Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07109427

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

- 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Arnold Bullock, M.D.

SUB_INVESTIGATOR

Christopher Abraham, M.D.

SUB_INVESTIGATOR

Cliff Robinson, M.D.

SUB_INVESTIGATOR

Jingqin (Rosy) Luo, Ph.D.

SUB_INVESTIGATOR

Kristina Williams

SUB_INVESTIGATOR

Lannis Hall, M.D., MPH

CONTACT

[email protected]

636-916-9947

Lannis Hall, M.D., MPH

PRINCIPAL_INVESTIGATOR

Michael Johnson, M.D.

SUB_INVESTIGATOR

Saira Khan, Ph.D., MPH

SUB_INVESTIGATOR

Timothy Eberlein, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7)

    Time frame: Through 5 years

  2. Incidence of advanced and metastatic disease at diagnosis of prostate cancer

    Time frame: Through 5 years

  3. Incidence of early-stage prostate cancer

    Time frame: Through 5 years

  4. Stage distribution of prostate cancer diagnoses

    Time frame: Through 5 years

  5. Biopsy rates

    Time frame: Through 5 years

  6. Percent of PSA screening ordered but not completed

    Time frame: Through 5 years

  7. Median PSA at time of diagnosis

    Time frame: Through 5 years

  8. Evaluate the agreement between 3T MRI and biomarker test results

    Time frame: 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.

  9. PSA screening rate by age group

    Time frame: Through 5 years

    Age groups will include 40-49, 50-70, and 70-75

  10. PSA screening rate by race

    Time frame: Through 5 years

  11. PSA screening rate by comorbidity burden

    Time frame: Through 5 years

  12. PSA screening rate by insurance coverage

    Time frame: Through 5 years

  13. PSA screening rate by provider

    Time frame: Through 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Lannis Hall, M.D., MPH

CONTACT

[email protected]

636-916-9947

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Aug 7, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.