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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06821009
Enrollment
6500
Registered
2025-02-11
Start date
2025-06-09
Completion date
2026-06-30
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

Brief summary

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.

Interventions

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.

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.

Sponsors

Digital Health Navigation Solutions, Inc
Lead SponsorINDUSTRY
National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 74 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of mPATH-CRC180 DaysThe proportion of individuals who complete a CRC screening test (colonoscopy, FIT, or FIT-DNA) within 180 days of randomization in both arms

Secondary

MeasureTime frameDescription
Reach of mPATH-CRC30 DaysThe 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
Reporting current CRC screening30 DaysThe proportion of participants within the mPATH arm who report they are current with CRC screening within the mPATH program.
CRC screening ordered180 DaysThe proportion of patients who have a CRC screening test ordered within 180 days of randomization in both arms.
Colorectal Neoplasia180 daysThe proportion of patients in each arm with neoplasia found on colonoscopy within 180 days after randomization.
Mean revenue generated in a Fee-for-Service setting365 DaysMean 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.
Quality gaps closed in a value-based care setting180 DaysProportion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026