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Choice Architecture and Colorectal Cancer Screening Outreach

Primary Purpose

Cancer of Colon

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Colonoscopy only
Colonoscopy outreach + mailed FIT follow-up
Colonoscopy + Mailed FIT outreach and follow-up
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer of Colon

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Control

Sequential Choice

Active Choice

Arm Description

Colonoscopy only outreach and follow-up

Colonoscopy outreach + mailed FIT follow-up

Colonoscopy + mailed FIT outreach and follow-up

Outcomes

Primary Outcome Measures

CRC screening completion
The percentage of participants who successfully complete FIT or colonoscopy

Secondary Outcome Measures

Choice of screening test
The percentage of participants who choose either screening method (FIT vs. colonoscopy)

Full Information

First Posted
August 8, 2017
Last Updated
February 19, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03246438
Brief Title
Choice Architecture and Colorectal Cancer Screening Outreach
Official Title
Choice Architecture and Mailed Outreach for Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
March 14, 2018 (Actual)
Study Completion Date
July 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
423 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Colonoscopy only outreach and follow-up
Arm Title
Sequential Choice
Arm Type
Experimental
Arm Description
Colonoscopy outreach + mailed FIT follow-up
Arm Title
Active Choice
Arm Type
Experimental
Arm Description
Colonoscopy + mailed FIT outreach and follow-up
Intervention Type
Behavioral
Intervention Name(s)
Colonoscopy only
Other Intervention Name(s)
Control
Intervention Description
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
Intervention Name(s)
Colonoscopy outreach + mailed FIT follow-up
Other Intervention Name(s)
Sequential Choice
Intervention Description
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
Intervention Name(s)
Colonoscopy + Mailed FIT outreach and follow-up
Other Intervention Name(s)
Active Choice
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRC screening completion
Description
The percentage of participants who successfully complete FIT or colonoscopy
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Choice of screening test
Description
The percentage of participants who choose either screening method (FIT vs. colonoscopy)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chyke Doubeni, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31469393
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.
Results Reference
derived

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Choice Architecture and Colorectal Cancer Screening Outreach

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