Clinical trial NCT05889416: The Perfect-CR Implementation Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Myocardial Infarction
Risk Reduction
Keywords: Myocardial infarction
Cardiac rehabilitation
Secondary prevention
Audit
Implementation
Practice facilitation
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
name: Uppsala University
First posted: 2023-06-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility 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

Primary outcomes:
measure: Adherence score
timeFrame: 3 years
Secondary outcomes:
measure: Blood pressure target attainment
timeFrame: One year
measure: Systolic blood pressure
timeFrame: One year
measure: Low-density lipoprotein cholesterol target attainment
timeFrame: One year
measure: Low-density lipoprotein cholesterol
timeFrame: One year
measure: Self-reported quality of life
timeFrame: One year
measure: Self-reported smoking status
timeFrame: One year
measure: Self-reported dietary habits
timeFrame: One year
measure: Self-reported physical activity
timeFrame: One year
measure: Attendance in an exercise-based CR programme
timeFrame: One year
measure: Major adverse cardiovascular events (MACE)
timeFrame: Five years
measure: Total mortality
timeFrame: Five years
measure: Acceptability of the implementation support
timeFrame: Assessed at the time of implementation
measure: Adoption of the implementation support
timeFrame: Assessed six months after the implementation support has been provided
measure: Fidelity of the implementation support
timeFrame: Assessed six months after the implementation support has been provided
measure: Implementation cost and cost effectiveness
timeFrame: Assessed at the time of implementation
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Skane University Hospital Malmö
name: Margret Leosdottir
role: PRINCIPAL_INVESTIGATOR
References: