The Perfect-CR Implementation Study

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05889416
• Other study ID #: Perfect-CR V2.0 2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2030

Study information

• Verified date: November 2023
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: December 2030
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Risk Reduction

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Skane University Hospital	Lund University, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Systolic blood pressure	Continuous variable in mmHg	One year
Secondary	Low-density lipoprotein cholesterol target attainment	<1.4 mmol/L (yes/no)	One year
Secondary	Low-density lipoprotein cholesterol	Continuous variable in mmol/L	One year
Secondary	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
Secondary	Self-reported smoking status	Never smoker, former smoker (>1 month) or current smoker	One year
Secondary	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
Secondary	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
Secondary	Attendance in an exercise-based CR programme	Attended for at least 3 months (yes/no)	One year
Secondary	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
Secondary	Total mortality	Death from any cause.	Five years
Secondary	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
Secondary	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
Secondary	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
Secondary	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