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Myocardial InfarctionNCT05889416

The Perfect-CR Implementation Study

A study testing Audit and feedback through a quality registry and Implementation support in people with Myocardial Infarction and Risk Reduction, run by Skane University Hospital at 1 site in Sweden.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Myocardial Infarction, Risk Reduction
What is being tested?
Audit and feedback through a quality registry and Implementation support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSweden
Study dates
1 Oct 2023to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Centres report to the SWEDEHEART registry
  • 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

Who cannot join

  • Unwillingness to participate in the study
  • Patient-level
  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site

  • Skåne University Hospital

    Malmö, 20502

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Audit and feedback through a quality registry, Implementation support
Keywords
Myocardial infarction, Cardiac rehabilitation, Secondary prevention, Audit, Implementation, Practice facilitation
Medical subject headings
Myocardial Infarction, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Audit and feedback through a quality registryOther

    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 supportOther

    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.

Study groups in NCT05889416
Study groupRoleWhat they receive
Usual careNo interventionImplementation of national guidelines on secondary prevention according to local plan and preferences
Audit and feedbackActive comparatorAudit and feedback on implementation of national guidelines on secondary prevention through the national quality registry SWEDEHEART
Receives: Other: Audit and feedback through a quality registry
Implementation supportActive comparatorAudit and feedback through the national quality registry SWEDEHEART and structured implementation support for implementation of national guidelines on secondary prevention
Receives: Other: Audit and feedback through a quality registry; Other: Implementation support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3 years

Secondary outcomes (15)

  1. Blood pressure target attainment

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

    Measured: One year

  2. Systolic blood pressure

    Continuous variable in mmHg

    Measured: One year

  3. Low-density lipoprotein cholesterol target attainment

    <1.4 mmol/L (yes/no)

    Measured: One year

  4. Low-density lipoprotein cholesterol

    Continuous variable in mmol/L

    Measured: One year

  5. 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)

    Measured: One year

  6. Self-reported smoking status

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

    Measured: One year

  7. 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.

    Measured: One year

  8. 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).

    Measured: One year

  9. Attendance in an exercise-based CR programme

    Attended for at least 3 months (yes/no)

    Measured: One year

  10. 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

    Measured: Five years

  11. Total mortality

    Death from any cause.

    Measured: Five years

  12. 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.

    Measured: Assessed at the time of implementation

  13. 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.

    Measured: Assessed six months after the implementation support has been provided

  14. 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.

    Measured: Assessed six months after the implementation support has been provided

  15. 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.

    Measured: Assessed at the time of implementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start1 Oct 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label Cluster-randomized Effectiveness-implementation Hybrid Trial
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889416
Sponsor's protocol ID
Perfect-CR V2.0 2023
Status last verified
Nov 2024
First submitted
23 Mar 2023
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 38790045

Questions about this trial

What is this clinical trial studying?

A study testing Audit and feedback through a quality registry and Implementation support in people with Myocardial Infarction and Risk Reduction, run by Skane University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence score (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.

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