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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of California, San Francisco

Current Primary Outcome: Completion of FIT- one year [ Time Frame: One year ]

The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incomplete FIT- 28 days [ Time Frame: 28 days ]
    Of the patients mailed the FIT kit the number of patients that have not completed their FIT.
  • FIT Positive [ Time Frame: 1 year ]
    Among the patients that have completed the FIT the percentage that had a positive FIT test.
  • Completed Colonoscopy [ Time Frame: One year ]
    Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.
  • Colonoscopy Findings [ Time Frame: One year ]
    Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).
  • Cost [ Time Frame: Two years ]
    How much the program costed to start and the costs throughout program implementation.


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: November 20, 2015
Date Started: November 2015
Date Completion: November 2019
Last Updated: May 2, 2017
Last Verified: May 2017