Low Dose Aspirin Alerts in High-Risk Pregnancies

Not Applicable

Recruiting

• Conditions: Clinical Decision Support Systems; Preeclampsia; Aspirin; Economics, Behavioral
• Interventions: Behavioral: Electronic health record best practice alert

• Registration Number: NCT05802940
• Lead Sponsor: Geisinger Clinic

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-07
• Study Start: 2023-06-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-06-19
• Study Completion: 2025-06-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 640

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best practice alert (BPA) intervention group	Electronic health record best practice alert	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.

Primary Outcome Measures

Name	Time	Method
A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks	Assessed between initial prenatal visit and delivery after 28 weeks	yes/no

Secondary Outcome Measures

Name	Time	Method
The healthcare provider recommendation for low dose aspirin use in all randomized patients	Assessed between initial prenatal visit and delivery	yes/no

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States