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

Primary Purpose

Inflammatory Bowel Diseases, Dysplasia Colon, Dysplasia, Crohn Disease-Associated

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Online self-learning training module
Refresher training
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases focused on measuring Endoscopy, Optical diagnosis, Dysplasia surveillance, Inflammatory bowel disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary
  • University Aldo Moro
  • University of Milan
  • University Federico II
  • University of Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Received short refresher training on optical diagnosis

No refresher training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module
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

Secondary Outcome Measures

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
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
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
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
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module
Confidence in overall optical prediction of final histopathological diagnosis
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module, impact of short refresher training
Confidence in overall optical prediction of final histopathological diagnosis
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
Confidence in overall optical prediction of final histopathological diagnosis
Participant assessment of overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
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
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
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
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)

Full Information

First Posted
June 7, 2021
Last Updated
May 17, 2022
Sponsor
University of Birmingham
Collaborators
University of Calgary, University of Milan, Federico II University, University of Bari Aldo Moro
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1. Study Identification

Unique Protocol Identification Number
NCT04924543
Brief Title
OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD
Acronym
OPTIC-IBD
Official Title
OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham
Collaborators
University of Calgary, University of Milan, Federico II University, University of Bari Aldo Moro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Dysplasia Colon, Dysplasia, Crohn Disease-Associated, Polyp of Colon, Ulcerative Colitis, Crohn Colitis, Crohn Disease
Keywords
Endoscopy, Optical diagnosis, Dysplasia surveillance, Inflammatory bowel disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All enrolled participants are allocated to the same intervention, with pre-course and post-course assessments. Participants will then be randomized 1:1 to one of two arms: (1) to receive short refresher training on optical diagnosis, or (2) no additional intervention. All participants will complete a final late post-course assessment to test knowledge retention from the training module and the impact of refresher training.
Masking
None (Open Label)
Masking Description
No masking planned
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Received short refresher training on optical diagnosis
Arm Type
Active Comparator
Arm Description
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
Arm Title
No refresher training
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Online self-learning training module
Intervention Description
Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
Intervention Type
Other
Intervention Name(s)
Refresher training
Intervention Description
Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
Primary Outcome Measure Information:
Title
Change in percentage of participants who accurately characterized endoscopic lesions of the intestine in patients with inflammatory bowel disease - impact of training module
Description
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
Time Frame
Baseline and 2 weeks
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Baseline and 8-12 weeks
Title
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
Description
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
Time Frame
2 weeks and 8-12 weeks
Title
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module
Description
Confidence in overall optical prediction of final histopathological diagnosis
Time Frame
Baseline and 2 weeks
Title
Change in participant assessment of confidence of prediction for each video (High vs. Low) - impact of training module, impact of short refresher training
Description
Confidence in overall optical prediction of final histopathological diagnosis
Time Frame
Baseline and 8-12 weeks
Title
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
Description
Confidence in overall optical prediction of final histopathological diagnosis
Time Frame
2 weeks and 8-12 weeks
Title
Participant assessment of overall confidence in characterization of endoscopic lesions in patients with inflammatory bowel disease - impact of training module
Description
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
Time Frame
Baseline assessment
Title
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
Description
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
Time Frame
Early post-training assessment at 2 weeks
Title
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
Description
Confidence by Likert scale (0 = no confidence, 1, 2 , 3 = moderate confidence, 4, 5, 6 = high confidence)
Time Frame
Late post-training assessment by 8-12 weeks
Other Pre-specified Outcome Measures:
Title
Quality of training module
Description
Participant assessment of quality of each video (High vs. Low)
Time Frame
Baseline assessment
Title
Quality of training module
Description
Participant assessment of quality of each video (High vs. Low)
Time Frame
Early post-training assessment by 2 weeks
Title
Quality of training module
Description
Participant assessment of quality of each video (High vs. Low)
Time Frame
Late post-training assessment by 8-12 weeks
Title
Quality of training module
Description
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?"
Time Frame
At provision of training module by 2 weeks
Title
Quality of brief refresher training
Description
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?"
Time Frame
At provision of brief refresher training by 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marietta Iacucci, MD PhD
Organizational Affiliation
University of Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose G Ferraz, MD PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gian E Tontini, MD PhD
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University Aldo Moro
City
Bari
Country
Italy
Facility Name
University of Milan
City
Milano
Country
Italy
Facility Name
University Federico II
City
Napoli
Country
Italy
Facility Name
University of Birmingham
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD as not applicable to this study
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Links:
URL
http://www.opticendoscopy.com
Description
OPTIC-IBD

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OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

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