Clinical trial NCT06821009: Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
Official title: Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer Screening
Lead sponsor: Digital Health Navigation Solutions, Inc
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: Wake Forest University Health Sciences
First posted: 2025-02-11
Enrollment: 6500
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Effectiveness of mPATH-CRC
timeFrame: 180 Days
Secondary outcomes:
measure: Reach of mPATH-CRC
timeFrame: 30 Days
measure: Reporting current CRC screening
timeFrame: 30 Days
measure: CRC screening ordered
timeFrame: 180 Days
measure: Colorectal Neoplasia
timeFrame: 180 days
measure: Mean revenue generated in a Fee-for-Service setting
timeFrame: 365 Days
measure: Quality gaps closed in a value-based care setting
timeFrame: 180 Days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
References: