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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emily Lau, MD, MPH
- Número de teléfono: 617-643-6161
- Correo electrónico: elau6@mgh.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Mass General Brigham
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Contacto:
- Emily Lau, MD, MPH
- Número de teléfono: 617-643-6161
- Correo electrónico: elau6@mgh.harvard.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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.
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Sin intervención: Usual Care
Eligible patient encounters will receive routine outpatient obstetric care without study-generated clinician notification of elevated preeclampsia risk.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Aspirin prophylaxis utilization
Periodo de tiempo: From 12 weeks' gestation through 28 weeks' gestation
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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.
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From 12 weeks' gestation through 28 weeks' gestation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Aspirin prescription or medication list entry
Periodo de tiempo: From 12 weeks' gestation through 28 weeks' gestation
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Proportion of eligible encounters with aspirin prescribed or documented as an active medication in the electronic health record.
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From 12 weeks' gestation through 28 weeks' gestation
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Clinician documentation of aspirin recommendation
Periodo de tiempo: From 12 weeks' gestation through 28 weeks' gestation
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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
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Timing of aspirin prophylaxis implementation
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Notification actionability / clinician response
Periodo de tiempo: From notification delivery through 28 weeks' gestation
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2023P002133
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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