EHR Alerts for Aspirin Use in High-Risk Pregnancies

Overseen By Amir Goren, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Not pregnant, Allergy to aspirin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool that alerts doctors through electronic health records to recommend low-dose aspirin for pregnant women at high risk for preeclampsia, a condition that causes high blood pressure during pregnancy. The goal is to determine if these alerts lead to more consistent aspirin recommendations compared to usual care. Women receiving prenatal care and identified as high-risk for preeclampsia may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative healthcare solutions that could enhance prenatal care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on assessing aspirin use in high-risk pregnancies.

What prior data suggests that this EHR best practice alert is safe for use in high-risk pregnancies?

Research has shown that low-dose aspirin can lower the risk of preeclampsia, a condition in pregnant women that can cause high blood pressure and organ damage. Aspirin is generally safe in low doses, particularly when taken under a doctor's guidance. It is a common medication with a well-established safety record. The electronic health record alert under study serves as a reminder for doctors to consider recommending aspirin and does not pose any safety issues itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using electronic health record (EHR) alerts for aspirin use in high-risk pregnancies because this approach streamlines the process of identifying and managing patients at risk for preeclampsia. Unlike traditional methods, where healthcare providers rely solely on their knowledge and judgment to recommend aspirin, this system automatically prompts providers to consider prescribing low-dose aspirin. The alert not only suggests the treatment but also simplifies the ordering process and ensures the prescription is documented in the patient's medical records. This could lead to more consistent and timely interventions, potentially improving outcomes for pregnant individuals at risk of preeclampsia.

What evidence suggests that this EHR alert is effective for increasing aspirin recommendations in high-risk pregnancies?

This trial will compare electronic health record alerts with standard care in recommending low-dose aspirin to pregnant patients at high risk of preeclampsia. Research has shown that electronic health record alerts help doctors recommend low-dose aspirin effectively. Studies have found that low-dose aspirin reduces the risk of developing preeclampsia in these pregnancies. In this trial, the alert system reminds doctors to suggest aspirin, increasing the likelihood that patients will benefit from this preventive step. For pregnant women with certain risk factors, such as age or health conditions, this alert can be crucial in preventing complications. ^{1 2 3 4 6}

Who Is on the Research Team?

A. Dhanya Mackeen, MD, MPH

Principal Investigator

Geisinger Clinic

Are You a Good Fit for This Trial?

This trial is for pregnant individuals under the care of Geisinger who are less than 28 weeks along and at high risk for preeclampsia, as determined by specific medical guidelines. It's not specified who can't join.

Inclusion Criteria

You are at high risk for developing preeclampsia based on specific health factors.

You are currently receiving pregnancy care at Geisinger.

You need to have your first prenatal visit before you are 28 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to either receive a best practice alert (BPA) for low dose aspirin recommendation or standard care without alerts

28 weeks

Regular prenatal visits

Follow-up

Participants are monitored for healthcare provider recommendations and patient outcomes, including preeclampsia and aspirin use, until delivery

4 weeks post-delivery

What Are the Treatments Tested in This Trial?

Interventions

• Electronic health record best practice alert

Trial Overview The study tests if a new alert in doctors' electronic health records increases recommendations for low dose aspirin to prevent preeclampsia in high-risk pregnancies compared to usual care.

How Is the Trial Designed?

Group I: Best practice alert (BPA) intervention group Active Control 1 Intervention

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 II: Standard care group Active Control 1 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.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Published Research Related to This Trial

A quality improvement project in an academic OB/Gyn practice showed that implementing a standardized approach to aspirin (ASA) prescription significantly increased screening rates for preeclampsia risk from 47% to 99% among new obstetric patients.

Post-intervention, 79% of patients who screened positive received an ASA recommendation, demonstrating that the standardized process is effective and equitable, with no significant differences in recommendations based on race.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging quality improvement to promote health equity: standardization of prenatal aspirin recommendations. Gross, ME., Godecker, A., Hughes, A., et al.[2023]

In a study of 1,228 women with a history of pregnancy losses, low-dose aspirin (81 mg) was found to be well tolerated, with similar rates of possible aspirin-related symptoms and emergency care visits compared to a placebo group.

