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The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Sponsor: Louisiana State University Health Sciences Center Shreveport
Summary
The investigators will expand an existing, patient-centered, health literacy strategy to promote longer-term adherence to colorectal cancer (CRC) screening in resource-limited, rural health clinics via colonoscopy or annual fecal immunochemical test (FIT). In the proposed 2-arm study, both PRIME-CRC and enhanced usual care (control) will incorporate health literacy evidence-based practices for delivering CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy, including simplified test instructions. In addition, the PRIME-CRC arm will use a "stepped care" approach for reminding patients on proper CRC screening preparation for scheduled colonoscopy or completion of annual FIT. Patients in the PRIME-CRC arm will receive frequent follow-up contact from their health care provider via audio-recorded, automated call or SMS text, based on patient preference.
Official title: Patient-Centered Reminders to Inform, Motivate, and Engage Colorectal Cancer Screening Adherence in Rural Communities: the PRIME-CRC Trial
Key Details
Gender
All
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
804
Start Date
2021-09-20
Completion Date
2026-05-31
Last Updated
2025-01-29
Healthy Volunteers
Yes
Conditions
Interventions
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.
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.
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.
Locations (3)
CommuniHealth (dba Morehouse Community Medical Centers, Inc.)
Bastrop, Louisiana, United States
CommuniHealth (dba Morehouse Community Medical Centers, Inc.)
Marion, Louisiana, United States
Tensas Community Health Centers
Saint Joseph, Louisiana, United States