Patient-Centered Reminders to Inform, Motivate, and Engage Colorectal Cancer Screening Adherence in Rural Communities: The PRIME-CRC Trial

Project Summary/Abstract: We 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, we 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, our team has
studied the effectiveness of specific interventions to enhance initial and repeat CRC screening completion
among lower income, lower health literate, racial/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. Our 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. We now propose a novel intervention guided by evidence
learned from our previous studies and recent literature - the Patient-centered Reminders to Inform, Motivate,
and Engage-CRC Screening (PRIME-CRC).In our proposed 2-arm, randomized control trial (N=1200), both
PRIME-CRC and enhanced usual care arms will receive our health literacy evidence-based practices for
delivering CRC patient information and counseling to aid patient decision making for selecting FIT or
colonoscopy 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. Our 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, or reliability of PRIME-CRC
components, and explore patient, provider, and healthcare system barriers to implementation. Evaluate the
cost associated with the intervention from a FQHC perspective. This study extends our team’s longstanding
collaboration on health literacy, health disparities, rural health and cancer screening.

Grant Number: 5R01CA240496-05
NIH Institute/Center: NIH
Principal Investigator: Connie Arnold