Outreach and Choice in Colorectal Cancer Screening

Study Overview
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Brief Summary
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The primary objective of this clinical trial will be to compare overall colorectal cancer (CRC) screening participation between an active choice (fecal immunochemical test [FIT] or colonoscopy) and a sequential choice (FIT offered first, then colonoscoscopy offered in those still unscreened) arm. Secondarily, we will (1) compare the proportions of FIT vs. colonoscopy per arm, (2) compare active choice vs FIT only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding CRC screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of CRC, adenomas and SSLs per arm, and the operational results of the outreach program across arms.

Official Title
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Outreach and Choice in Colorectal Cancer Screening

Conditions
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Colorectal Cancer Screening

Intervention / Treatment
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* Behavioral: Outreach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter). The assessment of screening status will happen monthly, on a rolling basis. Definition of being up to date with CRC screening includes any one of the following: i) FIT or guaiac-FOBT within 1 year, OR ii) Colonoscopy within 10 years, OR iii) Sigmoidoscopy within 5 years, OR iv) CT colonography within 5 years, OR v) Cologuard within 3 years Exclusion Criteria: Age outside the 45-75 range. History of precancerous polyps requiring colonoscopy surveillance. Already being up to date with CRC screening, as defined above. Evidence of total removal of the colon which would eliminate the need for screening.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active choice<br>FIT or colonoscopy | Behavioral: Outreach<br>* Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened<br>|
| Experimental: Sequential choice<br>FIT offered first, then colonoscopy offered to those still unscreened | Behavioral: Outreach<br>* Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with screening completion | Number of patients with FIT or colonoscopy completed | 6 months from initial offer |