A Pragmatic Cluster-Randomized Trial of Clinician Notification to Increase Aspirin Prophylaxis Utilization Among Pregnant Individuals at Elevated Risk for Preeclampsia
Massachusetts General Hospital
Summary
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.
Description
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 rando…