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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Other: Fecal Immunochemical Test
* Other: Interview
* Behavioral: Patient Navigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMARTER CRC Intervention Year 1<br>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<br>* Patients due for CRC screening are mailed a FIT test by the clinic or health plan<br>* Other names: immunologic fecal occult blood test;Other: Interview<br>* Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations<br>Behavioral: Patient Navigation<br>* Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators<br>* Other names: Patient Navigator Program;|
| Active Comparator: SMARTER CRC Intervention Year 2<br>In year 2, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected. | Other: Fecal Immunochemical Test<br>* Patients due for CRC screening are mailed a FIT test by the clinic or health plan<br>* Other names: immunologic fecal occult blood test;Other: Interview<br>* Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations<br>Behavioral: Patient Navigation<br>* Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators<br>* Other names: Patient Navigator Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likelihood of any colorectal cancer (CRC) screening (for study-eligible patients) | Will use claims and vendor data 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, will use 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 testing types (fecal testing, FIT-DNA, CT Colonography, Colonoscopy, Flex Sigmoidoscopy) and % completion | Will use claims and vendor data for calculating whether or not the patient completed each different type of screening. | Up to 12 months | 
| Rate of CRC screening among the study-eligible population (by clinic) | Will use claims and vendor data for calculating CRC screening rates in clinics. For each clinic, N completed CRC screening / N eligible | 6 months | 
| Time to screening from study-eligible patient list pull | Days from study-eligible patient list pull to return of FIT or completion of other screening modality (colonoscopy, flex, FIT-DNA). Number of days at individual level. | Up to 12 months | 
| FIT Results | Results of the completed FITs | 6 months | 
| Patient Navigation Trainings (Intervention group) | Clinic participation (i.e., attendance count and staff roles) in patient navigation training. | 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. | 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 | 
| Adaptations to core program components made by payer or clinic | Key informant interviews and practice facilitator field notes based on the FRAME framework for tracking adaptations will be used to identify and qualitatively assess adaptations. | Up to 36 months | 
| Key Implementation Factors | Qualitative key informant interviews with patient, clinic, and payer stakeholders to identify implementation strategies and factors relevant to rural context. Guided by Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) classification. | Up to 36 months | 
| Colonoscopy referral | For each clinic, the percent of patients who receive a referral to colonoscopy. Proportion at the clinic level. | Up to 12 months |