Among patients reporting suicidal ideation, resolution of ideation was faster among intervention patients (P =.03); differences peaked at 8 months (70.7% vs 43.9% resolution; P =.005). Intervention patients had a more favorable course of depression in both degree and speed of symptom reduction; group difference peaked at 4 months. The effects on depression were not significant among patients with minor depression unless suicidal ideation was present. Evidence of the intervention's effectiveness in community-based primary care with a heterogeneous sample of depressed patients introduces new challenges related to its sustainability and dissemination. The intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Telephone-delivered collaborative care for treating post-CABG depression: a randomized controlled trial.

Depressive symptoms commonly follow coronary artery bypass graft (CABG) surgery and are associated with less positive clinical outcomes. To test the effectiveness of telephone-delivered collaborative care for post-CABG depression vs usual physician care. Single-blind effectiveness trial at 7 university-based and community hospitals in or near Pittsburgh, Pennsylvania. Participants were 302 post-CABG patients with depression (150, intervention; 152, usual care) and a comparison group of 151 randomly sampled post-CABG patients without depression recruited between March 2004 and September 2007 and observed as outpatients until June 2008. Eight months of telephone-delivered collaborative care provided by nurses working with patients' primary care physicians and supervised by a psychiatrist and primary care physician from this study. Mental health-related quality of life (HRQL) measured by the Short Form-36 Mental Component Summary (SF-36 MCS) at 8-month follow-up; secondary outcome measures included assessment of mood symptoms (Hamilton Rating Scale for Depression [HRS-D]), physical HRQL (SF-36 PCS), and functional status (Duke Activity Status Index [DASI]); and hospital readmissions. The intervention patients reported greater improvements in mental HRQL (all P < or = .02) (SF-36 MCS: Delta, 3.2 points; 95% confidence interval [CI], 0.5-6.0), physical functioning (DASI: Delta, 4.6 points; 95% CI, 1.9-7.3), and mood symptoms (HRS-D: Delta, 3.1 points; 95% CI, 1.3-4.9); and were more likely to report a 50% or greater decline in HRS-D score from baseline (50.0% vs 29.6%; number needed to treat, 4.9 [95% CI, 3.2-10.4]) than usual care patients (P < .001). Men with depression were particularly likely to benefit from the intervention (SF-36 MCS: Delta, 5.7 points; 95% CI, 2.2-9.2; P = .001). However, the mean HRQL and physical functioning of intervention patients did not reach that of the nondepressed comparison group. Compared with usual care, telephone-delivered collaborative care for treatment of post-CABG depression resulted in improved HRQL, physical functioning, and mood symptoms at 8-month follow-up. clinicaltrials.gov Identifier: NCT00091962.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative Depression Trial (CADET): multi-centre randomised controlled trial of collaborative care for depression--study protocol.

Comprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment model can replicate benefits for patients outside the US. This Phase III trial was preceded by a Phase II patient level RCT, following the MRC Complex Intervention Framework. A multi-centre controlled trial with cluster-randomised allocation of GP practices. GP practices will be randomised to usual care control or to "collaborative care" - a combination of case manager coordinated support and brief psychological treatment, enhanced specialist and GP communication. The primary outcome will be symptoms of depression as assessed by the PHQ-9. If collaborative care is demonstrated to be effective we will have evidence to enable the NHS to substantially improve the organisation of depressed patients in primary care, and to assist primary care providers to deliver a model of enhanced depression care which is both effective and acceptable to patients.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Case management for depression by health care assistants in small primary care practices: a cluster randomized trial.

Case management by health care assistants in small primary care practices provides unclear benefit for improving depression symptoms. To determine whether case management provided by health care assistants in small primary care practices is more effective than usual care in improving depression symptoms and process of care for patients with major depression. Cluster randomized, controlled trial. A central automated system generated the randomization scheme, which was stratified by urban and rural practices; allocation sequence was concealed until groups were assigned. 74 small primary care practices in Germany from April 2005 to September 2007. 626 patients age 18 to 80 years with major depression. Structured telephone interview to monitor depression symptoms and support for adherence to medication, with feedback to the family physician. Depression symptoms at 12 months, as measured by the Patient Health Questionnaire-9 (PHQ-9); secondary outcomes were patient assessment of chronic illness care, adherence to medication, and quality of life. A total of 310 patients were randomly assigned to case management and 316 to usual care. At 12 months, 249 intervention recipients and 278 control patients were assessed; 555 patients were included in a modified intention-to-treat-analysis (267 intervention recipients vs. 288 control patients). Compared with control patients, intervention recipients had lower mean PHQ-9 values in depression symptoms (-1.41 [95% CI, -2.49 to -0.33]; P = 0.014), more favorable assessments of care (3.41 vs. 3.11; P = 0.011), and increased treatment adherence (2.70 vs. 2.53; P = 0.042). Quality-of-life scores did not differ between groups. Patients, health care assistants, family physicians, and researchers were not blinded to group assignment, and 12-month follow-up of patients was incomplete. Case management provided by primary care practice-based health care assistants may reduce depression symptoms and improve process of care for patients with major depression more than usual care. German Ministry of Education and Research.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Delivery of evidence-based treatment for multiple anxiety disorders in primary care: a randomized controlled trial.

Improving the quality of mental health care requires moving clinical interventions from controlled research settings into real-world practice settings. Although such advances have been made for depression, little work has been performed for anxiety disorders. To determine whether a flexible treatment-delivery model for multiple primary care anxiety disorders (panic, generalized anxiety, social anxiety, and posttraumatic stress disorders) would be better than usual care (UC). A randomized controlled effectiveness trial of Coordinated Anxiety Learning and Management (CALM) compared with UC in 17 primary care clinics in 4 US cities. Between June 2006 and April 2008, 1004 patients with anxiety disorders (with or without major depression), aged 18 to 75 years, English- or Spanish-speaking, were enrolled and subsequently received treatment for 3 to 12 months. Blinded follow-up assessments at 6, 12, and 18 months after baseline were completed in October 2009. CALM allowed choice of cognitive behavioral therapy (CBT), medication, or both; included real-time Web-based outcomes monitoring to optimize treatment decisions; and a computer-assisted program to optimize delivery of CBT by nonexpert care managers who also assisted primary care clinicians in promoting adherence and optimizing medications. Twelve-item Brief Symptom Inventory (BSI-12) anxiety and somatic symptoms score. Secondary outcomes included proportion of responders (> or = 50% reduction from pretreatment BSI-12 score) and remitters (total BSI-12 score < 6). A significantly greater improvement for CALM vs UC in global anxiety symptoms was found (BSI-12 group mean differences of -2.49 [95% confidence interval {CI}, -3.59 to -1.40], -2.63 [95% CI, -3.73 to -1.54], and -1.63 [95% CI, -2.73 to -0.53] at 6, 12, and 18 months, respectively). At 12 months, response and remission rates (CALM vs UC) were 63.66% (95% CI, 58.95%-68.37%) vs 44.68% (95% CI, 39.76%-49.59%), and 51.49% (95% CI, 46.60%-56.38%) vs 33.28% (95% CI, 28.62%-37.93%), with a number needed to treat of 5.27 (95% CI, 4.18-7.13) for response and 5.50 (95% CI, 4.32-7.55) for remission. For patients with anxiety disorders treated in primary care clinics, CALM compared with UC resulted in greater improvement in anxiety symptoms, depression symptoms, functional disability, and quality of care during 18 months of follow-up. clinicaltrials.gov Identifier: NCT00347269.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized effectiveness trial of brief cognitive-behavioral therapy for depressed adolescents receiving antidepressant medication.

To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the experimental protocol (n = 75) versus TAU SSRI plus brief CBT (n = 77). Participants were identified by a recent dispense of SSRI medication followed by telephone screening. Adolescents with a diagnosis of major depressive disorder (n = 152) were enrolled. The CBT program employed cognitive restructuring and/or behavioral activation training. Therapists consulted with prescribing pediatricians to improve medication adherence. Through 1-year follow-up, the authors found CBT advantages on the Short Form-12 Mental Component Scale (p = .04), reductions in TAU outpatient visits (p = .02), and days' supply of all medications (p = .01). No effects were detected for major depressive disorder episodes; a nonsignificant trend favoring CBT was detected on the Center for Epidemiology Depression Scale (p = .07). The authors detected a weak CBT effect, possibly rendered less significant by the small sample and likely attenuated by the unexpected reduction in SSRI pharmacotherapy in the CBT condition. Small, incremental improvements over monotherapy, such as observed in this study, most likely represent the new norm in adolescent depression treatment research.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Managing depression as a chronic disease: a randomised trial of ongoing treatment in primary care.

To evaluate the long term effect of ongoing intervention to improve treatment of depression in primary care. Randomised controlled trial. Twelve primary care practices across the United States. Participants: 211 adults beginning a new treatment episode for major depression; 94% of patients assigned to ongoing intervention participated. Practices assigned to ongoing intervention encouraged participating patients to engage in active treatment, using practice nurses to provide care management over 24 months. Main outcome measures: Patients' report of remission and functioning. Ongoing intervention significantly improved both symptoms and functioning at 24 months, increasing remission by 33 percentage points (95% confidence interval 7% to 46%), improving emotional functioning by 24 points (11 to 38) and physical functioning by 17 points (6 to 28). By 24 months, 74% of patients in enhanced care reported remission, with emotional functioning exceeding 90% of population norms and physical functioning approaching 75% of population norms. Ongoing intervention increased remission rates and improved indicators of emotional and physical functioning. Studies are needed to compare the cost effectiveness of ongoing depression management with other chronic disease treatment routinely undertaken by primary care.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Integrating clinical nurse specialists into the treatment of primary care patients with depression.

To examine the effectiveness of integrating generalist and specialist care for veterans with depression. We conducted a randomized trial of patients screening positive for depression at two Veterans Affairs Medical Center general medicine clinic firms. Control firm physicians were notified prior to the encounter when eligible patients had PRIME-MD depression diagnoses. In the intervention firm, a mental health clinical nurse specialist (CNS) was to: design a treatment plan; implement that plan with the primary care physician; and monitor patients via telephone or visits at two weeks, one month and two months. Primary outcomes (depressive symptoms, patient satisfaction with health care) were collected at 3 and 12 months. Of 268 randomized patients, 246 (92%) and 222 (83%) completed 3- and 12-month follow-up interviews. There were no between-group differences in depressive symptoms or satisfaction at 3 or 12 months. The intervention group had greater chart documentation of depression at baseline (63% versus 33%, p = 0.003) and a higher referral rate to mental health services at 3 months (27% versus 9%, p = 0.019). There was no difference in the rate of new prescriptions for, or adequate dosing of, anti-depressant medications. In 40% of patients, CNSs disagreed with the PRIME-MD depression diagnosis, and their rates of watchful waiting were correspondingly high. Implementing an integrated care model did not occur as intended. Experienced CNSs often did not see the need for treatment in many primary care patients identified by the PRIME-MD. Integrating integrated care models in actual practice may prove challenging.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Promotoras as mental health practitioners in primary care: a multi-method study of an intervention to address contextual sources of depression.

We assessed the role of promotoras--briefly trained community health workers--in depression care at community health centers. The intervention focused on four contextual sources of depression in underserved, low-income communities: underemployment, inadequate housing, food insecurity, and violence. A multi-method design included quantitative and ethnographic techniques to study predictors of depression and the intervention's impact. After a structured training program, primary care practitioners (PCPs) and promotoras collaboratively followed a clinical algorithm in which PCPs prescribed medications and/or arranged consultations by mental health professionals and promotoras addressed the contextual sources of depression. Based on an intake interview with 464 randomly recruited patients, 120 patients with depression were randomized to enhanced care plus the promotora contextual intervention, or to enhanced care alone. All four contextual problems emerged as strong predictors of depression (chi square, p < .05); logistic regression revealed housing and food insecurity as the most important predictors (odds ratios both 2.40, p < .05). Unexpected challenges arose in the intervention's implementation, involving infrastructure at the health centers, boundaries of the promotoras' roles, and "turf" issues with medical assistants. In the quantitative assessment, the intervention did not lead to statistically significant improvements in depression (odds ratio 4.33, confidence interval overlapping 1). Ethnographic research demonstrated a predominantly positive response to the intervention among stakeholders, including patients, promotoras, PCPs, non-professional staff workers, administrators, and community advisory board members. Due to continuing unmet mental health needs, we favor further assessment of innovative roles for community health workers.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized effectiveness trial of collaborative care for patients with panic disorder in primary care.

Effectiveness studies have tested interventions to improve quality of care for depression in primary care, but none, to our knowledge, have been completed for panic disorder (PD) in this setting. This study sought to test the clinical effectiveness of PD pharmacotherapy embedded in a disease management framework of "collaborative care" (CC). One hundred fifteen patients with PD from 3 primary care clinics were randomized to CC or "usual care" (UC). Patients in CC (n = 57) received educational videotapes and pamphlets; pharmacotherapy with the selective serotonin reuptake inhibitor paroxetine; 2 psychiatrist visits and 2 telephone calls in the first 8 weeks; and up to 5 telephone calls between 3 and 12 months' follow-up. Usual care patients (n = 58) were treated by their primary care physician. Telephone assessments of panic, anxiety sensitivity, depression, and disability variables were performed at 3, 6, 9, and 12 months' follow-up. Adequacy of pharmacotherapy was assessed with an algorithm based on a review of efficacy studies. Patients in CC were more likely to receive adequate (type, dose, duration) medication and more likely to adhere to this medication at 3 and 6 months. Random regression analyses showed that CC patients improved significantly more over time compared with UC patients on anxiety, depression, and disability measures, with the greatest effects at 3 and 6 months. Compared with UC, CC interventions significantly improved both quality of care and clinical and functional outcomes in primary care PD patients. Clinical differences were greatest in the first 6 months, corresponding to the greater quality of care and the greater intensity of intervention.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Care management of poststroke depression: a randomized, controlled trial.

Poststroke depression is a prevalent and disabling disorder, yet evidence regarding the effectiveness of treating poststroke depression is inconclusive. Our objective was to determine the effectiveness of the Activate-Initiate-Monitor care management program for the treatment of poststroke depression. We conducted a prospective, randomized, outcome-blinded trial in 188 ischemic stroke survivors identified at the time of admission to one of 4 Indianapolis hospitals. Depression screening and enrollment occurred between 1 and 2 months poststroke. The Activate-Initiate-Monitor intervention was a care management program that included Activation of the patient to recognize depression symptoms and accept treatment, Initiation of an antidepressant medication, and Monitoring and adjusting treatment. Usual care subjects received nondepression-related education and were prescribed antidepressants at the discretion of their provider. The primary outcome measure was depression response, defined as a Hamilton Depression Inventory score <8 (remission) or a decrease from baseline of at least 50% at 12 weeks. Intervention and usual care groups did not differ on any key baseline measures. Both depression response (51% versus 30%, P=0.005) and remission (39% versus 23%, P=0.01) were more likely in the Activate-Initiate-Monitor intervention than in the usual care group. This difference in depression scores was present by 6 weeks and persisted through the 12-week assessment. Serious adverse events did not differ between the 2 groups. The Activate-Initiate-Monitor care management model is significantly more effective than usual care in improving depression outcomes in patients with poststroke depression.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Treating depression in primary care in low-income women in Santiago, Chile: a randomised controlled trial.

Depression in women is one of the commonest problems encountered in primary care. We aimed to compare the effectiveness of a stepped-care programme with usual care in primary-care management of depression in low-income women in Santiago, Chile. In a randomised controlled trial, in three primary-care clinics in Chile, 240 adult female primary-care patients with major depression were allocated stepped care or usual care. Stepped care was a 3-month, multicomponent intervention led by a non-medical health worker, which included a psychoeducational group intervention, structured and systematic follow-up, and drug treatment for patients with severe depression. Data were analysed on an intention-to-treat basis. The primary outcome measure was the Hamilton depression rating scale (HDRS) administered at baseline and at 3 and 6 months after randomisation. About 90% of randomised patients completed outcome assessments. There was a substantial between-group difference in all outcome measures in favour of the stepped-care programme. The adjusted difference in mean HDRS score between the groups was -8.89 (95% CI -11.15 to -6.76; p<0.0001). At 6-months' follow-up, 70% (60-79) of the stepped-care compared with 30% (21-40) of the usual-care group had recovered (HDRS score <8). Despite few resources and marked deprivation, women with major depression responded well to a structured, stepped-care treatment programme, which is being introduced across Chile. Socially disadvantaged patients might gain the most from systematic improvements in treatment of depression.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Graduate mental health worker case management of depression in UK primary care: a pilot study.

