Clinical trial NCT05802940: Low Dose Aspirin Alerts in High-Risk Pregnancies
Official title: Best Practice Alert (BPA) for Low Dose Aspirin Recommendation in High-risk Pregnancies: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preeclampsia
Aspirin
Clinical Decision Support Systems
Economics, Behavioral
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 640
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks
timeFrame: Assessed between initial prenatal visit and delivery after 28 weeks
Secondary outcomes:
measure: The healthcare provider recommendation for low dose aspirin use in all randomized patients
timeFrame: Assessed between initial prenatal visit and delivery
Other outcomes:
measure: Patient taking low dose aspirin
timeFrame: Assessed at time of delivery (>/= 28 weeks)
measure: Rate of preeclampsia
timeFrame: Assessed at time of delivery
measure: Timing of low dose aspirin recommendation
timeFrame: Assessed between initial prenatal visit to delivery (>/= 28 weeks)
measure: Timing of low dose aspirin initiation
timeFrame: Assessed between initial prenatal visit to delivery (>/= 28 weeks)
measure: Preterm delivery
timeFrame: Assessed at delivery
measure: Provider response to best practice alert
timeFrame: Assessed between initial prenatal visit to delivery (>/= 28 weeks)
measure: Number of times the best practice alert fired for a patient
timeFrame: Assessed between initial prenatal visit to delivery (>/= 28 weeks)
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: A. Dhanya Mackeen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: ACOG Committee Opinion No. 743: Low-Dose Aspirin Use During Pregnancy. Obstet Gynecol. 2018 Jul;132(1):e44-e52. doi: 10.1097/AOG.0000000000002708.