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Recruiting NCT07109427

Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System

No phase Interventional Prostate Cancer Cancer of the Prostate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Annual PSA Health Maintenance Reminder.
Who it may be relevant to
Registry conditions: Prostate Cancer, Cancer of the Prostate. Basic parameters: 40 years — 75 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

\- 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.

Interventions

  • 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.

Primary outcome measures

  • Change in PSA screening completion rates in the BJC East Health System [Time frame: Through 5 years]
Secondary outcome measures (12)
  • Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7) [Time frame: Through 5 years]
  • Incidence of advanced and metastatic disease at diagnosis of prostate cancer [Time frame: Through 5 years]
  • Incidence of early-stage prostate cancer [Time frame: Through 5 years]
  • Stage distribution of prostate cancer diagnoses [Time frame: Through 5 years]
  • Biopsy rates [Time frame: Through 5 years]
  • Percent of PSA screening ordered but not completed [Time frame: Through 5 years]
  • Median PSA at time of diagnosis [Time frame: Through 5 years]
  • Evaluate the agreement between 3T MRI and biomarker test results [Time frame: Through 5 years]
  • PSA screening rate by age group [Time frame: Through 5 years]
  • PSA screening rate by race [Time frame: Through 5 years]
  • PSA screening rate by comorbidity burden [Time frame: Through 5 years]
  • PSA screening rate by insurance coverage [Time frame: Through 5 years]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07109427 · 202507064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