Choice Architecture and Colorectal Cancer Screening Outreach

Study Overview
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Brief Summary
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This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

Detailed Description
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This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms: Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).

Official Title
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Choice Architecture and Mailed Outreach for Colorectal Cancer Screening

Conditions
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Cancer of Colon

Intervention / Treatment
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* Behavioral: Colonoscopy only
* Behavioral: Colonoscopy outreach + mailed FIT follow-up
* Behavioral: Colonoscopy + Mailed FIT outreach and follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 50 and 74 years old Has a primary care provider who is a University City or Valley Forge Family Medicine provider Has had at least 2 office visits at either practice Is due for colorectal cancer screening Is asymptomatic for CRC Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area Exclusion Criteria: Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures) Has a history of CRC or colonic polyps Has a history of GI cancer Has a history of confirmed Inflammatory Bowel Disease (IBD) has a history of colitis other than Crohns disease or ulcerative colitis) Has a first degree relative that has been diagnosed with CRC Has had a colectomy Has been diagnosed with Familial Adenomatous Polyposis (FAP) Has been diagnosed with Lynch Syndrome (i.e. HNPCC) Has iron-deficiency anemia Has a history of lower GI bleeding Has metastatic (Stage IV) blood or solid tumor cancer Has end stage renal disease Has cirrhosis Has heart failure Has dementia Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Colonoscopy only outreach and follow-up | Behavioral: Colonoscopy only<br>* Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.<br>* Other names: Control;|
| Experimental: Sequential Choice<br>Colonoscopy outreach + mailed FIT follow-up | Behavioral: Colonoscopy outreach + mailed FIT follow-up<br>* Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.<br>* Other names: Sequential Choice;|
| Experimental: Active Choice<br>Colonoscopy + mailed FIT outreach and follow-up | Behavioral: Colonoscopy + Mailed FIT outreach and follow-up<br>* Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.<br>* Other names: Active Choice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRC screening completion | The percentage of participants who successfully complete FIT or colonoscopy | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of screening test | The percentage of participants who choose either screening method (FIT vs. colonoscopy) | 4 months |