Veteran Primers for CRC Screening

January 5, 2024 updated by: Alaina Mori, VA Puget Sound Health Care System

Primers to Improve Adherence to Annual CRC Screening Among Veterans: A Randomized Control Trial

This is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a FIT kit in improving adherence to annual CRC screening. This project is for the purpose of quality improvement and has been designated as non-research by the VHA Office of Primary Care, Improvement & Innovation (VHA Program Guide 1200.21).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions:

  1. Active arm: Primer

    1. Intervention Type: Other
    2. Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
  2. Control arm: No primer a. Intervention Type: No intervention

Randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Our primary outcome of interest is the return rate at three months post randomization. Our secondary outcome of interest is the return rate at six months post randomization. Enrollment in the trial will occur between May 1, 2021 and January 1, 2022.

Study Type

Interventional

Enrollment (Actual)

2404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request.

Inclusion criteria:

  • Veteran
  • Assigned to a primary care provider at the VA Puget Sound as of January 1, 2021
  • At least 1 year of prior data available (evidence of at least one outpatient visit)
  • Due for annual colorectal (CRC) screening

Exclusion criteria:

  • Not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment.
  • Not currently receiving hospice care
  • No record of recent death in the administrative data.
  • No history of CRC or history of prior colectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Primer
Other: Primer
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
No Intervention: Control
No Primer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return proportion
Time Frame: 3 months
Percent of returned FIT tests
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return proportion
Time Frame: 6 months
Percent of returned FIT tests
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Puget Sound Health Care System

Investigators

  • Principal Investigator: Ashok Reddy, MD, VA Puget Sound Health Care System
  • Principal Investigator: Stefanie Deeds, MD, VA Puget Sound Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 19, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIT1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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