Audit and Feedback for Primary Care: a Cluster-randomized Trial

November 21, 2014 updated by: Sunnybrook Health Sciences Centre

Optimizing Audit and Feedback for Primary Care - Testing Scalable Approaches to Providing Feedback Reports, a Cluster-randomized Trial

In a previous study, the investigators delivered graphs to family physicians that outlined the proportion of patients with a history of diabetes or heart disease achieving evidence-based quality targets derived from guideline recommendations. A qualitative evaluation found that participating family physicians did not act upon the feedback for two main reasons. First, they felt that targets recommended in guidelines often did not apply for particular patients. Second, they complained that had difficulty using the feedback reports that only provided aggregate level data for clinical action. In this cluster-randomized trial, the investigators test two approaches to conducting audit and feedback that aims to address these issues. The investigators hypothesize that feedback identifying a small number of patients at high-risk for cardiovascular events requiring action will more effectively lead to changes in clinical behavior than feedback identifying all patients not reaching optimal care targets.

Study Overview

Status

Completed

Detailed Description

For the last two years, all physicians contributing data to the Electronic Medical Record Administrative data Linked Database (EMRALD) have received two feedback reports. The first focused on diabetes and the second on patients with heart disease. The reports provide aggregate information regarding the proportion of the family physician's patients meeting quality targets, but no patient-specific information. Currently the feedback is sent to physicians by courier from the EMRALD team every six months.

The intervention arms in this trial are as follows:

  • Arm 1 - Standard, aggregate-level feedback reports focusing on the proportion of patients with hypertension and/or diabetes and/or ischemic heart disease meeting targets sent via courier every six months and available on a password protected website. Family physicians in this arm will also have access through this website to patient-level data to identify patients not achieving optimal quality of care targets.
  • Arm 2 - Aggregate-level feedback reports focusing on the proportion of patients with hypertension and/or diabetes and/or ischemic heart disease meeting criteria for high-risk sent via courier every six months and available on a password protected website. Family physicians in this arm will also have access through this website to a list of chart numbers identifying those patients at highest risk.

Both arms will have the opportunity to receive continuing medical education credits by completing worksheets that prompt them to reflect upon the data. Family physicians in Arm 1 are asked to complete a worksheet that follows continuous quality improvement principles, including setting an aim statement, engagement with team members in the clinic, testing change concepts at first on a small scale, and then scaling up in a effort to spread best practices. Family physicians in Arm 2 are asked to complete a worksheet that also includes goal setting and action planning, but focuses on reducing the number of patients with high-risk criteria and offers some suggested practice-based approaches.

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Institute for Clinical Evaluative Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family physicians belonging to and sharing data with the Electronic Medical Record Administrative Linked Database in Ontario
  • Patients rostered to these family physicians with diabetes or hypertension or ischemic heart disease

Exclusion Criteria:

  • Family physicians without at least two years of Electronic Medical Record data in EMRALD
  • Family physicians without at least 100 rostered, active patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High risk
Feedback reports focusing on the identification and management of patients who appear to have poorly managed diseases and who may require recall into clinic.

Aggregate-level feedback reports focusing on the proportion of patients with hypertension and/or diabetes and/or ischemic heart disease meeting criteria for high-risk sent via courier every six months and available on a password protected website. Family physicians in this arm will also have access through this website to a list of chart numbers identifying those patients at highest risk.

Family physicians in Arm 2 are asked to complete a worksheet that also includes goal setting and action planning, but focuses on reducing the number of patients with high-risk criteria and offers some suggested practice-based approaches.

Experimental: Best Practice
Feedback reports focusing on the achievement of optimal care targets for patients with chronic disease.

Standard, aggregate-level feedback reports focusing on the proportion of patients with hypertension and/or diabetes and/or ischemic heart disease meeting targets sent via courier every six months and available on a password protected website. Family physicians in this arm will also have access through this website to patient-level data to identify patients not achieving optimal quality of care targets.

Family physicians in Arm 1 are asked to complete a worksheet that follows continuous quality improvement principles, including setting an aim statement, engagement with team members in the clinic, testing change concepts at first on a small scale, and then scaling up in a effort to spread best practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
composite quality score
Time Frame: 12 months
The number of best-practice quality indicators that a patient is achieving divided by the number for which they are eligible.
12 months
composite high risk score
Time Frame: 12 months
The number of high risk indicators a patient meets divided by the number for which they are eligible.
12 months
Proportion of patients with perfect composite quality score
Time Frame: 12 months
perfect composite quality score is equal to one hundred percent
12 months
Proportion of patients with perfect composite high risk score
Time Frame: 12 months
perfect composite high risk score is zero
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 12 months
12 months
cholesterol (LDL)
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Each metric within the composite scores
Time Frame: 12 months

For Hypertension (HTN):

Blood Pressure (BP) tested in 15 months (M) BP meeting target BP test in 4 M if >target Weight (WT) measured in 15 M Lipids measures in 15 M

For Diabetes:

HbA1c tested in 6 M HbA1c < 7 BP <130/80 Angiotensin agent (ACE/ARB) if also HTN WT measured within 15 M Lipids in 15 M LDL <2 Statin if >50yrs Albumin-creatinine ratio in 15 M

For Heart disease:

BP in 15 M BP meeting target Anti-platelet (or Anti-coagulant) WT within 15 M Lipids measured within 15 M LDL <2 Statin

For Diabetes High Risk:

no HbA1c 15 M HbA1c >9 no BP in 15 M BP >160/100 no ACE/ARB if also HTN no WT within 24 M no lipids measured within 36 M LDL >4

For Heart disease high risk:

no BP in 24 M BP >160/100 no anti-platelet (anti-coagulant) no WT within 24 M no lipids measured within 36 M LDL >4

For Hypertension high risk:

no BP in 24 M BP >160/100 no WT within 24 M no lipids in 36 M

12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Tu, MD MSc, Institute for Clinical Evaluative Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 21, 2014

Last Verified

November 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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