Low Dose Aspirin Alerts in High-Risk Pregnancies

Best Practice Alert (BPA) for Low Dose Aspirin Recommendation in High-risk Pregnancies: a Randomized Controlled Trial

The goal of this study is to assess the effect of an electronic health record (EHR) clinical decision support tool, also known as a best practice alert (BPA), on healthcare provider recommendations for low dose aspirin use in a high-risk pregnant patient population. The investigators hypothesize that the implementation of the EHR BPA tool will increase the healthcare provider's recommendation for low dose aspirin compared to current standard care.

Study Overview

• Status: Completed
• Conditions: Aspirin; Preeclampsia; Clinical Decision Support Systems; Economics, Behavioral
• Intervention / Treatment: Behavioral: Electronic health record best practice alert

Detailed Description

Low dose aspirin (LDA) has been found to reduce the incidence of preeclampsia in high-risk pregnant patients. At a health system serving central and northeastern Pennsylvania, electronic health record data reveal that clinicians recommend an LDA regimen to only 60% of eligible high-risk pregnant patients, suggesting the need and opportunity for increased LDA recommendation. This study will assess the efficacy of an electronic health record based clinician-facing interruptive clinical decision support tool/best practice alert (BPA) aimed at increasing LDA recommendation for pregnant patients who are at high risk of preeclampsia.

Up to 704 patients will be randomized to account for possible 10% miscarriage and early termination rate as we require outcome data on a total of 640 patients for adequate power. Eligible patients will be randomized to a control group, where the clinician receives no BPA, and one experimental group, where the provider receives a BPA noting the patient is at high-risk and recommend the provider order LDA. If LDA is not recommended, there will be a required acknowledgment reason from the provider noting a rationale for not initiating a LDA regimen.

• Study Type: Interventional
• Enrollment (Actual): 830
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Receiving prenatal care within Geisinger
• Initial prenatal visit prior to 28 weeks gestation
• Determined to be high risk for preeclampsia based on the modified United States Preventive Services Task Force and American College of Obstetrics and Gynecology criteria (at least 1 high risk factor)

Exclusion Criteria:

• Not pregnant
• No prenatal visit prior to 28 weeks gestation
• Maternal-Fetal Medicine only visits
• Not meeting the modified USPSTF high-risk criteria
• Contraindication to aspirin, including allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Best practice alert (BPA) intervention group; An electronic health record best practice alert (BPA) will alert healthcare providers to recommend low dose aspirin for pregnant patients at high-risk for preeclampsia. This alert also allows the healthcare provider to order an over-the-counter-prescription for low dose aspirin and automatically documents LDA in the patient's medication list.	Behavioral: Electronic health record best practice alert; The electronic health record will identify patients at high-risk for preeclampsia and candidate for low dose aspirin (LDA) prophylaxis. For those in the intervention group, a best practice alert will notify the healthcare provider within the patient's chart during a prenatal visit that LDA should be recommended.
No Intervention: Standard care group; Healthcare provider's recommendation for aspirin in patients at high-risk for preeclampsia will be based on current practice (no alerts) and the healthcare provider's knowledge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks	yes/no	Assessed between initial prenatal visit and delivery after 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The healthcare provider recommendation for low dose aspirin use in all randomized patients	yes/no	Assessed between initial prenatal visit and delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of preeclampsia	yes/no	Assessed at time of delivery
Preterm delivery	yes/no	Assessed at delivery
Patient taking low dose aspirin	yes/no	Assessed at time of delivery (>/= 28 weeks)
Timing of low dose aspirin recommendation	gestational age (weeks)	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Timing of low dose aspirin initiation	gestational age (weeks)	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Provider response to best practice alert	recommended, declined, etc.	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Number of times the best practice alert fired for a patient	1,2,3,4...	Assessed between initial prenatal visit to delivery (>/= 28 weeks)

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: A. Dhanya Mackeen, MD, MPH, Geisinger Clinic

Publications and helpful links

General Publications

• ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.
• US Preventive Services Task Force; Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Li L, Ogedegbe G, Pbert L, Silverstein M, Simon MA, Stevermer J, Tseng CW, Wong JB. Aspirin Use to Prevent Preeclampsia and Related Morbidity and Mortality: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Sep 28;326(12):1186-1191. doi: 10.1001/jama.2021.14781.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): October 9, 2025
• Study Completion (Actual): January 27, 2026

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Behavior
• Other Study ID Numbers: LDA BPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No