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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01878370
First received: June 12, 2013
Last updated: August 1, 2013
Last verified: August 2013

June 12, 2013
August 1, 2013
June 2013
June 2014   (final data collection date for primary outcome measure)
  • composite quality score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    perfect composite quality score is equal to one hundred percent
  • Proportion of patients with perfect composite high risk score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    perfect composite high risk score is zero
Same as current
Complete list of historical versions of study NCT01878370 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • cholesterol (LDL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 12M ] [ Designated as safety issue: No ]
  • cholesterol (LDL) [ Time Frame: 12 M ] [ Designated as safety issue: No ]
Each metric within the composite scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Each metric within the composite scores [ Time Frame: 12M ] [ Designated as safety issue: No ]

For Hypertension:

BP tested in 15M BP meeting target BP test in 4M if >target WT/BMI in 15M Lipids in 15M

Diabetes A1c tested in 6M A1c <7 BP <130/80 ACE/ARB if HTN WT/BMI in 15M Lipids in 15M LDL <2 Statin if >50yrs ACR in 15M

Heart disease BP in 15M BP meeting targets Antiplatelet/Anticoag WT/BMI in 15M Lipids in 15M LDL <2 Statin

Diabetes High Risk no A1c 15M A1c >9 no BP in 15M BP >160/100 no ACE/ARB if HTN no WT/BMI in 24M no lipids in 36M LDL >4

Heart disease high risk no BP in 24M BP >160/100 no antiplatelet/anticoag no Statin if LDL>2 no WT/BMI in 24M no Lipids in 36M LDL >4

Hypertension high risk no BP in 24M BP >160/100 no WT/BMI in 24M no lipids in 36M

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Diabetes
  • Hypertension
  • Ischemic Heart Disease
  • 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.

  • Other: 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.

  • 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.
    Intervention: Other: High risk
  • Experimental: Best Practice
    Feedback reports focusing on the achievement of optimal care targets for patients with chronic disease.
    Intervention: Other: Best Practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
177
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01878370
075-2013
No
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
  • Institute for Clinical Evaluative Sciences
  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Canada
Principal Investigator: Karen Tu, MD MSc Institute for Clinical Evaluative Sciences
Sunnybrook Health Sciences Centre
August 2013

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