OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

NCT ID: NCT04924543

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2022-04-30

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.

Conditions

Inflammatory Bowel Diseases; Dysplasia Colon; Dysplasia, Crohn Disease-Associated; Polyp of Colon; Ulcerative Colitis; Crohn Colitis; Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Online self-learning training module

Intervention Type: OTHER

Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Refresher training

Intervention Type: OTHER

Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

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

Group Type: ACTIVE_COMPARATOR

Online self-learning training module

Intervention Type: OTHER

Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Interventions

Online self-learning training module

Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Intervention Type: OTHER

Refresher training

Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: collaborator

University of Bari Aldo Moro

OTHER

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marietta Iacucci, MD PhD

Role: STUDY_DIRECTOR

University of Birmingham

Jose G Ferraz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Gian E Tontini, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

University of Calgary

Calgary, Alberta, Canada

University Aldo Moro

Bari, , Italy

University of Milan

Milan, , Italy

University Federico II

Napoli, , Italy

University of Birmingham

Birmingham, , United Kingdom

Countries

Canada; Italy; United Kingdom

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Other Identifiers

REB21-0409

Identifier Type: OTHER

Identifier Source: secondary_id

ERN-18-0222A

Identifier Type: -

Identifier Source: org_study_id