Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,749
- 试验地点
- 305
- 主要终点
- Time-to-first HF rehospitalization or death during the 12-months post-discharge
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time-to-first HF rehospitalization or death during the 12-months post-discharge
时间窗: 12-months after discharge
Improvement in an opportunity-based composite score of adherence to quality metrics for HF.
时间窗: Baseline to 12 months post discharge
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
次要结局
- Improvement in an opportunity-based composite score for adherence to HF discharge quality measures(Baseline through study completion, an average of 3 years)
- Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations(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)