Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

Jonsson Comprehensive Cancer Center

Status

Enrolling

Conditions

Colorectal Carcinoma

Treatments

Other: Best Practice

Other: Communication Intervention

Other: Interview

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06376565

22-000647

R01CA271034 (U.S. NIH Grant/Contract)

NCI-2024-02090 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,680 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,680 participants in 2 patient groups

Arm I(Multilevel intervention)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Communication Intervention

Arm II (Standard follow up)

Active Comparator group

Description:

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

Treatment:

Other: Interview

Other: Best Practice