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Video-based Project to Improve Colonoscopy Quality in Lower-Volume Clinicians

2026年11月9日 更新者:Anthony Yang、Indiana University

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:

  1. Are there ways we should customize the colonoscopy quality improvement report card to the participating doctors?
  2. 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?

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

15

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Brianna D'Orazio, MPH
  • 電話番号:317-274-3220
  • メール:bdorazio@iu.edu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pre-post Change in Adenoma Detection Rate (ADR) at the individual and cohort levels
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Colonoscopist technical skill scores (E-CTSS) assessed by expert review of video-recorded colonoscopies at the individual and cohort levels
時間枠: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
時間枠: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
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Anthony Yang, MD MS、Indiana University
  • 主任研究者:Rajesh Keswani, MD、Northwestern University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月1日

一次修了 (推定)

2028年10月1日

研究の完了 (推定)

2029年7月1日

試験登録日

最初に提出

2026年11月3日

QC基準を満たした最初の提出物

2026年11月9日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 31536
  • 1R01DK147605 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

all IPD that underlie results in a publication

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。