Enhancing antiepileptic drug adherence: a randomized controlled trial. Can just-in-time, evidence-based "reminders" improve pain management among home health care nurses and their patients? Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. Adherence by African American men to prostate cancer education and early detection. Implementing practice guidelines for diabetes care using problem-based learning. A prospective controlled trial using firm systems. A cognitive-behavioral approach to substance abuse prevention: one-year follow-up. A clinic-based mammography intervention targeting inner-city women. A randomized controlled trial of an HIV prevention intervention for street-based female sex workers in Yerevan, Armenia: preliminary evidence of efficacy. An educational intervention as decision support for menopausal women. Texting appointment reminders to repeated non-attenders in primary care: randomised controlled study. Multivariate analysis of the Fugl-Meyer outcome measures assessing the effectiveness of GENTLE/S robot-mediated stroke therapy.
Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (P<0.01). The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence. The purpose of this randomized, controlled, home care intervention was to test the effectiveness of two nurse-targeted, e-mail-based interventions to increase home care nurses' adherence to pain assessment and management guidelines, and to improve patient outcomes. Nurses from a large urban non-profit home care organization were assigned to usual care or one of two interventions upon identification of an eligible cancer patient with pain. The basic intervention consisted of a patient-specific, one-time e-mail reminder highlighting six pain-specific clinical recommendations. The augmented intervention supplemented the initial e-mail reminder with provider prompts, patient education material, and clinical nurse specialist outreach. Over 300 nurses were randomized and outcomes of 673 of their patients were reviewed. Data collection involved clinical record abstraction of nurse care practices and patient interviews completed approximately 45 days after start of care. The intervention had limited effect on nurse-documented care practices but patient outcomes were positively influenced. Patients in the augmented group improved significantly over the control group in ratings of pain intensity at its worst, whereas patients in the basic group had better ratings of pain intensity on average. Other outcomes measures were also positively influenced but did not reach statistical significance. Our findings suggest that although reminders have some role in improving cancer pain management, a more intensive approach is needed for a generalized nursing workforce with limited recent exposure to state-of-the-art pain management practices. There is limited evidence on whether growing mobile phone availability in sub-Saharan Africa can be used to promote high adherence to antiretroviral therapy (ART). This study tested the efficacy of short message service (SMS) reminders on adherence to ART among patients attending a rural clinic in Kenya.
                A randomized controlled trial of four SMS reminder interventions with 48 weeks of follow-up.
                Four hundred and thirty-one adult patients who had initiated ART within 3 months were enrolled and randomly assigned to a control group or one of the four intervention groups. Participants in the intervention groups received SMS reminders that were either short or long and sent at a daily or weekly frequency. Adherence was measured using the medication event monitoring system. The primary outcome was whether adherence exceeded 90% during each 12-week period of analysis and the 48-week study period. The secondary outcome was whether there were treatment interruptions lasting at least 48 h.
                In intention-to-treat analysis, 53% of participants receiving weekly SMS reminders achieved adherence of at least 90% during the 48 weeks of the study, compared with 40% of participants in the control group (P = 0.03). Participants in groups receiving weekly reminders were also significantly less likely to experience treatment interruptions exceeding 48 h during the 48-week follow-up period than participants in the control group (81 vs. 90%, P = 0.03).
                These results suggest that SMS reminders may be an important tool to achieve optimal treatment response in resource-limited settings. This study was designed to identify factors that predict adherence by African American men to prostate cancer education and early detection.
                In the spring of 1995, the authors identified 548 African American men who were patients at the University Health Services of the University of Chicago, were ages 40-70 years, and did not have a personal history of prostate cancer. Baseline telephone survey data were collected from 413 men (75%). Participants were randomly assigned to either a minimal or an enhanced intervention group. Men in the former group were mailed a letter and a reminder that invited them to a urology clinic for prostate cancer education and early detection. Men in the enhanced intervention group were sent the same correspondence and were also given print material and telephone contacts, which were tailored to each recipient.
                Adherence was significantly higher (OR = 2.6, CI: 1.7-3.9) in the enhanced intervention group than in the minimal intervention group (51% and 29%, respectively). Men who were age 50 years or older (OR = 1.7, CI: 1.1-2.8), were married (OR = 1.8, CI: 1.2-2.9), believed that prostate cancer early detection examination should be performed in the absence of symptoms (OR = 2.3, CI: 1.3-4.0), and self-reported an intention to have an early detection examination (OR = 1.9, CI: 1.2-2.9) were also more likely to adhere.