Based on data from large multicentre US trials, the National Institute for Health and Clinical Excellence (NICE) is advocating a stepped-care model for the management of depression, with 'case management' or 'collaborative care' for selected patients in primary care. To conduct a pilot study examining the use of graduate mental health workers case managing depressed primary care NHS patients. A randomised controlled trial comparing usual GP care with or without case management over 16 weeks of acute antidepressant drug treatment. Three primary care practices in the North East of England. Patients with depression, aged 18-65 years, who had failed to adequately respond to antidepressant treatment, were randomised to the two treatments. Assessments were made at baseline, 12, and 24 weeks using a combination of observer and self ratings. Randomisation of 62 patients required screening of 1073 potential patients. There was little difference in outcome between the two treatment arms but a gradual improvement in symptoms over time was seen. Client satisfaction was assessed as high across both treatments. While this pilot study confirmed the integrity of the study protocol and the suitability of the outcome measures and randomisation procedure, it raises questions regarding the practicality of recruitment and feasibility of the intervention. It would be crucial to address these issues prior to the implementation of a large multi-centre randomised controlled trial.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized trial of telephone psychotherapy and pharmacotherapy for depression: continuation and durability of effects.

Randomized trial evidence and expert guidelines are mixed regarding the value of combined pharmacotherapy and psychotherapy as initial treatment for depression. This study describes long-term results of a randomized trial (N = 393) evaluating telephone-based cognitive-behavioral therapy (CBT) plus care management for primary care patients beginning antidepressant treatment versus usual care. In a repeated measures linear model with adjustment for baseline scores, the phone therapy group showed significantly lower mean Hopkins Symptom Checklist (HSCL) Depression Scale scores (L. Derogatis, K. Rickels, E. Uhlenhuth, & L. Covi, 1974) from 6 months to 18 months versus usual care, F(1, 336) = 11.28, p = .001. Average HSCL depression scores over the period from 6 months to 18 months were 0.68 (SD = 0.55) in the telephone therapy group and 0.85 (SD = 0.65) in the usual-care comparison group. Addition of a brief, structured CBT program can significantly improve clinical outcomes for the large number of patients beginning antidepressant treatment in primary care. Copyright 2007 APA, all rights reserved.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Randomized trial of a depression management program in high utilizers of medical care.

High utilizers of nonpsychiatric health care services have disproportionally high rates of undiagnosed or undertreated depression. To determine the impact of offering a systematic primary care-based depression treatment program to depressed "high utilizers" not in active treatment. Randomized clinical trial. One hundred sixty-three primary care practices in 3 health maintenance organizations located in different geographic regions of the United States. A group of 1465 health maintenance organization members were identified as depressed high utilizers using a 2-stage telephone screening process. Eligibility criteria were met by 410 patients and 407 agreed to enroll: 218 in the depression management program (DMP) practices and 189 in the usual care (UC) group. The DMP included patient education materials, physician education programs, telephone-based treatment coordination, and antidepressant pharmacotherapy initiated and managed by patients' primary care physicians. Depression severity was measured using the Hamilton Depression Rating Scale (Ham-D) and functional status using the Medical Outcomes Study 20-item short form (SF-20) subscales. Outpatient visit and hospitalization rates were measured using the health plan's encounter data. Based on an intent-to-treat analysis, at least 3 antidepressant prescriptions were filled in the first 6 months by 151 (69.3%) of 218 of DMP patients vs 35 (18.5%) of 189 in UC (P < .001). Improvements in Ham-D scores were significantly greater in the intervention group at 6 weeks (P = .04), 3 months (P = .02), 6 months (P < .001), and 12 months (P < .001). At 12 months, DMP intervention patients were more improved than UC patients on the mental health, social functioning, and general health perceptions scales of the SF-20 (P < .05 for all). In depressed high utilizers not already in active treatment, a systematic primary care-based treatment program can substantially increase adequate antidepressant treatment, decrease depression severity, and improve general health status compared with usual care.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

The Pathways Study: a randomized trial of collaborative care in patients with diabetes and depression.

There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) and high hemoglobin A1c (HbA1c) levels in patients with diabetes. To determine whether enhancing quality of care for depression improves both depression and diabetes outcomes in patients with depression and diabetes. Randomized controlled trial with recruitment from March 1, 2001, to May 31, 2002. Nine primary care clinics from a large health maintenance organization. A total of 329 patients with diabetes mellitus and comorbid major depression and/or dysthymia. Intervention Patients were randomly assigned to the Pathways case management intervention (n = 164) or usual care (n = 165). The intervention provided enhanced education and support of antidepressant medication treatment prescribed by the primary care physician or problem-solving therapy delivered in primary care. Independent blinded assessments at baseline and 3, 6, and 12 months of depression (Hopkins Symptom Checklist 90), global improvement, and satisfaction with care. Automated clinical data were used to evaluate adherence to antidepressant regimens, percentage receiving specialty mental health visits, and HbA1c levels. When compared with usual care patients, intervention patients showed greater improvement in adequacy of dosage of antidepressant medication treatment in the first 6-month period (odds ratio [OR], 4.15; 95% confidence interval [CI], 2.28-7.55) and the second 6-month period (OR, 2.90; 95% CI, 1.69-4.98), less depression severity over time (z = 2.84, P = .004), a higher rating of patient-rated global improvement at 6 months (intervention 69.4% vs usual care 39.3%; OR, 3.50; 95% CI, 2.16-5.68) and 12 months (intervention 71.9% vs usual care 42.3%; OR, 3.50; 95% CI, 2.14-5.72), and higher satisfaction with care at 6 months (OR, 2.01; 95% CI, 1.18-3.43) and 12 months (OR, 2.88; 95% CI, 1.67-4.97). Although depressive outcomes were improved, no differences in HbA1c outcomes were observed. The Pathways collaborative care model improved depression care and outcomes in patients with comorbid major depression and/or dysthymia and diabetes mellitus, but improved depression care alone did not result in improved glycemic control.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

The impact of a pharmacist intervention on 6-month outcomes in depressed primary care patients.

The object of the study was to evaluate outcomes of a randomized clinical trial (RCT) of a pharmacist intervention for depressed patients in primary care (PC). We report antidepressant (AD) use and depression severity outcomes at 6-months. The RCT was conducted between 1998 and 2000 in 9 eastern Massachusetts PC practices. We studied 533 patients with major depression and/or dysthymia as determined by a screening test done at the time of a routine PC office visit. The majority of participants had recurrent depressive episodes (63.5% with >/=4 lifetime episodes), and 49.5% were taking AD medications at enrollment. Consultation in person and by telephone was performed by a clinical pharmacist who assisted the primary care practitioner (PCP) and patient in medication choice, dose, and regimen, in accordance with AHCPR depression guidelines. Six-month AD use rates for intervention patients exceeded controls (57.5% vs. 46.2%, P =.03). Furthermore, the intervention was effective in improving AD use rates for patients not on ADs at enrollment (32.3% vs. 10.9%, P =.001). The pharmacist intervention proved equally effective in subgroups traditionally considered difficult to treat: those with chronic depression and dysthymia. Patients taking ADs had better modified Beck Depression Inventory (mBDI) outcomes than patients not taking ADs, (-6.3 points change, vs. -2.8, P =.01) but the outcome differences between intervention and control patients were not statistically significant (17.7 BDI points vs. 19.4 BDI points, P =.16). Pharmacists significantly improved rates of AD use in PC patients, especially for those not on ADs at enrollment, but outcome differences were too small to be statistically significant. Difficult-to-treat subgroups may benefit from pharmacists' care.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized effectiveness trial of cognitive-behavioral therapy and medication for primary care panic disorder.

Panic disorder is a prevalent, often disabling condition among patients in the primary care setting. Although numerous studies have assessed the effectiveness of treatments for depression in primary care, few such studies have been conducted for panic disorder. To implement and test the effectiveness of a combined pharmacotherapy and cognitive-behavioral intervention for panic disorder tailored to the primary care setting. Randomized, controlled study comparing intervention to treatment as usual. Six primary care clinics associated with 3 university medical schools, serving an ethnically and socioeconomically diverse patient population. Two hundred thirty-two primary care patients meeting DSM-IV criteria for panic disorder. Comorbid mental and physical disorders were permitted, provided these did not contraindicate the treatment to be provided and were not acutely life threatening. Patients were randomized to receive either treatment as usual or an intervention consisting of a combination of up to 6 sessions (across 12 weeks) of cognitive-behavioral therapy (CBT) modified for the primary care setting, with up to 6 follow-up telephone contacts during the next 9 months, and algorithm-based pharmacotherapy provided by the primary care physician with guidance from a psychiatrist. Behavioral health specialists, the majority inexperienced in CBT for panic disorder, were trained to deliver the CBT and coordinated overall care, including pharmacotherapy. Proportion of subjects remitted (no panic attacks in the past month, minimal anticipatory anxiety, and agoraphobia subscale score <10 on Fear Questionnaire) and responding (Anxiety Sensitivity Index score <20) and change over time in World Health Organization Disability Scale and short form 12 scores. The combined cognitive-behavioral and pharmacotherapeutic intervention resulted in sustained and gradually increasing improvement relative to treatment as usual, with significantly higher rates at all points of both the proportion of subjects remitted (3 months, 20% vs 12%; 12 months, 29% vs 16%) and responding (3 months, 46% vs 27%; 12 months, 63% vs 38%) and significantly greater improvements in World Health Organization Disability Scale (all points) and short form 12 mental health functioning (3 and 6 months) scores. These effects were obtained in spite of similar rates of delivery of guideline-concordant pharmacotherapy to the 2 groups. Delivery of evidence-based CBT and medication using the collaborative care model and a CBT-naive, midlevel behavioral health specialist is feasible and significantly more effective than usual care for primary care panic disorder.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized trial of relapse prevention of depression in primary care.

