Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System

University of California San Francisco (UCSF)

Status: Completed

Conditions: Colonic Neoplasms

Treatments: Behavioral: FIT Outreach

Study type: Interventional

Funder types: Other

Identifiers

NCT02613260

14-14861

Details and patient eligibility

About

Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.

Full description

Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy.

Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.

Enrollment: 13,470 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Asymptomatic men and women
• 50 to 75 years of age

Exclusion criteria

• Personal history of polyps requiring colonoscopic surveillance
• Homeless
• Severe co-morbidities limiting life expectancy e.g., advanced stage cancer

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13,470 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients in this study arm will receive usual care from their primary care clinic.

FIT Outreach + Usual Care

Experimental group

Description:

Patients in this study arm will receive usual care at their primary care clinic and the intervention.

Treatment:

Behavioral: FIT Outreach