Using Behavioral Science to Improve Colorectal Cancer Screening Rates With Mailed FIT Kits (FIT)
Primary Purpose
Colorectal Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed automated phone call
Sponsored by

About this trial
This is an interventional screening trial for Colorectal Cancer Screening
Eligibility Criteria
Inclusion Criteria:
- Overdue for average-risk colorectal cancer screening
- Active primary care provider at UCLA seen within last 3 years
Exclusion Criteria:
- Inactive mychart status at time of enrollment
- Died within follow-up period
- Received FIT kit in prior 6 months
Sites / Locations
- UCLA Health Department of Medicine, Quality Office
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)
This group will receive standard FIT mailer protocol (as above) PLUS delayed automated phone reminder
Outcomes
Primary Outcome Measures
Overall colorectal cancer screening uptake (any modality)
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
Secondary Outcome Measures
Colorectal cancer screening uptake by modality
Rate of completion of CRC screening by modality type
Full Information
NCT ID
NCT04746469
First Posted
January 24, 2021
Last Updated
September 11, 2022
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT04746469
Brief Title
Using Behavioral Science to Improve Colorectal Cancer Screening Rates With Mailed FIT Kits
Acronym
FIT
Official Title
Impact of Automated Telephone Outreach on Colorectal Cancer Screening Uptake Among Patients Who Receive Mailed Fecal Immunochemical Tests (FIT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
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
As a part of UCLA Health's continued goal of improving patient care the investigators are updating our mailing campaign for our FIT Kit colorectal cancer screening that the investigators administer 2 times per year to include an automated phone call reminder to patients who are overdue for average-risk colorectal cancer screening and enrolled in a mailed FIT program. This will help the investigators evaluate if automated phone calls are effective at improving compliance with CRC screening, in addition to mailed FIT and embedded electronic health record (EHR) portal messages to patients.
Detailed Description
UCLA Health has a biannual mailed FIT program designed to capture patients overdue for CRC screening who are average-risk for CRC. With every campaign, the investigators attempt to improve the return rates for patients receiving the FIT Kits. For the current campaign, all patients enrolled will receive usual care and the investigators are delivering an automated phone call to half the eligible patients reminding them to return their FIT kits and prompting them to request a new kit if needed. The investigators will investigate if this intervention increases the number of patients who complete the mailed Fit Kit or any type of CRC screening over a 6-month follow up period. This quality improvement project will help the investigators improve the processes of care for the patients, and community. If this phone call is successful the investigators will likely expand it to the entire population in future FIT Kit mailer campaigns. However, if it is not effective this will help the investigators minimize the number of calls/interventions the investigators send to patients and will hopefully allow for more useful outreach to patients in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
~2500 patients who are overdue for average-risk CRC screening and are enrolled in UCLA Health biannual mailed FIT program will be randomized to either control (mailed FIT kit + standard messaging) or intervention (mailed FIT Kit + standard messaging + delayed automated phone reminder)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will receive standard FIT mailer protocol (as above) PLUS delayed automated phone reminder
Intervention Type
Behavioral
Intervention Name(s)
Delayed automated phone call
Other Intervention Name(s)
Cipher phone reminder
Intervention Description
Cipher provides automated phone calls to patients; in this case the script for Cipher was modified to provide patients a reminder to return FIT kits, allow patients to request a new kit in case they need a replacement, and to allow patients to provide information if they already completed CRC screening
Primary Outcome Measure Information:
Title
Overall colorectal cancer screening uptake (any modality)
Description
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Colorectal cancer screening uptake by modality
Description
Rate of completion of CRC screening by modality type
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overdue for average-risk colorectal cancer screening
Active primary care provider at UCLA seen within last 3 years
Exclusion Criteria:
Inactive mychart status at time of enrollment
Died within follow-up period
Received FIT kit in prior 6 months
Facility Information:
Facility Name
UCLA Health Department of Medicine, Quality Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Behavioral Science to Improve Colorectal Cancer Screening Rates With Mailed FIT Kits
We'll reach out to this number within 24 hrs