Protocol for a Pragmatic, Multicenter, Factorial, Randomized Controlled Trial of Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC Trial) for Emergency Department Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 14,800
- 试验地点
- 1
- 主要终点
- Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle
研究概览
简要总结
The goal of this clinical trial is to study systemic inflammatory response syndrome (SIRS) electronic health record (EHR) alerts for sepsis in the emergency department (ED). The main question it aims to answer is: do nurse alerts, prescribing clinician alerts, or both nurse and prescribing clinician alerts improve time to sepsis treatment for patients in the ED?
Nurses and prescribing clinicians will receive SIRS alerts based on the group to which the patient is randomly assigned. Researchers will compare four groups: no alerts, nurse alerts only, prescribing clinician alerts only, or both nurse and prescribing clinician alerts.
详细描述
SEPTIC is a master protocol for two trials on distinct subpopulations: emergency department (ED) patients and inpatients. This protocol "ID: AAAU1002 - ED" describes the ED subpopulation study while "ID: AAAU1002 - IP" describes the inpatient subpopulation study.
Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving outcomes. International guidelines recommend hospital sepsis screening programs, which are commonly implemented in the electronic health record (EHR) as an interruptive screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care. This study tests interruptive (pop-up) EHR alerts. Epic Systems, the company that produces the EHR, refers to these types of alerts as BestPractice Advisories (BPAs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Care providers will be unblinded in that nurses and clinicians will be aware if they receive an alert for the patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years-old
- •meets SIRS criteria
- •physically located in the emergency department
- •not located in a hospital unit that takes care of pregnant and peri-partum patients
- •not SARS-COV-2 PCR positive in past 7 days
- •does not have an active order for "comfort measures only"
排除标准
- •already having sepsis treatment ordered (if prescribing clinician alert) or collected/completed (if nurse alert)
- •already enrolled in the SEPTIC study (including as an emergency department patient or as an inpatient)
结局指标
主要结局
Percentage of patients treated with Surviving Sepsis Campaign (SSC) hour-1 bundle
时间窗: Up to 3 hours
The primary outcome is whether a patient receives a modified SSC hour-1 bundle within three hours from the time of first SIRS alert. The modified SSC hour-1 bundle includes (1) lactate lab collected, (2) two blood cultures collected, (3) new intravenous antimicrobial administration (from the Centers for Disease Control and Prevention (CDC) Adult Sepsis Event (ASE) list). Patients will be tallied.
次要结局
- Time to blood culture collection(24 hours)
- Time to lactate order(24 hours)
- Time to antibiotic order(24 hours)
- Time to lactate collection(24 hours)
- Percentage of patients transferred to ICU transfer(Up to 90 days)
- Median number of days of hospitalization(Up to 90 days)
- Percentage of patients discharged as deceased or discharged to hospice(Up to 90 days)
- Time to modified SSC hour-1 bundle completion(24 hours)
- Time to blood culture order(24 hours)
- Time to antibiotic treatment(24 hours)
- Number of positive blood cultures(Up to 90 days)
- Sepsis incidence(Up to 90 days)
- Percentage of patients discharged home(Up to 90 days)
- Percentage of patients discharged to rehab(Up to 90 days)
- Percentage inpatient mortality at 90 days(Up to 90 days)
- Adverse antibiotic events(Up to 90 days)
- Percentage of patients discharged to skilled nursing facility(Up to 90 days)
研究者
Jason Adelman
Associate Professor of Medicine
Columbia University