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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Behavioral: FIT Outreach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Patients in this study arm will receive usual care from their primary care clinic. | |
| Experimental: FIT Outreach + Usual Care<br>Patients in this study arm will receive usual care at their primary care clinic and the intervention. | Behavioral: FIT Outreach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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