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Recruiting NCT06376565

Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

No phase Interventional Colorectal Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Communication Intervention, Communication Intervention, Communication Intervention.
Who it may be relevant to
Registry conditions: Colorectal Carcinoma. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multilevel Health System Intervention to Increase Guideline-Concordant Surveillance Colonoscopy for High Risk Colon Polyps

Overview

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.

Detailed description

PRIMARY OBJECTIVE:

I. To increase completion of surveillance colonoscopy within 3.5 years of high risk neoplasia (HRN) diagnosis.

OUTLINE:

AIM 1: Participants complete an interview over 20-30 minutes.

AIM 2: Primary care clinics are randomized to 1 of 2 arms.

ARM I: 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. 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.

ARM II: Patients receive care according to the clinics' usual care practices.

Interventions

  • Other Best Practice
    Receive standard care
  • Other Communication Intervention
    Complete clinic EHR interventions
  • Other Communication Intervention
    Receive scheduling reminders
  • Other Communication Intervention
    Receive reminders and pending EHR orders
  • Other Interview
    Complete interview
  • Other Interview
    Ancillary studies

Primary outcome measures

  • Stakeholder perspectives on the multilevel intervention (Aim 1) [Time frame: At time of interview]
  • Completion of surveillance colonoscopy (Aim 2) [Time frame: At 3.5 years]
  • Implementation quality (Aim 3a) [Time frame: Up to 3 years]
  • Cost effectiveness (Aim 3b) [Time frame: Up to 3 years]
Secondary outcome measures (1)
  • Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) [Time frame: From HRN diagnosis to colonoscopy, up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Publications

  • 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. PMID 41260460

Identifiers

NCT: NCT06376565 · 22-000647 · NCI-2024-02090 · R01CA271034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