Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
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|ClinicalTrials.gov Identifier: NCT02613260|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colonic Neoplasms||Behavioral: FIT Outreach||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||November 29, 2017|
|Estimated Study Completion Date :||November 2019|
No Intervention: Usual Care
Patients in this study arm will receive usual care from their primary care clinic.
Experimental: FIT Outreach + Usual Care
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 [ 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613260
|United States, California|
|University of California, San Francisco-San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Ma Somsouk, MD||University of California, San Francisco|