- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595775
A Trial of an Audit and Feedback Report to Improve Colonoscopy Performance
September 5, 2018 updated by: Sunnybrook Health Sciences Centre
A Randomized Controlled Trial of an Audit and Feedback Report to Improve Colonoscopy Performance
This project aims to measure the impact of a physician report card (also called an audit & feedback report) on colonoscopy performance.
Endoscopists in Ontario will be randomly assigned to either receive the endoscopist report card or to no feedback.
Using Ontario health administrative data, the quality of colonoscopy will be compared between those who received the report card and those who do not.
The investigators will also measure the effect of receiving endoscopist report card on colonoscopy performance amongst endoscopists who perform poorly at baseline compared to those who do not.
Further, the acceptability of two educational interventions that aim to improve the quality of colonoscopy will be evaluated by conducting one-on-one interviews with select participants.
This study is critical to ensure that Canadians have access to the highest quality colonoscopy possible.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
833
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All practising endoscopists in Ontario who performed at least 5 colonoscopies in 2014
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Round 1: Intervention arm
Half of the endoscopists in Ontario will receive an individualized audit & feedback report. Individualized A/F report. |
Individualized A/F report containing 9 colonoscopy quality measures.
|
No Intervention: Round 1: Control
Half of the endoscopists in Ontario will NOT receive an individualized audit & feedback report.
|
|
Other: Round 2: Month 12
All endoscopists in Ontario will receive an individualized audit & feedback report at month 12. Individualized A/F report |
Individualized A/F report containing 9 colonoscopy quality measures.
|
Other: Round 2: Poor performers
In Round 2, selected 60 poorer performers will be randomly assigned to receive one of the following interventions at month 12:
|
E.g.
Master class in colonoscopy
E.g.
Access to a video/presentation on good colonoscopy technique followed by a post presentation assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in polypectomy rate from baseline
Time Frame: At month 12
|
Measure change in polypectomy rate from baseline
|
At month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional outcome 1- Change in cecal intubation rate
Time Frame: At month 12
|
Change in cecal intubation rate from baseline
|
At month 12
|
Additional outcome 2 - Change in annual colonoscopy volume
Time Frame: At month 12
|
Change in annual colonoscopy volume from baseline
|
At month 12
|
Additional outcome 3 - Change in poor bowel preparation rate
Time Frame: At month 12
|
Change in poor bowel preparation rate from baseline
|
At month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jill Tinmouth, MD, Sunnybrook Health Sciences Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
July 10, 2015
First Submitted That Met QC Criteria
November 2, 2015
First Posted (Estimate)
November 3, 2015
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 477-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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