The effect of a tailored message intervention on heart failure readmission rates, quality of life, and benefit and barrier beliefs in persons with heart failure. Pilot Testing of a Multicomponent Home Care Intervention for Older Adults With Heart Failure: An Academic Clinical Partnership Swiss Interdisciplinary Management Programme for Heart Failure (SWIM-HF): a randomised controlled trial study of an outpatient inter-professional management programme for heart failure patients in Switzerland. Randomized, Controlled Evaluation of Short- and Long-Term Benefits of Heart Failure Disease Management Within a Diverse Provider Network: The SPAN-CHF Trial The effect of nurse-led education on hospitalisation, readmission, quality of life and cost in adults with heart failure. A systematic review. Design and methodology of the COACH study: a multicenter randomised Coordinating study evaluating Outcomes of Advising and Counselling in Heart failure. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial Multicenter randomized trial of a comprehensive hospital discharge and outpatient heart failure management program. Lack of improvement of clinical outcomes by a low-cost, hospital-based heart failure management programme Advanced practice nurse strategies to improve outcomes and reduce cost in elders with heart failure. Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. Optimising self-care support for people with heart failure and their caregivers: development of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention using intervention mapping Prevalence and prognostic importance of precipitating factors leading to heart failure hospitalization: recurrent hospitalizations and mortality Evaluation of a self-management programme for congestive heart failure patients: design of a randomised controlled trial [Randomized controlled clinical trial of a home care unit intervention to reduce readmission and death rates in patients discharged from hospital following admission for heart failure]. Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial Care Management for Low-Risk Patients with Heart Failure
OBJECTIVE The purpose of this study was to determine the effect of a tailored message intervention on heart failure readmission rates , quality of life , and health beliefs in persons with heart failure ( HF ) . DESIGN This r and omized control trial provided a tailored message intervention during hospitalization and 1 week and 1 month after discharge . Theoretic framework The organizing framework was the Health Belief Model . SUBJECTS Seventy persons with a primary diagnosis of chronic HF were included in the study . RESULTS HF readmission rates and quality of life did not significantly differ between the treatment and control groups . Health beliefs , except for benefits of medications , significantly changed from baseline in the treatment group in directions posited by the Health Belief Model . CONCLUSIONS A tailored message intervention changed the beliefs of the person with HF in regard to the benefits and barriers of taking medications , following a sodium-restricted diet , and self-monitoring for signs of fluid overload . Future research is needed to explore the effect of health belief changes on actual self-care behaviors Background : Heart failure ( HF ) has clinical ly significant psychological and physical consequences for older persons , and hospitalization for HF is frequent and costly to the Medicare program . As HF is the most common primary Medicare home care diagnosis , there is a critical need to develop home care services that improve heath-related outcomes for this population . The primary aim of this pilot study was to develop , implement , and test the initial feasibility and potential efficacy of the Home-Care Education , Assessment , Remote-Monitoring , and Therapeutic Activities ( HEART ) trial , a nurse-directed multicomponent home care intervention . Observed outcomes were quality of life ( QOL ) , depressive symptoms , and 90-day hospitalization . Methods : Twenty-four patients with a primary diagnosis of HF were assigned to the intervention ( n = 12 ) or control group ( n = 12 ) according to geographical location in a large multibranch Medicare-certified home health agency . Intervention group patients received 8 structured nurse education visits using evidence -based protocol s design ed in previous trials to teach HF self-management and to prevent/reduce depression , as well as a telemonitoring system . Control group patients received usual care and telemonitoring .  