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

Digital Health Navigation Solutions

Status: Not yet enrolling

Conditions: Colorectal Cancer Screening

Treatments: Other: Usual Care (Control); Other: mPATH-CRC

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06821009

IRB00118236

4R42CA275665 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 6,500 estimated patients

Sex: All

Ages: 45 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,500 participants in 2 patient groups, including a placebo group

mPATH-CRC

Experimental group

Description:

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.

Treatment:

Other: mPATH-CRC

Usual Care (Control)

Placebo Comparator group

Description:

Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening.

Treatment:

Other: Usual Care (Control)