Ulcerative Colitis Clinical Trial
— OPTIC-IBDOfficial title:
OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease
Verified date | May 2022 |
Source | University of Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 182 |
Est. completion date | April 30, 2022 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Italy | University Aldo Moro | Bari | |
Italy | University of Milan | Milano | |
Italy | University Federico II | Napoli | |
United Kingdom | University of Birmingham | Birmingham |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham | Federico II University, University of Bari Aldo Moro, University of Calgary, University of Milan |
Canada, Italy, United Kingdom,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quality of training module | Participant assessment of quality of each video (High vs. Low) | Baseline assessment | |
Other | Quality of training module | Participant assessment of quality of each video (High vs. Low) | Early post-training assessment by 2 weeks | |
Other | Quality of training module | Participant assessment of quality of each video (High vs. Low) | Late post-training assessment by 8-12 weeks | |
Other | Quality of training module | 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 | |
Other | Quality of brief refresher training | 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 | |
Primary | 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 | Baseline and 2 weeks | |
Secondary | 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 | Baseline and 8-12 weeks | |
Secondary | 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 | 2 weeks and 8-12 weeks | |
Secondary | 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 | Baseline and 2 weeks | |
Secondary | 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 | Baseline and 8-12 weeks | |
Secondary | 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 | 2 weeks and 8-12 weeks | |
Secondary | 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) | Baseline assessment | |
Secondary | 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) | Early post-training assessment at 2 weeks | |
Secondary | 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) | Late post-training assessment by 8-12 weeks |
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