Colorectal CancerNCT01667198
Randomized Study of Train the Colonoscopy Leaders Course Versus Audit and Feedback on Colonoscopy Quality Indicators
A study testing Train the leaders course and Audit and feedback in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
Professional societies recommend that endoscopists measure their ceacal intubation rate, adenoma detection rate as indicators of the screening colonoscopy quality. However, it is uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in the detection of adenomas. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Train the leaders course and Audit and feedback
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2012to Dec 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- screening center leading colonoscopist
- at least 30 screening colonoscopies in the 2011 edition of the screening program
- adenoma detection rate lower than 25%
Who cannot join
- lack of participation in the 2012 edition of the screening program
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
About this study
Official title: Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.
Professional societies recommend that endoscopists measure their ceacal intubation rate, adenoma detection rate as indicators of the screening colonoscopy quality. However, it is uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in the detection of adenomas. The investigators hypothesize that a hands-on-training intervention tailored to the results of environmental assessment and audit on colonoscopy quality indicators results in higher adenoma detection rate improvement than simple audit and feedback. The investigators further hypothesize that by training the leaders of the screening centres, the effect of the intervention will be further disseminated among other endoscopists from the participating centers, and will thus result in additional increase in individual adenoma detection rate.
The primary aim is to compare the impact on adenoma detection rate of two screening colonoscopy improvement programs:
- Tailored training intervention.
- Audit feedback on colonoscopy quality indicators.
- Conditions
- Colorectal Cancer
- Being tested
- Train the leaders course, Audit and feedback
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train the leaders courseProcedure or surgery
Screening centre leaders randomized to the training intervention group will be invited to take part in a train-the-leaders course. The Train-the-leaders course will consist of three phases: (i) pre-training assessment, (ii) hands-on-training and (iii) post-training evaluation and feedback. The Train-the-leaders course will be run in polish by the team from the Maria Sklodowska-Curie Memorial Cancer Center and Institute on Oncology, Warsaw, which was trained in delivering such intervention by experts from the United Kingdom.
Audit and feedbackBehavioural
Screening centre leaders randomized to the feedback group will receive (by e-mail and conventional mail) feedback on their individual screening colonoscopy quality indicators (adenoma detection rate and ceacal intubation rate) measured for the 2011 edition of the national screening program. The results will be presented in a league table in order to enable comparison with anonymous results of all endoscopists who performed at least 30 colonoscopies within the screening program. In addition, a link to a webpage containing data on individual and overall colonoscopy quality indicators over the last four years of the screening program will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Train the leaders course | Experimental | Not described Receives: Procedure: Train the leaders course |
| Audit and feedback | Active comparator | Not described Receives: Behavioral: Audit and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening centre leader's adenoma detection rate
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
Measured: till the end of calendar year after the training intervention
Secondary outcomes (5)
Screening center's overall adenoma detection rate
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
Measured: Till the end of calendar year after the training intervention
Screening centre leader's proximal and distal adenoma detection rate
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
Measured: Till the end of calendar year after the training intervention
Screening centre's non-polypoid lesion detection rate
Measured: Till the end of calendar year after the training intervention
Overall screening centre's ceacal intubation rate
Ceacal intubation is defined as the passage of the colonoscope tip to a point proximal to the ileoceacal valve and visualization of the entire ceacum.
Measured: Till the end of calendar year after the training intervention
Screening centre leader's withdrawal technique
Withdrawal technique assessed by a trained endoscopy nurse
Measured: Till the end of calendar year after the training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
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 CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education, Gloucestershire Hospitals NHS Foundation Trust, University of Oslo, Erasmus Medical Center, Ministry of Science and Higher Education, Poland
- Responsible party
- Sponsor
- Investigators
- Michal F. Kaminski, MD, PhD, Principal investigator, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of OncologyJaroslaw Regula, MD, PhD, Study chair, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667198
- Sponsor's protocol ID
- IP2010016270
- Status last verified
- Apr 2014
- First submitted
- 14 Aug 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.
