Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Integrated Health System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40,000
- 试验地点
- 2
- 主要终点
- Change in PSA screening completion rates in the BJC East Health System
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
- •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)
排除标准
- 未提供
研究组 & 干预措施
Annual PSA Health Maintenance Reminder
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.
干预措施: Annual PSA Health Maintenance Reminder (Other)
结局指标
主要结局
Change in PSA screening completion rates in the BJC East Health System
时间窗: 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.
次要结局
- 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)
- PSA screening rate by age group(Through 5 years)
- PSA screening rate by insurance coverage(Through 5 years)
- PSA screening rate by provider(Through 5 years)
- PSA screening rate by race(Through 5 years)
- PSA screening rate by comorbidity burden(Through 5 years)