Choice Architecture and Colorectal Cancer Screening Outreach
Choice Architecture and Mailed Outreach for Colorectal Cancer Screening
1 other identifier
interventional
423
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2018
CompletedFebruary 20, 2019
February 1, 2019
4 months
August 8, 2017
February 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
CRC screening completion
The percentage of participants who successfully complete FIT or colonoscopy
4 months
Secondary Outcomes (1)
Choice of screening test
4 months
Study Arms (3)
Control
EXPERIMENTALColonoscopy only outreach and follow-up
Sequential Choice
EXPERIMENTALColonoscopy outreach + mailed FIT follow-up
Active Choice
EXPERIMENTALColonoscopy + mailed FIT outreach and follow-up
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 31469393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shivan Mehta, MD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Chyke Doubeni, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 11, 2017
Study Start
November 14, 2017
Primary Completion
March 14, 2018
Study Completion
July 14, 2018
Last Updated
February 20, 2019
Record last verified: 2019-02