Contemporary clinical trials · 2025
Increasing timely colonoscopy surveillance for patients with high-risk colorectal polyps: Protocol for a cluster randomized trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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May Folasade P, McEwan Jenna A, Tuan Jessica J, Crespi Catherine M, Maehara Cleo K, Yang Jamie O, Uy Alexandria, Gupta Samir, Kang Yuna, Myint Anthony, Naini Bita V, Elmore Joann G, Kadiyala Srikanth, Ong Michael K, Bui Alex A T, Hamilton Alison B, Chang L Cindy, Gelvezon Alex, Hsu William, Bastani Roshan
Аннотация
INTRODUCTION: Colorectal cancer (CRC) is largely preventable through the removal of precancerous polyps from the colon and rectum. Polyp surveillance guidelines recommend that individuals with polyps categorized as high-risk neoplasia (HRN) undergo surveillance colonoscopy 3 years after HRN diagnosis. However, over half of patients fail to receive their surveillance colonoscopy within this recommended timeframe, highlighting the need for effective interventions to improve 3-year colonoscopy surveillance rates.
METHODS: A hybrid type 1 effectiveness-implementation, 2-group cluster-randomized trial is being conducted at 30 primary health care clinics in a large, urban academic health center in Southern California. The study includes two arms: (1) a multilevel intervention arm in which a natural language processing (NLP) algorithm processes electronic health record (EHR) data to facilitate the identification of patients with HRN and providers and patients receive electronic notification when surveillance colonoscopy is due; and (2) a usual care arm, where no intervention is applied.
RESULTS: The primary outcome will be completion of surveillance colonoscopy within 3.5 years of the HRN diagnosis. The secondary outcome will be time from the HRN diagnosis to completion of surveillance colonoscopy.
CONCLUSIONS: This study evaluates the effectiveness of a multilevel health system intervention designed to improve adherence to surveillance colonoscopy guidelines for patients with a history of high-risk colorectal polyps. The findings are expected to offer valuable insights into strategies for leveraging EHR-informed algorithms to increase surveillance rates and improve CRC outcomes.
TRIAL REGISTRATION: NCT06376565.
METHODS: A hybrid type 1 effectiveness-implementation, 2-group cluster-randomized trial is being conducted at 30 primary health care clinics in a large, urban academic health center in Southern California. The study includes two arms: (1) a multilevel intervention arm in which a natural language processing (NLP) algorithm processes electronic health record (EHR) data to facilitate the identification of patients with HRN and providers and patients receive electronic notification when surveillance colonoscopy is due; and (2) a usual care arm, where no intervention is applied.
RESULTS: The primary outcome will be completion of surveillance colonoscopy within 3.5 years of the HRN diagnosis. The secondary outcome will be time from the HRN diagnosis to completion of surveillance colonoscopy.
CONCLUSIONS: This study evaluates the effectiveness of a multilevel health system intervention designed to improve adherence to surveillance colonoscopy guidelines for patients with a history of high-risk colorectal polyps. The findings are expected to offer valuable insights into strategies for leveraging EHR-informed algorithms to increase surveillance rates and improve CRC outcomes.
TRIAL REGISTRATION: NCT06376565.