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Low Dose Aspirin Alerts in High-Risk Pregnancies

NCT ID: NCT05802940

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

839 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preeclampsia Aspirin Clinical Decision Support Systems Economics, Behavioral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Electronic health record best practice alert

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Awathif Dhanya Mackeen

MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A. Dhanya Mackeen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34581729 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 29939940 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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LDA BPA

Identifier Type: -

Identifier Source: org_study_id