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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2024-07-01

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.

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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.

Conditions

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Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fecal Immunochemical Test

Intervention Type OTHER

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

Interview

Intervention Type OTHER

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

Patient Navigation

Intervention Type BEHAVIORAL

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

SMARTER CRC Usual Care

Usual clinical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fecal Immunochemical Test

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

Intervention Type OTHER

Interview

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

Intervention Type OTHER

Patient Navigation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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FIT iFOBT immunoassay fecal occult blood test immunochemical fecal occult blood test Immunochemical FOBT immunologic fecal occult blood test Patient Navigator Program

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes