Veteran Primers for CRC Screening

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04923646
• Other study ID #: FIT1
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: January 19, 2022

Study information

• Verified date: January 2024
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2404
• Est. completion date: January 19, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Primer
Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return proportion	Percent of returned FIT tests	3 months
Secondary	Return proportion	Percent of returned FIT tests	6 months