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Purpose

- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care: - Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines. - Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices. - The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Sex
Male
Accepts Healthy Volunteers
Yes

Criteria

Eligibility Criteria:

- Receive care within the BJC Health System

- Have had at least one primary care physician appointment in the calendar year of PSA
screening (primary care)

- Be male

- Not have a history of prostate cancer

- Meet one of the following risk criteria:

- High Risk for Prostate Cancer

- African American, between the ages of 40 and 75 (inclusive), or

- Family history of prostate, breast, ovarian, and/or pancreatic cancer, or

- Known familial germline mutation OR

- Average Risk for Prostate Cancer

- Between the ages of 50 and 75 (inclusive)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Annual PSA Health Maintenance Reminder 		An annual health maintenance reminder will be implemented for all men who meet the American Cancer Society guidelines for average- and high-risk eligibility criteria. The goal is to encourage their primary care provider (PCP) to engage in a shared decision-making discussion with the patient about the benefits and risks of prostate cancer screening. This alert will appear in the health maintenance reminder section of the electronic health record (EHR). Although all providers with access to EPIC can view the alert, it is typically the PCPs who review and take action on alerts in the health maintenance reminder section.
  • Other: Annual PSA Health Maintenance Reminder
    The annual health maintenance reminder does not mandate PSA screening for eligible patients. Instead, it recommends that primary care providers (PCPs) initiate a shared decision-making discussion with their patients. As part of this conversation, patients will be informed of their individual risk factors-including race, family history, and germline mutations-and can then make an informed choice about whether to proceed with PSA screening.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
Contact:
Lannis Hall, M.D., MPH
636-916-9947
lannishall@wustl.edu

More Details

NCT ID
NCT07109427
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Lannis Hall, M.D., MPH
636-916-9947
lannishall@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.