NCT01878370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

1.2 years

First QC Date

June 12, 2013

Last Update Submit

November 21, 2014

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • composite high risk score

    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

    perfect composite quality score is equal to one hundred percent

    12 months

  • Proportion of patients with perfect composite high risk score

    perfect composite high risk score is zero

    12 months

Secondary Outcomes (2)

  • Blood pressure

    12 months

  • cholesterol (LDL)

    12 months

Other Outcomes (1)

  • Each metric within the composite scores

    12 months

Study Arms (2)

High risk

EXPERIMENTAL

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

Best Practice

EXPERIMENTAL

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

Other: Best Practice

Interventions

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.

High risk

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.

Best Practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusHypertensionMyocardial Ischemia

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Karen Tu, MD MSc

    Institute for Clinical Evaluative Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 14, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 24, 2014

Record last verified: 2014-11

Locations