Aspirin Prophylaxis, Hypertensive Disorders of Pregnancy (HDP), Preeclampsia, Pregnancy Complications
Conditions
Keywords
preeclampsia, aspirin prophylaxis
Brief 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.
Detailed 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 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.
Interventions
BEHAVIORALClinician notification of elevated preeclampsia risk
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Clusters of outpatient obstetric clinics, care teams, or clinician groups will be randomized to clinician notification versus usual care. Eligible patient encounters will be assigned according to the randomized cluster to which their obstetric clinician, care team, or clinic is assigned.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aspirin prophylaxis utilization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspirin prescription or medication list entry | 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. |
| Clinician documentation of aspirin recommendation | From 12 weeks' gestation through 28 weeks' gestation | Proportion of eligible encounters with clinician documentation recommending aspirin prophylaxis for preeclampsia prevention. |
| Timing of aspirin prophylaxis implementation | From 12 weeks' gestation through 28 weeks' gestation | Gestational age at first evidence of aspirin prescription, medication list entry, or documented clinician recommendation. |
Countries
United States
Contacts
CONTACTEmily Lau, MD, MPH
Outcome results
None listed