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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
75
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.
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.
Skåne University Hospital
Malmö, Sweden
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).
Time frame: 3 years
Blood pressure target attainment
For patients \<70 years of age \<130/80 mmHg and for patients ≥70 years \<140/80 mmHg (yes/no)
Time frame: One year
Systolic blood pressure
Continuous variable in mmHg
Time frame: One year
Low-density lipoprotein cholesterol target attainment
\<1.4 mmol/L (yes/no)
Time frame: One year
Low-density lipoprotein cholesterol
Continuous variable in mmol/L
Time frame: 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)
Time frame: One year
Self-reported smoking status
Never smoker, former smoker (\>1 month) or current smoker
Time frame: One year
Self-reported dietary habits
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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.
Time frame: 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).
Time frame: One year
Attendance in an exercise-based CR programme
Attended for at least 3 months (yes/no)
Time frame: 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
Time frame: Five years
Total mortality
Death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at the time of implementation