Myocardial Infarction, Risk Reduction
Conditions
Keywords
Myocardial infarction, Cardiac rehabilitation, Secondary prevention, Audit, Implementation, Practice facilitation
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.
Interventions
OTHERAudit and feedback through a quality registry
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.
Sponsors
Lund University
Uppsala University
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | One year | Continuous variable in mmHg |
| Blood pressure target attainment | One year | For patients \<70 years of age \<130/80 mmHg and for patients ≥70 years \<140/80 mmHg (yes/no) |
| Low-density lipoprotein cholesterol | One year | Continuous variable in mmol/L |
| 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 smoking status | One year | Never smoker, former smoker (\>1 month) or current smoker |
| 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. |
| 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). |
| Low-density lipoprotein cholesterol target attainment | One year | \<1.4 mmol/L (yes/no) |
| 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 failure |
| Total mortality | Five years | Death from any cause. |
| 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. |
| 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. |
| 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. |
| Attendance in an exercise-based CR programme | One year | Attended for at least 3 months (yes/no) |
Countries
Sweden
Outcome results
None listed