Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
NCT ID: NCT06821009
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6500 participants
INTERVENTIONAL
2025-06-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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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.
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.
Usual Care (Control)
Patients randomized to the control arm will receive usual care, which includes the organizations' standard procedures for addressing CRC screening.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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)
45 Years
74 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Digital Health Navigation Solutions, Inc
INDUSTRY
Responsible Party
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David P. Miller, Jr.
CEO
Locations
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Atrium Health Floyd
Rome, Georgia, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Countries
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Central Contacts
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Other Identifiers
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IRB00118236
Identifier Type: -
Identifier Source: org_study_id
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