search
Back to results

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

Primary Purpose

Diabetes, Hypertension, Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High risk
Best Practice
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Clinical Evaluative Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High risk

Best Practice

Arm Description

Feedback reports focusing on the identification and management of patients who appear to have poorly managed diseases and who may require recall into clinic.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Blood pressure
cholesterol (LDL)

Full Information

First Posted
June 12, 2013
Last Updated
November 21, 2014
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT01878370
Brief Title
Audit and Feedback for Primary Care: a Cluster-randomized Trial
Official Title
Optimizing Audit and Feedback for Primary Care - Testing Scalable Approaches to Providing Feedback Reports, a Cluster-randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Ischemic Heart Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High risk
Arm Type
Experimental
Arm Description
Feedback reports focusing on the identification and management of patients who appear to have poorly managed diseases and who may require recall into clinic.
Arm Title
Best Practice
Arm Type
Experimental
Arm Description
Feedback reports focusing on the achievement of optimal care targets for patients with chronic disease.
Intervention Type
Other
Intervention Name(s)
High risk
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
composite quality score
Description
The number of best-practice quality indicators that a patient is achieving divided by the number for which they are eligible.
Time Frame
12 months
Title
composite high risk score
Description
The number of high risk indicators a patient meets divided by the number for which they are eligible.
Time Frame
12 months
Title
Proportion of patients with perfect composite quality score
Description
perfect composite quality score is equal to one hundred percent
Time Frame
12 months
Title
Proportion of patients with perfect composite high risk score
Description
perfect composite high risk score is zero
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
12 months
Title
cholesterol (LDL)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Each metric within the composite scores
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Tu, MD MSc
Organizational Affiliation
Institute for Clinical Evaluative Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical Evaluative Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs