Heart Failure Center Accreditation Program (HF-CAP) in China: A Prospective Multicenter Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,240
- 主要终点
- Composite of Heart Failure Rehospitalization or All-Cause Mortality
研究概览
简要总结
Heart failure is a common and serious condition that affects millions of people in China and worldwide. Although effective treatments and clinical guidelines are available, the quality of heart failure care varies across hospitals, and many patients do not receive optimal management in real-world practice.
The Heart Failure Center Accreditation Program (HF-CAP) is a national quality improvement initiative in China designed to standardize and improve the diagnosis, treatment, and follow-up care of patients hospitalized with heart failure. This study aims to evaluate whether implementation of the HF-CAP program improves the quality of heart failure management and clinical outcomes compared with usual care.
This is a prospective, multicenter, cluster randomized controlled trial conducted in hospitals across China. Hospitals will be randomly assigned to either the HF-CAP intervention group or the usual care group. Adult patients hospitalized primarily for heart failure will be enrolled and followed for 12 months after discharge.
The main outcomes of this study are (1) a composite of heart failure rehospitalization or all-cause mortality within 12 months after discharge, and (2) a heart failure management quality score. Secondary outcomes include heart failure rehospitalization, all-cause rehospitalization, and all-cause mortality.
The results of this study are expected to provide high-quality evidence on whether hospital-based accreditation and quality improvement programs can improve the care and outcomes of patients with heart failure in real-world clinical practice in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Eligibility Criteria for Participating Centers
- •The participating center must be registered on the China Heart Failure Center website.Institutions applying for standard-level or primary-level heart failure center accreditation are required to have reported at least 300 or 100 heart failure cases, respectively, and must continuously report at least 10 or 8 heart failure cases per month, respectively.
- •The participating center must have the capability to implement quality improvement measures.
- •Eligibility Criteria for Participants
- •Age 18 years or older.
- •Heart failure is the primary reason for hospitalization.
- •Whether hospitalization is due to heart failure will be determined by local investigators, but must meet the following criteria:
- •i. Presence of symptoms of heart failure (such as dyspnea or fatigue), signs of heart failure (such as elevated jugular venous pressure or peripheral edema), or laboratory or imaging evidence, including but not limited to: Pulmonary congestion on chest X-ray, Elevated natriuretic peptide levels, Echocardiographic evidence of structural or functional cardiac abnormalities. ii. Receipt of treatment targeting acute or chronic heart failure etiology, such as intravenous diuretics, vasodilators, positive inotropic agents, or coronary revascularization.
排除标准
- •Presence of a life-threatening condition unrelated to heart failure with an expected life expectancy of less than 1 year (for example, advanced malignancy).
- •Inability to complete the planned follow-up assessments.
研究组 & 干预措施
HF-CAP Intervention
Hospitals assigned to this arm will implement the Heart Failure Center Accreditation Program (HF-CAP).
The intervention includes standardized heart failure care processes, multidisciplinary team-based management, regular training of healthcare professionals, patient and caregiver education, structured discharge planning, and post-discharge follow-up, as well as continuous quality monitoring and feedback. Patients hospitalized for heart failure in these hospitals will receive care under the HF-CAP framework.
干预措施: Heart Failure Center Accreditation Program (HF-CAP) (Other)
Usual Care
Hospitals assigned to this arm will provide usual care for patients hospitalized with heart failure.
Usual care is delivered according to local clinical practice and existing guidelines, without implementation of the Heart Failure Center Accreditation Program (HF-CAP) or additional quality improvement interventions.
干预措施: Usual Care (Other)
结局指标
主要结局
Composite of Heart Failure Rehospitalization or All-Cause Mortality
时间窗: Within 12 months after hospital discharge
Heart Failure Management Quality Score
时间窗: From baseline hospitalization to 12 months after discharge
次要结局
- Time to First Heart Failure Rehospitalization(Within 12 months after hospital discharge)
- Number of Heart Failure Rehospitalizations(Within 12 months after hospital discharge)
- All-Cause Rehospitalization(Within 12 months after hospital discharge)
- All-Cause Mortality(Within 12 months after hospital discharge)