The Perfect-CR Implementation Study

Skane University Hospital

Status: Invitation-only

Conditions: Myocardial Infarction; Risk Reduction

Treatments: Other: Audit and feedback through a quality registry; Other: Implementation support

Study type: Interventional

Funder types: Other

Identifiers

NCT05889416

Perfect-CR V2.0 2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Centre-level

Inclusion Criteria:

• Centres report to the SWEDEHEART registry

Exclusion Criteria:

• 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:

• None

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Usual care

No Intervention group

Description:

Implementation of national guidelines on secondary prevention according to local plan and preferences

Audit and feedback

Active Comparator group

Description:

Audit and feedback on implementation of national guidelines on secondary prevention through the national quality registry SWEDEHEART

Treatment:

Other: Audit and feedback through a quality registry

Implementation support

Active Comparator group

Description:

Audit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention

Treatment:

Other: Implementation support

Other: Audit and feedback through a quality registry