This clinical trial studies whether an intervention that addresses two or more levels of care (multilevel intervention) increases follow-up of abnormal, non-invasive, colorectal cancer (CRC) screening test results. The fecal immunochemical test (FIT) is a non-invasive, stool-based, CRC screening test. FITs are relatively inexpensive and can be completed at home, for these reasons, it is a preferred method of CRC screening in healthcare settings that care for under-resourced patients or have limited colonoscopy access. For FIT-based CRC screening to be effective, abnormal results must be followed by a colonoscopy, however many patients fail to complete this recommended follow-up test. The multilevel intervention addresses barriers to follow-up colonoscopy at the patient and health system levels of care through a CRC screening patient navigator, an educational video, and transportation assistance. The navigator provides patient support and assistance with colonoscopy scheduling. The educational video addresses identified patient fears around colonoscopies. Transportation assistance is offered after the colonoscopy through a rideshare program to address transportation barriers. Therefore, this multilevel intervention may increase follow-up colonoscopy completion in patients with abnormal FIT results.
PATIENTS: Age >= 45 years old and =< 75 years old
PATIENTS: Receives care at an Harborview Medical Center (HMC) or University of Washington-Kent-Des Moines (UW-KDM) or University of Washington- Federal Way (UW-Federal Way) primary care clinic
PATIENTS: >= 1 month from documented abnormal FIT result
PATIENTS: Has not received a colonoscopy between the abnormal FIT and enrollment
None
Parallel
Best Practice
Other interventionReceive usual care CRC screening program navigation
Educational Intervention
Other interventionReceive QR code and link to video addressing fears of colonoscopy
Electronic Health Record Review
Other interventionAncillary studies
Interview
Other interventionAncillary studies
Supportive Care
Other interventionReceive rideshare transportation home after colonoscopy
Survey Administration
Other interventionAncillary studies
Rate of colonoscopy completion within 6 months
Will descriptively compare the rates of colonoscopy completion at 6 months. Will fit a generalized mixed effects model with a logit link and a random effect for clinic. Will include an indicator variable for the randomized group (usual care versus (vs.) multilevel intervention) and adjust for patient-level clinical and demographic factors (e.g., age, sex, race, ethnicity, primary language, marital status, last primary care visit, insurance) and clinic-level factors (e.g., clinic size, average full-time equivalent providers per clinic, average provider panel size, primary care provider mix (Doctor of Medicine/Doctor of Osteopathic Medicine vs. other advanced degree).
Time to colonoscopy completion
Will assess the time to colonoscopy completion in days and compare these times across individual clinics.
Rate of colonoscopy completion > 6 months
Will fit separate generalized mixed effects model for each binary outcome, with a logit link and a random effect for clinic. In all models, will include an indicator variable for the randomized group and adjust for patient-level clinical and demographic factors and clinic-level factors.
Colonoscopy referral: Number of participants referred for a colonoscopy
Will assess colonoscopy referral (yes/no) as the number of participants who have a colonoscopy referral placed after randomization.
Time to colonoscopy referral (days)
Will assess the number of days from randomization to colonoscopy referral.
Number of participants who schedule a colonoscopy
Will assess the number of referred participants who schedule a colonoscopy.
Click on the lead sponsor to view all of their trials.
Fred Hutchinson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
