Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05802940
Other study ID # LDA BPA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03510286 - Validation of a PrCr Dipstick Diagnostic Test in Ghana
Recruiting NCT03313024 - Berlin-Brandenburg Pregnancy Cohort
Active, not recruiting NCT04990141 - Molecular Screening Method for Preeclampsia (PREMOM)
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT05999851 - Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy N/A
Recruiting NCT02923206 - Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis N/A
Terminated NCT02558023 - The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine Phase 3
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Withdrawn NCT05016440 - Lisinopril for Renal Protection in Postpartum Preeclamptic Women N/A
Completed NCT02554604 - Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
Completed NCT02854501 - Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Not yet recruiting NCT02541110 - Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler N/A
Recruiting NCT02337049 - Preeclampsia Subtypes and Surrogate Markers of CVD Risk N/A
Recruiting NCT02247297 - Pancreatic Stone Protein (PSP) in Pregnant Women
Completed NCT02238704 - Cornell University-Micronutrient Initiative Calcium Supplementation Study N/A
Completed NCT01195441 - Prediction and Prevention of Preeclampsia by First Trimester Ultrasound N/A
Withdrawn NCT01179542 - The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR N/A
Completed NCT00456118 - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Recruiting NCT00117546 - Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia Phase 4
Completed NCT00787241 - Platelet Count Trends in Pre-eclamptic Parturients N/A