NCT05889416

The Perfect-CR Implementation Study

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Myocardial Infarction
• Risk Reduction

Interventions

Type	Name	Description
OTHER	Audit and feedback through a quality registry	Centres answer CR process and structure variables through the SWEDEHEART registry every six months for three years. Feedback will be accessible online and through annual reports, enabling comparisons with own prior and other centres´ results.
OTHER	Implementation support	On-site support to implement guidelines on secondary prevention applying practice facilitation - a multifaceted approach carried out by CR experts who enable personnel at intervention centres to address and overcome challenges in implementing guidelines.

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-12-01
• Completion: 2030-12-01
• First posted: 2023-06-05
• Last updated: 2024-11-29

Locations

1 site across 1 country: Sweden