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Optimizing Audit and Feedback for Primary Care

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00996645
First received: October 15, 2009
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Coronary Artery Disease
Other: Worksheet to facilitate goal-setting and action plans

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Primary Disease-Related Outcomes: mean BP and mean LDL level. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prescriptions: percent of patients on insulin, beta blockers, ace-inhibitors or angiotensin-receptor blockers, aspirin, statins. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • proportion of patients who are meeting targets recommended in guidelines for glucose, blood pressure and LDL cholesterol [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Efficacy of intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 55
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996645

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Investigators
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
  More Information

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Noah Ivers, MD CCFP PhD(c), Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00996645     History of Changes
Other Study ID Numbers: 271-2006
Study First Received: October 15, 2009
Last Updated: June 4, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Sunnybrook Health Sciences Centre:
Diabetes Mellitus, Type 2
Coronary Artery Disease
Primary Health Care
Feedback, Psychological
Quality Assurance, Health Care

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014