                A tailored behavioral intervention can influence adherence to prostate cancer early detection among African American men. Individual background and cognitive and psychosocial characteristics may also affect behavior. Future studies should assess the impact of this type of intervention on cognitive and psychologic correlates of decision-making and behavior along the continuum of prostate cancer care. [See editorial on pages 1-2, this issue.] A controlled trial with 15-month follow-up was conducted in two outpatient clinics to study the effects of using the problem-based learning technique to implement a diabetes clinical practice guideline.
                A total of 144 patients with type 2 diabetes aged 25-65 years in two internal medicine outpatient clinics were enrolled in the study. African-Americans and Hispanics made up > 75% of the patients. Doctors and staff in one of the clinics were trained in the use of a clinical practice guideline based on Staged Diabetes Management. A problem-based learning educational program was instituted to reach consensus on a stepped intensification scheme for glycemic control and to determine the standards of care used in the clinic. HbA1c was obtained at baseline and at 9 and 15 months after enrollment.
                At 9 months, there was a mean -0.90% within-subject change in HbA1c in the intervention group, with no significant changes in the control group. The 15-month mean within-subject change in HbA1c of -0.62% in the intervention group was also significant. Among intervention patients, those with the poorest glycemic control at baseline realized the greatest benefit in improvement of HbA1c. The intervention group also exhibited significant changes in physician adherence with American Diabetes Association standards of care.
                Clinical practice guidelines are an effective way of improving the processes and outcomes of care for patients with diabetes. Problem-based learning is a useful strategy to gain physician support for clinical practice guidelines. More intensive interventions are needed to maintain treatment gains. This study presents one-year follow-up data from an evaluation study testing the effectiveness of a cognitive-behavioral substance abuse prevention approach which emphasizes the teaching of social resistance skills within the larger context of an intervention designed to enhance general social and personal competence. The follow-up study involved 998 eighth graders from 10 suburban New York junior high schools. Two schools were assigned to each of the following conditions (a) peer-led intervention, (b) peer-led intervention with booster sessions, (c) teacher-led intervention, (d) teacher-led intervention with booster sessions, and (e) control. The original intervention was implemented in the seventh grade; the booster intervention was implemented during the eighth grade. Results indicate that this type of prevention strategy, when implemented by peer leaders in the seventh grade and when additional booster sessions are provided during the eighth grade, can reduce tobacco, alcohol, and marijuana use. Similar effects are evident for females when the prevention program is implemented with fidelity by classroom teachers. Moreover, the prevention program is also capable of producing a significant impact on several hypothesized mediating variables. The objective was to evaluate the effect of a clinic-based intervention program on mammography use by inner-city women.
                A randomized controlled trial employing firm system methodology was conducted.
                The study setting was a general internal medicine clinic in the university-affiliated county hospital serving metropolitan Seattle.
                Women aged 50 to 74 years with at least one routine clinic appointment (when they were due for mammography) during the study period were enrolled in the trial (n = 314).
                The intervention program emphasized nursing involvement and included physician education, provider prompts, use of audiovisual and printed patient education materials, transportation assistance in the form of bus passes, preappointment telephone or postcard reminders, and rescheduling assistance. Control firm women received usual care.
                Mammography completion within 8 weeks of clinic visits was significantly higher among intervention (49%) than control (22%) firm women (p < .001). These effects persisted after adjustment for potential confounding by age, race, medical insurance coverage, and previous mammography experience at the hospital (odds ratio 3.5; 95% confidence interval 1.9, 6.5). The intervention effect was modified by type of insurance coverage as well as prior mammography history. Process evaluation indicated that bus passes and rescheduling efforts did not contribute to the observed increases in screening participation.
