A Multicenter, Stepped Wedge, Cluster Randomized Study of a Prehospital Sepsis Protocol and Its Impact on Timely Antibiotic Administration in the Emergency Department and Subsequent Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 984
- 试验地点
- 4
- 主要终点
- Time to First Antibiotic Administration in the ED
研究概览
简要总结
The primary purpose of this study is to evaluate the impact of an Emergency Medical Services (EMS) based sepsis screening and early warning protocol on the timing of early sepsis care in the Emergency Department (ED).
详细描述
Sepsis is life-threatening medical emergency and a common cause of morbidity and mortality among hospitalized patients. Recognizing and treating sepsis immediately is key to achieving optimal patient outcomes after sepsis. The prehospital, EMS setting represents a unique opportunity to implement best practice by operationalizing guideline-recommended, system-wide sepsis screening protocols in an effort to facilitate earlier recognition of sepsis and minimize delays in evaluation and treatment. Unfortunately, evidence-based screening tools to assist EMS providers in recognizing this heterogenous syndrome are lacking, and recognition by EMS providers is generally poor.
The purpose of this study is to evaluate the prehospital sepsis (PRESS) protocol, which is an evidence-based sepsis screening and early communication protocol designed for use in the prehospital, EMS environment. The PRESS protocol pairs a validated sepsis screening tool with a prehospital sepsis alert to the receiving ED for patients who are screen positive. This innovative approach has been used to improve patient care and outcomes in other life-threatening, time-sensitive medical emergencies including heart attack and stroke. Prehospital screening and an early warning call to the ED before patient arrival provides valuable lead time that makes immediate evaluation and treatment by EMS providers possible once a patient arrives in the ED.
This study includes three study sites which are each comprised of cluster pairs of one EMS organization and one partnered acute care hospital. Each cluster pair will participate in both a baseline and intervention phase of study. EMS providers will be trained to screen for sepsis according to the PRESS protocol. The PRESS EMS protocol includes 2 major components: 1) an evidence-based sepsis screening tool, and 2) a prehospital sepsis alert call to the receiving hospital for participants who screen positive. Upon arrival to the ED, ED providers will provide immediate medical assessment to the patient to determine whether there is concern for sepsis. The overarching hypothesis is that implementation of an EMS-based sepsis screening and early warning protocol will be associated with a reduction in time first antibiotic administration in the ED among patients with sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Lowest EMS systolic blood pressure <110 mmHg
- •Highest EMS pulse rate >90 beats per minute
- •Highest EMS respiratory rate >20 breaths per minute
- •EMS transport to a participating study ED/hospital
- •At least one of the following present:
- •Lowest systolic blood pressure <90 mmHg
- •Age 40 years or greater
- •Hot temperature assessment or temp >38 degrees Celsius
- •Oxygen saturation <90%
- •Nursing home patient
- •Emergency Medical Dispatch classification = 'sick person'
排除标准
- •Any of the following EMS conditions present:
- •Trauma injury
- •Cardiac arrest
- •Psychiatric emergency
- •Toxic ingestion
- •Pregnant patient
- •Inability to administratively link EMS and ED/hospital records
- •Patient left emergency department prior to being evaluated by a medical provider (inability to classify sepsis status)
研究组 & 干预措施
PRESS Intervention
Study sites will participate in the intervention phase for 6 to 18 months, depending on the order of cluster randomization. Sites will switch from the baseline phase in approximately 6 month blocks, with all sites delivering the intervention for the final 6 months of the study.
干预措施: PRESS Intervention (Behavioral)
Standard of Care
Study sites will participate in the standard of care phase to collect baseline data for 6 to 18 months, depending on the order of cluster randomization. All sites are in the baseline phase for the first 6 months then sites will switch one at a time, every 6 months, to the intervention phase of the study.
结局指标
主要结局
Time to First Antibiotic Administration in the ED
时间窗: During ED stay on Day 1
Among eligible EMS patients with sepsis, the time from ED arrival to first antibiotic administration (parenteral only) in the ED will be examined. Time will be censored at the time of hospital admission or ED discharge.
次要结局
- Time to Sepsis Bundle from ED Arrival(During ED stay on Day 1)
- In-hospital Death(During hospital stay (up to 20 days, on average))
- EMS Documentation of a Prehospital Sepsis Alert(During ED stay on Day 1)
- Proportion of Patients Admitted to the ICU(During hospital stay (up to 20 days, on average))
- Hospital Length of Stay(During hospital stay (up to 20 days, on average))
- Proportion of Patients Without Sepsis Receiving Antibiotics in the ED(During ED stay on Day 1)
- Antibiotic Days of Therapy(Up to 10 days (on average))
- EMS Documentation of Sepsis(During ED stay on Day 1)
- Time to First Care Provider Documentation(During ED stay on Day 1)
研究者
Carmen Polito
Assistant Professor
Emory University