Clinical trial NCT04890054: Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
Official title: Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2021-05-18
Enrollment: 15510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

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

Primary outcomes:
measure: Likelihood of any colorectal cancer (CRC) screening (for study-eligible patients)
timeFrame: Primary outcome at 6 months following CCO eligible patient list pull date
Secondary outcomes:
measure: Completion of testing types (fecal testing, FIT-DNA, CT Colonography, Colonoscopy, Flex Sigmoidoscopy) and % completion
timeFrame: Up to 12 months
measure: Rate of CRC screening among the study-eligible population (by clinic)
timeFrame: 6 months
measure: Time to screening from study-eligible patient list pull
timeFrame: Up to 12 months
measure: FIT Results
timeFrame: 6 months
measure: Patient Navigation Trainings (Intervention group)
timeFrame: Up to 12 months
measure: Patient Navigation completed (Intervention group)
timeFrame: Up to 12 months
measure: Follow-up colonoscopy completion
timeFrame: Up to 12 months
measure: Time to colonoscopy from abnormal FIT result
timeFrame: Up to 12 months
measure: Adenomas or cancers detected
timeFrame: Up to 12 months
measure: Adaptations to core program components made by payer or clinic
timeFrame: Up to 36 months
measure: Key Implementation Factors
timeFrame: Up to 36 months
measure: Colonoscopy referral
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Melinda Davis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Gloria Coronado, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.