                A clinic-based program incorporating physician education, provider prompts, patient education materials, and appointment reminders and emphasizing nursing involvement can facilitate adherence to breast cancer screening guidelines among inner-city women. This study evaluated the efficacy of an HIV intervention among female sex workers (FSWs) randomized to an intervention or wait-list control. FSWs (N = 120) completed baseline, 3- and 6-month assessments. A health educator implemented 2-hour intervention emphasized gender-empowerment, self-efficacy to persuade clients to use condoms, condom application skills, and eroticizing safer sex. Over the 6-month follow-up, FSWs in the intervention reported more consistent condom use with clients (P = .004) and were more likely to apply condoms on clients (P = .0001). Intervention effects were observed for other psychosocial mediators of safer sex. Brief, gender and culturally congruent interventions can enhance HIV-preventive behaviors among FSWs. The purpose of this study was to develop and test a decision support intervention (DSI) to assist women to make and act on informed decisions that are consistent with their values in the area of menopause and hormone replacement therapy (HRT). Mode and intensity of intervention were tested in midlife women (N = 248), randomly assigned to one of three intervention formats: written information only, guided discussion, or personalized decision exercise. Data were collected over 12 months. Knowledge, decisional conflict, satisfaction with health care provider, and self-efficacy improved following intervention and were maintained for 12 months for all groups. Women's adherence to their own plans over 12 months was 59% (exercise), 76% (calcium intake), and 89% (HRT). Carefully written information is effective in promoting knowledge, adherence, and satisfaction among well-educated, interested women. It was concluded that women can understand complex information, including tradeoffs regarding treatment options. Women will adhere to their own plans, suggesting that consumer rather than provider plans may be the more appropriate gold standard for measuring adherence. Failure to attend appointments compromises health service efficiency. Despite considerable interest in using novel technologies to improve attendance, evidence from rigorously conducted controlled studies is lacking.
                To evaluate the effectiveness of texting appointment reminders to patients who persistently fail to attend appointments.
                Randomised controlled study.
                Inner city general practice in Lothian, Scotland.
                We included 415 appointments made by patients (n = 173) who had failed to attend two or more routine appointments in the preceding year. Patients whose appointments were randomised to the intervention group received a text message reminder of the appointment. Patients whose appointments were in the control group received no reminder. Our primary outcome measure was non-attendance rates. We undertook an intention-to-treat analysis and multi-level analysis to take account of the lack of independence of the outcomes of repeated appointments for the same patient.
                Of the 418 appointments originally included in the study, three were excluded due to clerical error; 189 were randomised to the intervention group and 226 to the control group. Twenty-two appointments (12%) were not attended in the intervention group compared with 39 (17%) in the control group. A chi-square analysis, considering the outcome of appointments as independent from one another, gave a non-significant difference of 5% (95% CI of difference -1.1 to 12.3%, p = 0.13). Multilevel analysis applied to the binary outcome data on non-attendance gave an odds ratio for non-attendance in the intervention group compared with the control group of 0.63 (95% CI 0.36 to 1.1, p = 0.11).
                Although the intervention showed promise, we failed to demonstrate significant reduction in non-attendance rates, as a result of texting appointment reminders to patients who persistently fail to attend their general practice appointments. Robot-mediated therapies offer entirely new approaches to neurorehabilitation. In this paper we present the results obtained from trialling the GENTLE/S neurorehabilitation system assessed using the upper limb section of the Fugl-Meyer (FM) outcome measure.
                We demonstrate the design of our clinical trial and its results analysed using a novel statistical approach based on a multivariate analytical model. This paper provides the rational for using multivariate models in robot-mediated clinical trials and draws conclusions from the clinical data gathered during the GENTLE/S study.
                The FM outcome measures recorded during the baseline (8 sessions), robot-mediated therapy (9 sessions) and sling-suspension (9 sessions) was analysed using a multiple regression model. The results indicate positive but modest recovery trends favouring both interventions used in GENTLE/S clinical trial. The modest recovery shown occurred at a time late after stroke when changes are not clinically anticipated.
                This study has applied a new method for analysing clinical data obtained from rehabilitation robotics studies. While the data obtained during the clinical trial is of multivariate nature, having multipoint and progressive nature, the multiple regression model used showed great potential for drawing conclusions from this study. An important conclusion to draw from this paper is that this study has shown that the intervention and control phase both caused changes over a period of 9 sessions in comparison to the baseline. This might indicate that use of new challenging and motivational therapies can influence the outcome of therapies at a point when clinical changes are not expected. Further work is required to investigate the effects arising from early intervention, longer exposure and intensity of the therapies. Finally, more function-oriented robot-mediated therapies or sling-suspension therapies are needed to clarify the effects resulting from each intervention for stroke recovery.
Intensive reminders and 'implementation intention' interventions appear promising in enhancing adherence to antiepileptic mediations, however we need more reliable evidence on their efficacy from carefully designed randomised controlled trials before a firm conclusion can be reached.