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临床试验/NCT05625464
NCT05625464已完成不适用

Effect of Automated Real-time Feedback on Early Sepsis Care

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 3,269 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,269
试验地点
2
主要终点
3-hour sepsis bundle order compliance

研究概览

简要总结

Sepsis is the leading cause of death among US hospitals, accounting for 6% of all hospitalizations and 35% of all inpatient deaths. International guidelines and the CMS SEP-1 bundle stress the importance of adhering to specific steps in the diagnosis and management of sepsis. This can be very difficult, especially in the setting of a busy ED, ward, or ICU where there are multiple simultaneous demands on providers' attention and time. Critical steps can be missed or delayed. The CMS SEP-1 bundle is a measure of compliance with sepsis care that is being tracked nationally across hospitals.

Unfortunately, a recent study demonstrated that every hour of delay to the completion of a sepsis bundle, including antibiotic administration, was associated with a 4% increase in risk-adjusted hospital mortality.

One strategy to improve the care and outcomes of patients with sepsis is the use of information technology to support our providers in a targeted manner. Technology has already been developed and deployed to help with the early identification of patients with sepsis using a Best Practice Alert (BPA), which has been in place at our hospital since 2017. This pop-up window alerts the team to the possibility of sepsis based on data within the medical record. However, once the alert is accepted or declined, the BPA does not offer ongoing support to clinicians, leaving the clinician to track and execute multiple time-based and inter-dependent sepsis bundle measures in a busy, hectic environment. To augment this existing tool, here we propose to study the efficacy of a novel technology called the Sepsis Care Tracking Platform (SCTP) to provide ongoing support at the bedside to providers, thus improving the care we deliver to patients.

SCTP is a monitoring and notification platform that aims to increase the timely delivery of key elements of evidence-based sepsis care. This platform, which was built by clinicians for clinicians, leverages the electronic medical record (EMR) to track real-time compliance with key components of the CMS SEP-1 bundle - timely antibiotics, blood cultures prior to antibiotics, initial lactate, and repeat lactate for those patients with an initially elevated level. SCTP underwent technical validation in Fall 2019 with a pilot in the MGH Emergency Department. The pilot confirmed that SCTP correctly identified missing bundle elements and paged the appropriate team members connected with the patient's care. The pilot also did not find alarm fatigue to be an issue. We hypothesize that SCTP will increase our hospital's compliance with sepsis process metrics and improve patient outcomes.

By monitoring real-time data and automatically alerting bedside providers to missing elements within an actionable timeframe, SCTP has the potential to drive improvements in clinical care even in the extremely busy and complex environment of the emergency department and inpatient units.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 years old and over
  • Who triggered a sepsis best practice advisory that was subsequently acknowledged by a treating clinician as "yes, sepsis possible"

排除标准

  • Transfer from an outside hospital
  • Sepsis best practice advisory triggered while the patient is in an intensive care unit
  • Sepsis best practice advisory triggered while the patient is in a perioperative care area

结局指标

主要结局

3-hour sepsis bundle order compliance

时间窗: Within 3 hours of sepsis BPA trigger (time zero)

Overall 3-hour bundle ordering compliance, defined as orders for all 3-hour bundle measures monitored by the study platform completed within the bundle time limits - i.e., orders for antibiotics, blood cultures, and lactate measurement measured from the electronic medical record at the end of the study period

次要结局

  • Repeat lactate delivery compliance(within 6 hours of time-zero and within 3 hours of initial lactate measurement)
  • Hospital length of stay(Through day 28 after time zero)
  • 3-hour sepsis bundle care delivery compliance(Within 3 hours of sepsis BPA trigger (time zero))
  • Antibiotic delivery compliance(within 3 hours of timezero)
  • Mortality by Day 28(Within 28 days of time zero)
  • Early intensive care unit admission(within 72 hours of time-zero)
  • Mechanical ventilation during hospitalization(within 28 days of time-zero)
  • Early antibiotic discontinuation(at least 24 hours by 48 hours post-time-zero)
  • Antibiotic order compliance(within 3 hours of timezero)
  • Initial lactate delivery compliance(within 3 hours of time-zero)
  • Early mechanical ventilation(within 72 hours of time-zero)
  • Blood culture order compliance(within 3 hours of time-zero)
  • Initial lactate order compliance(within 3 hours of time-zero)
  • Repeat lactate order compliance(placed within 6 hours of time-zero and within 3 hours of initial lactate measurement)
  • Blood culture delivery compliance(within 3 hours of timezero and prior to antibiotic administration)
  • Any culture positivity(24 hours before or 7 days after time zero)
  • Blood culture positivity(24 hours before or 7 days after time zero)
  • Non-blood culture positivity(24 hours before or 7 days after time zero)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyan Safavi

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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