Cancer of the Prostate, Prostate Cancer
Conditions
Keywords
PSA Screening, Clinically Significant Prostate Cancer, African American men, Electronic Health Record
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.
Interventions
OTHERAnnual 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 race | Through 5 years | — |
| PSA screening rate by comorbidity burden | Through 5 years | — |
| PSA screening rate by insurance coverage | Through 5 years | — |
| PSA screening rate by provider | Through 5 years | — |
Countries
United States
Contacts
CONTACTLannis Hall, M.D., MPH
PRINCIPAL_INVESTIGATORLannis Hall, M.D., MPH
Washington University School of Medicine
Outcome results
None listed