Veteran Primers for CRC Screening

VA Puget Sound Health Care System

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Primer

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04923646

FIT1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,404 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,404 participants in 2 patient groups

Active

Experimental group

Description:

Primer

Treatment:

Other: Primer

Control

No Intervention group

Description:

No Primer