Low Dose Aspirin Alerts in High-Risk Pregnancies

NCT05802940 | Completed

• 1 other identifier: LDA BPA
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aspirin; Economics, Behavioral; Preeclampsia; Clinical Decision Support Systems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The healthcare provider recommendation for low dose aspirin use in all randomized patients

  Assessed between initial prenatal visit and delivery

Other Outcomes (7)

• Patient taking low dose aspirin

  Assessed at time of delivery (>/= 28 weeks)

• Rate of preeclampsia

  Assessed at time of delivery

• Timing of low dose aspirin recommendation

  Assessed between initial prenatal visit to delivery (>/= 28 weeks)

Study Arms (2)

Best practice alert (BPA) intervention group

ACTIVE COMPARATOR

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

Standard care group

NO INTERVENTION

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.

Interventions

Electronic health record best practice alert BEHAVIORAL

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.

Best practice alert (BPA) intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Related Publications (2)

• 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.

  PMID: 34581729 BACKGROUND

• ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.

  PMID: 29939940 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Behavior

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• A. Dhanya Mackeen, MD, MPH

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will randomize at level of the patient as to whether or not a BPA will fire when the patient is seen in clinic. Any obstetric care provider who sees a patient that has been randomized to BPA group will receive the alert if indicated. If the alert doesn't fire, the care provider will not be aware as to whether the patient is randomized to the BPA group or whether the alert was not indicated. Clinical investigators and outcomes assessors are blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 7, 2023
• Study Start: June 19, 2023
• Primary Completion: October 9, 2025
• Study Completion: January 27, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)