Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

NCT ID: NCT06376565

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1680 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2027-11-30

Brief Summary

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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

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Arm I(Multilevel intervention)

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.

Group Type EXPERIMENTAL

Communication Intervention

Intervention Type OTHER

Complete clinic EHR interventions

Communication Intervention

Intervention Type OTHER

Receive scheduling reminders

Communication Intervention

Intervention Type OTHER

Receive reminders and pending EHR orders

Interview

Intervention Type OTHER

Complete interview

Arm II (Standard follow up)

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

Group Type ACTIVE_COMPARATOR

Interview

Intervention Type OTHER

Ancillary studies

Best Practice

Intervention Type OTHER

Receive standard care

Interventions

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Communication Intervention

Complete clinic EHR interventions

Intervention Type OTHER

Communication Intervention

Receive scheduling reminders

Intervention Type OTHER

Communication Intervention

Receive reminders and pending EHR orders

Intervention Type OTHER

Interview

Complete interview

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Best Practice

Receive standard care

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Folasade P May

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jenna Alarcon

Role: CONTACT

Phone: 310-794-6197

Email: [email protected]

Facility Contacts

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Jenna Alarcon

Role: primary

Other Identifiers

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NCI-2024-02090

Identifier Type: REGISTRY

Identifier Source: secondary_id

R01CA271034

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-000647

Identifier Type: -

Identifier Source: org_study_id