TY - JOUR
T1 - Disease management in the treatment of patients with chronic heart failure who have universal access to health care
T2 - A randomized controlled trial
AU - The Israel Heart Failure Disease Management Study (IHF-DMS) investigators
AU - Kalter-Leibovici, Ofra
AU - Freimark, Dov
AU - Freedman, Laurence S.
AU - Kaufman, Galit
AU - Ziv, Arnona
AU - Murad, Havi
AU - Benderly, Michal
AU - Silverman, Barbara G.
AU - Friedman, Nurit
AU - Cukierman-Yaffe, Tali
AU - Asher, Elad
AU - Grupper, Avishay
AU - Goldman, Dorit
AU - Amitai, Miriam
AU - Matetzky, Shlomi
AU - Shani, Mordechai
AU - Silber, Haim
AU - Admon, Dan
AU - Arad, Michael
AU - Dvorkin, Yaakov
AU - Gercenshtein, Vered
AU - Klempner, Robert
AU - Lerner, Lev
AU - Menachemi, Doron M.
AU - Mutlak, Diab
AU - Peled-Potashnik, Yael
AU - Rispler, Shmuel
AU - Rosenblatt, Simcha
AU - Satanovsky, Yaron
AU - Shohat-Zabarski, Ronit
AU - Socher, Edgar
AU - Vered, Zvi
AU - Zwas, Donna R.
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/5/1
Y1 - 2017/5/1
N2 - 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.
AB - 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.
KW - Congestive heart failure
KW - Depression
KW - Disease management
KW - Health-related quality of life
KW - Hospital admissions
KW - Mortality
KW - Tele-monitoring
UR - http://www.scopus.com/inward/record.url?scp=85018450401&partnerID=8YFLogxK
U2 - 10.1186/s12916-017-0855-z
DO - 10.1186/s12916-017-0855-z
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AN - SCOPUS:85018450401
SN - 1741-7015
VL - 15
JO - BMC Medicine
JF - BMC Medicine
IS - 1
M1 - 90
ER -