Despite high rates of relapse and recurrence, few primary care patients with recurrent or chronic depression are receiving continuation and maintenance-phase treatment. We hypothesized that a relapse prevention intervention would improve adherence to antidepressant medication and improve depression outcomes in high-risk patients compared with usual primary care. Three hundred eighty-six patients with recurrent major depression or dysthymia who had largely recovered after 8 weeks of antidepressant treatment by their primary care physicians were randomized to a relapse prevention program (n = 194) or usual primary care (n = 192). Patients in the intervention group received 2 primary care visits with a depression specialist and 3 telephone visits over a 1-year period aimed at enhancing adherence to antidepressant medication, recognition of prodromal symptoms, monitoring of symptoms, and development of a written relapse prevention plan. Follow-up assessments were completed at 3, 6, 9, and 12 months by a telephone survey team blinded to randomization status. Those in the intervention group had significantly greater adherence to adequate dosage of antidepressant medication for 90 days or more within the first and second 6-month periods and were significantly more likely to refill medication prescriptions during the 12-month follow-up compared with usual care controls. Intervention patients had significantly fewer depressive symptoms, but not fewer episodes of relapse/recurrence over the 12-month follow-up period. A relapse prevention program targeted to primary care patients with a high risk of relapse/recurrence who had largely recovered after antidepressant treatment significantly improved antidepressant adherence and depressive symptom outcomes.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Differential effectiveness of depression disease management for rural and urban primary care patients.

Federally qualified health centers across the country are adopting depression disease management programs following federally mandated training; however, little is known about the relative effectiveness of depression disease management in rural versus urban patient populations. To explore whether a depression disease management program has a comparable impact on clinical outcomes over 2 years in patients treated in rural and urban primary care practices and whether the impact is mediated by receiving evidence-based care (antidepressant medication and specialty care counseling). A preplanned secondary analysis was conducted in a consecutively sampled cohort of 479 depressed primary care patients recruited from 12 practices in 10 states across the country participating in the Quality Enhancement for Strategic Teaming study. Depression disease management improved the mental health status of urban patients over 18 months but not rural patients. Effects were not mediated by antidepressant medication or specialty care counseling in urban or rural patients. Depression disease management appears to improve clinical outcomes in urban but not rural patients. Because these programs compete for scarce resources, health care organizations interested in delivering depression disease management to rural populations need to advocate for programs whose clinical effectiveness has been demonstrated for rural residents.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Efficacy of nurse telehealth care and peer support in augmenting treatment of depression in primary care.

Primary care treatment of depression needs improvement. To evaluate the efficacy of 2 augmentations to antidepressant drug treatment. Randomized trial comparing usual care, telehealth care, and telehealth care plus peer support; assessments were conducted at baseline, 6 weeks, and 6 months. Two managed care adult primary care clinics. A total of 302 patients starting antidepressant drug therapy. For telehealth care: emotional support and focused behavioral interventions in ten 6-minute calls during 4 months by primary care nurses; and for peer support: telephone and in-person supportive contacts by trained health plan members recovered from depression. For depression: the Hamilton Depression Rating Scale and the Beck Depression Inventory; and for mental and physical functioning: the SF-12 Mental and Physical Composite Scales and treatment satisfaction. Nurse-based telehealth patients with or without peer support more often experienced 50% improvement on the Hamilton Depression Rating Scale at 6 weeks (50% vs 37%; P =.01) and 6 months (57% vs 38%; P =.003) and on the Beck Depression Inventory at 6 months (48% vs 37%; P =. 05) and greater quantitative reduction in symptom scores on the Hamilton scale at 6 months (10.38 vs 8.12; P =.006). Telehealth care improved mental functioning at 6 weeks (47.07 vs 42.64; P =.004) and treatment satisfaction at 6 weeks (4.41 vs 4.17; P =.004) and 6 months (4.20 vs 3.94; P =.001). Adding peer support to telehealth care did not improve the primary outcomes. Nurse telehealth care improves clinical outcomes of antidepressant drug treatment and patient satisfaction and fits well within busy primary care settings.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

PEARLS depression treatment for individuals with epilepsy: a randomized controlled trial.

Depression is associated with higher rates of suicide and lower levels of functioning and quality of life in individuals with epilepsy. The objective of this randomized controlled trial was to determine the effectiveness of PEARLS, a home-based program for managing depression in adult individuals with epilepsy and clinically significant acute and chronic depression. Delivered by masters-level counselors, PEARLS is a collaborative care intervention consisting of problem solving treatment, behavioral activation, and psychiatric consultation. Patients were randomly assigned to the PEARLS intervention (N = 40) or usual care (N = 40), and assessed at baseline, 6 months, and 12 months. Compared with patients who received usual care, patients assigned to the PEARLS intervention achieved lower depression severity (P<0.005) (Hopkins Symptoms Checklist-20) and lower suicidal ideation (P = 0.025) over 12 months. The PEARLS program, a community-integrated, home-based treatment for depression, effectively reduces depressive symptoms in adults with epilepsy and comorbid depression. Copyright © 2010 Elsevier Inc. All rights reserved.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A pilot study of telephone care management and structured disease self-management groups for chronic depression.

The authors developed, implemented, and pilot-tested intervention programs to provide effective care for chronic or recurrent depression. A total of 104 patients with chronic or recurrent depression were randomly assigned to one of four groups: continued usual behavioral health care, usual care plus telephone monitoring and care management by a care manager, usual care plus care management plus a peer-led chronic-disease self-management group program, or usual care plus care management plus a professionally led depression psychotherapy group. Outcomes in intent-to-treat analyses were assessed at three, six, nine, and 12 months and included treatment participation rates, Hopkins Symptom Checklist depression scale scores, major depression (Structured Clinical Interview for DSM-IV), Patient-Rated Global Improvement ratings, treatment satisfaction, and adequacy of medication. Participation in care management was high in the three intervention groups. Close to 60% of participants invited to both group interventions attended at least an initial meeting, but a greater number assigned to the care management plus the professionally led group continued participation through the 12-month period. The sample was too small to reliably detect small or moderate differences in clinical outcomes, but various measures consistently favored the care management plus professionally led group. It is feasible to direct additional intervention services to patients with persistent or recurring depression. A larger trial of organized self-management support for chronic depression will be necessary for a definitive evaluation of program effectiveness.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Enhanced treatment for depression in primary care: long-term outcomes of a psycho-educational prevention program alone and enriched with psychiatric consultation or cognitive behavioral therapy.

The long-term outcome of major depression is often unfavorable, and because most cases of depression are managed by general practitioners (GPs), this places stress on the need to improve treatment in primary care. This study evaluated the long-term effects of enhancing the GP's usual care (UC) with three experimental interventions. A randomized controlled trial was conducted from 1998 to 2003. The main inclusion criterion was receiving GP treatment for a depressive episode. We compared: (1) UC (n=72) with UC enhanced with: (2) a psycho-educational prevention (PEP) program (n=112); (3) psychiatrist-enhanced PEP (n=37); and (4) brief cognitive behavioral therapy followed by PEP (CBT-enhanced PEP) (n=44). We assessed depression status quarterly during a 3-year follow-up. Pooled across groups, depressive disorder-free and symptom-free times during follow-up were 83% and 17% respectively. Almost 64% of the patients had a relapse or recurrence, the median time to recurrence was 96 weeks, and the mean Beck Depression Inventory (BDI) score over 12 follow-up assessments was 9.6. Unexpectedly, PEP patients had no better outcomes than UC patients. However, psychiatrist-enhanced PEP and CBT-enhanced PEP patients reported lower BDI severity during follow-up than UC patients [mean difference 2.07 (95% confidence interval (CI) 1.13-3.00) and 1.62 (95% CI 0.70-2.55) respectively] and PEP patients [2.37 (95% CI 1.35-3.39) and 1.93 (95% CI 0.92-2.94) respectively]. The PEP program had no extra benefit compared to UC and may even worsen outcome in severely depressed patients. Enhancing treatment of depression in primary care with psychiatric consultation or brief CBT seems to improve the long-term outcome, but findings need replication as the interventions were combined with the ineffective PEP program.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Short-term effects of enhanced treatment for depression in primary care: results from a randomized controlled trial.

