Clinical trial NCT03246438: Choice Architecture and Colorectal Cancer Screening Outreach
Official title: Choice Architecture and Mailed Outreach for Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Colon
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 423
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: CRC screening completion
timeFrame: 4 months
Secondary outcomes:
measure: Choice of screening test
timeFrame: 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Chyke Doubeni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta SJ, Induru V, Santos D, Reitz C, McAuliffe T, Orellana C, Volpp KG, Asch DA, Doubeni CA. Effect of Sequential or Active Choice for Colorectal Cancer Screening Outreach: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e1910305. doi: 10.1001/jamanetworkopen.2019.10305.