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

9 de noviembre de 2026 actualizado por: 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?

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

15

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Brianna D'Orazio, MPH
  • Número de teléfono: 317-274-3220
  • Correo electrónico: bdorazio@iu.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pre-post Change in Adenoma Detection Rate (ADR) at the individual and cohort levels
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Colonoscopist technical skill scores (E-CTSS) assessed by expert review of video-recorded colonoscopies at the individual and cohort levels
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Anthony Yang, MD MS, Indiana University
  • Investigador principal: Rajesh Keswani, MD, Northwestern University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de noviembre de 2026

Finalización primaria (Estimado)

1 de octubre de 2028

Finalización del estudio (Estimado)

1 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

3 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 31536
  • 1R01DK147605 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

all IPD that underlie results in a publication

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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