Clinical trial NCT04313114: The PRIME-CRC Trial to Promote CRC Screening in Rural Communities
Official title: Patient-Centered Reminders to Inform, Motivate, and Engage Colorectal Cancer Screening Adherence in Rural Communities: the PRIME-CRC Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: health literacy
shared decision making
colonoscopy
fecal immunochemical test
rural community clinics
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Northwestern University
First posted: 2020-03-18
Enrollment: 804
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: 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). Guided by recently completed trials, the investigators will leverage consumer technologies that are now available in rural areas and implement a multifaceted approach - designed for scale in resource-limited federally qualified health centers (FQHCs). While significant gains have been made to improve CRC screening, compliance with those guidelines is sub-optimal and disparities remain. In particular, adults who receive care at rural FQHCs that have limited resources struggle to initiate and maintain annual CRC screening via the most common method, FIT. Over the past decade, this team has studied the effectiveness of specific interventions to enhance initial and repeat CRC screening completion among lower income, lower health literate, racially/ethnically diverse adults in rural FQHC settings. The majority of patients will complete the initial test (67% - 69%), yet fewer (32% - 40%) complete an annual test in years 2 and 3. This indicates a "stepped care" approach is needed to promote long-term CRC screening. The investigators' rural health literacy interventions have until now been limited to the FIT due to restrictions of state Medicaid coverage and clinical bandwidth of colonoscopy services available to rural FQHCs. Changes to Medicaid have now expanded the availability of colonoscopy. The investigators propose a novel intervention guided by evidence learned from the investigators' previous studies and recent literature - the Patient-Centered Reminders to Inform, Motivate, and Engage-CRC Screening (PRIME-CRC). In this proposed 2-arm, randomized control trial (N=1200), both PRIME-CRC and enhanced usual care arms will at point of care receive CRC patient information and counseling to aid patient decision making for selecting FIT or colonoscopy utilizing core components including evidence-based Health Literacy education and counseling, along with printed, simplified CRC screening information and simplified test instructions. PRIME-CRC will additionally have 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 have frequent follow-up with tailored contact via automated call or SMS text (based on patient preference) from their healthcare provider (audio recorded or personalized text). The primary outcome will be completion of either colonoscopy or annual FIT over 3 years. The specific aims are to: test the effectiveness of the PRIME-CRC intervention to improve CRC screening completion rates in rural FQHCs compared to enhanced usual care; investigate whether the intervention can reduce CRC screening disparities by patient health literacy, race or sex; determine the fidelity of PRIME-CRC components, and explore patient, provider, and healthcare system barriers to implementation, and evaluate the cost associated with the intervention from a FQHC perspective. This study extends this team's longstanding collaboration on health literacy, health disparities, rural health and cancer screening.

Eligibility criteria: Inclusion Criteria:

1. have been a patient at one of the participating FQHCs with at least one prior visit in the past 12 months;
2. age 45 to 75 (based on USPSTF guidelines);
3. English-speaking.

Exclusion Criteria:

1. have a previous history of cancer other than non-melanoma skin cancer;
2. are up-to-date with CRC screening according to USPSTF guidelines (FOBT in less than a year, sigmoidoscopy less than 5 years, or colonoscopy less than 10 years);
3. a family history that requires a more complete history and possible colonoscopy because of their risk factor;
4. have a documented or uncorrectable cognitive, hearing, or visual impairment;
5. are too ill to participate

Primary outcomes:
measure: CRC Screening
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bastrop
country: United States
facility: CommuniHealth (dba Morehouse Community Medical Centers, Inc.)
state: Louisiana
city: Marion
country: United States
facility: CommuniHealth (dba Morehouse Community Medical Centers, Inc.)
state: Louisiana
city: St. Joseph
country: United States
facility: Tensas Community Health Centers
state: Louisiana
Study officials:
affiliation: LSU Health Sciences Center Shreveport
name: Connie L Arnold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis TC, Morris JD, Reed EH, Curtis LM, Wolf MS, Davis AB, Arnold CL. Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve three-year adherence to colorectal cancer screening among patients cared for in rural community health centers. Contemp Clin Trials. 2022 Feb;113:106654. doi: 10.1016/j.cct.2021.106654. Epub 2021 Dec 11.