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
  Purpose

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.


Condition Intervention
Diabetes
Hypertension
Ischemic Heart Disease
Other: High risk
Other: Best Practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Optimizing Audit and Feedback for Primary Care - Testing Scalable Approaches to Providing Feedback Reports, a Cluster-randomized Trial

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • cholesterol (LDL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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



Enrollment: 177
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01878370

Locations
Canada, Ontario
Institute for Clinical Evaluative Sciences
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Institute for Clinical Evaluative Sciences
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Karen Tu, MD MSc Institute for Clinical Evaluative Sciences
  More Information

No publications provided

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01878370     History of Changes
Other Study ID Numbers: 075-2013
Study First Received: June 12, 2013
Last Updated: August 1, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hypertension
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014