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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
5,749
Patient engagement to improve self-management/medication adherence
Health system engagement to improve local QI programs
Time-to-first HF rehospitalization or death during the 12-months post-discharge
Time frame: 12-months after discharge
Improvement in an opportunity-based composite score of adherence to quality metrics for HF.
The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be the number of times that good care is provided; the denominator will be the number of opportunities available. The score will consist of the following quality metrics assessed at the time of hospital discharge and during outpatient follow-up: * Use of evidence-based specific β-blockers at ≥ 50% target dose * ACE-I, ARB, or sacubitril/valsartan use at ≥ 50% target dose * Aldosterone antagonist use * Anticoagulation use in participants with atrial fibrillation * In participants with an LVEF ≤ 35%, implantable cardioverter defibrillator placement including cardiac resynchronization therapy placement for participants with sinus rhythm, LBBB, and a QRS ≥ 150 ms * Attendance at 1 or more of the following: a multidisciplinary HF disease management program, a cardiac rehabilitation program, or HF group educational classes
Time frame: Baseline to 12 months post discharge
Improvement in an opportunity-based composite score for adherence to HF discharge quality measures
The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be adherence to medications; the denominator will be the number of opportunities available. The per-opportunity adherence rate will consist of the following quality metrics assessed at the time of hospital discharge: * ACE-I, ARB, or sacubitril/valsartan prescription at discharge * ß-blocker prescription at discharge * Discharge instructions addressing activity level, diet, discharge medications, follow-up appointment, weight monitoring, and how to respond to a change in symptoms * LVEF assessment * Smoking cessation counseling * Medication adherence
Time frame: Baseline through study completion, an average of 3 years
If there is a significant positive effect on at least one of the primary endpoints, then participant-level healthcare expenditures
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University of Alabama Hospital
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, United States
Arkansas Heart Hospital and Clinics
Little Rock, Arkansas, United States
San Gorgonio Memorial Hospital
Banning, California, United States
Memorial Medical Center
Modesto, California, United States
Dignity Health Sequoia Hospital
Redwood City, California, United States
Riverside Community Hospital
Riverside, California, United States
Sutter Medical Center
Sacramento, California, United States
Stanford University
Stanford, California, United States
...and 144 more locations
Time frame: 6 months and 1 year postdischarge
Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations
Time frame: Baseline through study completion, an average of 3 years