Quality of life was assessed using the Minnesota Living With Heart Failure question naire . Depressive symptoms were assed using the Patient Health Question naire 9 at baseline and 90-day study end point . Results : Study protocol s and instrumentation were found to be feasible and effective . Examination of enrollment data led to a reevaluation of eligibility criteria . Patients participating in the HEART intervention demonstrated significantly improved QOL ( F = 8.99 , P = .007 ) and significantly reduced depressive symptoms ( F = 35.10 , P = .001 ) in comparison to control group patients at the study end point . There was a trend toward lower hospital readmission rates in the intervention group ( 16 % vs 25 % ) , but this was not statistically significant . Conclusion : This pilot study suggests that a full-scale trial of the HEART intervention is feasible PRINCIPLES International guidelines for heart failure ( HF ) care recommend the implementation of inter-professional disease management programmes . To date , no such programme has been tested in Switzerl and . The aim of this r and omised controlled trial ( RCT ) was to test the effect on hospitalisation , mortality and quality of life of an adult ambulatory disease management programme for patients with HF in Switzerl and . METHODS Consecutive patients admitted to internal medicine in a Swiss university hospital were screened for decompensated HF . A total of 42 eligible patients were r and omised to an intervention ( n = 22 ) or usual care group ( n = 20 ) . Medical treatment was optimised and lifestyle recommendations were given to all patients . Intervention patients additionally received a home visit by a HF-nurse , followed by 17 telephone calls of decreasing frequency over 12 months , focusing on self-care . Calls from the HF nurse to primary care physicians communicated health concerns and identified goals of care . Data were collected at baseline , 3 , 6 , 9 and 12 months . Mixed regression analysis ( quality of life ) was used . Outcome assessment was conducted by research ers blinded to group assignment . RESULTS After 12 months , 22 ( 52 % ) patients had an all-cause re-admission or died . Only 3 patients were hospitalised with HF decompensation . No significant effect of the intervention was found on HF related to quality of life . CONCLUSIONS An inter-professional disease management programme is possible in the Swiss healthcare setting but effects on outcomes need to be confirmed in larger studies Background —Several trials support the usefulness of disease management ( DM ) for improving clinical outcomes in heart failure ( HF ) . Most of these studies are limited by small sample size ; absence of concurrent , r and omized controls ; limited follow-up ; restriction to urban academic centers ; and low baseline use of effective medications . Methods and Results —We performed a prospect i ve , r and omized assessment of the effectiveness of HF DM delivered for 90 days across a diverse provider network in a heterogeneous population of 200 patients with high baseline use of approved HF pharmacotherapy . During a 90-day follow-up , patients r and omized to DM experienced fewer hospitalizations for HF [ primary end point , 0.55±0.15 per patient-year alive versus 1.14±0.22 per patient-year alive in control subjects ; relative risk ( RR ) , 0.48 , P=0.027 ] . Intervention patients experienced reductions in hospital days related to a primary diagnosis of HF ( 4.3±0.4 versus 7.8±0.6 days hospitalized per patient-year ; RR , 0.54 ; P<0.001 ) , cardiovascular hospitalizations ( 0.81±0.19 versus 1.43±0.24 per patient-year alive ; RR , 0.57 ; P=0.043 ) , and days in hospital per patient-year alive for cardiovascular cause ( RR , 0.64 ; P<0.001 ) . Intervention patients showed a trend toward reduced all-cause hospitalizations and total hospital days . On long-term ( mean , 283 days ) follow-up , there was substantial attrition of the 3-month gain in outcomes , with sustained significant reduction only in days in hospital for cardiac cause . Conclusions —In a population with high background use of st and ard HF therapy  , a DM intervention , uniformly delivered across varied clinical sites , produced significant short-term improvement in HF-related clinical outcomes . Longer-term benefit likely requires more active chronic intervention , even among patients who appear clinical ly stable OBJECTIVE The purpose of this systematic review was to highlight the effect of nurse-led 1:1 patient education sessions on Quality of Life ( QoL ) , readmission rates and healthcare costs for adults with heart failure ( HF ) living independently in the community . METHOD A systematic review of r and omised control trials was undertaken . Using the search terms nurse , education , heart failure , hospitalisation , readmission , rehospitalisation , economic burden , cost , expenditure and quality of life in PubMed , CINAHL and Google Scholar data bases were search ed . Papers pertaining to  nurse-led 1:1 HF disease management of education of adults in the community with a history of HF were review ed . RESULT The results of this review identified nurse-led education sessions for adults with HF contribute to reduction in hospital readmissions , reduction in hospitalisation and a cost benefit . Additionally , higher functioning and improved QoL were also identified . CONCLUSION These results suggest that nurse-led patient education for adults with HF  improves QoL and reduces hospital admissions and readmissions . PRACTICE IMPLICATION S Nurse-led education can be delivered utilising diverse methods and impact to reduce readmission as well as hospitalisation BACKGROUND While there are data to support the use of comprehensive non-pharmacological intervention programs in patients with heart failure ( HF ) , other studies have not confirmed these positive findings . Substantial differences in the type and intensity of disease management programs make it impossible to draw definitive conclusions about the effectiveness , optimal timing and frequency of interventions . AIMS 1 . To determine the effectiveness of two interventions ( basic support vs. intensive support ) compared to ' care as usual ' in HF patients , on time to first major event ( HF readmission or death ) , quality of life and costs . 