- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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?
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Brianna D'Orazio, MPH
- Número de telefone: 317-274-3220
- E-mail: bdorazio@iu.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pre-post Change in Adenoma Detection Rate (ADR) at the individual and cohort levels
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Colonoscopist technical skill scores (E-CTSS) assessed by expert review of video-recorded colonoscopies at the individual and cohort levels
Prazo: 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
Prazo: 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
Prazo: 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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anthony Yang, MD MS, Indiana University
- Investigador principal: Rajesh Keswani, MD, Northwestern University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 31536
- 1R01DK147605 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
all IPD that underlie results in a publication
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