Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924543
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2021-06-07
Brief Title:
OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD
Sponsor:
University of Birmingham
Organization:
University of Birmingham
Study Overview
Official Title:
OPtical Diagnosis Training to Improve Dysplasia Characterisation in Inflammatory Bowel Disease
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIC-IBD
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
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 Crohns 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 11 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 doctorsresidents who have previously had no or little endoscopic experience
Training endoscopists will be gastroenterology and general surgery traineesresidentsfellows
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 11 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
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 Crohns 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 11 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 doctorsresidents who have previously had no or little endoscopic experience
Training endoscopists will be gastroenterology and general surgery traineesresidentsfellows
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| REB21-0409 | OTHER | University of Calgary Canada | None |