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

Abstract

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-017-0855-z) contains supplementary material, which is available to authorized users.

Heart failure disease management: a systematic review of effectiveness in heart failure with preserved ejection fraction

“…reported separate HFpEF statistics (HFpEF defined as those with EF > 45%) and found no difference in percentage with HFpEF by survived or died. Nine studies reported no significant difference of their respective interventions on mortality between either intervention groups or intervention and usual care . Kalter‐Leibovici and colleagues dichotomized findings by HF group and found no significant difference by composite outcome (all‐cause mortality/HF hospitalization), or all‐cause mortality alone, and much wider confidence intervals in those with EF ≥ 50%.…”

“…If we use the ESC criterion that HFpEF includes an EF ≥ 50%, then seven studies are of interest. The outcomes of mortality and/or hospitalization were measured in six studies . Of these, only one had significantly fewer events in the intervention group, specifically in all‐cause mortality .…”

“…It is noticeable that the ESC recommended cut-off point of EF ≥ 50% was used only in seven studies. [17][18][19][20][21][22][23] Three…”

“…Only one study included an exercise component delivered as part of the study, 17 although advice or referral for increasing physical activity was frequently a component in other studies. Telemonitoring was included in the intervention in two studies, 18,22 and five provided medication adjustment by nurses or via general practitioners. [18][19][20]24,28 Patient assessment was included in all but two studies, 17,18 although the extent, frequency, and type of assessment varied.…”

“…The duration of the interventions ranged from 3 months to over 2 years, and interventions in seven of the studies were ≥12 months. 18,20,22,24,27,29,32 All studies included at least one face-to-face encounter with patients, but telephone contact was used in all to deliver some of the intervention. Home visits were used in 11 studies.…”