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Enrolling by Invitation

NCT Number: NCT05889416

The Perfect-CR Implementation Study

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital

Malmö, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audit and feedback through a quality registry

Other

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

Other

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.

Primary outcomes

  1. Adherence score

    Time frame: 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 outcomes

  1. Blood pressure target attainment

    Time frame: One year

    For patients <70 years of age <130/80 mmHg and for patients ≥70 years <140/80 mmHg (yes/no)

  2. Systolic blood pressure

    Time frame: One year

    Continuous variable in mmHg

  3. Low-density lipoprotein cholesterol target attainment

    Time frame: One year

    <1.4 mmol/L (yes/no)

  4. Low-density lipoprotein cholesterol

    Time frame: One year

    Continuous variable in mmol/L

  5. Self-reported quality of life

    Time frame: 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)

  6. Self-reported smoking status

    Time frame: One year

    Never smoker, former smoker (>1 month) or current smoker

  7. Self-reported dietary habits

    Time frame: 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.

  8. Self-reported physical activity

    Time frame: 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).

  9. Attendance in an exercise-based CR programme

    Time frame: One year

    Attended for at least 3 months (yes/no)

  10. Major adverse cardiovascular events (MACE)

    Time frame: 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
  11. Total mortality

    Time frame: Five years

    Death from any cause.

  12. Acceptability of the implementation support

    Time frame: 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.

  13. Adoption of the implementation support

    Time frame: 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.

  14. Fidelity of the implementation support

    Time frame: 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.

  15. Implementation cost and cost effectiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Lund University
  • Uppsala University

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Jun 5, 2023
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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