Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based care setting; and (2) determine the value generated by mPATH in each healthcare setting.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Other: mPATH-CRC; Other: Usual Care (Control)

• Study Type: Interventional
• Enrollment (Estimated): 6500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Rome, Georgia, United States, 30161
      • Atrium Health Floyd
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 45-74 years

2. Be identified in the electronic health record as due for routine CRC screening, defined as

   1. No colonoscopy in prior 10 years
   2. No flexible sigmoidoscopy in prior 5 years
   3. No CT colography in prior 5 years
   4. No FIT-DNA test (Cologuard) within prior 3 years
   5. No Fecal Occult Blood Test within prior 1 year
3. Have a cell phone number listed in the EHR
4. Have a preferred language of English or Spanish in the EHR
5. Upcoming appointment within 9 to 16 days
6. Georgia Market Only: Insurance type is listed as Medicare Advantage.

Exclusion Criteria

1. Prior diagnosis of colorectal cancer
2. Prior history of total colectomy
3. Currently enrolled in palliative care or Hospice
4. Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
5. Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mPATH-CRC; Participants randomized to the mPATH arm will receive a text message inviting them to use the mPATH-CRC WebApp. The WebApp verifies individuals are due for routine colorectal cancer (CRC) screening, educates them about their options, and lets them request a screening test via the program.	Other: mPATH-CRC; Individuals will receive an automated text message inviting them to use the mPATH-CRC WebApp. The WebApp takes approximately 5 to 8 minutes to complete. The WebApp verifies patients are due for routine CRC screening, educates them about their options, and lets them request a screening test via the program.
Placebo Comparator: Usual Care (Control); Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening.	Other: Usual Care (Control); Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening. In the participating Fee-for-Service and Value-Based settings, the EHR flags patients who are overdue for CRC screening as a "care gap" that is visible to all primary care providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of mPATH-CRC	The proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms	180 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of mPATH-CRC	The proportion of patients in the mPATH-CRC arm who complete the mPATH-CRC Web App to the point of being told if screening is due or not due	30 Days
Reporting current CRC screening	The proportion of participants within the mPATH arm who report they are current with CRC screening within the mPATH program.	30 Days
CRC screening ordered	The proportion of patients who have a CRC screening test ordered within 180 days of randomization in both arms.	180 Days
Colorectal Neoplasia	The proportion of patients in each arm with neoplasia found on colonoscopy within 180 days after randomization.	180 days
Mean revenue generated in a Fee-for-Service setting	Mean revenue generated in a Fee-for-Service setting from screening and resulting downstream care within 12 months (365 days) of the screening event, assuming Medicare reimbursement rates in both arms.	365 Days
Quality gaps closed in a value-based care setting	Proportion of quality gaps closed in a value-based setting in each arm defined as completing screening or acquiring documentation of previously completed screening in both arms.	180 Days

Collaborators and Investigators

• Sponsor: Digital Health Navigation Solutions, Inc
• Collaborators: National Cancer Institute (NCI); Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB00118236; 4R42CA275665 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified individual participant data that underlie our published or presented results.
• IPD Sharing Time Frame: Within one year of the publication of the study's results. Data will be kept available until 4 years after the publication of the study's results.
• IPD Sharing Access Criteria: Researchers must provide the investigative team a methodologically sound proposal. Use of the data will be limited to achieve the aims in their submitted proposal. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No