Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening

Part of paid clinical trials in New York, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT06549036
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • Veteran Peer Decision Coaching Session for PSA Screening — BEHAVIORAL
    Veterans in the intervention arm will review the content of the mailed DA, including the values clarification exercise, with the Veteran PDC. Veteran PDC Counseling includes: 1) a structured interview with the patient that focuses on determining his understanding of his prostate cancer risk, his screening options, and his goals and values related to his decision making and 2) role playing exercises to improve SDM skills.

Study Details

The project will investigate the efficacy of a Veteran-peer-navigator-led decision coaching (PDC) program to promote Shared Decision Making (SDM) for prostate cancer screening among Veterans at the Veterans Health Administration (VA). Prostate cancer is commonly screen detected using PSA, a non-specific test which has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. This trade off in outcomes is ideally addressed using SDM which can be challenging to implement in time constrained primary care office visits. The investigators propose the evaluation of a PDC intervention to promote SDM for PSA screening to improve both access and quality of care for Veterans. The investigators results will enhance understanding of the efficacy, cost-effectiveness, and sustainability of PDC interventions for SDM promotion across communication formats in the VA. Lessons learned through this proposal will not only improve quality of care for PSA screening but also will suggest a paradigm for dissemination of SDM across preventive services.

Key Dates

Start date
Aug 14, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Intervention Group
    Veterans randomized to the intervention arm will receive a decision aid in the mail along with decision coaching on PSA screening from a Veteran Veteran-peer-navigator decision coach. The intervention will be administered prior to the Veteran patient's appointment with the provider.
  • No Intervention: Control Group
    Veteran patients in the control arm will receive a decision aid alone in the mail without any additional counseling prior to their office visit.

Primary Outcome Measure

Decisional Conflict [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA NY Harbor Healthcare System, New York, NYNew YorkNew York10010-5011
Jerry K Thomas, MPH BA
[email protected]
(201) 316-3440
Danil V Makarov, MD MHS (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
VA NY Harbor Healthcare System, New York, NY· New York, NY

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