Best Practice Alert (BPA) for Low Dose Aspirin Recommendation in High-risk Pregnancies: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 830
- 试验地点
- 1
- 主要终点
- A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Electronic health record best practice alert (Behavioral)
结局指标
主要结局
A sensitivity analysis of the healthcare provider recommendation for low dose aspirin use in patients, specifically those who deliver after 28 weeks
时间窗: Assessed between initial prenatal visit and delivery after 28 weeks
yes/no
次要结局
- The healthcare provider recommendation for low dose aspirin use in all randomized patients(Assessed between initial prenatal visit and delivery)