The Perfect-CR Implementation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Myocardial Infarction, Risk Reduction

Intervention / Treatment
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* Other: Audit and feedback through a quality registry
* Other: Implementation support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Implementation of national guidelines on secondary prevention according to local plan and preferences | |
| Active Comparator: Audit and feedback<br>Audit and feedback on implementation of national guidelines on secondary prevention through the national quality registry SWEDEHEART | Other: Audit and feedback through a quality registry<br>* 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.<br>|
| Active Comparator: Implementation support<br>Audit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention | Other: Audit and feedback through a quality registry<br>* 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.<br>Other: Implementation support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence score | 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). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure target attainment | For patients <70 years of age <130/80 mmHg and for patients ≥70 years <140/80 mmHg (yes/no) | One year | 
| Systolic blood pressure | Continuous variable in mmHg | One year | 
| Low-density lipoprotein cholesterol target attainment | <1.4 mmol/L (yes/no) | One year | 
| Low-density lipoprotein cholesterol | Continuous variable in mmol/L | One year | 
| Self-reported quality of life | 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) | One year | 
| Self-reported smoking status | Never smoker, former smoker (>1 month) or current smoker | One year | 
| Self-reported dietary habits | 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. | One year | 
| Self-reported physical activity | 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). | One year | 
| Attendance in an exercise-based CR programme | Attended for at least 3 months (yes/no) | One year | 
| Major adverse cardiovascular events (MACE) | A composite endpoint of the following events: cardiovascular mortality non-fatal MI non-fatal ischemic stroke coronary revascularization hospitalization for new or worsening heart failure | Five years | 
| Total mortality | Death from any cause. | Five years | 
| Acceptability of the implementation support | 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. | Assessed at the time of implementation | 
| Adoption of the implementation support | 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. | Assessed six months after the implementation support has been provided | 
| Fidelity of the implementation support | 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. | Assessed six months after the implementation support has been provided | 
| Implementation cost and cost effectiveness | 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. | Assessed at the time of implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Cardiac rehabilitation, Secondary prevention, Audit, Implementation, Practice facilitation