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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878370
• Other study ID #: 075-2013
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: November 21, 2014
• Start date: June 2013
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Diabetes
• Hypertension
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• High risk
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.
• Best Practice
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.

Locations

Country	Name	City	State
Canada	Institute for Clinical Evaluative Sciences	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Canada, Institute for Clinical Evaluative Sciences

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Each metric within the composite scores	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	No
Primary	composite quality score	The number of best-practice quality indicators that a patient is achieving divided by the number for which they are eligible.	12 months	No
Primary	composite high risk score	The number of high risk indicators a patient meets divided by the number for which they are eligible.	12 months	No
Primary	Proportion of patients with perfect composite quality score	perfect composite quality score is equal to one hundred percent	12 months	No
Primary	Proportion of patients with perfect composite high risk score	perfect composite high risk score is zero	12 months	No
Secondary	Blood pressure		12 months	No
Secondary	cholesterol (LDL)		12 months	No