Predicting and Addressing Colonoscopy in Safety Net Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 1,200
- Locations
- 1
- Primary Endpoint
- Rate of follow-up colonoscopy
Study Overview
Brief Summary
The prospective cohort study will evaluate the effectiveness of patient navigation in community health center settings. The investigators will collaborate with the advisory board, composed of key clinicians and patients, researchers, and policymakers, to establish a procedure to conduct and evaluate a patient navigation program that aims to increase rates of follow-up colonoscopy among diverse patient populations served by safety net clinics. Phase 1 will be a milestone-driven planning process in which the investigators will validate the risk prediction model and apply the risk prediction model to stratify the patients and adapt patient navigation materials for the local context. Phase II will be a large-scale, patient randomized-controlled trial that will include 1200 patients at a large 34-clinic community health center in Washington State.
Detailed Description
The study will fulfill the following aims:
Aim 1: Validate externally the predictive risk score using Sea Mar CHC's robust data including 29,000 patients age-eligible for colorectal cancer screening; stratify patients according to risk of non-adherence to follow-up colonoscopy; and adapt patient navigation program for the local context.
Aim 2: Assess the effectiveness, costs, and cost-effectiveness of a centralized, phone-based patient navigation program for follow-up colonoscopy receipt for patients at moderate risk or high risk for non-adherence.
Aim 3: Assess differences in the intervention arms in secondary outcomes (e.g. time to colonoscopy receipt, no-show/canceled appointments, colonoscopy quality) and moderators of intervention effectiveness (e.g. probability level, intervention dose, and patient age, ethnicity, and sex)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Positive FIT test
Exclusion Criteria
- •Prior colorectal cancer
- •Dialysis patient
Arms & Interventions
Patient Navigation
Patients randomized to this arm will receive patient navigation with the goal of completing a follow-up colonoscopy within 12 months of a positive FIT result.
Intervention: Patient navigation (Behavioral)
Usual Care
Patients will receive usual care screening opportunities
Outcomes
Primary Outcomes
Rate of follow-up colonoscopy
Time Frame: 12 months
Receipt of colonoscopy within 1 year of abnormal Fecal Immunochemical Test (FIT) result
Secondary Outcomes
No secondary outcomes reported