N/A
N=5,696
Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
Colorectal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04890054 ↗Enrolled (actual)
5,696
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) — 11.8; 4.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fecal Immunochemical Test (Other); Interview (Other); Patient Navigation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients) |
11.8; 4.5 | — |
| SECONDARY Completion of CRC Screening |
16.8; 9 | — |
| SECONDARY Rate of CRC Screening Among the Intervention-eligible Population |
181 | — |
| SECONDARY Time to Screening From Study-eligible Patient List Pull |
118.5; 103.2 | — |
| SECONDARY Abnormal FIT Results |
19; 7 | — |
| SECONDARY Patient Navigation Trainings (Intervention Group) |
22 | — |
| SECONDARY Patient Navigation Completed (Intervention Group) |
22 | — |
| SECONDARY Follow-up Colonoscopy Completion |
49.1; 19.7 | — |
| SECONDARY Time to Colonoscopy From Abnormal FIT Result |
96.3; 114.6 | — |
| SECONDARY Adenomas or Cancers Detected |
7; 14; 1; 4 | — |
| SECONDARY Key Implementation Barriers |
4; 19; 5; 54 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04890054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.