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Optimizing Audit and Feedback for Primary Care

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ClinicalTrials.gov Identifier: NCT00996645
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : June 5, 2013
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Noah Ivers, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date June 5, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
  • 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 ]
  • Primary Disease-Related Outcomes: mean BP and mean LDL level. [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Composite Process Index: % of the provider's patients with chronic disease who are have received appropriate laboratory testing and have had their blood pressure checked within the appropriate time-frame. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
  • Prescriptions: percent of patients on insulin, beta blockers, ace-inhibitors or angiotensin-receptor blockers, aspirin, statins. [ Time Frame: 24 months ]
  • 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. [ Time Frame: 24 months ]
  • proportion of patients who are meeting targets recommended in guidelines for glucose, blood pressure and LDL cholesterol [ Time Frame: 24 months ]
  • Efficacy of intervention [ Time Frame: 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
  • Prescriptions: percent of patients on insulin, beta blockers, ace-inhibitors or angiotensin-receptor blockers, aspirin, statins. [ Time Frame: 12 months ]
  • Clinical parameters: mean blood pressure, mean low density lipoprotein (LDL), mean A1C. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimizing Audit and Feedback for Primary Care
Official Title  ICMJE Cluster Randomized Trial of a Goal-Setting Intervention With Performance Feedback Reports Regarding Diabetes and Coronary Artery Disease for Family Physicians in Ontario
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Coronary Artery Disease
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • No Intervention: Feedback report only
    This arm will receive performance feedback reports but no worksheet to facilitate goal-setting and action plans.
  • Experimental: 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.
    Intervention: Other: Worksheet to facilitate goal-setting and action plans
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2010)
55
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
40
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996645
Other Study ID Numbers  ICMJE 271-2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Noah Ivers, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE
  • Institute for Clinical Evaluative Sciences
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Noah M Ivers, MD Sunnybrook Health Sciences Centre
Principal Investigator: Karen Tu, MD MSc Sunnybrook Health Sciences Centre
Principal Investigator: Merrick Zwarenstein, MBBS MSc PhD Sunnybrook Health Sciences Centre
Principal Investigator: Jack V Tu, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP