The Perfect-CR Implementation Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Myocardial Infarction; Risk Reduction
• Intervention / Treatment: Other: Audit and feedback through a quality registry; Other: Implementation support

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margret Leosdottir, Assoc Prof; Phone Number: 0046732561536; Email: Margret.Leosdottir@med.lu.se
• Study Contact Backup: Name: Halldora Ögmundsdottir Michelsen, PhD; Phone Number: 0046760680682; Email: halldora.ogmundsdottir_michelsen@med.lu.se

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Skane University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Implementation of national guidelines on secondary prevention according to local plan and preferences
Active Comparator: Audit and feedback; 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; 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.
Active Comparator: Implementation support; 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; 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.; Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Collaborators: Lund University; Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Implementation; Myocardial infarction; Cardiac rehabilitation; Secondary prevention; Audit; Practice facilitation
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: Perfect-CR V2.0 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data to be used in this study is based on the SWEDEHEART registry. Access to data from the registry needs to be applied for and third-party data usage is not allowed, irrespective of whether the data contain potentially identifying or sensitive data or not. Instead, given ethical study approval from the Swedish Ethical Review Authority, access to SWEDEHEART data can be applied for from the Uppsala Clinical Research Center (UCR) in Sweden. Further information can be found on the UCR www.ucr.uu.se/en/ and Swedish Ethical Review Authority etikprovningsmyndigheten.se/ websites.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No