This clinical trial evaluates whether a proactive screening intervention composed of a fecal immunochemical test kit and outreach reminders works to increase colorectal cancer (CRC) screening among patients in Federally Qualified Health Centers in Brooklyn. CRC screening rates are 72% in New York State but 48-55% in the Federally Qualified Health Centers where researchers will be performing the study. Undeserved communities are less likely to have a clinic visit for preventive purposes, less likely to receive provider recommendation for screening and less likely to undergo a screening test due to low knowledge, lack of insurance, financial barriers and logistical barriers such as inability to navigate the complex health system to get required care. There is an unmet need to organize and implement CRC screening using multilevel interventions to improve screening rates while reducing disparities. The current model for CRC screening is far from optimal and poses many barriers at the patient, provider and systems levels. Identification of screen eligible patients using health records from the clinics and a proactive invitation program, with mailed invitation, a package of materials so patients can complete a fecal immunochemical test (FIT) from their homes (i.e., FIT kit), and instructions on how to schedule colonoscopy if they prefer this to completing the FIT may likely reach all individuals eligible for CRC screening.
Additional locations may be listed on ClinicalTrials.gov for NCT06269744.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU LangoneStatus: Active
Contact: Aasma Shaukat
Phone: 929-458-5502
PRIMARY OBJECTIVE:
I. To compare the effectiveness of a strategy of proactive invitation (eligibility assessment and invitation to screen followed by mailed screening materials and navigation) versus (vs.) standard-care CRC screening at five federally qualified clinics serving medically underrepresented communities in Brooklyn with lower-than-average CRC screening rates.
SECONDARY OBJECTIVE:
I. To identify potential barriers and facilitators to the implementation of a proactive outreach CRC screening program by performing qualitative interviews of a purposive sample of providers and intervention group patients.
TERTIARY OBJECTIVE:
I. To estimate the cost and cost-effectiveness of a proactive invitation strategy versus standard care from a health care system perspective.
EXPLORATORY OBJECTIVE:
I. To systematically evaluate screening uptake in 45-49 year olds, a newly added population to the screen eligible pool, and in whom the best practices to increase uptake are not known.
OUTLINE: Patients are randomized to 1 of 2 groups and providers are assigned to the provider arm.
OPPORTUNISTIC SCREENING GROUP: Patients receive usual care on study.
PROACTIVE SCREENING GROUP: Patients receive mailed outreach letters with information and education about colon cancer screening options (FIT and colonoscopy) and receive mailed FIT kit on study. Patients who do not complete FIT kit within 4 weeks receive phone call or text message reminding them to participate in CRC screening. Patients who have not completed screening after 6 weeks will receive a mailed reminder to participate. Patients who have not completed screening after 9 weeks have a final note placed in their medical chart alerting the patient's primary care provider or preferred caregiver that they should complete further action regarding CRC screening as they see fit.
PROVIDERS: Providers complete an interview on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorAasma Shaukat
