Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial

Ofra Kalter-Leibovici, Dov Freimark, Laurence S Freedman, Galit Kaufman, Arnona Ziv, Havi Murad, Michal Benderly, Barbara G Silverman, Nurit Friedman, Tali Cukierman-Yaffe, Elad Asher, Avishay Grupper, Dorit Goldman, Miriam Amitai, Shlomi Matetzky, Mordechai Shani, Haim Silber, Israel Heart Failure Disease Management Study (IHF-DMS) investigators, Dan Admon, Miriam Amitai, Michael Arad, Elad Asher, Michal Benderly, Tali Cukierman-Yaffe, Yaakov Dvorkin, Laurence S Freedman, Dov Freimark, Nurit Friedman, Vered Gercenshtein, Dorit Goldman, Avishay Grupper, Ofra Kalter-Leibovici, Galit Kaufman, Robert Klempner, Lev Lerner, Doron M Menachemi, Havi Murad, Diab Mutlak, Yael Peled-Potashnik, Shmuel Rispler, Simcha Rosenblatt, Yaron Satanovsky, Mordechai Shani, Ronit Shohat-Zabarski, Haim Silber, Barbara G Silverman, Edgar Socher, Zvi Vered, Arnona Ziv, Donna R Zwas, Ofra Kalter-Leibovici, Dov Freimark, Laurence S Freedman, Galit Kaufman, Arnona Ziv, Havi Murad, Michal Benderly, Barbara G Silverman, Nurit Friedman, Tali Cukierman-Yaffe, Elad Asher, Avishay Grupper, Dorit Goldman, Miriam Amitai, Shlomi Matetzky, Mordechai Shani, Haim Silber, Israel Heart Failure Disease Management Study (IHF-DMS) investigators, Dan Admon, Miriam Amitai, Michael Arad, Elad Asher, Michal Benderly, Tali Cukierman-Yaffe, Yaakov Dvorkin, Laurence S Freedman, Dov Freimark, Nurit Friedman, Vered Gercenshtein, Dorit Goldman, Avishay Grupper, Ofra Kalter-Leibovici, Galit Kaufman, Robert Klempner, Lev Lerner, Doron M Menachemi, Havi Murad, Diab Mutlak, Yael Peled-Potashnik, Shmuel Rispler, Simcha Rosenblatt, Yaron Satanovsky, Mordechai Shani, Ronit Shohat-Zabarski, Haim Silber, Barbara G Silverman, Edgar Socher, Zvi Vered, Arnona Ziv, Donna R Zwas

Abstract

Background: The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies.

Methods: In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center.

Results: During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up.

Conclusions: This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint, but it improved health-related quality of life and depression. A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care.

Clinical trial registration: Clinicaltrials.gov identifier: NCT00533013 . Trial registration date: 9 August 2007. Initial protocol release date: 20 September 2007.

Keywords: Congestive heart failure; Depression; Disease management; Health-related quality of life; Hospital admissions; Mortality; Tele-monitoring.

Figures

Fig. 1
Fig. 1
Screening, randomization and completion of follow-up. CHF congestive heart failure, NYHA New York Heart Association
Fig. 2
Fig. 2
a First hospital admission for heart failure or death from all causes by study group. b First hospital admission for heart failure by study group. c Death from all causes by study group. The p value refers to a comparison between the two study groups using a log-rank test. DM Disease management, UC Usual care
Fig. 3
Fig. 3
a Effect of disease management on the composite outcome (first hospital admission for heart failure or death) by subgroups of patients. b Effect of disease management on all-cause mortality by subgroups of patients. c Effect of disease management on first hospital admission for heart failure by subgroups of patients. Information on the effect of disease management in subgroups of patients was derived from Cox proportional hazard models, adjusted for age, sex, heart failure center and baseline values of NYHA functional class and 6-minute walk test. NYHA New York Heart Association

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Source: PubMed

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