While there was a slightly higher incidence of vaginal bleeding in the low-dose aspirin group (22% vs. 17%), overall maternal and fetal complications were comparable between the aspirin and placebo groups, suggesting that low-dose aspirin is generally safe for women trying to conceive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and Safety of Preconception Low-Dose Aspirin Among Women With Prior Pregnancy Losses. Ahrens, KA., Silver, RM., Mumford, SL., et al.[2021]

The implementation of a best practice alert (BPA) for patients on anticoagulants before elective gastrointestinal endoscopies led to an 80% referral rate to anticoagulation clinics, significantly improving guideline-adherent medication management (97.4% vs 91.0%).

Patients referred to the anticoagulation clinic also had a much higher documentation rate of their medication management plans (99.1% vs 59.4%), indicating that the BPA effectively streamlined preprocedural medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving preprocedure antithrombotic management: Implementation and sustainment of a best practice alert and pharmacist referral process. Han, H., Chung, G., Sippola, E., et al.[2023]

A quality improvement project implemented a preeclampsia risk screening in electronic health records, leading to a significant increase in screening rates from 74.2% to 95.6% over 9 months among 2,371 patients.

The project ensured that 97.1% of high-risk patients who screened positive were prescribed low-dose aspirin therapy, aligning with professional guidelines to help prevent preeclampsia, a serious condition in pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing Screening for Preeclampsia Risk Factors to Improve Prescribing of Low-Dose Aspirin. Burgess, A., Dalke, K., Wheeling, J., et al.[2022]

Only one of the three low-dose aspirin guidelines could be effectively implemented using electronic health record (EHR) data, highlighting challenges in translating clinical guidelines into actionable EHR definitions.

The study identified 86,555 patients (2% of a total of 5,598,604) who may be candidates for aspirin deprescribing, indicating that many individuals may be taking low-dose aspirin unnecessarily, as only 60% of those self-reporting aspirin use had corresponding EHR records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating Aspirin Overuse for Primary Prevention of Atherosclerotic Cardiovascular Disease (from a Nationwide Healthcare System). Ong, SY., Chui, P., Bhargava, A., et al.[2020]

Low-dose aspirin should only be used in pregnancy for specific high-risk groups, as its long-term safety is not well established.

Effective indications for low-dose aspirin include women with a history of preeclampsia leading to premature birth, those with multiple preeclampsia episodes, and women with antiphospholipid syndrome or lupus with related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[For a targeted use of aspirin]. Madar, H., Brun, S., Coatleven, F., et al.[2018]

In a study of 970 pregnant women, only 31% of those eligible for low-dose aspirin prophylaxis to prevent preeclampsia actually received the recommendation, highlighting significant underutilization of this preventive measure.

Women with multiple 'moderate' risk factors were the least likely to receive aspirin prophylaxis (0-6%), indicating a critical gap in care that could be addressed through improved education and adherence to guidelines among obstetricians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between risk factor profile and prescription of low-dose aspirin for preeclampsia prevention. Phelps, AJD., Holmgren, C.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05802940

Low Dose Aspirin Alerts in High-Risk Pregnancies This study will assess the efficacy of an electronic health record based clinician-facing interruptive clinical decision support tool/best practice alert (BPA)

2. pulse.cedars-sinai.org pulse.cedars-sinai.org/news/new-best-practice-alert-helps-clinicians-identify-patients-at-risk-of-preeclampsia

New Best-Practice Alert Helps Clinicians Identify Patients ... Low-dose aspirin is proven to reduce the risk of preeclampsia for pregnant women at high risk of the condition, including those over 40 years ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05802940/low-dose-aspirin-alerts-in-high-risk-pregnancies?mp=Me&state=PA&city=Danville

Low Dose Aspirin Alerts in High-Risk Pregnancies Low dose aspirin (LDA) has been found to reduce the incidence of preeclampsia in high-risk pregnant patients. At a health system serving central ...

4. withpower.com withpower.com/trial/phase-pre-eclampsia-3-2023-40b43

EHR Alerts for Aspirin Use 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12309040/

Effectiveness of low-dose aspirin in reducing the risk ... Evidence on the use of aspirin in women with chronic hypertension has indicated low effectiveness in preventing superimposed preeclampsia.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12536866/

Prevention of preeclampsia by aspirin consumption in high ... The current qualitative systematic review aims to thoroughly assess the outcomes of treatment with aspirin in high-risk preeclampsia women.