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 — BEHAVIORAL
    Mailed 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 1
    Usual care and planning period.
  • Other: Phase 2
    Implementation period. Clinics are randomized into clusters
  • Other: Phase 3
    Maintenance period.

Primary Outcome Measure

Effectiveness and Maintenance [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Monroe Family Medicine (Adams Medical Group Monroe)MonroeIndiana46772-

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