2 . To investigate the role of underlying mechanisms ( knowledge , beliefs , self-care behaviour , compliance ) on the effectiveness of the two interventions . METHODS This is a r and omised controlled trial in which 1050 patients with heart failure will be r and omised into three treatment arms : care as usual , basic education and support or intensive education and support . Outcomes of this study are ; time to first major event ( HF hospitalisation or death ) , quality of life ( Minnesota Living with HF Question naire , R AND 36 and Ladder of Life ) and costs . Data will be collected during initial admission and then 1 , 6 , 12 , and 18 months after discharge . In addition , data on knowledge , beliefs , self-care behaviour and compliance will be collected . RESULTS The study started in January 2002 and results are expected at the end of 2005 . CONCLUSIONS This study will help health care providers in future to make rational and informed choices about which components of a HF management program should be exp and ed and which components can possibly be deleted Background Heart failure is a prevalent health problem associated with costly hospital readmissions . Transitional care programs have been shown to reduce readmissions but are costly to implement . Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed . The objective of this r and omized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight , blood pressure , heart rate , and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure . Methods / Design A multi-center , r and omized controlled trial is being conducted at six academic health systems in California . A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure . Patients in the intervention group will receive intensive patient education using the ‘ teach-back ’ method and receive instruction in using the telemonitoring equipment . Following hospital discharge , they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a central ized call center . The nurses also will call patients and patients ’ physicians in response to alerts generated by the telemonitoring system , based on predetermined parameters . The primary outcome is readmission for any cause within 180 days . Secondary outcomes include 30-day readmission , mortality , hospital days , emergency department ( ED ) visits , hospital cost , and health-related quality of life . Discussion BEAT-HF is one of the largest r and omized controlled trials of telemonitoring in patients with heart failure , and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring . The study population also includes patients with a wide range of demographic and socioeconomic characteristics . Once completed , the study will be a rich re source of information on how best to use remote technology in the care management of patients with chronic heart failure . Trial registration Clinical Trials.gov # NCT01360203 AIMS Disease management programs can reduce hospitalizations in high-risk heart failure ( HF ) patients , but generalizability to the population hospitalized for HF remains to be proven . We aim ed to assess the effectiveness of a discharge and outpatient management program in a non-selected cohort of patients hospitalized for HF . METHODS AND RESULTS Patients admitted with decompensated HF were r and omized to receive usual care ( n=174 ) or an  intervention ( n=164 ) consisting of a comprehensive hospital discharge planning and close follow-up at a HF clinic . After a median of 509 days , there were fewer events ( readmission or death ) in the intervention as compared with the control group ( 156 vs. 250 ) , which represents 47 % ( 95%CI : 29 - 65 ; P<0.001 ) event reduction per observation year . At 1-year , time to first event , time to first all-cause and HF readmission , and time to death were increased in the intervention group ( P<0.001 ) . All-cause and HF readmission rates per observation year were significantly lower , quality of life improved and overall cost of care was reduced in the intervention group . CONCLUSIONS This comprehensive hospital discharge and outpatient management program prolonged time to first event , reduced hospital readmissions , improved survival and quality of life of patients hospitalized for HF , while reducing cost of management Objective Heart failure ( HF ) is a major health problem result ing in a high financial burden for the healthcare system . Many previous HF management programmes reduced adverse clinical outcomes and costs , but they usually involved several professional figures as well as huge investments , requiring re sources and budgets not often available in our healthcare system . We evaluated the effects of our HF management programme , which included patient education and regular outpatient contact with the HF team , on re-hospitalisation and death , optimising the few re sources already available