Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06821009

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Colorectal Cancer Screening

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Floyd, Rome, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45-74 years
  • Be identified in the electronic health record as due for routine CRC screening, defined as
  • No colonoscopy in prior 10 years
  • No flexible sigmoidoscopy in prior 5 years
  • No CT colography in prior 5 years
  • No FIT-DNA test (Cologuard) within prior 3 years
  • No Fecal Occult Blood Test within prior 1 year
  • Have a cell phone number listed in the EHR
  • Have a preferred language of English or Spanish in the EHR
  • Upcoming appointment within 9 to 16 days
  • Georgia Market Only: Insurance type is listed as Medicare Advantage.

Exclusion criteria

  • Prior diagnosis of colorectal cancer
  • Prior history of total colectomy
  • Currently enrolled in palliative care or Hospice
  • Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
  • 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)

Treatment and study plan

mPATH-CRC

Other

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.

Usual Care (Control)

Other

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.

Primary outcomes

  1. Effectiveness of mPATH-CRC

    Time frame: 180 Days

    The proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms

Secondary outcomes

  1. Reach of mPATH-CRC

    Time frame: 30 Days

    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

  2. Reporting current CRC screening

    Time frame: 30 Days

    The proportion of participants within the mPATH arm who report they are current with CRC screening within the mPATH program.

  3. CRC screening ordered

    Time frame: 180 Days

    The proportion of patients who have a CRC screening test ordered within 180 days of randomization in both arms.

  4. Colorectal Neoplasia

    Time frame: 180 days

    The proportion of patients in each arm with neoplasia found on colonoscopy within 180 days after randomization.

  5. Mean revenue generated in a Fee-for-Service setting

    Time frame: 365 Days

    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.

  6. Quality gaps closed in a value-based care setting

    Time frame: 180 Days

    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.

Sponsors and collaborators

Lead sponsor

Digital Health Navigation Solutions, Inc

Industry

Collaborators

  • National Cancer Institute (NCI)
  • Wake Forest University Health Sciences

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.