The PRIME-CRC Trial to Promote CRC Screening in Rural Communities

NAActive, not recruitingINTERVENTIONAL
Enrollment

804

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

December 1, 2025

Study Completion Date

May 31, 2026

Conditions
Colorectal Cancer
Interventions
BEHAVIORAL

health literacy appropriate education and demonstration

If a patient chooses the Fecal Immunochemical Test (FIT), the Screening Coordinator (SC) will give the FIT kit, emphasize the necessity of annual completion, and distribute an additional plain language, literacy appropriate, actionable handout with simplified illustrated instructions on how to complete the test and mail to the central lab. The SC will review the handout and instructions with the patient and use the 'teach back' method to confirm understanding.

BEHAVIORAL

shared decision making

Screening Coordinator (SC) will give patients a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; using the low literacy handout as a teaching tool, the SC will briefly counsel patients on CRC screening options prior to seeing their healthcare provider, reviewing the benefits of each, as well as applicable costs. After reviewing the CRC screening pamphlets with a patient, the SC will use shared decision-making techniques using the study CRC materials to aid patients in selecting the test they prefer and that meets their needs - colonoscopy or FIT.

BEHAVIORAL

automated call reminders or automated texts

"Colonoscopy year 1: Will receive an automated call recording by PCP 48 hours after the clinic visit to remind them of their choice of colonoscopy; then, one week before the test reminding them to pick up the preparation kit. Those who chose SMS will receive a text message from their PCP with content similar to the voice call. A 3rd reminder call/text will be sent 2 days prior to the test. If no colonoscopy with 3 months, the clinical manager (CCM) will call to determine if they want to switch screening options. The CCM will discuss barriers and option of choosing FIT for 3 years. If they opt to change, they will be mailed a FIT with simplified instructions and then follow the FIT follow-up protocol.~FIT year 1: Motivational reminders recorded by their PCP will be sent by automated call or text within 48 hours after the visit and again at 4, 8 and 12 weeks for those who have NOT completed the test. FIT will be mailed year 2 \& 3 - follow-up will follow same procedure as year 1."

Trial Locations (3)

71366

Tensas Community Health Centers, Saint Joseph

71220-5013

CommuniHealth (dba Morehouse Community Medical Centers, Inc.), Bastrop

71260-3653

CommuniHealth (dba Morehouse Community Medical Centers, Inc.), Marion

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Northwestern University

OTHER

lead

Louisiana State University Health Sciences Center Shreveport

OTHER