OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD (OPTIC-IBD)

May 17, 2022 updated by: University of Birmingham

OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease

People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal areas in their bowel. These abnormal areas can be due to active inflammation, healed inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that people with IBD are offered periodic surveillance colonoscopy procedures to identify, characterize and where necessary remove abnormal areas or lesions from the bowel. These can be difficult to characterize correctly, which is important to make the correct endoscopic diagnosis and management plan. Technical advancements in endoscopy mean that more tools are available to identify and characterize these lesions in real time during colonoscopy. Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists") will often receive special training, both during their initial postgraduate training and through continuous professional development programs.

This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterize dysplasia in IBD. The goal is to support improved decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the care and outcomes of people with IBD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterise dysplasia in inflammatory bowel disease (IBD), to ultimately improve decision-making, reporting of dysplastic lesions and management during IBD surveillance.

Colonoscopy (endoscopic examination of the lower bowel) is a well-established screening tool to identify lesions within the bowel and objectively assess the degree of inflammation present. Patients with IBD, both Ulcerative colitis (UC) and Crohn's disease (CD), have a higher risk of developing cancers of the bowel and it is for this reason that they undergo regular surveillance procedures. Guidelines recommend surveillance procedures using high definition white light endoscopy alongside either Dye-Based Chromoendoscopy (DCE) or Virtual Chromoendoscopy (VCE), with targeted biopsies. However, the real world adoption of DCE and VCE is still modest. Due to technological advances there are alternative endoscopic imaging techniques that selectively enhance certain mucosal and vascular features, including narrow-band imaging (NBI), i-Scan optical enhancement (i-Scan-OE) and blue laser imaging (BLI).

These technologies have been demonstrated to be more effective than standard white light endoscopy. Despite these advances in technology, detecting dysplasia within areas of inflammation due to IBD is challenging. An endoscopic classification was recently developed by Iacucci M et al called "FACILE" to characterise in detail the mucosal and vascular pattern to predict histological colonic lesions in IBD. Since traditional lesion assessment systems such as (unmodified) Kudo pit pattern are less reliable in IBD, there is a need for a robust scoring system to assist clinicians in detecting and characterising lesions in IBD.

This project is to validate a training module on surveillance and colonic lesion characterisation in IBD. We aim to compare polyp detection in IBD surveillance procedures before and after training and evaluate the impact. As a sub-study, an additional randomisation process will take place whereby one group will receive additional focused top-up training and the other group will not. We will seek to compare the impact of feedback on knowledge retention.

Study stages:

  • Stage 1. Potential participants are provided an electronic PIS outlining the study.
  • Stage 2. Participants consent to the study and complete the pre-training assessment on REDCap (1 hour).
  • Stage 3. Participants are provided with login details for online training.
  • Stage 4. Participants complete the online training in their own time (1 hour).
  • Stage 5. Participants complete the same assessment (as pre-training) and are given 1-2 weeks to complete this after training.
  • Sub-study: Participants are randomised 1:1 to either receive or not receive a short refresher training module (15 min).
  • Stage 6. After 8-12 weeks post-training participants are invited to complete the same assessment process (as pre-training).

All participants will receive computer-based training. Training will take place via an online computer- based self-learning platform. The training will include reviewing short videos of colorectal polyps in patients with IBD and videos of inflammation in IBD (quiescent, mild, moderate and severe) using NBI, i-Scan-OE and BLI. Patients were consented for the use of the use of videos for educational purposes. Videos used have been fully anonymised.

All Participants are given access to the secure REDCap platform hosted at the University of Birmingham. Participants will be required to register using a general survey to include their email address, anonymised demographic data, procedural experience and familiarity with optical endoscopic diagnosis platforms.

Participants comprise three categories: novice, training endoscopist and experienced endoscopist. The latter two are the key categories for evaluation.

  • Novice will include medical students and junior doctors/residents who have previously had no or little endoscopic experience.
  • Training endoscopists will be gastroenterology and general surgery trainees/residents/fellows.
  • Experienced endoscopists will be fully qualified endoscopists such as GI and general surgery staff, consultants and nurse endoscopists.

Participants will then complete pre-training assessment prior to e-learning training. There are 26 video clips representative of different types of colonic lesions in IBD. Each video clip is typically 20-30 seconds. The overall duration of the assessment is around one hour.

Participants will then be given a login for the online training material and will complete this in their own time. Participants will be taught on endoscopic surveillance in IBD and how to characterise polyps accurately. The duration of the training module is 1 hour. It is interactive with optional components for tailored self-directed learning.

A post-training assessment will be completed in the next 1-2 weeks, using the same video clips, allowing us to compare the performance of participants before and after training. The assessment will be repeated after 8-12 weeks to assess the retention of skills.

