Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

NCT06376565 | Recruiting

• 3 other identifiers: 22-000647NCI-2024-02090R01CA271034
• Study Type: interventional
• Target: 1,680
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (4)

• Stakeholder perspectives on the multilevel intervention (Aim 1)

  The Investigators will conduct 1-on-1 in-depth interviews with patients, advocates, providers, and administrators. these interviews will provide data in closer proximity to intervention implementation to optimize composition, timing, and acceptability of each component. Interview content is guided by the multiple health outcomes framework (MHOF) and addresses major barriers (patient, provider, system) to surveillance and challenges (patient, provider, system) to the planned implementation of intervention components.

  At time of interview

• Completion of surveillance colonoscopy (Aim 2)

  Will analyze rates during the study period using a generalized linear mixed model with a logit link that includes an indicator for study arm and random effects for clinic and primary care provider to account for the multilevel data structure.

  At 3.5 years

• Implementation quality (Aim 3a)

  The Investigators will assess implementation quality and outcomes through stakeholder interviews (patients, providers, administrators) and chart reviews. The information gained will guide adaptations of the intervention for future use so that clinicians maximize effectiveness, feasibility, acceptability, sustainability, and impact. Findings will also determine the resources needed to successfully scale the intervention to different settings

  Up to 3 years

• Cost effectiveness (Aim 3b)

  Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the natural language processing-based electronic health record intervention compared to usual care office outreach.

  Up to 3 years

Secondary Outcomes (1)

• Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2)

  From HRN diagnosis to colonoscopy, up to 3 years

Study Arms (2)

Arm I(Multilevel intervention)

EXPERIMENTAL

Aim 1: Participants complete an interview over 20-30 minutes. Aim 2: Clinics have the automatic addition of HRN to the medical problem list and indication of surveillance interval is added to the health maintenance portion of the electronic health records (EHR). Clinics also call patients to schedule their colonoscopy. Providers receive reminders and pending orders for the colonoscopy in the electronic health record. Patients receive a reminder 6 months in advance via their patient portal and mail to schedule a colonoscopy, and also receive a phone call from the patient communication center.

Other: Communication Intervention; Other: Interview

Arm II (Standard follow up)

ACTIVE COMPARATOR

Patients receive care according to the clinics' usual care practices.

Other: Best Practice; Other: Interview

Interventions

Best Practice OTHER

Receive standard care

Also known as: standard of care, standard therapy

Arm II (Standard follow up)

Communication Intervention OTHER

Complete clinic EHR interventions

Arm I(Multilevel intervention)

Interview OTHER

Complete interview

Arm I(Multilevel intervention)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AIM 1 PATIENTS: Patients between age 45 and 75 with a HRN diagnosis in the past 5 years
• AIM 1 PATIENTS: 12 patients who did and 12 patients who did not have surveillance colonoscopy
• AIM 1 PROVIDERS: Primary care providers (PCPs) and gastroenterologists (GIs)
• AIM 1 ADMINISTRATORS: Administrators who are involved in care processes related to CRC screening, HRN surveillance, and/or colonoscopy scheduling
• AIM 2: Patients age 45 to 75 diagnosed with a HRN during the pre-specified two-year HRN diagnosis period

You may not qualify if:

• AIM 2: Individuals with a personal history of colorectal carcinoma (CRC), inflammatory bowel disease (Crohn's, ulcerative colitis), or polyposis syndrome
• AIM 2: HRN cases not confirmed by chart review (human-in-the-loop)

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (1)

• May FP, McEwan JA, Tuan JJ, Crespi CM, Maehara CK, Yang JO, Uy A, Gupta S, Kang Y, Myint A, Naini BV, Elmore JG, Kadiyala S, Ong MK, Bui AAT, Hamilton AB, Chang LC, Gelvezon A, Hsu W, Bastani R. Increasing timely colonoscopy surveillance for patients with high-risk colorectal polyps: Protocol for a cluster randomized trial. Contemp Clin Trials. 2026 Jan;160:108147. doi: 10.1016/j.cct.2025.108147. Epub 2025 Nov 17.

  PMID: 41260460 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Interviews as Topic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Folasade P May

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Alarcon

CONTACT

310-794-6197; JCAlarcon@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 19, 2024
• Study Start: November 8, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)