Clinical trial · Interventional
Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Veteran Peer Decision Coaching Session for PSA Screening | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 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.
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 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 outcomes (6)
- measure
- Decisional Conflict
- timeFrame
- Up to 3 months
- description
- The 16-item Decisional Conflict Scale (DCS) measures Veterans' perceptions of 1) uncertainty in choosing options, 2) feelings of having adequate knowledge and clear values, and 3) effective decision making. DCS is scored on a 5-point Likert scales with scores ranging from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: Veteran patient participants: * Veteran * Male * Attending VANYHHS-Manhattan for routine primary care appointment Providers: * Primary care provider at VA New York Harbor Healthcare System (VANYHHS) * Caring for patients that fit inclusion criteria Exclusion Criteria: Veteran Patients: * Patients seen within 9 months of other PSA tests * Patients seen within 180 days after primary diagnosis of urinary obstruction, prostatitis, hematuria, other disorder of prostate, unexplained weight loss, or lumbar back pain * Patients with a prior diagnosis of prostate cancer (ICD-10-CM C61) * Patients visiting their provider for any indication other than a well-visit appointment Providers: \- Providers who do not treat adult male patients (e.g. OB/Gyns, pediatricians)
References
Publications (1)
- BACKGROUNDWright Nunes J, Kerr E, Ojo A, Powell C, Fan A, Brinley FJ, Devine A, Ellies T, Grzyb K, Garcia-Guzman L, Nakai T, Oliverio A, Chen E, Fagerlin A. Patient Education for CKD and Decision Support in Primary Care: Findings From the EPIK Pilot Study. Am J Kidney Dis. 2025 Mar;85(3):284-292. doi: 10.1053/j.ajkd.2024.10.005. Epub 2024 Dec 14. PMID 39675547