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

Clinicaltrials.gov ID: NCT07109427
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age 40 - 75 Years
b-bullseye-arrow Enrollments 40000

Conditions

Prostate Cancer, Cancer of the Prostate

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Lannis Hall, M.D., MPH

Eligibility 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)

Study Plan

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.nnThis alert will appear in the health maintenance reminder section of the electronic health record (EHR).nnAlthough 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

    Description:

    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.

Outcome Measures

Primary Outcome Measures

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

Time Frame: Through 5 years

Secondary Outcome Measures

Proportion of men diagnosed with clinically significant prostate cancer (Gleason score u2265 7)

Time Frame: Through 5 years

Incidence of advanced and metastatic disease at diagnosis of prostate cancer

Time Frame: Through 5 years

Incidence of early-stage prostate cancer

Time Frame: Through 5 years

Stage distribution of prostate cancer diagnoses

Time Frame: Through 5 years

Biopsy rates

Time Frame: Through 5 years

Percent of PSA screening ordered but not completed

Time Frame: Through 5 years

Median PSA at time of diagnosis

Time Frame: Through 5 years

Evaluate the agreement between 3T MRI and biomarker test results

Time Frame: Through 5 years

PSA screening rate by age group

Time Frame: Through 5 years

PSA screening rate by race

Time Frame: Through 5 years

PSA screening rate by comorbidity burden

Time Frame: Through 5 years

PSA screening rate by insurance coverage

Time Frame: Through 5 years

PSA screening rate by provider

Time Frame: Through 5 years

Timeline

  • Last Updated
    August 17, 2025
  • Start Date
    August 7, 2025
  • Today
    November 9, 2025
  • Completion Date ( Estimated )
    August 31, 2031

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