Clinical trial NCT02613260: Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
Official title: Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Neoplasms
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
name: San Francisco Department of Public Health
First posted: 2015-11-24
Enrollment: 13470
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of FIT- one year
timeFrame: One year
Secondary outcomes:
measure: Incomplete FIT- 28 days
timeFrame: 28 days
measure: FIT Positive
timeFrame: 1 year
measure: Completed Colonoscopy
timeFrame: One year
measure: Colonoscopy Findings
timeFrame: One year
measure: Cost
timeFrame: Two years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco-San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ma Somsouk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee B, Keyes E, Rachocki C, Grimes B, Chen E, Vittinghoff E, Ladabaum U, Somsouk M. Increased Colorectal Cancer Screening Sustained with Mailed Fecal Immunochemical Test Outreach. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1326-1333.e4. doi: 10.1016/j.cgh.2021.07.022. Epub 2021 Jul 16.
citation: Wang A, Rachocki C, Shapiro JA, Issaka RB, Somsouk M. Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. Clin Gastroenterol Hepatol. 2019 Aug;17(9):1822-1828. doi: 10.1016/j.cgh.2018.11.050. Epub 2018 Nov 29.