Low Dose Aspirin Alerts in High-Risk Pregnancies

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802940
• Other study ID #: LDA BPA
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: June 19, 2025

Study information

• Verified date: January 2024
• Source: Geisinger Clinic
• Contact: A. Dhanya Mackeen, MD, MPH
• Phone: 570-714-1099
• Email: admackeen[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: June 19, 2025
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aspirin
• Clinical Decision Support Systems
• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient taking low dose aspirin	yes/no	Assessed at time of delivery (>/= 28 weeks)
Other	Rate of preeclampsia	yes/no	Assessed at time of delivery
Other	Timing of low dose aspirin recommendation	gestational age (weeks)	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Other	Timing of low dose aspirin initiation	gestational age (weeks)	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Other	Preterm delivery	yes/no	Assessed at delivery
Other	Provider response to best practice alert	recommended, declined, etc.	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Other	Number of times the best practice alert fired for a patient	1,2,3,4...	Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Primary	A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks	yes/no	Assessed between initial prenatal visit and delivery after 28 weeks
Secondary	The healthcare provider recommendation for low dose aspirin use in all randomized patients	yes/no	Assessed between initial prenatal visit and delivery