NCT05802940

Low Dose Aspirin Alerts in High-Risk Pregnancies

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 839 (actual)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Preeclampsia
• Aspirin
• Clinical Decision Support Systems
• Economics, Behavioral

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2023-06-19
• Primary completion: 2025-10-09
• Completion: 2026-02-28
• First posted: 2023-04-07
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States