The Effect of Audit and Feedback Within a National Registry and Implementation Support on Guideline Adherence and Patient Outcomes in Cardiac Rehabilitation: an Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Adherence score
研究概览
简要总结
The goal of this open-label cluster-randomized effectiveness-implementation hybrid trial is to study whether a) audit and feedback of cardiac rehabilitation service delivery within a national quality registry and b) structured implementation support can improve center-level adherence to guidelines and short and long-term patient-level outcomes.
详细描述
Administering secondary prevention via structured cardiac rehabilitation (CR) programs for patients who have suffered a myocardial infarction (MI) reduces mortality and morbidity and improves quality of life. Still, treatment goal achievement at patient-level and service delivery at center-level are sub-optimal and there is a large variation in program structure and delivery at center-level.
Using an open-label cluster-randomized effectiveness-implementation hybrid trial design, the primary objective of this study is to prospectively evaluate whether a) audit and feedback of CR processes and structures within the national cardiac registry SWEDEHEART and b) supporting CR centers in implementing CR guidelines can increase center-level guideline adherence. The secondary objectives are the following:
- At baseline, to cross-sectionally evaluate the association between center-level adherence to guidelines and patient-level outcomes
- To prospectively study whether audit and feedback of CR processes and structures within the SWEDEHEART registry can improve short- and long-term patient-level outcomes
- To prospectively evaluate whether supporting CR centers in implementing CR guidelines can improve short- and long-term patient-level outcomes
- To evaluate the acceptability, adoption, fidelity, implementation cost, and cost effectiveness of the implementation support
All CR centers in Sweden (approximately 75 centers) will be offered participation in the study. Collectively these centers attend to approximately 8000 patients/year. Patient-level outcome data will be retrieved from national registries.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Centres report to the SWEDEHEART registry
排除标准
- •Unwillingness to participate in the study
- •Patient-level
- •Inclusion Criteria:
- •Diagnosis of a type 1 MI registered in the SWEDEHEART registry
- •Age 18-79 years at discharge from hospital
- •Attended at least two follow-up visits at CR centres included in the study
- •Exclusion Criteria:
结局指标
主要结局
Adherence score
时间窗: 3 years
The adherence score reflects center-level adherence to CR processes and structures as recommended in national guidelines on secondary prevention. The score is derived from 39 variables capturing guideline-directed CR structure and processes collected on center-level through the national cardiac registry SWEDEHEART. The score ranges from 0 (worst) to 39 (best).
次要结局
- Low-density lipoprotein cholesterol target attainment(One year)
- Self-reported smoking status(One year)
- Attendance in an exercise-based CR programme(One year)
- Systolic blood pressure(One year)
- Self-reported dietary habits(One year)
- Major adverse cardiovascular events (MACE)(Five years)
- Blood pressure target attainment(One year)
- Self-reported quality of life(One year)
- Self-reported physical activity(One year)
- Implementation cost and cost effectiveness(Assessed at the time of implementation)
- Low-density lipoprotein cholesterol(One year)
- Total mortality(Five years)
- Fidelity of the implementation support(Assessed six months after the implementation support has been provided)
- Acceptability of the implementation support(Assessed at the time of implementation)
- Adoption of the implementation support(Assessed six months after the implementation support has been provided)
研究者
Margret Leosdottir
Senior Cardiology Consultant, Associate Professor
Skane University Hospital