An interventional study of FIT Outreach in Colonic Neoplasms, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 13,470 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this study arm will receive usual care from their primary care clinic.
Patients in this study arm will receive usual care at their primary care clinic and the intervention.
Behavioral: FIT Outreach
This arm will consist of priming patients with a postcard and a possibly a phone call two weeks prior to them being mailed a FIT kit. The FIT kits will be mailed to the patients with a letter from their clinic's care team informing them why they should complete the FIT and wordless instructions to help them complete the FIT. Two weeks after the FIT kit is mailed the patients that have not returned the kit will receive up to two reminder calls. During the phone calls the outreach workers will use health coaching techniques to encourage patients to complete the FIT. All written materials have been translated into English and Chinese and during phone calls patients will be spoken to in the language that they are most comfortable using.
Completion of FIT- one year
The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
Time frame: One year
Incomplete FIT- 28 days
Of the patients mailed the FIT kit the number of patients that have not completed their FIT.
Time frame: 28 days
FIT Positive
Among the patients that have completed the FIT the percentage that had a positive FIT test.
Time frame: 1 year
Completed Colonoscopy
Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.
Time frame: One year
Colonoscopy Findings
Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).
Time frame: One year
Cost
How much the program costed to start and the costs throughout program implementation.
Time frame: Two years
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco