Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening

NCT ID: NCT06549036

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2028-08-31

Brief Summary

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.

Detailed Description

Prostate cancer is the most common non-cutaneous malignancy among men in the United States, accounting for one third of new cancer diagnoses in VA. Prostate Cancer is commonly detected using prostate-specific antigen (PSA), a non-specific test whose use in prostate cancer screening has led to modest population-level survival benefits at the cost of over-detection of low-risk disease. Recognizing this trade off, USPSTF and VHA Clinical Preventive Services recommend a Shared Decision Making (SDM) approach to PSA screening. Regardless of whether they ultimately elect PSA screening or not, patients should discuss the best evidence for and against it with clinicians and be supported to make high quality decisions. In spite of broad support for these recommendations, SDM is challenging to implement because primary care providers see it as too time consuming and have insufficient training and support to perform it. Moreover, primary care office visits are notoriously too brief to address the multitude of recommended, beneficial preventive interventions. There is an urgent need to incorporate SDM paradigms into routine VA clinical practice. An ideal intervention accomplishing this would improve decision quality at low cost and be acceptable to Veterans and clinicians.

The primary challenge to implementing routine PSA SDM counseling is clinic workflow. One solution may be to enlist non-clinician healthcare team members to offer SDM counseling. Decision coaches can provide non-directive support to help patients weigh options, prepare for provider discussions, and implement decisions. Decision coaches improve knowledge and promote SDM. In a pilot program, the investigators group trained lay health workers as decision coaches to counsel Black men considering PSA screening in a non-VA community care setting. There is an urgent need to expand this approach to all men considering PSA screening and adapt it to the VA setting. The investigators propose training Veteran peers, who are well-known to promote healthful behaviors among Veterans, to be decision coaches to promote SDM among Veterans considering PSA screening. This peer-led approach may provide excellent counseling at acceptable cost and decreased clinician burden.

The objective of this study is to test the efficacy of a Veteran-peer-navigator-led decision-coaching program (PDC) to facilitate SDM for PSA screening at VA NY Harbor. The investigators will randomize Veterans seeking primary care to receive 1) a standard of care screening decision aid (DA) along with PDC on PSA screening (intervention), or 2) the same DA without counseling (control). The outcomes of interest are decision quality, PSA utilization, acceptability and cost of the PDC program with the goal of future system-wide dissemination. Additionally, since VA is dedicated to promoting health equity through telehealth, the investigators will explore the effects of patient race (Black versus non-Black) and communication format (in-person versus telehealth).

Conditions

Prostate Cancer

Keywords

prostate cancer; Prostate-Specific Antigen; shared decision making

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Veteran Peer Decision Coaching Session for PSA Screening

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

PDC Intervention

Eligibility Criteria

Inclusion Criteria

Veteran patient participants:

• Age 40-69 years old
• Veteran
• Male
• Attending VANYHHS-Manhattan for routine primary care appointment

Providers:

• Primary care provider at VA New York Harbor Healthcare System (VANYHHS)

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danil V Makarov, MD MHS

Role: PRINCIPAL_INVESTIGATOR

VA NY Harbor Healthcare System, New York, NY

Locations

VA NY Harbor Healthcare System, New York, NY

New York, New York, United States

Countries

United States

Central Contacts

Jerry K Thomas, MPH BA

Role: CONTACT

Phone: (201) 316-3440

Email: Jerry.Thomas3@va.gov

Facility Contacts

Jerry K Thomas, MPH BA

Role: primary

Other Identifiers

I01HX003622-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IIR 22-090

Identifier Type: -

Identifier Source: org_study_id