Colorectal PolypsNCT02595775
A Trial of an Audit and Feedback Report to Improve Colonoscopy Performance
A study testing Individualized A/F report, A/F report plus a high intensity intervention and A/F report plus a low intensity intervention in people with Colorectal Polyps, run by Sunnybrook Health Sciences Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Individualized A/F report, A/F report plus a high intensity intervention and A/F report plus a low intensity intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 833 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All practising endoscopists in Ontario who performed at least 5 colonoscopies in 2014
Who cannot join
- -
About this study
Official title: 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.
- Conditions
- Colorectal Polyps
- Being tested
- Individualized A/F report, A/F report plus a high intensity intervention, A/F report plus a low intensity intervention, A/F report alone
- Keywords
- endoscopy measures, audit and feedback, quality improvement, randomized controlled trial, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized A/F reportOther
Individualized A/F report containing 9 colonoscopy quality measures.
A/F report plus a high intensity interventionOther
E.g. Master class in colonoscopy
A/F report plus a low intensity interventionOther
E.g. Access to a video/presentation on good colonoscopy technique followed by a post presentation assessment.
A/F report aloneOther
| Study group | Role | What they receive |
|---|---|---|
| Round 1: Intervention arm | Experimental | Half of the endoscopists in Ontario will receive an individualized audit \& feedback report.
Individualized A/F report. Receives: Other: Individualized A/F report |
| Round 1: Control | No intervention | Half of the endoscopists in Ontario will NOT receive an individualized audit \& feedback report. |
| Round 2: Month 12 | Other | All endoscopists in Ontario will receive an individualized audit \& feedback report at month 12.
Individualized A/F report Receives: Other: Individualized A/F report |
| Round 2: Poor performers | Other | In Round 2, selected 60 poorer performers will be randomly assigned to receive one of the following interventions at month 12:
1. A/F report plus a high intensity intervention
2. A/F report plus a low intensity intervention
3. A/F report alone Receives: Other: A/F report plus a high intensity intervention; Other: A/F report plus a low intensity intervention; Other: A/F report alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in polypectomy rate from baseline
Measure change in polypectomy rate from baseline
Measured: At month 12
Secondary outcomes (3)
Additional outcome 1- Change in cecal intubation rate
Change in cecal intubation rate from baseline
Measured: At month 12
Additional outcome 2 - Change in annual colonoscopy volume
Change in annual colonoscopy volume from baseline
Measured: At month 12
Additional outcome 3 - Change in poor bowel preparation rate
Change in poor bowel preparation rate from baseline
Measured: At month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Care Ontario
- Responsible party
- Sponsor
- Investigators
- Jill Tinmouth, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595775
- Sponsor's protocol ID
- 477-2014
- Status last verified
- May 2017
- First submitted
- 10 Jul 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tinmouth J, Sutradhar R, Li Q, Patel J, Baxter NN, Llovet D, Paszat LF, Rabeneck L. A Pragmatic Randomized Controlled Trial of an Endoscopist Audit and Feedback Report for Colonoscopy. Am J Gastroenterol. 2021 Oct 1;116(10):2042-2051. doi: 10.14309/ajg.0000000000001498.
PubMed 34515669
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Audit and Feedback Report to Improve Colonoscopy Performance
- ClinicalTrials.gov ID
- NCT02595775
- Acronym / sponsor ID
- 477-2014
- Conditions
- Colorectal Polyps
- Keywords
- endoscopy measures, audit and feedback, quality improvement, randomized controlled trial, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Cancer Care Ontario
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Round 1: Intervention arm | Experimental | Other: Individualized A/F reportHalf of the endoscopists in Ontario will receive an individualized audit \& feedback report. Individualized A/F report. |
| Round 1: Control | No intervention | –Half of the endoscopists in Ontario will NOT receive an individualized audit \& feedback report. |
| Round 2: Month 12 | Other | Other: Individualized A/F reportAll endoscopists in Ontario will receive an individualized audit \& feedback report at month 12. Individualized A/F report |
| Round 2: Poor performers | Other | Other: A/F report plus a high intensity intervention, Other: A/F report plus a low intensity intervention, Other: A/F report aloneIn Round 2, selected 60 poorer performers will be randomly assigned to receive one of the following interventions at month 12: 1. A/F report plus a high intensity intervention 2. A/F report plus a low intensity intervention 3. A/F report alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All practising endoscopists in Ontario who performed at least 5 colonoscopies in 2014
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized A/F reportIndividualized A/F report containing 9 colonoscopy quality measures. | Other | Round 1: Intervention arm, Round 2: Month 12 |
| A/F report plus a high intensity interventionE.g. Master class in colonoscopy | Other | Round 2: Poor performers |
| A/F report plus a low intensity interventionE.g. Access to a video/presentation on good colonoscopy technique followed by a post presentation assessment. | Other | Round 2: Poor performers |
| A/F report alone | Other | Round 2: Poor performers |
Primary outcome
Change in polypectomy rate from baseline
Time frame: At month 12
Measure change in polypectomy rate from baseline
3 secondary outcomes
Additional outcome 1- Change in cecal intubation rate
Time frame: At month 12
Additional outcome 2 - Change in annual colonoscopy volume
Time frame: At month 12
Additional outcome 3 - Change in poor bowel preparation rate
Time frame: At month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 34515669Tinmouth J, Sutradhar R, Li Q, Patel J, Baxter NN, Llovet D, Paszat LF, Rabeneck L. A Pragmatic Randomized Controlled Trial of an Endoscopist Audit and Feedback Report for Colonoscopy. Am J Gastroenterol. 2021 Oct 1;116(10):2042-2051. doi: 10.14309/ajg.0000000000001498.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Tinmouth, MD principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Individualized A/F report, A/F report plus a high intensity intervention and A/F report plus a low intensity intervention in people with Colorectal Polyps, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in polypectomy rate from baseline (time frame: At month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.