- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07934381
Video-based Project to Improve Colonoscopy Quality in Lower-Volume Clinicians
Video-based Bundle to Improve Screening Colonoscopy Quality in Lower-volume Clinicians
The goals of this project are to learn whether a quality improvement report card assessing technical skills from AI-augmented expert review of video recordings improves doctors' colonoscopy performance. Colonoscopy performance is important because colonoscopies are how doctors detect and remove pre-cancerous polyps. The participants in this study are doctors, usually surgeons, who perform some colonoscopies as part of their practice. These doctors usually do not receive feedback on their performance, and therefore lack information on how to potentially improve their ability to detect and remove pre-cancerous polyps.
The main questions it aims to answer are:
- Are there ways we should customize the colonoscopy quality improvement report card to the participating doctors?
- Does customizing the report card lead to better acceptance of the information shared?
(2) Does the colonoscopy quality improvement report card improve doctors' colonoscopy performance?
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Colonoscopy reduces the risk of colorectal cancer (CRC) mortality through the detection and removal of pre-cancerous polyps (adenomas), but the magnitude of risk reduction depends upon the quality of the colonoscopy. Most colonoscopy quality improvement (QI) initiatives have focused on higher-volume gastroenterologists. In rural and peri-urban communities in the United States, most colonoscopies are performed by lower-volume colonoscopists, who are mostly surgeons, and CRC outcomes are worse compared to urban areas. These lower-volume colonoscopists have marked variability in quality and many fail to adhere to best practices or meet national benchmarks. Higher adenoma detection rate (ADR) is the quality metric most associated with reduced CRC mortality. However, ADR is less accurate at lower colonoscopy volumes, suggesting that ADR alone cannot reliably differentiate quality or provide meaningful information to improve quality in lower-volume colonoscopists. Thus, alternative methods to measure and improve quality in lower-volume colonoscopists are needed. Video evaluation of procedures such as colonoscopy is a valuable tool for assessing and improving technical skills in multiple specialties. In prior work, we found that higher-volume gastroenterologists' colonoscopy skill, assessed by expert evaluation of video-recorded colonoscopies using a validated technical skill scoring rubric, is highly correlated with quality metrics requires fewer colonoscopies for accurate assessment, and correlates with ADR. Further, we showed that delivery of focused feedback based on technical skill scores improves colonoscopy quality. While expert video evaluation of colonoscopies is an effective tool to measure and improve quality in lower-volume colonoscopists, it is not feasible on a larger scale given the time and cost of manual video review. We therefore developed and validated an AI-based tool that identifies key steps in colonoscopy videos, for rapid expert review and scoring. This study focuses on the implementation and evaluation of an AI-augmented intervention to improve colonoscopy quality of lower-volume colonoscopists in rural and peri-urban areas to ultimately reduce CRC mortality. The intervention, the "Colonoscopy Quality Improvement Bundle" (ColonQI Bundle), combines (1) AI-augmented expert assessment and scoring of technical skills; (2) AI-augmented automated calculation of quality metrics (e.g., ADR, withdrawal time), and (3) Targeted feedback of specific technical skill deficits based on the scores (audit-feedback, structured video-based didactics, coaching, mentoring). Lower-volume colonoscopists, with a focus on surgeons will be recruited to: (1) Assess the needs and preferences of, and select strategies for implementation of the ColonQI Bundle using an implementation science framework; (2) Implement the ColonQI Bundle, using tailored implementation strategies tailored to the needs and preferences of lower-volume colonoscopists; and (3) Assess the effectiveness of the ColonQI Bundle to improve colonoscopy quality and technical skills among lower-volume colonoscopists.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Brianna D'Orazio, MPH
- Telefonnummer: 317-274-3220
- E-post: bdorazio@iu.edu
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Surgeons or gastroenterologists who perform 10-600 colonoscopies per year and who practice at a hospital affiliated with the Illiana Surgical Quality Improvement Collaborative (ISQIC)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Colonosopy Quality Improvement
Participating colonoscopists will receive the Colonoscopy Quality Improvement Bundle |
The "Colonoscopy Quality Improvement Bundle" (ColonQI Bundle) combines (1) calculation of quality metrics (e.g., CIR, WT); (2) AI-augmented expert technical skills assessment; and (3) targeted feedback of specific technical skill deficits (audit-feedback, structured video-based didactics, coaching, mentoring). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pre-post Change in Adenoma Detection Rate (ADR) at the individual and cohort levels
Tidsram: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
The rate at which a colonoscopist detects adenomas (pre-cancerous polyps) during a colonoscopy in an average-risk population. |
From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Colonoscopist technical skill scores (E-CTSS) assessed by expert review of video-recorded colonoscopies at the individual and cohort levels
Tidsram: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
Total E-CTSS score; composite of 3 individually scored skills (cleaning, distention, and examination behind colon folds) |
From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
|
Pre-post Change in Withdrawal time (WT) at the individual and cohort levels
Tidsram: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
Time spent inspecting the colon for polyps in screening and surveillance colonoscopies (not including time spent on polyp removal or biopsies) |
From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
|
Pre-post change in Sessile serrated polyp detection rate (SDR) at the individual and cohort levels
Tidsram: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
Proportion of colonoscopies in which a serrated polyp is removed |
From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Anthony Yang, MD MS, Indiana University
- Huvudutredare: Rajesh Keswani, MD, Northwestern University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 31536
- 1R01DK147605 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
all IPD that underlie results in a publication
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