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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Fecal Immunochemical Test; Other: Interview; Behavioral: Patient Navigation

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.

• Study Type: Interventional
• Enrollment (Actual): 5696
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SMARTER CRC Intervention Year 1; 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; Patients due for CRC screening are mailed a FIT test by the clinic or health plan; Other Names: FIT; iFOBT; immunoassay fecal occult blood test; immunochemical fecal occult blood test; Immunochemical FOBT; immunologic fecal occult blood test; 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; Other Names: Patient Navigator Program
No Intervention: SMARTER CRC Usual Care; Usual clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of CRC Screening	Completed CRC screening at 12 months. 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).	Up to 12 months
Rate of CRC Screening Among the Intervention-eligible Population	In the intervention clinics only, the list of patients eligible for screening was scrubbed by clinics. This percent is the N completed CRC screening out of the N included in intervention outreach after clinics scrubbed the list of eligible patients.	6 months
Time to Screening From Study-eligible Patient List Pull	Days from study-eligible patient list pull to abnormal FIT result. Number of days at individual level.	Up to 12 months
Abnormal FIT Results	Number of participants with abnormal FIT Results	6 months
Patient Navigation Trainings (Intervention Group)	Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial	Up to 12 months
Patient Navigation Completed (Intervention Group)	Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).	Up to 12 months
Follow-up Colonoscopy Completion	The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months	Up to 12 months
Time to Colonoscopy From Abnormal FIT Result	Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.	Up to 12 months
Adenomas or Cancers Detected	Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.	Up to 12 months
Key Implementation Barriers	Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers.	Up to 36 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Cancer Institute (NCI); Oregon Health and Science University
• Investigators: Principal Investigator: Melinda Davis, PhD, OHSU Knight Cancer Institute; Principal Investigator: Gloria Coronado, PhD, University of Arizona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: STUDY00020681 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-01032 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); UH3CA244298 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All non-identifiable data is going to be available through the ACCSIS coordinating center as a public common data set across all the ACCSIS studies along with paper-specific de-identified data sets.
• IPD Sharing Time Frame: Available Now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No