Colorectal Neoplasms
Conditions
Keywords
colonoscopy, artificial intelligence, adenoma, Veterans, quality assurance
Brief summary
The goal of this cluster randomized study is to determine if artificial intelligence systems used during colonoscopy can improve the detection of precancerous polyps in the colon. The primary question it aims to answer is whether computer-assisted detection devices improve the proportion of colonoscopies found to have precancerous adenomatous polyps. Secondary aims will assess if computer-assisted detection devices improve the proportion of colonoscopies found to other types of precancerous polyps known as sessile serrated lesions, or cancer of the colon and rectum. The study will also assess possible negative effects of use of computer-assisted detection (e.g., prolonging the procedure time or false-positive biopsies) and survey device users to learn about their experience with this technology. The study team will provide computer-assisted detection devices to randomly chosen VA medical centers for use during colonoscopy and compare colonoscopy findings for patients who undergo colonoscopy at facilities that are equipped with these devices to the findings of patients who undergo colonoscopy at VA facilities that do not have these devices. A survey will be distributed to physicians who perform colonoscopy to assess their experience using computer-assisted detection devices.
Interventions
DEVICEComputer Assisted Detection
Computer-assisted polyp detection system that utilizes artificial intelligence (AI) during colonoscopy
Sponsors
VA Salt Lake City Health Care System
San Francisco Veterans Affairs Medical Center
VA Puget Sound Health Care System
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Colonoscopy performed at a Veterans Affairs (VA) medical center
Exclusion criteria
* Colonoscopy performed at VA medical centers that acquired computer-assisted detection artificial intelligence devices through non-random assignment * Colonoscopy performed at a VA medical center where pathology results are not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma Detection Rate | Baseline and 6 months | Change in the proportion of colonoscopies in which one or more adenomas are detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sessile serrated lesion detection rate | Baseline and 6 months | Proportion of colonoscopies with one or more sessile serrated lesions detected |
| Proportion of colonoscopies with pathology obtained | Baseline and 6 months | Proportion of colonoscopies where specimens were obtained for pathologic review |
| Adenocarcinoma detection rate | Baseline and 6 months | Change in the proportion of colonoscopies where colorectal cancer is detected |
| Withdrawal time without interventions | Baseline and 6 months | Change in the duration of colonoscope withdrawal when no intervention (e.g., polypectomy, biopsy) is performed. This outcome can only be assessed at a subset of sites due to data availability issues (i.e., Provation MD sites). |
| Provider satisfaction with computer assisted detection for colonoscopy | Approximately 6 months after deployment | Provider ratings of satisfaction with the CADe device |
| Proportion of pathology without adenoma or adenocarcinoma | Baseline and 6 months | As a surrogate for false positive lesion identification during use of CADe |
Countries
United States
Outcome results
None listed