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OpenTrials
Completed

NCT Number: NCT04923646

Veteran Primers for CRC Screening

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).

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

About this study

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:

  • Active arm: Primer
  • Intervention Type: Other
  • Intervention Description: Mailed postcard notifying Veteran of upcoming FIT kit receipt for annual CRC screening
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primer

Other

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

Primary outcomes

  1. Return proportion

    Time frame: 3 months

    Percent of returned FIT tests

Secondary outcomes

  1. Return proportion

    Time frame: 6 months

    Percent of returned FIT tests

Sponsors and collaborators

Lead sponsor

VA Puget Sound Health Care System

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2021
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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