Veteran Primers for CRC Screening

NCT ID: NCT04923646

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-01-19

Brief 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).

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Active

Primer

Group Type: EXPERIMENTAL

Primer

Intervention Type: OTHER

Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.

Control

No Primer

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Primer

Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Puget Sound Health Care System

FED

Sponsor Role: lead

Responsible Party

Alaina Mori

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashok Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Stefanie Deeds, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

Other Identifiers

FIT1

Identifier Type: -

Identifier Source: org_study_id