at our hospital . Methods Two hundred consecutive patients admitted to the internal medicine department with a diagnosis of HF were r and omised to the intervention group ( nurse-led education programme , facilitated telephone communication and follow-up visits with an internist at 15 days , 1 and 6 months ) or to the usual care group ( follow-up by their primary care physician ) . The primary endpoints were all-cause readmissions and all-cause deaths during the 6-month post-discharge period . Results There were 81 all-cause hospital readmissions in the intervention group and 82 in the control group ( P = NS ) . Fourteen patients ( 14 % ) in the intervention group and eight patients ( 8 % ) in the control group died during the study period ( P = NS ) . Unplanned outpatient visits were less frequent in the intervention group than in the control group ( 39 [ 28 % ] versus 99 [ 72 % ] , P < 0.001 ) . Conclusions The present low-cost HF management programme reduced unplanned outpatient visits but proved ineffective in reducing subsequent readmissions and in improving clinical status . More intense follow-up monitoring and more re sources are needed to achieve better results The aim of this study was to investigate whether , in a r and omized controlled trial ( RCT ) of vulnerable elders with heart failure ( HF ) , advanced practice nurses ( APNs ) who were coordinating care in the transition from hospital to home could improve outcomes , prevent rehospitalizations , and reduce costs when compared with usual care . The APN strategies focused on improving patient and family or caregiver effectiveness in managing their illnesses , strengthening the patient-provider relationship , and managing comorbid conditions while improving overall health . The results were positive . By capitalizing on the patient 's desire to achieve their identified goals , APNs successfully educated patients about the meaning of their symptoms and appropriate self-management strategies ; improved patient-provider communication patterns ; and marshaled caregiver and community re sources to maximize patient adherence to the treatment plan and overall quality of life . While HF was the primary reason for enrollment in the study , optimal health outcomes dem and ed a strong focus on integrating management of comorbid conditions and other long-st and ing health problems . Specific strategies used by the APN to achieve these positive outcomes are addressed in this report . These strategies are compared with nursing interventions used in other RCTs of HF home management . Directions for future research are explored BACKGROUND Nursing approaches to manage patients with heart failure ( HF ) showed benefits in reducing the morbidity and mortality . However , combining intra-hospital education with telephone contact after hospital discharge has been little explored . OBJECTIVE To compare two nursing intervention groups among patients hospitalized due to decompensated HF : the intervention group ( IG ) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the  control group  ( CG ) received in-hospital intervention only . Outcomes were levels of HF and self-care knowledge , the frequency of visits to the emergency room , rehospitalizations and deaths in a three-month period . METHODS R and omized clinical trial . We studied adult HF patients with left ventricle ejection fraction ( LVEF ) < 45 % who could be contacted by telephone after discharge .  HF awareness was evaluated through a st and ardized question naire that also included questions regarding self-care knowledge , which was answered during the hospitalization period and three months later . For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study . RESULTS Forty-eight patients were assigned to the IG and 63 to the CG . Mean age ( 63 ± 13 years ) and L ( around 29 % ) were similar in the two groups . Scores for HF and self-care knowledge were similar at baseline . Three months later , both groups showed significantly improved HF awareness and self-care knowledge scores ( P < 0.001 ) . Other outcomes were similar . CONCLUSION An in-hospital educational nursing intervention benefitted all HF patients in underst and ing their disease , regardless of telephone contact after discharge Background We aim ed to establish the support needs of people with heart failure and their caregivers and develop an intervention to improve their health-related quality of life . Methods We used intervention mapping to guide the development of our intervention . We identified “ targets for change ” by synthesis ing research evidence and international guidelines and consulting with patients , caregivers and health service providers . We then used behaviour change theory , expert opinion and a taxonomy of behaviour change techniques , to identify barriers to and facilitators of change and to match intervention strategies to each target . A patient and public involvement group helped to identify patient and caregiver needs , refine the intervention objectives and strategies and deliver training to the intervention facilitators . A feasibility study ( IS RCT N25032672 ) involving 23 patients , 12 caregivers and seven trained facilitators at four sites assessed the feasibility and acceptability of the intervention and quality of delivery and generated ideas to help refine the intervention . Results The Rehabilitation Enablement in Chronic Heart Failure ( REACH-HF ) intervention is a comprehensive self-care support programme comprising the “ Heart Failure Manual ” , a choice of two exercise programmes for patients , a “ Family and Friends Re source ” for caregivers , a “ Progress Tracker ” tool and a facilitator training course . The main targets for change are engaging in exercise training , monitoring for symptom deterioration , managing stress and anxiety , managing medications and underst and ing heart failure . Secondary targets include managing low mood and smoking cessation . The intervention is facilitated by trained healthcare professionals with specialist cardiac experience over 12 weeks , via home and telephone contacts . The feasibility study found high levels of satisfaction and engagement with the intervention from facilitators , patients and caregivers . Intervention fidelity analysis and stakeholder feedback suggested that there was room for improvement in several areas , especially in terms of addressing caregivers ’ needs . The REACH-HF material s were revised accordingly . Conclusions We have developed a comprehensive , evidence -informed , theoretically driven self-care and rehabilitation intervention that is grounded in the needs of patients and caregivers . A r and omised controlled trial is underway to assess the effectiveness and cost-effectiveness of the REACH-HF intervention in people with heart failure and their caregivers AIMS Hospitalizations for heart failure ( HF ) are common and are associated with significant morbidity , mortality and cost . However , precipitating factors leading to HF hospitalization and their importance with respect to subsequent outcomes are not well understood . METHODS AND RESULTS The symptoms and signs present at admission and investigator-identified factors thought to have contributed to the first adjudicated HF hospitalization in the C and esartan in Heart Failure : Assessment of Reduction in Mortality and Morbidity ( CHARM ) programme were prospect ively collected and stratified by ejection fraction ( EF ) . Potential precipitants were collected using a specifically design ed case report form and categorized according to the presence of cardiovascular ( CV ) , non-CV and unknown factors . Associations between these factors and subsequent rehospitalization and mortality rates were examined . Of 1668 patients who experienced HF hospitalization , 1152 had reduced EF ( ≤40 % , HFrEF ) and 516 had preserved EF ( HFpEF ) . Overall , 54 % had CV , 32 % had non-CV and 14 % had unknown factors thought to have precipitated HF , with similar proportions in the HFrEF and HFpEF groups . The most common precipitants were arrhythmia ( 15 % ) , other non-CV factors ( 11 % ) and respiratory infection ( 10 % ) . Subsequent CV readmission rates were highest in those whose initial HF hospitalization was precipitated by CV factors . However , mortality rates were similar among patients with any of the three categories of precipitating factors . Results were similar in HFrEF and HFpEF . CONCLUSIONS Among chronic HF patients hospitalized for decompensation , the investigator-reported precipitating factor was not associated with the subsequent mortality rate , but was associated with type of readmission : readmissions for CV reasons were more likely when the index precipitant was CV Background Congestive heart failure ( CHF ) has a substantial impact on care utilisation and quality of life . It is crucial for patients to cope with CHF adequately , if they are to live an acceptable life . Self-management may play an important role in this regard . Previous studies have shown the effectiveness of the ' Chronic Disease Self-Management Program ' ( CDSMP ) , a group-based cognitive behavioural programme for patients with various chronic conditions . However , the programme 's effectiveness has not yet been studied specifically among CHF patients . This paper presents the design of a r and omised controlled trial to evaluate the effects of the CDSMP on psychosocial attributes , health behaviour , quality of life , and health care utilisation of CHF patients . Methods / Design The programme is being evaluated in a two-group r and omised controlled trial . Patients were eligible if they had been diagnosed with CHF and experienced slight to marked limitation of physical activity . They were selected from the Heart Failure and /or Cardiology Outpatient Clinics of six hospitals . Eligible patients underwent a baseline assessment and were subsequently allocated to the intervention or control group . Patients allocated to the intervention group were invited to attend the self-management programme consisting of six weekly sessions , led by a CHF nurse specialist and a CHF patient . Those allocated to the control group received care as usual . Follow-up measurements are being carried out immediately after the intervention period , and six and twelve months after the start of the intervention . An effect evaluation and a process evaluation are being conducted . The primary outcomes of the effect evaluation are self-efficacy expectancies , perceived control , and cognitive symptom management . The secondary outcome measures are smoking and drinking behaviour , Body Mass Index ( BMI ) , physical activity level , self-care behaviour , health-related quality of life , perceived autonomy , symptoms of anxiety and depression , and health care utilisation . The programme 's feasibility is assessed by measuring compliance with the protocol , patients ' attendance and adherence , and the opinions about the programme .  