Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Emily Lau, MD, MPH
- 電話番号：617-643-6161
- メール：elau6@mgh.harvard.edu
研究場所
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Mass General Brigham
-
コンタクト：
- Emily Lau, MD, MPH
- 電話番号：617-643-6161
- メール：elau6@mgh.harvard.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
介入なし：Usual Care
Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Aspirin prophylaxis utilization
時間枠：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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Aspirin prescription or medication list entry
時間枠：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
時間枠：From 12 weeks' gestation through 28 weeks' gestation
|
Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention.
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From 12 weeks' gestation through 28 weeks' gestation
|
|
Timing of aspirin prophylaxis implementation
時間枠：From 12 weeks' gestation through 28 weeks' gestation
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Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation.
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From 12 weeks' gestation through 28 weeks' gestation
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Notification actionability / clinician response
時間枠：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.
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From notification delivery through 28 weeks' gestation
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2023P002133
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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