Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Digital Engagement
* Other: Direct Engagement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Direct & Digital<br>Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence | Other: Digital Engagement<br>* Patient engagement to improve self-management/medication adherence<br>Other: Direct Engagement<br>* Health system engagement to improve local QI programs<br>|
| Other: Direct & Registry<br>Health system engagement to improve local QI programs and patient and control | Other: Direct Engagement<br>* Health system engagement to improve local QI programs<br>|
| Other: Digital & Registry<br>Patient engagement to improve self-management/medication adherence and control | Other: Digital Engagement<br>* Patient engagement to improve self-management/medication adherence<br>|
| No Intervention: Registry<br>Control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-first HF rehospitalization or death during the 12-months post-discharge |  | 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 | Baseline to 12 months post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 |  | 6 months and 1 year postdischarge | 
| Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations |  | Baseline through study completion, an average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Quality Improvement