A Multilevel Intervention to Increase Colorectal Cancer Screening Tests in Patients With Abnormal Fecal Immunochemical Test Results, PROACT Trial

N/AEnrolling By InvitationNCT06822530

Fred Hutchinson Cancer Center682 enrolled

Overview

This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.

OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive usual care from the CRC screening program navigator which includes monthly phone calls with the CRC screening program navigator, and assistance with colonoscopy scheduling. GROUP II: Patients receive usual care as described in Group I and additionally receive a quick response (QR) code with a link to a video to address patient-level fears of colonoscopy screening via text message, mailed letter, or EHR platform as well as access to transportation home after colonoscopy via a rideshare program arranged through the discharge nurse. After completion of study intervention, patients are followed up for 18 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

Interventions

Best PracticeOTHER

Receive usual care CRC screening program navigation

Educational InterventionOTHER

Receive QR code and link to video addressing fears of colonoscopy

Electronic Health Record ReviewOTHER

Ancillary studies

InterviewOTHER

Ancillary studies

Supportive CareOTHER

Receive rideshare transportation home after colonoscopy

Survey AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * PATIENTS: Age \>= 45 years old and =\< 75 years old * PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic * PATIENTS: \>= 1 month from documented abnormal FIT result * PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment * CLINIC STAFF: HMC, UW-Federal Way, or UW-KDM physician or staff member who provides primary care or gastroenterology care * CLINIC STAFF: Staff in the Fred Hutchinson (Fred Hutch)/UW Medicine Population Health Program that provide colorectal cancer screening and navigation

Outcomes

Primary Outcomes

Rate of colonoscopy completion within 6 months

Will descriptively compare the rates of colonoscopy completion at 6 months. Will fit a generalized mixed effects model with a logit link and a random effect for clinic. Will include an indicator variable for the randomized group (usual care versus (vs.) multilevel intervention) and adjust for patient-level clinical and demographic factors (e.g., age, sex, race, ethnicity, primary language, marital status, last primary care visit, insurance) and clinic-level factors (e.g., clinic size, average full-time equivalent providers per clinic, average provider panel size, primary care provider mix (Doctor of Medicine/Doctor of Osteopathic Medicine vs. other advanced degree).

Time frame: At 6 months after randomization

Time to colonoscopy completion

Will assess the time to colonoscopy completion in days and compare these times across individual clinics.

Time frame: Beginning 6 months after randomization until study completion

Secondary Outcomes

Rate of colonoscopy completion > 6 months

Will fit separate generalized mixed effects model for each binary outcome, with a logit link and a random effect for clinic. In all models, will include an indicator variable for the randomized group and adjust for patient-level clinical and demographic factors and clinic-level factors.

Time frame: At 9 and 12 months after randomization

Colonoscopy referral: Number of participants referred for a colonoscopy

Will assess colonoscopy referral (yes/no) as the number of participants who have a colonoscopy referral placed after randomization.