Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Optimizing Colorectal Cancer Screening Among Patients With Diabetes in Safety-Net Primary Care Settings: Targeting Implementation Approaches
This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for patients with diabetes in primary care safety-net settings.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 74 Years |
Eligibility | Inclusion Criteria: - Diagnosis of diabetes mellitus; - Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT/FIT in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years); - Age-eligible for CRC screening (50-74 years of age); - Participants in process of undergoing screening are eligible for participation if they have a FIT/FOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year. Exclusion Criteria: • Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC diagnosis, inflammatory bowel disease, renal failure, etc.). |
Country | Name | City | State |
---|---|---|---|
United States | RWJBarnabas Health - Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participant Acceptability | Implementation: participants opt-out and non-adherence rates based on proportion of overall eligible participants | 12 months | |
Other | Implementation Fidelity | Clinic-level proportion of eligible participants who were contacted for screening based on implementation plan targets | 12 months | |
Primary | Colonoscopy uptake | Preliminary effectiveness: Clinic-level proportion of participants who complete a colonoscopy | 12 months | |
Primary | Up-to-date CRC screening | Preliminary Effectiveness: Clinic-level proportion of participants who receive any CRC screening | 12 months | |
Secondary | Rate of CRC Screening Uptake by Glucose Control (Controlled vs. Uncontrolled) Among Participants with Type 2 Diabetes | Preliminary Effectiveness: Clinic-level CRC screening by glucose control (controlled vs. uncontrolled) | 12 months |
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