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

NCT04890054 | Completed Results

• 3 other identifiers: STUDY00020681NCI-2021-01032UH3CA244298
• Study Type: interventional
• Target: 5,696
• Locations: 1 country
• Sites: 1

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) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Likelihood of Any Colorectal Cancer (CRC) Screening (for Study-eligible Patients)

  Adjusted 6-month any CRC screening for enrollees in clinic units. These values are predicted estimates rather than crude number \[%\] generated using marginal standardization and accounting for clustering and covariates (i.e., sex, age, and Medicaid health plan). Claims and vendor data were used to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, we used the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.

  Primary outcome at 6 months following CCO eligible patient list pull date,

Secondary Outcomes (10)

• Completion of CRC Screening

  Up to 12 months

• Rate of CRC Screening Among the Intervention-eligible Population

  6 months

• Time to Screening From Study-eligible Patient List Pull

  Up to 12 months

• Abnormal FIT Results

  6 months

• Patient Navigation Trainings (Intervention Group)

  Up to 12 months

Study Arms (2)

SMARTER CRC Intervention Year 1

ACTIVE COMPARATOR

In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.

Other: Fecal Immunochemical Test; Other: Interview; Behavioral: Patient Navigation

SMARTER CRC Usual Care

NO INTERVENTION

Usual clinical care

Interventions

Fecal Immunochemical Test OTHER

Patients due for CRC screening are mailed a FIT test by the clinic or health plan

Also known as: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test

SMARTER CRC Intervention Year 1

Interview OTHER

Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations

SMARTER CRC Intervention Year 1

Patient Navigation BEHAVIORAL

Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators

Also known as: Patient Navigator Program

SMARTER CRC Intervention Year 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (3)

• Coronado GD, Petrik AF, Leo MC, Coury J, Durr R, Badicke B, Thompson JH, Edelmann AC, Davis MM. Mailed Outreach and Patient Navigation for Colorectal Cancer Screening Among Rural Medicaid Enrollees: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250928. doi: 10.1001/jamanetworkopen.2025.0928.

  PMID: 40094661 DERIVED

• Coury J, Coronado G, Currier JJ, Kenzie ES, Petrik AF, Badicke B, Myers E, Davis MM. Methods for scaling up an outreach intervention to increase colorectal cancer screening rates in rural areas. Implement Sci Commun. 2024 Jan 8;5(1):6. doi: 10.1186/s43058-023-00540-1.

  PMID: 38191536 DERIVED

• Coronado GD, Leo MC, Ramsey K, Coury J, Petrik AF, Patzel M, Kenzie ES, Thompson JH, Brodt E, Mummadi R, Elder N, Davis MM. Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial. Implement Sci Commun. 2022 Apr 13;3(1):42. doi: 10.1186/s43058-022-00285-3.

  PMID: 35418107 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Interviews as Topic; Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Robert Durr, M.P.H.
• Organization: Oregon Rural Practice Research Network

durrr@ohsu.edu

503-418-3592

Study Officials

• Melinda Davis, PhD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

• Gloria Coronado, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: May 14, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Available Now

Locations

US (1)