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

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Cancer of the Prostate

• Registration Number: NCT07109427
• Lead Sponsor: Washington University School of Medicine

Brief Summary

- 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Status Verified: 2025-08
• Study First Posted: 2025-08-07
• Study Start: 2025-08-11
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-17
• Primary Completion: 2031-08-31
• Study Completion: 2031-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in PSA screening completion rates in the BJC East Health System	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7)	Through 5 years
Incidence of advanced and metastatic disease at diagnosis of prostate cancer	Through 5 years
Incidence of early-stage prostate cancer	Through 5 years
Stage distribution of prostate cancer diagnoses	Through 5 years
Biopsy rates	Through 5 years
Percent of PSA screening ordered but not completed	Through 5 years
Median PSA at time of diagnosis	Through 5 years
Evaluate the agreement between 3T MRI and biomarker test results	Through 5 years	The 3T MRI and biomarker tests are used to help determine whether a biopsy is necessary. The investigators will categorize the results as positive versus negative and the agreement will be gauged based on Kappa coefficient.
PSA screening rate by age group	Through 5 years	Age groups will include 40-49, 50-70, and 70-75
PSA screening rate by insurance coverage	Through 5 years
PSA screening rate by provider	Through 5 years
PSA screening rate by race	Through 5 years
PSA screening rate by comorbidity burden	Through 5 years

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States