The Perfect-CR Implementation Study
- Conditions
- Risk ReductionMyocardial Infarction
- Interventions
- Other: Audit and feedback through a quality registryOther: Implementation support
- Registration Number
- NCT05889416
- Lead Sponsor
- Skane University Hospital
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 75
- Centres report to the SWEDEHEART registry
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Audit and feedback Audit and feedback through a quality registry Audit and feedback on implementation of national guidelines on secondary prevention through the national quality registry SWEDEHEART Implementation support Audit and feedback through a quality registry Audit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention Implementation support Implementation support Audit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention
- Primary Outcome Measures
Name Time Method Adherence score 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 Outcome Measures
Name Time Method Self-reported smoking status One year Never smoker, former smoker (\>1 month) or current smoker
Attendance in an exercise-based CR programme One year Attended for at least 3 months (yes/no)
Systolic blood pressure One year Continuous variable in mmHg
Low-density lipoprotein cholesterol target attainment One year \<1.4 mmol/L (yes/no)
Self-reported dietary habits One year Dietary habits are assessed by self-report through four questions covering intake of fruit, vegetables, fish and sweets. Each question gives points ranging from 0 (worst) to 3 (best), summing up to a total score of 0-12 points.
Major adverse cardiovascular events (MACE) Five years A composite endpoint of the following events:
* cardiovascular mortality
* non-fatal MI
* non-fatal ischemic stroke
* coronary revascularization
* hospitalization for new or worsening heart failureBlood pressure target attainment One year For patients \<70 years of age \<130/80 mmHg and for patients ≥70 years \<140/80 mmHg (yes/no)
Self-reported quality of life One year Measured using EuroQoL-Visual Analogue Scale (EQ-VAS) - a vertical visual analogue scale with a range of values between 100 (best imaginable health) and 0 (worst imaginable health)
Self-reported physical activity One year Number of days during the last week the patient has been physically active for a minimum of 30 minutes (at least 10 minutes at a time) with activity causing shortness of breath and a slightly increased pulse, corresponding to a brisk walk. Permissible values can thus range from 0 days (worst) to 7 days (best).
Implementation cost and cost effectiveness Assessed at the time of implementation Reflects resources required to implement the intervention, including the cost of material, staff, and any other expenses incurred as a result of the implementation of the intervention. Based on the cost estimates and the effect of the implementation assistance on patient outcomes, the economic evaluation will then be able to calculate cost-effectiveness ratios.
Low-density lipoprotein cholesterol One year Continuous variable in mmol/L
Total mortality Five years Death from any cause.
Fidelity of the implementation support Assessed six months after the implementation support has been provided Fidelity reflects the degree to which the implementation used in practice adheres to the original design of the intervention. Fidelity will be assessed through semi-structured interviews with healthcare personnel at centers subject to the implementation intervention.
Acceptability of the implementation support Assessed at the time of implementation Acceptability reflects the degree to which the intervention is perceived as being feasible, desirable, and appropriate by stakeholders (healthcare providers, i.e., the CR team and organizational leaders) and the level of preparedness of the organization to adopt the intervention. Acceptability will be assessed through semi-structured interviews with healthcare personnel at centers subject to the implementation intervention. Interview guides, allowing for flexibility in terms of order and form of questions and topics, using mainly open-ended and neutral questions will be developed. The exact number of interviews will be decided on after start of the study and will continue until a) no new concepts or categories are identified and b) when there is no need for further elaboration of these.
Adoption of the implementation support Assessed six months after the implementation support has been provided Adoption determines the extent to which the intervention is used in practice. Adoption of the implementation support will be assessed through semi-structured interviews with healthcare personnel at centers subject to the implementation intervention.
Trial Locations
- Locations (1)
Skåne University Hospital
🇸🇪Malmö, Sweden