Low Dose Aspirin Alerts in High-Risk Pregnancies

Sponsor

Geisinger Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05802940

Collaborator

(none)

640

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Aspirin Clinical Decision Support Systems Economics, Behavioral	Behavioral: Electronic health record best practice alert	N/A

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.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

640 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

We will randomize at level of the patient as to whether or not a BPA will fire when the patient is seen in clinic. Any obstetric care provider who sees a patient that has been randomized to BPA group will receive the alert if indicated. If the alert doesn't fire, the care provider will not be aware as to whether the patient is randomized to the BPA group or whether the alert was not indicated. Clinical investigators and outcomes assessors are blinded.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 3, 2023

Anticipated Primary Completion Date :

Oct 3, 2024

Anticipated Study Completion Date :

Apr 3, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Best practice alert (BPA) intervention group 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.	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.
No Intervention: Standard care group Healthcare provider's recommendation for aspirin in patients at high-risk for preeclampsia will be based on current practice (no alerts) and the healthcare provider's knowledge.

Arm

Intervention/Treatment

Active Comparator: Best practice alert (BPA) intervention group

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.

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.

No Intervention: Standard care group

Healthcare provider's recommendation for aspirin in patients at high-risk for preeclampsia will be based on current practice (no alerts) and the healthcare provider's knowledge.

Outcome Measures

Primary Outcome Measures

The healthcare provider recommendation for low dose aspirin use [Assessed between initial prenatal visit and delivery]
yes/no

Secondary Outcome Measures

Patient taking low dose aspirin [Assessed at time of delivery]
yes/no
Rate of preeclampsia [Assessed at time of delivery]
yes/no
Timing of low dose aspirin recommendation [Assessed between initial prenatal visit to delivery]
gestational age, weeks
Timing of low dose aspirin initiation [Assessed between initial prenatal visit to delivery]
gestational age, weeks
Preterm delivery [Assessed at delivery]
yes/no

Other Outcome Measures

Provider response to best practice alert [Assessed between initial prenatal visit to delivery]
recommended, declined, etc.
Complications of preeclampsia [Assessed at delivery]
yes/no
Number of times the best practice alert fired for a patient [Assessed between initial prenatal visit to delivery]
1,2,3,4...

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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
Not meeting the modified USPSTF criteria
Contraindication to aspirin, including allergy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Geisinger Clinic

Investigators

Principal Investigator: A. Dhanya Mackeen, MD, MPH, Geisinger Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Awathif Dhanya Mackeen, MD, MPH, Geisinger Clinic

ClinicalTrials.gov Identifier:

NCT05802940

Other Study ID Numbers:

LDA BPA

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pre-Eclampsia

Study Results

No Results Posted as of Apr 7, 2023