Using alerts to increase low dose aspirin recommendations in high-risk pregnancies
Best Practice Alert (BPA) for Low Dose Aspirin Recommendation in High-risk Pregnancies: a Randomized Controlled Trial
This study is testing if a reminder tool for doctors can help them recommend low dose aspirin more often to pregnant women at high risk for preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Sex | Female |
| Sponsor | Geisinger Clinic Academic / other |
| Locations | 1 site (Danville, Pennsylvania) |
| Trial ID | NCT05802940 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of an electronic health record clinical decision support tool, known as a best practice alert, on healthcare providers' recommendations for low dose aspirin in high-risk pregnant patients. The hypothesis is that the implementation of this alert will enhance the rate of aspirin recommendations compared to standard care. The study will involve randomizing up to 704 patients to either receive the alert or not, with the aim of improving adherence to aspirin guidelines for preventing preeclampsia. Providers will be required to document reasons if they choose not to recommend aspirin despite the alert.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals receiving prenatal care at Geisinger who are determined to be high risk for preeclampsia.
Not a fit: Patients who are not pregnant, do not meet the high-risk criteria, or have contraindications to aspirin will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the use of low dose aspirin in high-risk pregnancies, potentially reducing the incidence of preeclampsia.
How similar studies have performed: Previous studies have shown that clinical decision support tools can effectively improve adherence to treatment guidelines, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Danville, Pennsylvania
- Geisinger Medical Center — Danville, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: A. Dhanya Mackeen, MD, MPH — Geisinger Clinic
- Study coordinator: A. Dhanya Mackeen, MD, MPH
- Email: admackeen@geisinger.edu
- Phone: 570-714-1099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.