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

Colonic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613260
• Other study ID #: 14-14861
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13470
• Est. completion date: January 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco-San Francisco General Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Department of Public Health, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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