Choice Architecture and Colorectal Cancer Screening Outreach

NCT ID: NCT03246438

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2018-07-14

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).

Conditions

Cancer of Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Control

Colonoscopy only outreach and follow-up

Group Type: EXPERIMENTAL

Colonoscopy only

Intervention Type: BEHAVIORAL

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.

Sequential Choice

Colonoscopy outreach + mailed FIT follow-up

Group Type: EXPERIMENTAL

Colonoscopy outreach + mailed FIT follow-up

Intervention Type: BEHAVIORAL

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.

Active Choice

Colonoscopy + mailed FIT outreach and follow-up

Group Type: EXPERIMENTAL

Colonoscopy + Mailed FIT outreach and follow-up

Intervention Type: BEHAVIORAL

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.

Interventions

Colonoscopy only

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.

Intervention Type: BEHAVIORAL

Colonoscopy outreach + mailed FIT follow-up

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.

Intervention Type: BEHAVIORAL

Colonoscopy + Mailed FIT outreach and follow-up

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Control; Sequential Choice; 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Chyke Doubeni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31469393 (View on PubMed)

Other Identifiers

827818

Identifier Type: -

Identifier Source: org_study_id