Discussion A total number of 318 patients were included in the trial . At present , follow-up data are being collected . The results of the trial become clear after completion of the data collection in January 2007.Trial Registration Trialregister ( http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=467 ) IS RCT N88363287 INTRODUCTION AND OBJECTIVES To determine the effectiveness of a primarily educational intervention in heart failure ( HF ) patients implemented in a home care unit . METHODS This r and omized controlled clinical trial involved 279 HF patients who were discharged from a tertiary-care hospital between February 2001 and June 2002 . Patients with dementia , terminal non-cardiac disease , or chronic obstructive pulmonary disease were excluded . Data collected included the cause of cardiac decompensation . A primarily educational intervention was implemented in the patient 's home for up to 15 days after hospital discharge . Treatment was adjusted during the first week if necessary . The primary outcome measure was the 1-year cumulative incidence of readmission or death . Secondary measures were the incidence of readmission , mortality , and emergency department admission .  Telephone interviews were carried out 3 , 6 and 12 months after discharge , and clinical records were up date d when necessary . Emergency department admission in the first 6 months was monitored . RESULTS At 1-year follow-up , 62 of the 137 patients ( 45.3 % ) in the intervention group had been readmitted or died , compared with 75 of the 142 ( 52.8 % ) in the control group , ( relative risk=0.86 , P=.232 ) . Among patients who suffered decompensation because failure to adhere to treatment , 16 of the 45 ( 35.6 % ) in the intervention group were readmitted or died , compared with 34 of the 56 ( 60.7 % ) control group patients ( relative risk=0.59 , P=.016 ) . CONCLUSIONS This intervention is feasible but , when applied indiscriminately to every discharged heart failure patient , the best that can be expected is only a modest reduction in readmission and death rates , which , in this study in particular , did not achieve statistical significance Background Heart failure ( HF ) is common , costly and associated with significant morbidity and poor quality of life , particularly for patients with low socioeconomic status .  Self-management training has been shown to reduce HF related morbidity and hospitalization rates , but there is uncertainty about how best to deliver such training and what patients benefit . This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level . Methods / Design In this r and omized controlled multi-site trial , English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States . Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic . Baseline data , including literacy level , are collected at enrollment and follow-up surveys are conducted at 1 , 6 and 12 monthsUpon enrollment , both the control and intervention groups receive the same 40 minute , literacy-sensitive , in-person , HF education session covering the 4 key self-management components of daily self assessment and having a plan , salt avoidance , exercise , and medication adherence . All participants also receive a literacy-sensitive workbook and a digital bathroom scale . After the baseline education was completed , patients are r and omly allocated to return to usual care or to receive ongoing education and training . The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment , as well as periodic follow-up phone calls from the educator over the course of 1 year . These phone calls are design ed to reinforce the education , assess participant knowledge of the education and address barriers to success . The primary outcome is the combined incidence of all cause hospitalization and death . Secondary outcomes include HF-related quality of life , HF-related hospitalizations , knowledge regarding HF , self-care behavior , and self-efficacy . The effects of each intervention will be stratified by patient literacy , in order to identify any differential effects . Discussion Enrollment of the proposed 660 subjects will continue through the end of 2009 . Outcome assessment s are projected to be completed by early 2011.Trial Registration Clinical Trials.gov http://www . clinical trials.gov/ Context Case management by nurses improves outcomes for patients with heart failure , but studies have targeted patients at high risk for poor outcomes because of sociodemographic or clinical factors . Whether such programs benefit low-risk patients with heart failure is unknown . Contribution Among 462 patients in 1 staff-model health maintenance organization who were hospitalized with heart failure , those r and omly assigned to