Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening

NCT06549036 | Not Yet Recruiting

• 2 other identifiers: IIR 22-090I01HX003622-01A2
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; Prostate-Specific Antigen; shared decision making

Outcome Measures

Primary Outcomes (6)

• Decisional Conflict

  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)

  Up to 3 months

• Patient Knowledge Survey Score

  The Patient Knowledge Survey comprises of 12-items assessing prostate cancer and PSA screening knowledge. Respondents provide an answer of "True", "Unsure", or "False". The total score is the sum of correct responses and ranges from 0 - 12 with higher scores indicating greater knowledge levels.

  Day 1

• Decision Quality Score

  Decision quality will be measured through 3 domains: 1) decisional conflict 2) being informed (e.g. accurate understanding about screening and its risks and benefits) and 3) making preference-concordant decisions (i.e. treatment consistent with patient preferences). The Decision Quality Balance Scale consists of 12 questions (6 Pros and 6 Cons of testing) scored on a 5 point Likert scale (Strongly Disagree to Strongly Agree) that represents the relative strengths of the pros versus the cons and ranges from -24 to +24. A high quality decision is when patients are both well-informed and making preference-concordant decisions (i.e. treatment consistent with patient preferences as determined by responses to survey questions).

  Day 1

• Prostate-specific Antigen (PSA) Screening Rates

  Percentage of participants who receive at least one PSA screening test. Screening data is collected through patient self-report and electronic health record data.

  Up to Month 3

• Percentage of Participants Who Make Informed Choice (Knowledge Survey + Measure of Informed Choice Attitudes Scale)

  The percentage of participants who make an informed choice to either undergo or decline PSA testing. Informed choices are those in which: 1\. Men with good knowledge and positive measure of informed choice attitudes (\> or = 22) choose to undergo the test OR 2) Men with good knowledge but negative measure of informed choice attitudes (\<22) towards the test, do not undergo the test.

  Day 1

• Measure of Informed Choice Attitudes Scale

  The measure of Informed Choice evaluates the screening decision. The 4-item measure consists of items assessing knowledge, attitude towards the screening test, and a record of test uptake. The questions are graded on a 7 point Likert-type scale (1 to 7) with scores ranging from 4 to 28. The median of 22 was taken to classify men's attitudes as positive or negative, with scores 22 or above indicating positive attitudes, and those below 22 indicating negative attitudes.

  Day 1

Secondary Outcomes (6)

• Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness (COMRADE)

  Day 1

• Doctor-Patient Communication Survey

  Day 1

• Decision Self-Efficacy

  Day 1

• Self-efficacy for Communicating with Provider

  Day 1

• Satisfaction with Decision Scale

  Up to 3 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Control Group

NO INTERVENTION

Veteran patients in the control arm will receive a decision aid alone in the mail without any additional counseling prior to their office visit.

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.

Also known as: PDC Intervention

Eligibility Criteria

• Age: 40 Years - 69 Years
• Gender Eligibility Details: Patients must be male based on inclusion criteria. Providers do not have any gender eligibility requirements.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

Related Publications (1)

• Wright 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Danil V Makarov, MD MHS

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerry K Thomas, MPH BA

CONTACT

(201) 316-3440; Jerry.Thomas3@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start (Estimated): August 14, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)