Depression is a highly prevalent, often recurring or persistent disorder. The majority of patients are initially seen and treated in primary care. Effective treatments are available, but possibilities for providing adequate follow-up care are often limited in this setting. This study assesses the effectiveness of primary-care-based enhanced treatment modalities on short-term patient outcomes. In a randomized controlled trial we evaluated a psycho-educational self-management intervention. We included 267 adult patients meeting criteria for a DSM-IV diagnosis of major depressive disorder, assessed by a structured psychiatric interview. Patients were randomly assigned to: the Depression Recurrence Prevention (DRP) program (n=112); a combination of the DRP program with psychiatric consultation (PC+DRP, n=39); a combination with brief cognitive behavior therapy (CBT+DRP, n=44); and care as usual (CAU, n=72). Follow-up assessments were made at 3 months (response 90%) and 6 months (85%). Patient acceptance of enhanced care was good. The mean duration of the index episode was 11 weeks (S.D.=9.78) and similar in CAU and enhanced care. Recovery rate after 6 months was 67% overall; 17% of all participants remained depressed for the entire 6-month period. Enhanced care did not result in better short-term outcomes. We found no evidence that the DRP program was more effective than CAU and no indications for added beneficial effects of either the psychiatric evaluation or the CBT treatment to the basic format of the DRP program. Observed depression treatment rates in CAU were high.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Culturally sensitive collaborative treatment for depressed chinese americans in primary care.

We examined the feasibility and effectiveness of using culturally sensitive collaborative treatment (CSCT) to improve recognition, engagement, and treatment of depressed Chinese Americans in primary care. Chinese American patients in a primary care setting (n = 4228) were screened for depression. The primary study outcome was treatment engagement rate, and the secondary outcome was treatment response. Of the study participants, 296 (7%) screened positive for depression, 122 (41%) of whom presented for a psychiatric assessment; 104 (85%) were confirmed with major depressive disorder, and 100 (96%) of these patients were randomized into treatment involving either care management or usual care. Patients in the care management and usual care groups did not differ in terms of their outcomes. CSCT resulted in a nearly 7-fold increase in treatment rate among depressed patients in primary care. CSCT is both feasible and effective in improving recognition and treatment engagement of depressed Chinese Americans. Care management may have limited effects on depressed patients treated by psychiatrists, given that these patients tend to have favorable responses in general.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Integration of depression and hypertension treatment: a pilot, randomized controlled trial.

We wanted to examine whether integrating depression treatment into care for hypertension improved adherence to antidepressant and antihypertensive medications, depression outcomes, and blood pressure control among older primary care patients. Older adults prescribed pharmacotherapy for depression and hypertension from physicians at a large primary care practice in West Philadelphia were randomly assigned to an integrated care intervention or usual care. Outcomes were assessed at baseline, 2, 4, and 6 weeks using the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression, an electronic monitor to measure blood pressure, and the Medication Event Monitoring System to assess adherence. In all, 64 participants aged 50 to 80 years participated. Participants in the integrated care intervention had fewer depressive symptoms (CES-D mean scores, intervention 9.9 vs usual care 19.3; P <.01), lower systolic blood pressure (intervention 127.3 mm Hg vs usual care 141.3 mm Hg; P <.01), and lower diastolic blood pressure (intervention 75.8 mm Hg vs usual care 85.0 mm Hg; P <.01) compared with participants in the usual care group at 6 weeks. Compared with the usual care group, the proportion of participants in the intervention group who had 80% or greater adherence to an antidepressant medication (intervention 71.9% vs usual care 31.3%; P <.01) and to an antihypertensive medication (intervention 78.1% vs usual care 31.3%; P <.001) was greater at 6 weeks. A pilot, randomized controlled trial integrating depression and hypertension treatment was successful in improving patient outcomes. Integrated interventions may be more feasible and effective in real-world practices, where there are competing demands for limited resources.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative care for patients with depression and chronic illnesses.

Patients with depression and poorly controlled diabetes, coronary heart disease, or both have an increased risk of adverse outcomes and high health care costs. We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients. We conducted a single-blind, randomized, controlled trial in 14 primary care clinics in an integrated health care system in Washington State, involving 214 participants with poorly controlled diabetes, coronary heart disease, or both and coexisting depression. Patients were randomly assigned to the usual-care group or to the intervention group, in which a medically supervised nurse, working with each patient's primary care physician, provided guideline-based, collaborative care management, with the goal of controlling risk factors associated with multiple diseases. The primary outcome was based on simultaneous modeling of glycated hemoglobin, low-density lipoprotein (LDL) cholesterol, and systolic blood-pressure levels and Symptom Checklist-20 (SCL-20) depression outcomes at 12 months; this modeling allowed estimation of a single overall treatment effect. As compared with controls, patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels (difference, 0.58%), LDL cholesterol levels (difference, 6.9 mg per deciliter [0.2 mmol per liter]), systolic blood pressure (difference, 5.1 mm Hg), and SCL-20 depression scores (difference, 0.40 points) (P<0.001). Patients in the intervention group also were more likely to have one or more adjustments of insulin (P=0.006), antihypertensive medications (P<0.001), and antidepressant medications (P<0.001), and they had better quality of life (P<0.001) and greater satisfaction with care for diabetes, coronary heart disease, or both (P<0.001) and with care for depression (P<0.001). As compared with usual care, an intervention involving nurses who provided guideline-based, patient-centered management of depression and chronic disease significantly improved control of medical disease and depression. (Funded by the National Institute of Mental Health; ClinicalTrials.gov number, NCT00468676.).

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Community-integrated home-based depression treatment in older adults: a randomized controlled trial.

Older adults with social isolation, medical comorbidity, and physical impairment are more likely to be depressed but may be less able to seek appropriate care for depression compared with older adults without these characteristics. To determine the effectiveness of a home-based program of detecting and managing minor depression or dysthymia among older adults. Randomized controlled trial with recruitment through community senior service agencies in metropolitan Seattle, Wash, from January 2000 to May 2003. One hundred thirty-eight patients aged 60 years or older with minor depression (51.4%) or dysthymia (48.6%). Patients had a mean of 4.6 (SD, 2.1) chronic medical conditions; 42% of the sample belonged to a racial/ethnic minority, 72% lived alone, 58% had an annual income of less than 10 000 dollars, and 69% received a form of home assistance. Patients were randomly assigned to the Program to Encourage Active, Rewarding Lives for Seniors (PEARLS) intervention (n = 72) or usual care (n = 66). The PEARLS intervention consisted of problem-solving treatment, social and physical activation, and potential recommendations to patients' physicians regarding antidepressant medications. Assessments of depression and quality of life at 12 months compared with baseline. At 12 months, compared with the usual care group, patients receiving the PEARLS intervention were more likely to have at least a 50% reduction in depressive symptoms (43% vs 15%; odds ratio [OR], 5.21; 95% confidence interval [CI], 2.01-13.49), to achieve complete remission from depression (36% vs 12%; OR, 4.96; 95% CI, 1.79-13.72), and to have greater health-related quality-of-life improvements in functional well-being (P =.001) and emotional well-being (P =.048). The PEARLS program, a community-integrated, home-based treatment for depression, significantly reduced depressive symptoms and improved health status in chronically medically ill older adults with minor depression and dysthymia.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative care management of major depression among low-income, predominantly Hispanic subjects with diabetes: a randomized controlled trial.

To determine whether evidence-based socioculturally adapted collaborative depression care improves receipt of depression care and depression and diabetes outcomes in low-income Hispanic subjects. This was a randomized controlled trial of 387 diabetic patients (96.5% Hispanic) with clinically significant depression recruited from two public safety-net clinics from August 2005 to July 2007 and followed over 18 months. Intervention (INT group) included problem-solving therapy and/or antidepressant medication based on a stepped-care algorithm; first-line treatment choice; telephone treatment response, adherence, and relapse prevention follow-up over 12 months; plus systems navigation assistance. Enhanced usual care (EUC group) included standard clinic care plus patient receipt of depression educational pamphlets and a community resource list. INT patients had significantly greater depression improvement (> or =50% reduction in Symptom Checklist-20 depression score from baseline; 57, 62, and 62% vs. the EUC group's 36, 42, and 44% at 6, 12, and 18 months, respectively; odds ratio 2.46-2.57; P < 0.001). Mixed-effects linear regression models showed a significant study group-by-time interaction over 18 months in diabetes symptoms; anxiety; Medical Outcomes Study Short-Form Health Survey (SF-12) emotional, physical, and pain-related functioning; Sheehan disability; financial situation; and number of social stressors (P = 0.04 for disability and SF-12 physical functioning, P < 0.001 for all others) but no study group-by-time interaction in A1C, diabetes complications, self-care management, or BMI. Socioculturally adapted collaborative depression care improved depression, functional outcomes, and receipt of depression treatment in predominantly Hispanic patients in safety-net clinics.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Effectiveness of a quality improvement intervention for adolescent depression in primary care clinics: a randomized controlled trial.