nurse care management  had rates of rehospitalization and death similar to rates in those who received usual care . Implication s Care management for heart failure may offer limited benefit for patients with clinical and sociodemographic characteristics that put them at low risk for hospitalization or death . The Editors The societal and personal burden of heart failure is large and is growing apace with the aging of the population ( 1 ) . Heart failure is the largest Medicare expenditure and is the leading cause of hospitalization for persons 65 years of age or older ( 2 ) . Rates of hospital readmission within 6 months range from 25 % to 50 % ( 3 ) . Moreover , behavioral factors , such as nonadherence to diet and medications , and social factors , such as social isolation and indigence , frequently contribute to early rehospitalizations ( 3 - 4 ) . Previous studies of specialized treatment programs for heart failure have targeted clinical ly high-risk , medically underserved population s. These studies demonstrated reductions in rehospitalization for heart failure and , to a lesser extent , rehospitalization for all causes ( 4 - 6 ) . In a pilot study conducted at a single Kaiser Permanente medical center in 1994 to 1995 , we found a statistically significant reduction in rehospitalization rates during a 3-month period among low-risk patients with heart failure who received nurse care management over a 6-month period ( 7 ) . The present study evaluated nurse care management for heart failure in a low-risk population of patients selected from several medical centers in the same large health maintenance organization ( HMO ) . Methods Design This was a r and omized , controlled trial of a nurse care management system for heart failure . Patient Sample We selected patients who were hospitalized with a provisional diagnosis of heart failure from Kaiser Permanente medical centers located in San Francisco , Vallejo , Walnut Creek , Sacramento , and Roseville , California , between May 1998 and October 2000 .  Hospital-based project nurses review ed hospital charts to screen for patients with new-onset or worsening heart failure on the basis of 1 ) shortness of breath ( dyspnea at rest , including orthopnea or paroxysmal nocturnal dyspnea ) and 2 ) at least 1 corroborating clinical sign ( pulmonary congestion on examination , including rales , crackles , or wheezes ) or radiologic abnormality ( pulmonary congestion on chest radiograph ) consistent with heart failure . We excluded patients who were scheduled for coronary artery bypass or valvular surgery ; had undergone cardiac surgery in the preceding 8 weeks ; had a serum creatinine value of 13.26 mol/L ( 5 mg/dL ) or greater ; were receiving dialysis or awaiting renal transplantation ; had a history of severe pulmonary disease requiring home oxygen ; had 1 or more additional diseases that were expected to result in death within 1 year ; had cognitive mental deficits , substance abuse , or severe psychiatric disorders ; or were expected to move from the area within 1 year . We did not use measurements of left ventricular function by echocardiography , radionuclide angiography , or contrast angiography as selection criteria . Among the 59 % of patients who had left ventricular ejection fraction measured , 28 % had an ejection fraction less than 0.40 and 31 % had an ejection fraction of 0.40 or greater . Study nurses interviewed patients during hospitalization or by telephone within 2 weeks after discharge , explained the purpose of the study , and obtained written informed consent . Research staff who were not associated with delivering the intervention r and omly assigned patients to treatment conditions by using sealed assignments . Equal numbers of patients were allocated to the 2 groups in each medical center by using the Efron procedure ( 8) . Physicians were notified of r and omization assignment by letter . The institutional review boards at Stanford University and Kaiser Permanente approved the study . Baseline Data Collection Baseline data , recorded by staff nurses on st and ardized forms , included sociodemographic characteristics , self-reported illnesses , medications , and results of st and ard diagnostic studies and laboratory tests . Treatment Environment Before the study , the investigators met with the medical staffs of the 5 participating hospitals to present and discuss the research protocol , including detailed descriptions of the planned interactions between the nurse care managers and the medical staff . The medical staffs were multispecialty groups of 20 to 60 physiciansapproximately 480 physicians total . After r and omization , all patients continued to receive usual care , including instruction on diet , drug adherence , physical activity , and response to changing symptoms .  