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Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention

2026年5月22日 更新者:Emily Lau、Massachusetts General Hospital

A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia

Preeclampsia is a leading cause of maternal morbidity and mortality. Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice. This pragmatic cluster-randomized implementation trial will test whether clinician notification of elevated preeclampsia risk increases aspirin prophylaxis utilization among eligible pregnant individuals receiving outpatient obstetric care.

Clusters will be randomized to clinician notification versus usual care. In the intervention arm, obstetric clinicians will receive notification that a patient is at elevated risk for preeclampsia and a recommendation to consider initiation of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. The intervention does not assign participants to aspirin and does not require any study-mandated medication. All decisions regarding aspirin prophylaxis will remain at the discretion of the treating obstetric clinician and patient.

研究概览

详细说明

This study is a pragmatic, cluster-randomized implementation trial conducted across two medical centers. The trial will evaluate whether clinician notification of elevated preeclampsia risk increases utilization of aspirin prophylaxis among eligible pregnant individuals in routine outpatient obstetric care.

Eligible encounters will include pregnant individuals receiving outpatient obstetric care who are identified as having elevated risk for preeclampsia based on a clinical risk prediction model. Clusters, defined as outpatient obstetric clinics, care teams, or clinician groups, will be randomized to clinician notification or usual care.

For encounters assigned to the intervention arm, clinicians will receive a notification indicating that the patient is at elevated predicted risk for preeclampsia. The notification will recommend consideration of aspirin prophylaxis initiation between 12 and 28 weeks' gestation when clinically appropriate and consistent with applicable clinical guidelines. The notification is intended to support clinician awareness and evidence-based preventive care. It does not mandate aspirin use or assign patients to receive aspirin.

Encounters assigned to usual care will proceed according to existing clinical workflows without study-generated clinician notification. The primary outcome will be aspirin prophylaxis utilization, defined by electronic health record evidence of aspirin prescription, active medication list entry, or documented clinician recommendation during the eligible gestational window.

研究类型

介入性

注册 (估计的)

1000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Mass General Brigham
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Pregnant individuals receiving outpatient obstetric care at participating medical centers.
  • Age 18 years or older.
  • Currently pregnant and within 12 to 28 weeks' gestation
  • Identified as having elevated predicted risk for preeclampsia as defined by USPSTSF and ACOG criteria
  • Receiving care from a clinician, care team, or clinic participating in the randomized implementation trial.

Exclusion Criteria:

  • Known contraindication to aspirin prophylaxis documented in the electronic health record.
  • Pregnancy beyond the prespecified gestational age window for aspirin prophylaxis implementation at the time of eligibility assessment.
  • Not receiving ongoing obstetric care at a participating site.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Clinician Notification
Obstetric clinicians caring for eligible pregnant individuals will receive a notification indicating elevated preeclampsia risk and recommending consideration of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. Aspirin use will not be mandated by the study.
A clinician-facing electronic or workflow-based notification identifying elevated predicted preeclampsia risk and recommending consideration of aspirin prophylaxis according to routine clinical care and applicable guidelines.
无干预:Usual Care
Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Aspirin prophylaxis utilization
大体时间:From 12 weeks' gestation through 28 weeks' gestation
Proportion of eligible patient encounters with evidence of aspirin prophylaxis utilization, defined as aspirin prescription, aspirin documented on the medication list, or clinician documentation recommending aspirin prophylaxis during the eligible gestational window.
From 12 weeks' gestation through 28 weeks' gestation

次要结果测量

结果测量
措施说明
大体时间
Aspirin prescription or medication list entry
大体时间:From 12 weeks' gestation through 28 weeks' gestation
Proportion of eligible encounters with aspirin prescribed or documented as an active medication in the electronic health record.
From 12 weeks' gestation through 28 weeks' gestation
Clinician documentation of aspirin recommendation
大体时间:From 12 weeks' gestation through 28 weeks' gestation
Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention.
From 12 weeks' gestation through 28 weeks' gestation
Timing of aspirin prophylaxis implementation
大体时间:From 12 weeks' gestation through 28 weeks' gestation
Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation.
From 12 weeks' gestation through 28 weeks' gestation

其他结果措施

结果测量
措施说明
大体时间
Notification actionability / clinician response
大体时间:From notification delivery through 28 weeks' gestation
Proportion of notifications followed by aspirin prescription, medication list entry, or clinician documentation of aspirin discussion or recommendation.
From notification delivery through 28 weeks' gestation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年5月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2030年5月1日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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