NCT00996645

Brief Summary

There remains a large gap between ideal and actual care provided to patients with chronic diseases. Performance feedback reports are often used as a foundation for quality improvement interventions. There have been hundreds of trials investigating the use of feedback reports; the important question to ask now is not whether performance feedback reports can help to improve quality of care, but how to optimize feedback interventions to accomplish that goal. The purpose of this study is to test whether a theory-based intervention added to feedback reports sent to primary care providers can result in improved outcomes for patients with chronic disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

2.1 years

First QC Date

October 15, 2009

Last Update Submit

June 4, 2013

Conditions

Keywords

Diabetes Mellitus, Type 2Coronary Artery DiseasePrimary Health CareFeedback, PsychologicalQuality Assurance, Health Care

Outcome Measures

Primary Outcomes (2)

  • Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions

    24 months

  • Primary Disease-Related Outcomes: mean BP and mean LDL level.

    24 months

Secondary Outcomes (4)

  • Prescriptions: percent of patients on insulin, beta blockers, ace-inhibitors or angiotensin-receptor blockers, aspirin, statins.

    24 months

  • Subgroup Analysis: 1) Compare effect of intervention for patients with only diabetes, only coronary artery disease, or both. 2) Compare outcomes for those with high vs low baseline performance.

    24 months

  • proportion of patients who are meeting targets recommended in guidelines for glucose, blood pressure and LDL cholesterol

    24 months

  • Efficacy of intervention

    24 months

Study Arms (2)

Feedback report only

NO INTERVENTION

This arm will receive performance feedback reports but no worksheet to facilitate goal-setting and action plans.

Goal-Setting Worksheet

EXPERIMENTAL

This arm will receive a theory-informed worksheet to facilitate the development of goals and action plans in response to the performance feedback reports.

Other: Worksheet to facilitate goal-setting and action plans

Interventions

Developed based on goal-setting theory and implementation intentions, the worksheet will be mailed out with the feedback reports and is expected to facilitate improved quality of care in response to feedback reports.

Goal-Setting Worksheet

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • family physicians in Ontario who have signed data sharing agreements with the CCORT-ICES EMR team

You may not qualify if:

  • specializing in an area (such as palliative care) where general guidelines do not apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

  • Ivers NM, Tu K, Young J, Francis JJ, Barnsley J, Shah BR, Upshur RE, Moineddin R, Grimshaw JM, Zwarenstein M. Feedback GAP: pragmatic, cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care. Implement Sci. 2013 Dec 17;8:142. doi: 10.1186/1748-5908-8-142.

  • Ivers NM, Tu K, Francis J, Barnsley J, Shah B, Upshur R, Kiss A, Grimshaw JM, Zwarenstein M. Feedback GAP: study protocol for a cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care. Implement Sci. 2010 Dec 17;5:98. doi: 10.1186/1748-5908-5-98.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Noah M Ivers, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
  • Karen Tu, MD MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
  • Merrick Zwarenstein, MBBS MSc PhD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR
  • Jack V Tu, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD CCFP PhD(c)

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

July 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations