Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
75 participants
INTERVENTIONAL
2023-10-01
2030-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Usual care
Implementation of national guidelines on secondary prevention according to local plan and preferences
No interventions assigned to this group
Audit and feedback
Audit and feedback on implementation of national guidelines on secondary prevention through the national quality registry SWEDEHEART
Audit 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.
Implementation support
Audit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention
Audit 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.
Implementation support
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.
Interventions
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Audit 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.
Implementation support
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.
Eligibility Criteria
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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
Patient-level
* None
18 Years
79 Years
ALL
No
Sponsors
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Lund University
OTHER
Uppsala University
OTHER
Skane University Hospital
OTHER
Responsible Party
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Margret Leosdottir
Senior Cardiology Consultant, Associate Professor
Principal Investigators
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Margret Leosdottir
Role: PRINCIPAL_INVESTIGATOR
Skane University Hospital Malmö
Locations
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Skåne University Hospital
Malmo, , Sweden
Countries
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References
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Michelsen HO, Lidin M, Back M, Duncan TS, Ekman B, Hagstrom E, Hagglund M, Lindahl B, Schlyter M, Leosdottir M. The effect of audit and feedback and implementation support on guideline adherence and patient outcomes in cardiac rehabilitation: a study protocol for an open-label cluster-randomized effectiveness-implementation hybrid trial. Implement Sci. 2024 May 24;19(1):35. doi: 10.1186/s13012-024-01366-8.
Other Identifiers
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Perfect-CR V2.0 2023
Identifier Type: -
Identifier Source: org_study_id