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

Trial Summary

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 data supports the effectiveness of this treatment for high-risk pregnancies?

Research shows that using low-dose aspirin can help prevent preeclampsia, a serious condition during pregnancy, in people who are at high risk. A study found that after implementing a system to screen for preeclampsia risk and prescribe aspirin, the rate of appropriate aspirin prescriptions increased significantly, suggesting that electronic health record alerts can improve the use of aspirin in high-risk pregnancies. ^{1 2 3 4 5}

Is low-dose aspirin safe for use in high-risk pregnancies?

Research supports the use of low-dose aspirin to prevent preeclampsia in high-risk pregnancies, and it is generally considered safe when prescribed according to guidelines. ^{1 3 4 5 6}

How does the drug used in EHR Alerts for Aspirin Use in High-Risk Pregnancies differ from other treatments for this condition?

This treatment is unique because it uses electronic health record (EHR) alerts to ensure that low-dose aspirin is prescribed to pregnant individuals at high risk of preeclampsia, improving adherence to guidelines and standardizing care. Unlike other treatments, this approach focuses on enhancing the screening and prescribing process through technology, rather than introducing a new medication or dosage. ^{3 4 5 6 7}

What is the purpose of this 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.

Research Team

A. Dhanya Mackeen, MD, MPH

Principal Investigator

Geisinger Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Estimating Aspirin Overuse for Primary Prevention of Atherosclerotic Cardiovascular Disease (from a Nationwide Healthcare System). [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Improving preprocedure antithrombotic management: Implementation and sustainment of a best practice alert and pharmacist referral process. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Standardizing Screening for Preeclampsia Risk Factors to Improve Prescribing of Low-Dose Aspirin. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Leveraging quality improvement to promote health equity: standardization of prenatal aspirin recommendations. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Complications and Safety of Preconception Low-Dose Aspirin Among Women With Prior Pregnancy Losses. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Relationship between risk factor profile and prescription of low-dose aspirin for preeclampsia prevention. [2023]

7. France pubmed.ncbi.nlm.nih.gov

[For a targeted use of aspirin]. [2018]