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

NCT ID: NCT07109427

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-11
• Study Completion Date: 2031-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Annual PSA Health Maintenance Reminder

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)
• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lannis Hall, M.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lannis Hall, M.D., MPH

Role: CONTACT

lannishall@wustl.edu

636-916-9947

Facility Contacts

Lannis Hall, M.D., MPH

Role: primary

lannishall@wustl.edu

636-916-9947

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

202507064

Identifier Type: -

Identifier Source: org_study_id