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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Skane University Hospital
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Adherence score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
Outcomes
Primary Outcomes
Adherence score
Time Frame: 3 years
The adherence score reflects center-level adherence to CR processes and structures as recommended in national guidelines on secondary prevention. The score is derived from 39 variables capturing guideline-directed CR structure and processes collected on center-level through the national cardiac registry SWEDEHEART. The score ranges from 0 (worst) to 39 (best).
Secondary Outcomes
- Low-density lipoprotein cholesterol target attainment(One year)
- Self-reported smoking status(One year)
- Attendance in an exercise-based CR programme(One year)
- Systolic blood pressure(One year)
- Self-reported dietary habits(One year)
- Major adverse cardiovascular events (MACE)(Five years)
- Blood pressure target attainment(One year)
- Self-reported quality of life(One year)
- Self-reported physical activity(One year)
- Implementation cost and cost effectiveness(Assessed at the time of implementation)
- Low-density lipoprotein cholesterol(One year)
- Total mortality(Five years)
- Fidelity of the implementation support(Assessed six months after the implementation support has been provided)
- Acceptability of the implementation support(Assessed at the time of implementation)
- Adoption of the implementation support(Assessed six months after the implementation support has been provided)
Investigators
Margret Leosdottir
Senior Cardiology Consultant, Associate Professor
Skane University Hospital