Rural Indiana Screening for Colorectal Cancer
Part of paid clinical trials in Monroe, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06133439
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Colorectal Screen rates with implementation of evidence-based intervention — BEHAVIORALMailed FIT kits, Cologuard, and diagnostic colonoscopies.
Study Details
The goal of this implementation study is to support an evidence-based intervention to the improve colorectal cancer (CRC) screening and diagnostic colonoscopy rates in rural Indiana. The main questions the study aims to answer are: * How does the implementation of an evidence based intervention to increase CRC screening in rural Indiana improve CRC screening and diagnostic colonoscopy rates, defined as completed screening episode? * Will dose and type of implementation strategies contribute to differences in contextual factors and readiness as well as different levels of implementation outcomes (reach and implementation) in rural clinic? * Will Contextual factors (innovation, recipient, inner and outer context) and implementation outcomes (reach, and implementation) vary with the levels of CRC screening and diagnostic colonoscopy following active implementation (effectiveness) and throughout maintenance compared to baseline (usual care)? * What is the cost and budget impact of the deployment of implementation strategies and processes for rural clinics and evaluate the cost-effectiveness of implementing and sustaining the CRC screening intervention? Approach: Participating clinics tasks consist of mailing FIT kits, sending text messages, phone reminders, and the use of a Patient Navigator to initiate a screening episode with eligible patients who are 45-75 (and have no colonoscopy in the last 10 years or FIT in the last 12 months) as identified from medical records.
Key Dates
- Start date
- Jan 3, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 11 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- SCREENING
Arms
- No Intervention: Phase 1Usual care and planning period.
- Other: Phase 2Implementation period. Clinics are randomized into clusters
- Other: Phase 3Maintenance period.
Primary Outcome Measure
Effectiveness and Maintenance [ Time Frame: Up to 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Monroe Family Medicine (Adams Medical Group Monroe) | Monroe | Indiana | 46772 | - |
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