NCT07109427 · Washington University School of Medicine
Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System
What this study is about
\- 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.
View original scientific description
\- 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
The overall PSA screening rate will be calculated as the number of PSA screening tests that are ordered by PCPs who will receive the alert and completed by patients within a year of the ordering date, divided by the total number of eligible patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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)
- 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)
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2025 · Source of record for eligibility and locations