Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889416
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-22
First Post:
2023-03-23
Brief Title:
The Perfect-CR Implementation Study
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsyear Patient-level outcome data will be retrieved from national registries
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 patientsyear Patient-level outcome data will be retrieved from national registries
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None