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

BMC Medicine

Research Article

Havi Murad¹  Laurence S. Freedman¹  Ofra Kalter-Leibovici²  Michal Benderly²  Arnona Ziv³  Galit Kaufman⁴  Haim Silber⁵  Miriam Amitai⁵  Dorit Goldman⁶  Tali Cukierman-Yaffe⁷  Dov Freimark⁸  Avishay Grupper⁸  Shlomi Matetzky⁹  Elad Asher⁹  Barbara G. Silverman^1,10  Nurit Friedman^1,11  Mordechai Shani^1,12 

[1] Biostatistics Unit, The Gertner Institute for Epidemiology & Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel;Cardiovascular Epidemiology Unit, The Gertner Institute for Epidemiology & Health Policy Research, Chaim Sheba Medical Center, 5265601, Tel-Hashomer, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Information and Computer Unit, The Gertner Institute for Epidemiology & Health Policy Research, Chaim Sheba Medical Center, Tel-Hashomer, Israel;Maccabi Healthcare Services, Northern District, Israel;Maccabi Healthcare Services, Tel Aviv, Israel;Meuhedet Health Services, South District, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Endocrinology Institute, Chaim Sheba Medical Center, Tel-Hashomer, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Heart Failure Institute, Lev Leviev Heart Center, Chaim Sheba Medical Center, Tel-Hashomer, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Intensive Cardiac Care Unit, Lev Leviev Heart Center, Chaim Sheba Medical Center, Tel -Hashomer, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Israel National Cancer Registry, Israel Center for Disease Control, Gertner Building, Chaim Sheba Medical Center, Tel-Hashomer, Israel;Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;Research and Evaluation Unit, Maccabi Healthcare Services, Tel Aviv, Israel;The Medical Research Infrastructure Development and Health Services Fund, Chaim Sheba Medical Center, Tel-Hashomer, Israel;

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

DOI  :  10.1186/s12916-017-0855-z

 received in 2017-02-14, accepted in 2017-04-11,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsIn 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.ResultsDuring 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.ConclusionsThis 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 registrationClinicaltrials.gov identifier: NCT00533013. Trial registration date: 9 August 2007. Initial protocol release date: 20 September 2007.

【 授权许可】

CC BY   
© The Author(s). 2017