Veteran Primers for CRC Screening

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: Colorectal Cancer
• Intervention / Treatment: Other: Primer

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Percent of returned FIT tests	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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: Adherence; Behavioral economics; Cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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