NCT04890054

Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC

Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,696 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.

Detailed description

PRIMARY OBJECTIVE: I. Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs. OUTLINE: This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys. The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months. Implementation outcomes and adaptations will be evaluated through interviews with clinic staff, patients, and CCO partners. Clinic staff in various roles related to the program (e.g., outreach workers, patient navigators, quality improvement leads) complete surveys and participate in interviews and observations at baseline, 6-9 months (post-implementation) and at approximately 12 months later, to assess clinic/health system level factors that may influence outcomes. Patients participate in interviews to explore patient experiences with the program. Regional and Organizational partners: CCO leaders, endoscopy providers (e.g., gastrointestinal specialists, general surgeons, primary care clinicians), and community organizations also participate in interviews.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
OTHER	Fecal Immunochemical Test	Patients due for CRC screening are mailed a FIT test by the clinic or health plan
OTHER	Interview	Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations
BEHAVIORAL	Patient Navigation	Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators

Timeline

• Start date: 2021-05-14
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2021-05-18
• Last updated: 2025-08-19
• Results posted: 2025-08-19

Locations

1 site across 1 country: United States