Depression is a common condition associated with significant morbidity in adolescents. Few depressed adolescents receive effective treatment for depression in primary care settings. To evaluate the effectiveness of a quality improvement intervention aimed at increasing access to evidence-based treatments for depression (particularly cognitive-behavior therapy and antidepressant medication), relative to usual care, among adolescents in primary care practices. Randomized controlled trial conducted between 1999 and 2003 enrolling 418 primary care patients with current depressive symptoms, aged 13 through 21 years, from 5 health care organizations purposively selected to include managed care, public sector, and academic medical center clinics in the United States. Usual care (n = 207) or 6-month quality improvement intervention (n = 211) including expert leader teams at each site, care managers who supported primary care clinicians in evaluating and managing patients' depression, training for care managers in manualized cognitive-behavior therapy for depression, and patient and clinician choice regarding treatment modality. Participating clinicians also received education regarding depression evaluation, management, and pharmacological and psychosocial treatment. Depressive symptoms assessed by Center for Epidemiological Studies-Depression Scale (CES-D) score. Secondary outcomes were mental health-related quality of life assessed by Mental Health Summary Score (MCS-12) and satisfaction with mental health care assessed using a 5-point scale. Six months after baseline assessments, intervention patients, compared with usual care patients, reported significantly fewer depressive symptoms (mean [SD] CES-D scores, 19.0 [11.9] vs 21.4 [13.1]; P = .02), higher mental health-related quality of life (mean [SD] MCS-12 scores, 44.6 [11.3] vs 42.8 [12.9]; P = .03), and greater satisfaction with mental health care (mean [SD] scores, 3.8 [0.9] vs 3.5 [1.0]; P = .004). Intervention patients also reported significantly higher rates of mental health care (32.1% vs 17.2%, P<.001) and psychotherapy or counseling (32.0% vs 21.2%, P = .007). A 6-month quality improvement intervention aimed at improving access to evidence-based depression treatments through primary care was significantly more effective than usual care for depressed adolescents from diverse primary care practices. The greater uptake of counseling vs medication under the intervention reinforces the importance of practice interventions that include resources to enable evidence-based psychotherapy for depressed adolescents.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative care for depression in UK primary care: a randomized controlled trial.

Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial. We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9). We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32). Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

Collaborative management to achieve treatment guidelines. Impact on depression in primary care.

To compare the effectiveness of a multifaceted intervention in patients with depression in primary care with the effectiveness of "usual care" by the primary care physician. A randomized controlled trial among primary care patients with major depression or minor depression. Over a 12-month period a total of 217 primary care patients who were recognized as depressed by their primary care physicians and were willing to take antidepressant medication were randomized, with 91 patients meeting criteria for major depression and 126 for minor depression. Intervention patients received increased intensity and frequency of visits over the first 4 to 6 weeks of treatment (visits 1 and 3 with a primary care physician, visits 2 and 4 with a psychiatrist) and continued surveillance of adherence to medication regimens during the continuation and maintenance phases of treatment. Patient education in these visits was supplemented by videotaped and written materials. Primary outcome measures included short-term (30-day) and long-term (90-day) use of antidepressant medication at guideline dosage levels, satisfaction with overall care for depression and antidepressant medication, and reduction in depressive symptoms. In patients with major depression, the intervention group had greater adherence than the usual care controls to adequate dosage of antidepressant medication for 90 days or more (75.5% vs 50.0%; P < .01), were more likely to rate the quality of the care they received for depression as good to excellent (93.0% vs 75.0%; P < .03), and were more likely to rate antidepressant medications as helping somewhat to helping a great deal (88.1% vs 63.3%; P < .01). Seventy-four percent of intervention patients with major depression showed 50% or more improvement on the Symptom Checklist-90 Depressive Symptom Scale compared with 43.8% of controls (P < .01), and the intervention patients also demonstrated a significantly greater decrease in depression severity over time compared with controls (P < .004). In patients with minor depression, the intervention group had significantly greater adherence than controls to adequate dosage of antidepressant medication for 90 days or more (79.7% vs 40.3%; P < .001) and more often rated antidepressant medication as helping somewhat to helping a great deal (81.8% vs 61.4%; P < .02). However, no significant differences were found between the intervention and control groups in the percentage of patients who were satisfied with the care they received for depression (94.4% vs 89.3%), in the percentage who experienced a 50% or more decrease in depressive symptoms, or in the decrease of depressive symptoms over time. A multifaceted intervention consisting of collaborative management by the primary care physician and a consulting psychiatrist, intensive patient education, and surveillance of continued refills of antidepressant medication improved adherence to antidepressant regimens in patients with major and with minor depression. It improved satisfaction with care and resulted in more favorable depressive outcomes in patients with major, but not minor, depression.

CD006525

Collaborative care is associated with significant improvement in depression and anxiety outcomes compared with usual care, and represents a useful addition to clinical pathways for adult patients with depression and anxiety.

A randomized controlled trial of a close monitoring program for minor depression and distress.

Minor depression is almost twice as common in primary care (PC) as major depression. Despite the high prevalence, few evidence-based algorithms exist for managing patients with minor depression or patients presenting solely with distress. The aim of this study was to test the effectiveness of a telephone-based close monitoring program to manage PC patients with minor depression or distress. Subjects were randomly assigned to either the control arm (usual care; UC) or the intervention arm (close monitoring; CM). We hypothesized that those randomized to CM would exhibit less depression and be less likely to have symptoms progress to the point of meeting diagnostic criteria. Overall, 223 PC subjects with minor depression or distress consented to participation in this trial. At baseline, subjects completed a telephone-based evaluation comprised of validated diagnostic assessments of depression and other MH disorders. Outcomes were assessed at six months utilizing this same battery. Chart reviews were conducted to track care received, such as prescribed antidepressants and MH and primary care visits. Subjects in the CM arm exhibited fewer psychiatric diagnoses than those in the UC arm (chi(2) = 4.04, 1 df, p = 0.04). In addition, the intervention group showed improved overall physical health (SF-12 PCS scores) (M = 45.1, SD = 11.8 versus M = 41.5, SD = 12.4) (chi(2) = 5.90, 1 df, p = .02). Those randomized to CM exhibited less MH problems at the conclusion of the trial, indicating that the close monitoring program is effective, feasible and valuable. The findings of this study will allow us to enhance clinical care and support the integration of mental health services and primary care.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Role of antibiotic prophylaxis for wound infection in percutaneous endoscopic gastrostomy (PEG): result of a prospective double-blind randomized trial.

A randomized, double-blind, controlled trial was carried out to determine the value of antibiotic prophylaxis in the prevention of wound infection in percutaneous endoscopic gastrostomy (PEG) procedures. The wound was evaluated using ASEPSIS method and categorized as disturbance of healing, minor or major wound infection on the 7th day and the 28th day. The rate of infection including major wound infection was lower in the prophylaxis group of patients at both seven and 28 days. Copyright 2002 The Hospital Infection Society.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Antibiotic prophylaxis for percutaneous endoscopic gastrostomy--a prospective, randomised, double-blind trial.

Peristomal infection can sometimes complicate percutaneous endoscopic gastrostomy (PEG) placement. Antibiotic prophylaxis has, in some studies, been shown to reduce the incidence. However, the use of prophylaxis varies widely, possibly because the design and findings of the studies have differed, making their relevance to clinical practice difficult to interpret. To determine the efficacy of antibiotics, either prophylaxis or concurrent antibiotics at the time of the procedure, in reducing peristomal infection after PEG insertion in the context of a study designed to reflect current practice. One hundred and forty-one patients undergoing PEG placement were randomised to group one to receive either a single dose of 750 mg of intravenous cefuroxime (n=50) or placebo (n=51) 30 min before PEG insertion. Forty patients who, for various reasons, were already receiving antibiotics were allocated to group two. The peristomal site was evaluated on day 3, 5 and 7 following insertion. Erythema and exudate were scored on a scale from 0 to 4; induration was scored on a scale of 0-3. A maximum combined score of 8 or higher or the presence of pus was criteria for infection. The primary outcome measure was the occurrence of a peristomal wound infection at any time within one week of PEG insertion. Peristomal wound infection was significantly reduced in patients who received antibiotics either as a single dose of cefuroxime [one of 33 (3%)], or in those on antibiotics for prior indications [one of 36 (3%)], compared with placebo [six of 33 (18%)], P=0.04 and 0.03, respectively. Antibiotics, either prophylaxis or concurrent, reduce the incidence of peristomal wound infection after PEG placement.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Addition of local antiseptic spray to parenteral antibiotic regimen reduces the incidence of stomal infection following percutaneous endoscopic gastrostomy: A randomized controlled trial.