PubMed 25670810
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement in Screening Colonoscopy - a Randomized Trial of Tailored Training Intervention Versus Simple Feedback on the Quality Indicators.
- ClinicalTrials.gov ID
- NCT01667198
- Acronym / sponsor ID
- IP2010016270
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education, Gloucestershire Hospitals NHS Foundation Trust, University of Oslo, Erasmus Medical Center, Ministry of Science and Higher Education, Poland
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Aug 2012 (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.
Professional societies recommend that endoscopists measure their ceacal intubation rate, adenoma detection rate as indicators of the screening colonoscopy quality. However, it is uncertain how to improve adenoma detection rate and reduce inter-endoscopists' variability in the detection of adenomas. The investigators hypothesize that a hands-on-training intervention tailored to the results of environmental assessment and audit on colonoscopy quality indicators results in higher adenoma detection rate improvement than simple audit and feedback. The investigators further hypothesize that by training the leaders of the screening centres, the effect of the intervention will be further disseminated among other endoscopists from the participating centers, and will thus result in additional increase in individual adenoma detection rate.
The primary aim is to compare the impact on adenoma detection rate of two screening colonoscopy improvement programs:
- Tailored training intervention.
- Audit feedback on colonoscopy quality indicators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Train the leaders course | Experimental | Procedure: Train the leaders course |
| Audit and feedback | Active comparator | Behavioral: Audit and feedback |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- screening center leading colonoscopist
- at least 30 screening colonoscopies in the 2011 edition of the screening program
- adenoma detection rate lower than 25%
Key exclusion criteria (1 listed)
- lack of participation in the 2012 edition of the screening program
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 |
|---|---|---|
| Train the leaders courseScreening centre leaders randomized to the training intervention group will be invited to take part in a train-the-leaders course. The Train-the-leaders course will consist of three phases: (i) pre-training assessment, (ii) hands-on-training and (iii) post-training evaluation and feedback. The Train-the-leaders course will be run in polish by the team from the Maria Sklodowska-Curie Memorial Cancer Center and Institute on Oncology, Warsaw, which was trained in delivering such intervention by experts from the United Kingdom. | Procedure or surgery | Train the leaders course |
| Audit and feedbackScreening centre leaders randomized to the feedback group will receive (by e-mail and conventional mail) feedback on their individual screening colonoscopy quality indicators (adenoma detection rate and ceacal intubation rate) measured for the 2011 edition of the national screening program. The results will be presented in a league table in order to enable comparison with anonymous results of all endoscopists who performed at least 30 colonoscopies within the screening program. In addition, a link to a webpage containing data on individual and overall colonoscopy quality indicators over the last four years of the screening program will be provided. | Behavioural | Audit and feedback |
Primary outcome
Screening centre leader's adenoma detection rate
Time frame: till the end of calendar year after the training intervention
Adenoma detection rate is defined as the proportion of screened subjects in whom at least one adenomatous lesion is identified.
5 secondary outcomes
Screening center's overall adenoma detection rate
Time frame: Till the end of calendar year after the training intervention
Screening centre leader's proximal and distal adenoma detection rate
Time frame: Till the end of calendar year after the training intervention
Screening centre's non-polypoid lesion detection rate
Time frame: Till the end of calendar year after the training intervention
Overall screening centre's ceacal intubation rate
Time frame: Till the end of calendar year after the training intervention
Screening centre leader's withdrawal technique
Time frame: Till the end of calendar year after the training intervention
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 16 Apr 2014.
- Derived from this study: PubMed 25670810Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.
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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.
Michal F. Kaminski, MD, PhD principal investigator
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Jaroslaw Regula, MD, PhD study chair
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Train the leaders course and Audit and feedback in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 3 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 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Screening centre leader's adenoma detection rate (time frame: till the end of calendar year after the training intervention). 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 NCT01667198, 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 16 Apr 2014.