Intervention In addition to usual care , patients in the intervention group received a physician-directed , nurse-managed , home-based program for heart failure developed by the investigators ( 9 ) . Originally design ed for coronary risk factor management , this program was exp and ed to encompass heart failure . It incorporated the features of best practice design ated by Rich ( 10 ) : coordination of care across disciplines , patient and caregiver education , enhancement of self-management skills , effective follow-up , and guidelines -based medications for heart failure . Our system also incorporated the principles of heart failure management developed by the Cardiovascular Nursing Council of the American Heart Association ( 11 ) . The st and ardized , telephone-mediated intervention included the following elements : initial educational session , including a videotape ; baseline telephone counseling session ; nurse-initiated follow-up telephone contacts ; pharmacologic management ; and nurse-initiated communication with physicians . The initial 1-hour educational session with a nurse occurred in the patient 's medical center . Patients received printed educational material s , including methods for self-monitoring of symptoms , body weight , and medications ; a dietary management workbook ; food-frequency question naires ; and instructions on how to access emergency care in case symptoms abruptly worsened . Patients viewed a videotape portraying the treatment process . Two experienced Stanford-based nurse care managers provided a 45-minute baseline telephone counseling session within 1 week of r and omization ; subsequent nurse contacts were tailored to the needs of the individual patients . Nurse-initiated follow-up telephone contacts with patients during daytime weekday hours were scheduled at weekly intervals for 6 weeks ; biweekly for 8 weeks ; monthly for 3 months ; bimonthly for 6 months ; and as needed to monitor patients ' medications , laboratory assessment s , symptoms , and other medical problems . We based pharmacologic management for heart failure on published treatment guidelines ( 12 , 13 ) . The nurse care managers obtained permission from physicians to initiate and regulate pharmacologic therapy for heart failure according to study protocol . Nurse-initiated communication with physicians about patients ' current medical status was maintained and specific management problems were addressed . Nurse care managers spent an average of 9 hours per patient coordinating the treatment plan with patients and physicians during the first year . The intervention did not include consultation with social services to facilitate discharge planning or home visits after discharge . Measurement Research staff who were not associated with , and were blinded to , the intervention conditions measured health outcomes at 12 months . On the basis of review of the Kaiser Permanente medical records , project nurses used st and ardized forms to record the cause , number , and duration of hospitalizations and emergency department visits during the 12-month follow-up period . Kaiser Permanente provided more than 90 % of all care . Two cardiologists who were not associated with implementing the intervention review ed medical records on deaths , rehospitalizations , and emergency department visits to determine whether these events were primarily due to heart failure or due to other causes . They did not use discharge diagnoses recorded in the medical record to make these judgments . Rehospitalizations and emergency department visits were classified as either due to heart failure or due to other causes ; the latter were classified as cardiac or noncardiac . Outcomes The primary outcome of the study was the time to first rehospitalization for heart failure or for any cause . In our analysis , we treated deaths occurring before rehospitalization as censored data . However , analysis in which we classified deaths occurring before rehospitalization as outcome events result ed in similar conclusions , primarily because most observed deaths occurred after a rehospitalization . Secondary outcomes were the time to a composite outcome of death , rehospitalization , or emergency department visits for cardiac cause or for any cause , the proportion of patients receiving recommended pharmacotherapy , and the rate of outpatient clinic and emergency department visits . We based the study 's power on a proposed reduction in the risk for rehospitalization for heart failure from 21 % to 13 % , corresponding to a number needed to treat for benefit of 12.5 . We expected that the actual number needed to treat for benefit would be less than 12.5 . Statistical Analysis We evaluated the effect of care management on rehospitalization rates by using KaplanMeier survival curves and Cox proportional hazards regression models . We compared nominal variables by using chi-square tests , ordered variables by
Main Findings : The results indicate that an intervention involving any human factor principles may nearly double an individual ’s probability of not being readmitted .
Principal Conclusions : Interventions with human factor principles reduce readmissions among HF patients .
Background : Human factors play an important role in health-care outcomes of heart failure ( HF ) patients .
A systematic review and meta- analysis of clinical trial studies on HF hospitalization may yield positive proofs of the beneficial effect of specific care management strategies .
Purpose : To investigate how the 8 guiding principles of choice , rest , environment , activity , trust , interpersonal relationships , outlook , and nutrition reduce HF readmissions .