To study the effectiveness of local antiseptic spray with or without a three-dose antibiotic regimen in the prevention of stomal infection following percutaneous endoscopic gastrostomy. Ninety-six patients were randomized into three groups: A, intravenous cefuroxime 750 mg just before the procedure followed by two further doses every 8 h; B, single application of povidone-iodine (Betadine) antiseptic spray; C, combination of A and B. The stomal site was examined at midweek and at the end of week 1 for evidence of infection using a validated scoring system. Fisher's exact test was used for analysis of primary end point, namely, stomal infection at midweek and at the end of week 1. Logistic regression models were used for secondary analysis to consider the effects of diabetes, acid suppressants, steroids, age and sex on outcome. Group A had 34 patients, group B had 28 and group C had 34. Age, sex and indications in groups A, B and C are broadly comparable. Stomal infection was 32% in group B vs. groups A (6%) and C (9%) (P = 0.0114) at midweek, and 3% in group C vs. 32% each in groups A and B (P = 0.0013) at the end of week 1. Cumulative infections (n) at the end of week 1 were lower in group C (3) (9%) than in groups A (11) (32%) and B (12) (43%) (P = 0.003). No significant difference was observed between the three groups in terms of the number of patients who were given antibiotics for other indications (P = 0.363). By logistic regression only diabetes, but not other covariates, seems to have a significant effect on stomal infection (odds ratio, 33.34; 95% CI, 4.33-256.7). A combination of cefuroxime and Betadine spray significantly reduces stomal infection following percutaneous endoscopic gastrostomy at the end of week 1. Both the antibiotic group (A) and the combined group (C) did well compared with the Betadine only group (B) at midweek.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG)--results from a prospective randomized multicenter trial.

To determine the efficacy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG) as a part of a standardized regimen. An open prospective randomised multicenter study in 216 patients. 106 received ceftriaxone 1 g i.v. 30 min preinterventionally and 110 no study medication. A standardized protocol was followed for PEG preparation, insertion, and aftercare; all patients received a 15 French gastrostomy tube. Follow-up of local and systemic infection and clinical course was continued to postintervention day 10. An aggregate erythema and exudation score > 3 or the presence of pus was taken as indicative of peristomal infection. The pharmacoeconomics of antibiotic use were also examined. In no-prophylaxis patients, wound infection rates were 23.6% on day 4 and 24.5% on day 10 vs. 7.6% (p < 0.05) and 11.4% (p < 0.05), respectively, in prophylaxis patients. Results were disproportionally better in tumor patients in comparison with neurological patients. Patients systemic infection rates were 11.8% vs. 1.9% in noprophylaxis vs. prophylaxis (p < 0.05), and overall infection rates 36.3% vs. 13.3%, respectively (p < 0.05). Pneumonia was more frequent in patients with underlying neurological disease and reduced in the prophylaxis group. Antibiotic and application costs were similar in both groups (p = 0.400). Single-dose ceftriaxone 1 g is a effective prophylaxis against local and systemic infection after PEG and should be a part of a standard regimen.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Antibiotic prophylaxis for percutaneous endoscopic gastrostomy for non-malignant conditions: a double-blind prospective randomized controlled trial.

The use of antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy insertion has been encouraged following development of guidelines by a number of professional societies within the past few years. However, not all evidence supports routine prophylaxis, particularly in patients with 'benign' disease indications for percutaneous endoscopic gastrostomy insertion. To identify whether prophylactic antibiotic usage is beneficial in patients undergoing percutaneous endoscopic gastrostomy insertion without malignant disease. Adult patients without malignant disease who were referred for percutaneous endoscopic gastrostomy insertion at our unit were assessed for participation in this prospective, double-blind, randomized controlled study. Patients were randomized to receive either placebo or 2.2 g co-amoxiclav (or 2 g cefotaxime if penicillin-allergic) at time of percutaneous endoscopic gastrostomy insertion. Clinical endpoints studies were percutaneous endoscopic gastrostomy site or systemic infection and death within 7 days of percutaneous endoscopic gastrostomy insertion. Results : Ninety-nine patients completed the study (51 antibiotics, 48 placebo). Outcomes in the antibiotic and placebo groups respectively were: percutaneous endoscopic gastrostomy site infection, 11% vs. 47% (P < 0.01); systemic infection, 16% vs. 38% (P < 0.05); and death, 8% vs. 15% (P = 0.5). Antibiotic prophylaxis prior to percutaneous endoscopic gastrostomy insertion reduces both percutaneous endoscopic gastrostomy site and systemic infections in patients without malignant disease.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Percutaneous endoscopic gastrostomy (PEG): comparison of push and pull methods and evaluation of antibiotic prophylaxis.

Infection of the gastrostomy opening after placement of a percutaneous endoscopic gastrostomy (PEG) catheter has been reported to occur quite often, especially when the pull method is used. We therefore compared complications occurring with the pull and push methods, and evaluated the role of antibiotic prophylaxis. In a prospective study, 100 consecutive patients were randomly assigned to group A (pull plus antibiotic prophylaxis: amoxycillin-clavulanic acid 3 x 1.2 g i.v. over 24 hours; 37 patients), group B (pull without antibiotic prophylaxis; 34 patients) and group C (push without antibiotic prophylaxis; 29 patients). The indications for PEG placement were dysphagia due to oropharyngeal tumors (56%), neurological disease (32%), or other (12%). Patients were evaluated twice weekly for one month after the PEG placement. PEG catheters were successfully placed in 96% of the patients. The total procedure-related complication rate was significantly lower in group A than in groups B and C (28%, 58%, and 70%, respectively; p < 0.01). Major complications occurred in one patient in group A (seeding metastasis of a hypopharyngeal carcinoma in the gastrostomy tract), and in four patients in group B (three cases of peritonitis and one aspiration, resulting in two deaths), but in none of the group C patients. Group A patients experienced fewer peristomal infections than the other two groups (14%, 30%, and 41%, respectively: p = 0.05). The risk of peristomal pain was similar (11%, 15%, and 11%, respectively; p = n.s.). In three patients in group C, the PEG catheter had to be replaced by the pull method, due to repeated dislocation of the balloon catheter. The complication rate with PEG placement is high with both the push and pull methods. The complication rate with the pull method is significantly reduced when antibiotic prophylaxis is used.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

New introducer PEG gastropexy does not require prophylactic antibiotics: multicenter prospective randomized double-blind placebo-controlled study.

Peristomal infections are the most common complications of PEG, despite prophylactic antibiotics. The "introducer" PEG-placement technique avoids the sojourn of a PEG catheter through the oropharynx, and hence minimizes the chances of infectious complications. Despite the obvious potential advantage, this technique failed to gain popularity, mainly as a result of other associated risks and complications. Recently, a modified introducer endoscopic PEG-gastropexy technique was shown to be quite safe. The present study is the first study that evaluated the need of prophylactic antibiotics for "introducer" PEG. To determine the incidence of peristomal wound infections during the immediate 7-day postprocedure follow-up. Prospective, randomized, double-blind, placebo-controlled trial. Multicenter; a university tertiary-care hospital and a private practice endoscopy clinic. A total of 633 patients undergoing PEG were assessed for inclusion. Ninety-seven patients who had malignant stenotic oropharyngeal stricture were randomized: group I (49 patients) received prophylactic ceftriaxone, and group II (48 patients) received a placebo. Both groups were similar in patient characteristics. Introducer PEG was performed by using the Freka Pexact-15 CH/FR, with the gastric wall nonsurgically sutured to the anterior abdominal wall by use of an endoscope. The peristomal area was assessed daily for 7 days by using 2 different types of infection scores. Clinically significant wound reaction was observed in 1 patient in each group. Wound infection scores were marginally higher in the placebo group, but the differences in the values of infection scores between both the groups were not statistically significant during the 7-day post-PEG follow-up. The introducer gastropexy kit is 5 times more expensive than the "pull" PEG. The new introducer PEG-gastropexy technique can be performed safely, without prophylactic antibiotics in patients potentially at high risk of peristomal infectious complications (those with advanced oropharyngeal malignancy) (ClinicalTrials.gov identifier NCT00375414).

