Optimizing Audit and Feedback for Primary Care

NCT ID: NCT00996645

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-08-31

Brief Summary

There remains a large gap between ideal and actual care provided to patients with chronic diseases. Performance feedback reports are often used as a foundation for quality improvement interventions. There have been hundreds of trials investigating the use of feedback reports; the important question to ask now is not whether performance feedback reports can help to improve quality of care, but how to optimize feedback interventions to accomplish that goal. The purpose of this study is to test whether a theory-based intervention added to feedback reports sent to primary care providers can result in improved outcomes for patients with chronic disease.

Detailed Description

There remains a large gap between ideal and actual care provided to patients with chronic diseases such as type-2 diabetes (DM2) and coronary artery disease (CAD), making them a common focus for translational research. Quality improvement strategies such as audit and feedback, which can increase adoption and adherence to guidelines, may be a good choice for such problems. Audit and feedback is felt to be effective because it may overcome physicians' limited ability to accurately self-assess. A recent Cochrane review concluded that it may increase appropriate clinical practice by 5 to 10 percentage points. However, the authors noted great variability in the results of the trials. It is thought that optimal design and delivery of feedback will more consistently lead to improved results, but few studies have tested different designs of feedback. A more recent meta-analysis of feedback found that interventions incorporating theoretical principles from psychology in the design were more effective than intuitive feedback designs. The author of that study has urged the creation of more 'actionable' feedback. There is both theoretical and empirical reason to believe that feedback will be more effective if the recipients set goals and develop action plans.

A group of family physicians across Ontario have previously signed data sharing agreements with ICES allowing their electronic medical records to be audited. These physicians will be invited to participate in this trial. Participants will receive performance feedback reports summarizing the percentage of their DM2 and CAD patients who are meeting evidence-based targets for quality of care.

Participating physicians will be split into two groups at the level of their practice to reduce risk of contamination. Minimization software will be used to ensure balance at baseline in the primary outcomes between the intervention and control group. New potential participants that have signed data sharing agreements at ICES will be invited to join the trial for a maximum of six months after the first practices are allocated.

The intervention group will receive in addition to the feedback reports a theoretically informed worksheet meant to facilitate goal-setting and the development of action plans. This will occur every six months for two years. Outcomes will be analyzed after 24 months.

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Feedback report only

This arm will receive performance feedback reports but no worksheet to facilitate goal-setting and action plans.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Goal-Setting Worksheet

This arm will receive a theory-informed worksheet to facilitate the development of goals and action plans in response to the performance feedback reports.

Group Type: EXPERIMENTAL

Worksheet to facilitate goal-setting and action plans

Intervention Type: OTHER

Developed based on goal-setting theory and implementation intentions, the worksheet will be mailed out with the feedback reports and is expected to facilitate improved quality of care in response to feedback reports.

Interventions

Worksheet to facilitate goal-setting and action plans

Developed based on goal-setting theory and implementation intentions, the worksheet will be mailed out with the feedback reports and is expected to facilitate improved quality of care in response to feedback reports.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• family physicians in Ontario who have signed data sharing agreements with the CCORT-ICES EMR team

Exclusion Criteria

• specializing in an area (such as palliative care) where general guidelines do not apply

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Clinical Evaluative Sciences

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Noah Ivers

MD CCFP PhD(c)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noah M Ivers, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Karen Tu, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Merrick Zwarenstein, MBBS MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Jack V Tu, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

Ivers NM, Tu K, Young J, Francis JJ, Barnsley J, Shah BR, Upshur RE, Moineddin R, Grimshaw JM, Zwarenstein M. Feedback GAP: pragmatic, cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care. Implement Sci. 2013 Dec 17;8:142. doi: 10.1186/1748-5908-8-142.

Reference Type: DERIVED

PMID: 24341511 (View on PubMed)

Ivers NM, Tu K, Francis J, Barnsley J, Shah B, Upshur R, Kiss A, Grimshaw JM, Zwarenstein M. Feedback GAP: study protocol for a cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care. Implement Sci. 2010 Dec 17;5:98. doi: 10.1186/1748-5908-5-98.

Reference Type: DERIVED

PMID: 21167034 (View on PubMed)

Other Identifiers

271-2006

Identifier Type: -

Identifier Source: org_study_id