Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
Department of Emergency medicine and Geriatrics, Helsingborg Hospital, Helsingborg, Sweden.
Implement Sci. 2024 May 24;19(1):35. doi: 10.1186/s13012-024-01366-8.
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.
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.
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.
ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.
通过对心肌梗死（MI）后患者进行结构化和全面的心脏康复计划提供二级预防，可以降低死亡率和发病率，并提高与健康相关的生活质量。心脏康复在当前指南中的推荐级别最高。虽然瑞典心脏康复中心的治疗目标达标率在欧洲处于较高水平，但在服务提供方面存在相当大的差异，各中心之间患者水平的结果也存在差异。在这项试验中，我们旨在研究通过以下两种方式是否可以提高瑞典心脏康复中心的中心层面指南遵循情况和患者水平结果：a）通过全国质量登记处定期对心脏康复结构和过程进行审核和反馈；b）支持心脏康复中心实施二级预防指南。此外，我们旨在评估实施过程和成本。
该研究是一项开放标签的群组随机有效性-实施混合试验，包括向 SWEDEHEART 登记处报告的所有 78 个心脏康复中心（每年收治约 10000 例 MI 患者）。这些中心将以 1:1:1 的比例随机分为三组：1）每六个月向 SWEDEHEART 报告心脏康复结构和过程变量（审核干预），并提供实施二级预防指南的支持（实施支持干预）；2）仅审核干预；或 3）不提供干预。将收集基线心脏康复结构和过程变量。主要结局是测量中心层面遵循二级预防指南的依从性评分。次要结局包括 MI 后一年时患者水平的二级预防风险因素目标达标情况，以及 MI 后长达五年的主要不良冠状动脉结局。实施结局包括使用半结构化焦点小组访谈和相关问卷评估指南遵循的障碍和促进因素，以及通过比较健康经济评估评估成本和成本效益。
优化心脏康复中心的服务提供，以满足指南规定的标准，可能会改善心血管风险因素，包括生活方式因素，并最终降低 MI 后的发病率和死亡率。
ClinicalTrials.gov。标识符：NCT05889416。注册于 2023 年 3 月 23 日。