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Antibiotic prophylaxis in percutaneous endoscopic gastrostomy.

The benefit of antibiotic prophylaxis in percutaneous endoscopic gastrostomy is controversial. The aim of this study is to determine whether prophylactic antibiotic treatment with Cefazolin reduces the incidence of peristomal infection after percutaneous endoscopic gastrostomy. Of the 131 hospitalized or nursing home patients referred for percutaneous endoscopic gastrostomy, 115 were enrolled in a prospective randomized double-blind placebo controlled trial. Sixty-one (group 1) were randomized in a double-blind fashion and received either Cefazolin or saline pregastrostomy. Fifty-four patients (group 2) were on antibiotics for prior medical indications pregastrostomy. Patients had their peristomal area evaluated on a daily basis for 1 wk after gastrostomy. Erythema and exudate were scored on a scale from 0 to 4; induration was scored on a scale of 0 to 3; a maximum score of 8 or higher or the presence of pus was criteria for infection. Wound infection occurred in 4 of 30 (13%) participants receiving Cefazolin and in 6 of 31 (19%) participants receiving saline (p > 0.5). In the 54 patients on antibiotics for prior indications, wound infection was observed in 2 subjects (3%). This finding was a significant difference when compared with the placebo group (p < 0.02). A single dose of Cefazolin prophylaxis does not reduce the overall peristomal wound infection in percutaneous endoscopic gastrostomy. Patients receiving prior extended antibiotic therapy have fewer peristomal wound infections.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Effect of antibiotic prophylaxis in percutaneous endoscopic gastrostomy.

Thirty-three patients completed a prospective double-blind, randomized study to compare the effect of antibiotic prophylaxis or placebo on percutaneous endoscopic gastrostomy-associated wound infections. We define wound infection and arrive at an incidence of 29.4% in patients receiving Cefoxitin antibiotic prophylaxis and 31.2% in patients receiving placebo. Based on these results, we do not recommend antibiotic prophylaxis for percutaneous endoscopic gastrostomy tube placement.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): a prospective randomized clinical trial.

The most frequent complication reported for percutaneous endoscopic gastrostomy (PEG) is peristomal wound infection which occurs in as many as 30 % of patients. In the studies published so far, the question of whether antibiotic prophylaxis reduces the incidence of peristomal wound infection has remained controversial. We therefore conducted a prospective, randomized trial to determine whether antibiotic prophylaxis can reduce the incidence of peristomal wound infection associated with PEG. During a 2-year-period a total of 347 patients (251 men, 96 women; mean age 60.2+/-5) were included in our study. In all cases, a 9-French gauge Freka gastrostomy tube was inserted using the "pull" technique. The patients were randomly assigned to three different treatment groups (group 1, antibiotic prophylaxis with 2 g cefotaxime; group 2, antibiotic prophylaxis with 4g piperacillin plus 0.5g tazobactam; group 3, no antibiotic prophylaxis). For a period of one week after gastrostomy, the peristomal area was evaluated using a wound score. According to the score, peristomal infections were classified as being of degree I-IV. Infections of up to degree III were regarded as minor, while an infection of degree IV was defined as a severe complication. PEG tubes were successfully placed in 336/347 patients (97 %). Of the 336 patients, 29 were excluded because of incomplete follow up (dropout rate 9%). Cases included were: in group 1, n = 101; in group 2, n = 100, and in group 3, n = 106. There was no mortality related to PEG insertion. There were five instances of severe complications (1.6%). Patients who received antibiotic prophylaxis had mean daily combined wound scores that were significantly lower than those of patients without antibiotic prophylaxis (P < 0.01). The control group (no antibiotic prophylaxis) exhibited significantly more peristomal wound infections of degree III (n = 8) than antibiotic prophylaxis group 1 (n = 0, P < 0.001) or antibiotic prophylaxis group 2 (n = 1, P < 0.012). Three patients in group 3 (no antibiotic prophylaxis) and one patient in group 2 developed peritonitis. Severe wound infections requiring medical or endoscopic intervention are very rare events after PEG insertion. Antibiotic prophylaxis significantly reduces the risk of peristomal wound infection associated with PEG insertion. Antibiotic prophylaxis, therefore, is to be recommended as a general measure in percutaneous endoscopic gastrostomy.

CD005571

Administration of systemic prophylactic antibiotics for PEG tube placement reduces peristomal infection.

Prospective, randomised, double blind trial of prophylaxis with single dose of co-amoxiclav before percutaneous endoscopic gastrostomy.

To determine the efficacy of antibacterial prophylaxis in preventing infectious complications after percutaneous endoscopic gastrostomy. Prospective, randomised, placebo controlled, double blind, multicentre study. Departments of internal medicine at six German hospitals. Of 106 randomised adult patients with dysphagia, 97 received study medication, and 84 completed the study. The median age of the patients was 65 years. Most had dysphagia due to malignant disease (65%), and many (76%) had serious comorbidity. Interventions: A single intravenous 2.2 g dose of co-amoxiclav or identical appearing saline was given 30 min before percutaneous endoscopic gastrostomy performed by the thread pull method. Occurrence of peristomal wound infections and other infections within one week after percutaneous endoscopic gastrostomy. Results: The incidence of peristomal and other infections within one week after percutaneous endoscopic gastrostomy was significantly reduced in the antibiotic group (8/41 (20%) v 28/43 (65%), P<0.001). Similar results were obtained in an intention to treat analysis. Several peristomal wound infections were of minor clinical significance. After wound infections that required no or only local treatment were excluded from the analysis, antibiotic prophylaxis remained highly effective in reducing clinically important wound infections (1/41 (2%) v 11/43 (26%), P<0.01) and non-wound infections (2 (5%) v 9 (21%), P<0.05). Antibiotic prophylaxis with a single dose of co-amoxiclav significantly reduces the risk of infectious complications after percutaneous endoscopic gastrostomy and should be recommended.

CD003390

The limited available evidence suggests folate may have a potential role as a supplement to other treatment for depression. It is currently unclear if this is the case both for people with normal folate levels, and for those with folate deficiency.

Enhancement of the antidepressant action of fluoxetine by folic acid: a randomised, placebo controlled trial.

A consistent finding in major depression has been a low plasma and red cell folate which has also been linked to poor response to antidepressants. The present investigation was designed to investigate whether the co-administration of folic acid would enhance the antidepressant action of fluoxetine. 127 patients were randomly assigned to receive either 500 microg folic acid or an identical looking placebo in addition to 20 mg fluoxetine daily. All patients met the DSM-III-R criteria for major depression and had a baseline Hamilton Rating Scale (17 item version) score for depression of 20 or more. Baseline and 10-week estimations of plasma folate and homocysteine were carried out. Patients receiving folate showed a significant increase in plasma folate. This was less in men than in women. Plasma homocysteine was significantly decreased in women by 20.6%, but there was no significant change in men. Overall there was a significantly greater improvement in the fluoxetine plus folic acid group. This was confined to women where the mean Hamilton Rating Scale score on completion was 6.8 (S.D. 4. 1) in the fluoxetine plus folate group, as compared to 11.7 (S.D. 6. 7) in the fluoxetine plus placebo group (P<0.001).A percentage of 93. 9 of women, who received the folic acid supplement, showed a good response (>50% reduction in score) as compared to 61.1% of women who received placebo supplement (P<0.005). Eight (12.9%) patients in the fluoxetine plus folic acid group reported symptoms possibly or probably related to medication, whereas in the fluoxetine plus placebo group 19 (29.7%) patients reported such symptoms (P<0.05). Folic acid is a simple method of greatly improving the antidepressant action of fluoxetine and probably other antidepressants. Folic acid should be given in doses sufficient to decrease plasma homocysteine. Men require a higher dose of folic acid to achieve this than women, but more work is required to ascertain the optimum dose of folic acid.

CD003390

The limited available evidence suggests folate may have a potential role as a supplement to other treatment for depression. It is currently unclear if this is the case both for people with normal folate levels, and for those with folate deficiency.

Enhancement of recovery from psychiatric illness by methylfolate.

41 (33%) of 123 patients with acute psychiatric disorders (DSM III diagnosis of major depression or schizophrenia) had borderline or definite folate deficiency (red-cell folate below 200 micrograms/l) and took part in a double-blind, placebo-controlled trial of methylfolate, 15 mg daily, for 6 months in addition to standard psychotropic treatment. Among both depressed and schizophrenic patients methylfolate significantly improved clinical and social recovery. The differences in outcome scores between methylfolate and placebo groups became greater with time. These findings add to the evidence implicating disturbances of methylation in the nervous system in the biology of some forms of mental illness.