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Completed

NCT Number: NCT05802940

Low Dose Aspirin Alerts in High-Risk Pregnancies

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: Assessed between initial prenatal visit and delivery after 28 weeks

    yes/no

Secondary outcomes

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

    Time frame: Assessed between initial prenatal visit and delivery

    yes/no

Other outcomes

  1. Patient taking low dose aspirin

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

    yes/no

  2. Rate of preeclampsia

    Time frame: Assessed at time of delivery

    yes/no

  3. Timing of low dose aspirin recommendation

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

    gestational age (weeks)

  4. Timing of low dose aspirin initiation

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

    gestational age (weeks)

  5. Preterm delivery

    Time frame: Assessed at delivery

    yes/no

  6. Provider response to best practice alert

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

    recommended, declined, etc.

  7. Number of times the best practice alert fired for a patient

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

    1,2,3,4...

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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