An additional randomisation process on a 1:1 basis will take place, whereby one group will receive additional short refresher training following their responses to assessment questions and the other group will not. We will seek to compare the impact of feedback on sustainability of knowledge retention.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
  • Italy
      • Bari, Italy
        • University Aldo Moro
      • Milano, Italy
        • University of Milan
      • Napoli, Italy
        • University Federico II
  • United Kingdom
      • Birmingham, United Kingdom
        • University of Birmingham

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Specialist physicians performing gastrointestinal endoscopy
  • Non-medical endoscopists
  • Endoscopists in training with various levels of experience (such as Specialty Registrar, Fellow, Resident, non-medical endoscopists in training)
  • Novice endoscopists with no or limited experience (no previous exposure bias to endoscopy training or practice)

Exclusion criteria:

  • Unable to give informed consent to participate in study
  • Unwilling to give informed consent to participate in study

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
Active Comparator: Received short refresher training on optical diagnosis
All participants receive access to the training module, with assessments at baseline, week 2 and week 8-12 Half of participants randomized 1:1 will also receive access to brief refresher training by week 8
Other: Online self-learning training module
Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
Other: Refresher training
Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
Active Comparator: No refresher training
All participants receive access to the training module, with assessments at baseline, week 2 and week 8-12 This arm does not also receive access to brief refresher training
Other: Online self-learning training module
Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module
Time Frame: Baseline and 2 weeks
Accuracy in characterization by modified SCENIC classification [Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients: International Consensus Recommendations], modified Kudo pit pattern classification, FACILE classification [Frankfurt Advanced Chromoendoscopic Inflammatory Bowel Disease Lesions], optical prediction of final histopathological diagnosis
Baseline and 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module, impact of short refresher training
Time Frame: Baseline and 8-12 weeks
Accuracy in characterization by modified SCENIC classification [Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients: International Consensus Recommendations], modified Kudo pit pattern classification, FACILE classification [Frankfurt Advanced Chromoendoscopic Inflammatory Bowel Disease Lesions], overall optical prediction of final histopathological diagnosis
Baseline and 8-12 weeks
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - retention between participants randomized to receive or not receive refresher training
Time Frame: 2 weeks and 8-12 weeks
Accuracy in characterization by modified SCENIC classification [Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients: International Consensus Recommendations], modified Kudo pit pattern classification, FACILE classification [Frankfurt Advanced Chromoendoscopic Inflammatory Bowel Disease Lesions], overall optical prediction of final histopathological diagnosis
2 weeks and 8-12 weeks
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module
Time Frame: Baseline and 2 weeks
Confidence in overall optical prediction of final histopathological diagnosis
Baseline and 2 weeks
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module, impact of short refresher training
Time Frame: Baseline and 8-12 weeks
Confidence in overall optical prediction of final histopathological diagnosis
Baseline and 8-12 weeks
Change in participant assessment of confidence of prediction for each video (High vs. Low) - at re-assessment between participants randomized to receive or not receive short refresher training
Time Frame: 2 weeks and 8-12 weeks
Confidence in overall optical prediction of final histopathological diagnosis
2 weeks and 8-12 weeks
Participant assessment of overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module
Time Frame: Baseline assessment
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
Baseline assessment
Participant assessment of impact of training module on overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module
Time Frame: Early post-training assessment at 2 weeks
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
Early post-training assessment at 2 weeks
Participant assessment of impact of training program on overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module with or without brief refresher training
Time Frame: Late post-training assessment by 8-12 weeks
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
Late post-training assessment by 8-12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of training module
Time Frame: Baseline assessment
Participant assessment of quality of each video (High vs. Low)
Baseline assessment
Quality of training module
Time Frame: Early post-training assessment by 2 weeks
Participant assessment of quality of each video (High vs. Low)
Early post-training assessment by 2 weeks
Quality of training module
Time Frame: Late post-training assessment by 8-12 weeks
Participant assessment of quality of each video (High vs. Low)
Late post-training assessment by 8-12 weeks
Quality of training module
Time Frame: At provision of training module by 2 weeks
Module evaluation by Likert scales (strongly agree, agree, neither agree or disagree, disagree, strongly disagree) for "The module has been effective in helping me to learn" and "The module content was relevant" and "The module length was appropriate" and "I would recommend the module" and "The assessments matched the module content", and evaluation by free text comments "What have you learned in this module that will impact on your clinical practice?" and "Describe the best and worst thing about this module" and "How would you change or improve this module?"
At provision of training module by 2 weeks
Quality of brief refresher training
Time Frame: At provision of brief refresher training by 8 weeks
Module evaluation by Likert scales (strongly agree, agree, neither agree or disagree, disagree, strongly disagree) for "The refresher training has been effective in helping me to consolidate my learning" and "The refresher training content was relevant" and "The refresher training length was appropriate" and "I would recommend including refresher training in the program", and evaluation by free text comments "Describe the best and worst thing about this refresher training" and "How would you change or improve this refresher training?"
At provision of brief refresher training by 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Federico II University
University of Calgary
University of Milan
University of Bari Aldo Moro

Investigators

  • Study Director: Marietta Iacucci, MD PhD, University of Birmingham
  • Principal Investigator: Jose G Ferraz, MD PhD, University of Calgary
  • Principal Investigator: Gian E Tontini, MD PhD, University of Milan

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.

General Publications

Helpful Links

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 (Actual)

July 7, 2021

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERN-18-0222A
  • REB21-0409 (Other Identifier: University of Calgary, Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD as not applicable to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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