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

Обзор

\- 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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Change in PSA screening completion rates in the BJC East Health System [Срок оценки: Through 5 years]

Вторичные конечные точки (12)

• Proportion of men diagnosed with clinically significant prostate cancer (Gleason score ≥ 7) [Срок оценки: Through 5 years]
• Incidence of advanced and metastatic disease at diagnosis of prostate cancer [Срок оценки: Through 5 years]
• Incidence of early-stage prostate cancer [Срок оценки: Through 5 years]
• Stage distribution of prostate cancer diagnoses [Срок оценки: Through 5 years]
• Biopsy rates [Срок оценки: Through 5 years]
• Percent of PSA screening ordered but not completed [Срок оценки: Through 5 years]
• Median PSA at time of diagnosis [Срок оценки: Through 5 years]
• Evaluate the agreement between 3T MRI and biomarker test results [Срок оценки: Through 5 years]
• PSA screening rate by age group [Срок оценки: Through 5 years]
• PSA screening rate by race [Срок оценки: Through 5 years]
• PSA screening rate by comorbidity burden [Срок оценки: Through 5 years]
• PSA screening rate by insurance coverage [Срок оценки: Through 5 years]

Критерии участия

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07109427 · 202507064

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