This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2).

Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address.

The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2).

This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the intervention phase, Arm 1 receives usual care only.

Subjects randomized to the Mobile Health Decision Support intervention arm (Arm 2) receive a link to mobile Patient Technology for Health (mPATH™-Cloud), a digital health platform designed to alleviate the implementation burden on clinical teams by automating many key steps in the CRC screening process. If the subject uses mPATH-Cloud to select a screening test, mPATH-Cloud notifies the subject's primary care provider at the FQHC. Subjects who request colonoscopy are then referred by their primary care provider to colonoscopy as appropriate. Subjects who request FIT receive a FIT mailed to their home.

Primary outcome assessment: To assess intervention effectiveness, CRC screening completion within 6 months of randomization (primary outcome) is assessed by EHR chart review. Screening completion is defined as any of the following: colonoscopy completion (regardless of indication); at least one FIT test with a normal FIT result; or diagnostic colonoscopy following an abnormal FIT result.

Secondary outcome assessment: To assess intervention effectiveness on adherence to USPSTF recommendations over time (secondary outcome), the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review.

CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years. FIT should be repeated annually, and colonoscopy typically only needs to be repeated once every 10 years. Thus, subjects will be assigned one year per annual FIT completed (e.g., FIT in years 1, 2, and 3 would be assigned 3 years; FIT in year 1, and 3 would be assigned 2 years) and up to 3 years for colonoscopy depending on the year received (e.g., colonoscopy in year 1 would be assigned 3 years, colonoscopy in year 3 would be assigned 1 year). Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach.

Implementation assessment (exploratory outcome): This study will identify implementation processes and outcomes that will impact future dissemination and scalability. After the trial phase concludes, researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences.

Inclusion Criteria:

• Age 45-73 years at time of enrollment
• At average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: documented history in the EHR of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease)
• No record in the EHR of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
• No record in the EHR of any CRC diagnosis or total colectomy
• Active patient of the clinic as documented in the EHR (seen at least 2 times within the past 12 months)
• For the second and third study rounds only: No record of a positive (abnormal) CRC screening result in a previous study round

Exclusion Criteria:

• All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation:
• Age younger than 45 years or older than 73 years at the time of enrollment
• Not at average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease)
• Colorectal carcinoma screening in last 12 months Record in the electronic health record (HER) of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
• Record in the EHR any CRC diagnosis or total colectomy
• Not an active client of the clinic as documented in the EHR (not seen at least 2 times within the past 12 months)
• For second and third annual study rounds only: Record of a positive (abnormal) CRC screening result in a previous study round

All of the participant data collected during the trial, after de-identification, will be made available.

IPD Sharing Supporting Information Type: Study Protocol, SAP, and Analytic Code.

IPD Sharing Time Frame: Beginning 6 months after summary data are published or otherwise made available with no end date.

IPD Sharing Access Criteria: Investigators who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to leahf@unc.edu.