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Diabetes Mellitus, Type 2NCT00996645

Optimizing Audit and Feedback for Primary Care

A study testing Worksheet to facilitate goal-setting and action plans in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
What is being tested?
Worksheet to facilitate goal-setting and action plans
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteCanada
Study dates
Jul 2010to Aug 2012
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Cluster Randomized Trial of a Goal-Setting Intervention With Performance Feedback Reports Regarding Diabetes and Coronary Artery Disease for Family Physicians in Ontario

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.

Read the 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.

Being tested
Worksheet to facilitate goal-setting and action plans
Keywords
Diabetes Mellitus, Type 2, Coronary Artery Disease, Primary Health Care, Feedback, Psychological, Quality Assurance, Health Care
Medical subject headings
Diabetes Mellitus, Type 2, Coronary Artery Disease

What participants receive

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

  • Worksheet to facilitate goal-setting and action plansOther

    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.

Study groups in NCT00996645
Study groupRoleWhat they receive
Feedback report onlyNo interventionThis arm will receive performance feedback reports but no worksheet to facilitate goal-setting and action plans.
Goal-Setting WorksheetExperimentalThis arm will receive a theory-informed worksheet to facilitate the development of goals and action plans in response to the performance feedback reports.
Receives: Other: Worksheet to facilitate goal-setting and action plans

What is being measured

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

  1. Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions

    Measured: 24 months

  2. Primary Disease-Related Outcomes: mean BP and mean LDL level.

    Measured: 24 months

Secondary outcomes (4)

  1. Prescriptions: percent of patients on insulin, beta blockers, ace-inhibitors or angiotensin-receptor blockers, aspirin, statins.

    Measured: 24 months

  2. Subgroup Analysis: 1) Compare effect of intervention for patients with only diabetes, only coronary artery disease, or both. 2) Compare outcomes for those with high vs low baseline performance.

    Measured: 24 months

  3. proportion of patients who are meeting targets recommended in guidelines for glucose, blood pressure and LDL cholesterol

    Measured: 24 months

  4. Efficacy of intervention

    The direct efficacy of the goal-setting and action-plan worksheet will be assessed by 1) stratifying results by physicians who properly completed the worksheet and those who did not and 2) determining if improved outcomes were more often associated with clinical topics that providers specified in the worksheet.

    Measured: 24 months

Timeline

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

  1. First posted16 Oct 2009 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00996645
Sponsor's protocol ID
271-2006
Status last verified
Jun 2013
First submitted
15 Oct 2009
Last updated
5 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24341511

  • 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.

    PubMed 21167034

Questions about this trial

What is this clinical trial studying?

A study testing Worksheet to facilitate goal-setting and action plans in people with Diabetes Mellitus, Type 2 and Coronary Artery Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jun 2013. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT00996645, which also lists 2 linked publications.

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 5 Jun 2013.

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