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

NCT07109427 | Recruiting

• 1 other identifier: 202507064
• Study Type: interventional
• Target: 40,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Cancer of the Prostate

Keywords

PSA Screening; Clinically Significant Prostate Cancer; African American men; Electronic Health Record

Outcome Measures

Primary Outcomes (1)

• Change in PSA screening completion rates in the BJC East Health System

  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.

  Through 5 years

Secondary Outcomes (13)

• 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

Study Arms (1)

Annual PSA Health Maintenance Reminder

EXPERIMENTAL

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

Interventions

Annual PSA Health Maintenance Reminder OTHER

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.

Annual PSA Health Maintenance Reminder

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lannis Hall, M.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lannis Hall, M.D., MPH

CONTACT

636-916-9947; lannishall@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): August 31, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)