Recruiting

Electronic Health Record Alert on PSA Screening Rates

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What is being tested

Annual PSA Health Maintenance Reminder

Other
Who is being recruted

Prostate Cancer

+ Cancer of the Prostate
From 40 to 75 Years

See all eligibility criteria

How is the trial designed

Services Research Study

Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorWashington University School of Medicine
Study ContactLannis Hall, M.D., MPH
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 11, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to examine how using electronic health record alerts can influence the rates of PSA screening, a test for prostate cancer, across a network of ten hospitals. The focus is on encouraging annual discussions between healthcare providers and patients about PSA screening, using technology to support decisions based on the latest guidelines for prostate cancer risk. This study is important because it seeks to catch prostate cancer early while reducing unnecessary diagnoses, thereby improving patient care by ensuring that screenings are both available and effective. Participants in the study will engage in shared decision-making conversations guided by enhanced clinical decision support tools. These tools help standardize how healthcare providers decide on and refer patients for PSA screening, based on clinical guidelines. The study evaluates the effectiveness of these tools in reducing differences in how providers screen for prostate cancer and in ensuring that the screenings align with recommended practices. By doing so, the study hopes to find a balance between catching cancer early and avoiding unneeded treatments.

Official TitleImpact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System 
Principal SponsorWashington University School of Medicine
Study ContactLannis Hall, M.D., MPH
Last updated: August 17, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Services Research Study
These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 40 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Prostate Cancer
Cancer of the Prostate
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Study Objectives
Primary Objectives

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 Objectives

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.

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Washington University School of MedicineSaint Louis, United StatesSee the location
Recruiting
One Study Center