Clinical trial NCT06549036: Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
Official title: Randomized Trial of Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
Prostate-Specific Antigen
shared decision making
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-08-12
Enrollment: 228
Sex: MALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).

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)
* 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)

Primary outcomes:
measure: Decisional Conflict
timeFrame: Up to 3 months
measure: Patient Knowledge Survey Score
timeFrame: Day 1
measure: Decision Quality Score
timeFrame: Day 1
measure: Prostate-specific Antigen (PSA) Screening Rates
timeFrame: Up to Month 3
measure: Percentage of Participants Who Make Informed Choice (Knowledge Survey + Measure of Informed Choice Attitudes Scale)
timeFrame: Day 1
measure: Measure of Informed Choice Attitudes Scale
timeFrame: Day 1
Secondary outcomes:
measure: Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness (COMRADE)
timeFrame: Day 1
measure: Doctor-Patient Communication Survey
timeFrame: Day 1
measure: Decision Self-Efficacy
timeFrame: Day 1
measure: Self-efficacy for Communicating with Provider
timeFrame: Day 1
measure: Satisfaction with Decision Scale
timeFrame: Up to 3 Months
measure: Decisional Regret Scale
timeFrame: Up to 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Danil V Makarov, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: