Brief Summary
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.
Brief Title
Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
Detailed Description
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).
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Heart Failure
Quality Improvement
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03035474
Org Class
Other
Org Full Name
Duke University
Org Study Id
Pro00074513
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)
Primary Outcomes
Outcome Measure
Time-to-first HF rehospitalization or death during the 12-months post-discharge
Outcome Time Frame
12-months after discharge
Outcome Description
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
* 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
Outcome Measure
Improvement in an opportunity-based composite score of adherence to quality metrics for HF.
Outcome Time Frame
Baseline to 12 months post discharge
Secondary Outcomes
Outcome Description
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
* 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
Outcome Time Frame
Baseline through study completion, an average of 3 years
Outcome Measure
Improvement in an opportunity-based composite score for adherence to HF discharge quality measures
Outcome Time Frame
6 months and 1 year postdischarge
Outcome Measure
If there is a significant positive effect on at least one of the primary endpoints, then participant-level healthcare expenditures
Outcome Time Frame
Baseline through study completion, an average of 3 years
Outcome Measure
Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Richard Lucariello
Investigator Email
rilucari@montefiore.org
Investigator Phone