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.
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
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
5,696
Patients due for CRC screening are mailed a FIT test by the clinic or health plan
Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations
Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators
OHSU Knight Cancer Institute
Portland, Oregon, United States
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.
Time frame: Primary outcome at 6 months following CCO eligible patient list pull date,
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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Abnormal FIT Results
Number of participants with abnormal FIT Results
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Time frame: 6 months
Patient Navigation Trainings (Intervention Group)
Clinic participation (i.e., attendance) in patient navigation training, Year 1 clinical trial
Time frame: 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).
Time frame: Up to 12 months
Follow-up Colonoscopy Completion
The percentage of patients with abnormal FIT who completed follow-up colonoscopy within 12 months
Time frame: 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.
Time frame: Up to 12 months
Adenomas or Cancers Detected
Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.
Time frame: Up to 12 months
Key Implementation Barriers
Qualitative key informant interviews with clinic and payer stakeholders to identify implementation barriers.
Time frame: Up to 36 months