Abstract：
BACKGROUND: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs.
METHODS: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation.
CONCLUSIONS: Optimizing cardiac rehabilitation centres\' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI.
BACKGROUND: ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.
METHODS: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation.
CONCLUSIONS: Optimizing cardiac rehabilitation centres\' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI.
BACKGROUND: ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.
摘要：
背景：通过对心肌梗塞（MI）后患者的结构化和综合性心脏康复计划提供二级预防可降低死亡率和发病率，并改善与健康相关的生活质量。心脏康复在当前指南中具有最高的推荐。虽然瑞典心脏康复中心的治疗目标完成率是欧洲最高的，各中心之间在服务提供和患者层面结局方面存在相当大的差异.在这次审判中,我们的目的是研究是否可以通过以下方式改善瑞典心脏康复中心的中心级指南依从性和患者级结局:a)通过国家质量登记系统对心脏康复结构和流程进行定期审核和反馈;b)支持心脏康复中心实施二级预防指南.此外，我们的目标是评估实施过程和成本。
方法：该研究是一项开放标签的整群随机有效性-实施混合试验，包括所有78个心脏康复中心（每年约10000名MI患者参加），报告给SWEDEHEART注册中心。这些中心将以1：1：1随机分为三组：1）每六个月向SWEDEHEART报告心脏康复结构和过程变量（审计干预），并为实施二级预防指南提供实施支持（实施支持干预）；2）仅审计干预；或3）不提供干预。将收集基线心脏康复结构和过程变量。主要结果是依从性评分，用于衡量中心级别对二级预防指南的依从性。次要结果包括MI后一年达到患者水平的二级预防危险因素目标，以及MI后五年内的主要不良冠状动脉结果。实施结果包括使用半结构化焦点小组访谈和相关问卷评估指南依从性的障碍和促进者，以及通过比较卫生经济评估评估的成本和成本效益。
结论：优化心脏康复中心提供服务以满足指南中设定的标准可能会改善心血管危险因素，包括生活方式因素，并最终降低MI后的发病率和死亡率。
背景：ClinicalTrials.gov.标识符：NCT05889416。注册2023-03-23。
方法：该研究是一项开放标签的整群随机有效性-实施混合试验，包括所有78个心脏康复中心（每年约10000名MI患者参加），报告给SWEDEHEART注册中心。这些中心将以1：1：1随机分为三组：1）每六个月向SWEDEHEART报告心脏康复结构和过程变量（审计干预），并为实施二级预防指南提供实施支持（实施支持干预）；2）仅审计干预；或3）不提供干预。将收集基线心脏康复结构和过程变量。主要结果是依从性评分，用于衡量中心级别对二级预防指南的依从性。次要结果包括MI后一年达到患者水平的二级预防危险因素目标，以及MI后五年内的主要不良冠状动脉结果。实施结果包括使用半结构化焦点小组访谈和相关问卷评估指南依从性的障碍和促进者，以及通过比较卫生经济评估评估的成本和成本效益。
结论：优化心脏康复中心提供服务以满足指南中设定的标准可能会改善心血管危险因素，包括生活方式因素，并最终降低MI后的发病率和死亡率。
背景：ClinicalTrials.gov.标识符：NCT05889416。注册2023-03-23。
