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Veteran Primers for CRC Screening

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04923646
Enrollment
2404
Registered
2021-06-11
Start date
2021-06-30
Completion date
2022-01-19
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Cancer screening, Behavioral economics, Adherence

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.

Interventions

OTHERPrimer

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

Sponsors

VA Puget Sound Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Return proportion3 monthsPercent of returned FIT tests

Secondary

MeasureTime frameDescription
Return proportion6 monthsPercent of returned FIT tests

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026