Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.
- Heart Failure
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Age ≥ 18 years
- Acute HF as a primary cause of hospitalization
- Hospitalizations for acute HF will be determined by local clinician-investigators but should include the following:
- Symptoms (eg, dyspnea, fatigue), signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the hospitalization and
- Treatments aimed at acute HF (eg, intravenous diuretics, vasodilators, or inotropes)
- LVEF ≤ 40% based on last local measurement using echocardiography, multigated acquisition scan, computed tomography (CT) scanning, magnetic resonance imaging, or ventricular angiography
- Planned discharge to home or other supported care facility where patients are individually responsible for medication management
- Prior heart transplant or current/planned left ventricular assistance device
- Chronic kidney disease requiring dialysis
- Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
- Unable to participate in longitudinal follow-up, such as plans to move outside the US in the following year
- Study Type
- Intervention Model
- Factorial Assignment
- Primary Purpose
- None (Open Label)
Direct & Digital
|Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence||
Direct & Registry
|Health system engagement to improve local QI programs and patient and control||
Digital & Registry
|Patient engagement to improve self-management/medication adherence and control||
- NCT ID
- Duke University
Study ContactTracy Hofmann
This trial will be a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics. Outcomes will be assessed following discharge for participants hospitalized with acute HF and reduced left ventricular ejection fraction. All participants in the trial will be consented for follow-up as part of the CONNECT-HF registry on clinical outcomes, medication use, and participant-centered outcomes, including quality-of-life (QOL) assessments will be collected up to 12 months post-discharge at pre-specified intervals (6 weeks and 3, 6, and 12 months).
The health-system QI program will involve site visits and ongoing mentoring from teams of healthcare professionals with specialized training and field experience to help health systems and individual hospitals to design local QI plans.
A key substudy will assess a participant-engagement strategy (digital) of a mobile application utilizing behavioral tools to reinforce health behaviors, including self-monitoring/self-management and medication adherence.
Follow-up will occur via a centralized telephone interview by trained personnel via the DCRI Call Center. At each interview, participants will be asked to report current medications, rehospitalizations, and QOL assessments. Based on participant-reported events, medical billing data for rehospitalizations, emergency department visits, and procedures will be obtained.
Quality of life assessments will include the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQOL five dimensions questionnaire (EQ-5D).