Colon PolypsEquip 2NCT02325635
A Prospective Trial of an Endoscopic Quality Improvement Project
A study testing Educational Training in people with Colon Polyps, run by Mayo Clinic at 1 site in United States.
Trial summary
Randomized prospective multi-site validation study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Polyps
- What is being tested?
- Educational Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2015
- 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
- Endoscopy centers that are new to GIQuIC and have not yet received training
- All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate
Who cannot join
- Cases that involve acute indications such as bleeding and active colitis will not be included in data pool
- Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded
- Procedures that are deemed incomplete will be excluded
- Patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (Boston bowel preparation score <5, or inadequate to exclude polyps >5mm) will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of an Endoscopic Quality Improvement Project-2 (EQUIP-2) to Improve Adenoma Detection in Screening and Surveillance Colonoscopy
Randomized prospective multi-site validation study.
Read the detailed description
GI practice sites that have recently agreed to participate in the GIQuIC program will be randomized on a site-basis, to the EQUIP intervention or control.
Baseline ADR and polyp/surveillance predication accuracy will be collected for approximately 3 months.
Sites randomized to the EQUIP intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback.
Control sites will not receive supplemental training and will be monitored by with no feedback. After completion of the study all sites will be offered the intervention (as is standard feedback in GIQuIC ).
- Conditions
- Colon Polyps
- Being tested
- Educational Training
- Keywords
- Adenoma Detection, Adenoma Prediction
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational TrainingOther
Also called Intervention offered to endoscopist only.
Intervention/Training offered to endoscopists only.
| Study group | Role | What they receive |
|---|---|---|
| Training of Endoscopist | Experimental | A series of 1 hour classes with ongoing monitoring and feedback to endoscopist only. Receives: Other: Educational Training |
| Deferred Training of Endoscopist | No intervention | No intervention during the data collection period. Training will be deferred to end of study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adenoma detection rates.
The primary outcome will be the change in adenoma detection rates between baseline and the intervention. Validate the effect of a quality improvement training program on the proportion of patients among whom at least one adenoma is detected
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionSep 2015
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 Colon PolypsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GI Quality Improvement Consortium
- Responsible party
- Principal investigator, Michael Wallace, Mayo Clinic
- Investigators
- Michael Wallace, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325635
- Sponsor's protocol ID
- 13-002066
- Acronym
- Equip 2
- Status last verified
- Nov 2015
- First submitted
- 11 Dec 2014
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallace MB, Crook JE, Thomas CS, Staggs E, Parker L, Rex DK. Effect of an endoscopic quality improvement program on adenoma detection rates: a multicenter cluster-randomized controlled trial in a clinical practice setting (EQUIP-3). Gastrointest Endosc. 2017 Mar;85(3):538-545.e4. doi: 10.1016/j.gie.2016.07.042. Epub 2016 Jul 26.
PubMed 27473182
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of an Endoscopic Quality Improvement Project-2 (EQUIP-2) to Improve Adenoma Detection in Screening and Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT02325635
- Acronym / sponsor ID
- Equip 2 / 13-002066
- Conditions
- Colon Polyps
- Keywords
- Adenoma Detection, Adenoma Prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GI Quality Improvement Consortium
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Dec 2014 (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.
Randomized prospective multi-site validation study.
Detailed description
GI practice sites that have recently agreed to participate in the GIQuIC program will be randomized on a site-basis, to the EQUIP intervention or control.
Baseline ADR and polyp/surveillance predication accuracy will be collected for approximately 3 months.
Sites randomized to the EQUIP intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback.
Control sites will not receive supplemental training and will be monitored by with no feedback. After completion of the study all sites will be offered the intervention (as is standard feedback in GIQuIC ).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training of Endoscopist | Experimental | Other: Educational TrainingA series of 1 hour classes with ongoing monitoring and feedback to endoscopist only. |
| Deferred Training of Endoscopist | No intervention | –No intervention during the data collection period. Training will be deferred to end of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endoscopy centers that are new to GIQuIC and have not yet received training
- All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate
Key exclusion criteria (4 listed)
- Cases that involve acute indications such as bleeding and active colitis will not be included in data pool
- Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded
- Procedures that are deemed incomplete will be excluded
- Patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (Boston bowel preparation score <5, or inadequate to exclude polyps >5mm) will be excluded
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 |
|---|---|---|
| Educational TrainingAlso: Intervention offered to endoscopist only.Intervention/Training offered to endoscopists only. | Other | Training of Endoscopist |
Primary outcome
Change in adenoma detection rates.
Time frame: 6 months
The primary outcome will be the change in adenoma detection rates between baseline and the intervention. Validate the effect of a quality improvement training program on the proportion of patients among whom at least one adenoma is detected
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 13 Nov 2015.
- Derived from this study: PubMed 27473182Wallace MB, Crook JE, Thomas CS, Staggs E, Parker L, Rex DK. Effect of an endoscopic quality improvement program on adenoma detection rates: a multicenter cluster-randomized controlled trial in a clinical practice setting (EQUIP-3). Gastrointest Endosc. 2017 Mar;85(3):538-545.e4. doi: 10.1016/j.gie.2016.07.042. Epub 2016 Jul 26.
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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.
Michael Wallace, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Training in people with Colon Polyps, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 4 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 13 Nov 2015. 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 United States. 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?
Change in adenoma detection rates. (time frame: 6 months). 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 NCT02325635, 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 13 Nov 2015.