Status:
COMPLETED
Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Oregon Health and Science University
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 dire...
Eligibility Criteria
Inclusion
- CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10)
- CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews)
- CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening
- CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations
- CLINICS: Are served by CCOs agreeing to participate in the project
- CLINICS: Willing to implement the intervention into their clinic for the study
- CLINIC STAFF/PROVIDERS: Employed as a clinician or ancillary staff member in a participating clinic
- CLINIC STAFF/PROVIDERS: Willing to participate in data collection activities (e.g., interviews, observation, surveys)
- PATIENTS: Attributed to participating clinic
- PATIENTS: Are enrolled in Medicaid or dual eligible
- PATIENTS: Eligible for colorectal cancer (CRC) screening
- PATIENTS: For the subset of patients that will be invited to participate in key informant interviews, a 5th eligibility criteria is consented to participate
- COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: (Includes endoscopy providers, community-based outreach workers, or leaders from regional or national organizations who participate in the pilot, pragmatic trial, or scale-up study)
- COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Involved in study activities (training, care delivery)
- COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Willing to participate in data collection activities (e.g., trainings, interviews, surveys)
- Elderly - Yes - we anticipate that a limited number of clinic and CCO staff, or community organization representatives may be elderly; we limit our patient recruitment to those aged 45-75
- Rural - Yes
- Inner city - No
- Low income - Yes
- Disabled - Yes
- Chronic care - Yes
- End of life - Yes - This is possible, but we predict limited numbers because of the types of individuals we are recruiting: clinic and CCO staff, and patients who are not currently in hospice care
- Minorities - Yes
Exclusion
- CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population
- PATIENTS: Are current for screening
- PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice)
- PATIENTS: Are not an established patient or for other reasons documented by the clinics
- All patients that we recruit will be at least 45 years of age or older
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
5696 Patients enrolled
Trial Details
Trial ID
NCT04890054
Start Date
May 14 2021
End Date
July 1 2024
Last Update
August 19 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239