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临床试验/NCT02830126
NCT02830126已完成不适用

Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 15,158 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15,158
试验地点
1
主要终点
Compliance with recommendations for intraoperative temperature management

研究概览

简要总结

This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs.

详细描述

The study will logically build on our previous work and utilize the already established infrastructure and resources of the intra-operative electronic medical record and the AlertWatch® alerting system. In conceptualizing this pilot study, as well as a larger follow-up trial focused on clinical outcomes, we have been mindful of challenges put forward to investigators by the National Institutes of Health, which seek to support low-cost, pragmatic, patient-centered randomized controlled trials. Specifically in relation to ACTFAST, (1) the highly developed, specialized IT infrastructure limits the investment required for embarking on this study; (2) the study will be conducted entirely within the context of routine clinical care, negating the need for dedicated trial-related visits; (3) access to registries with granular data on complications and patient-reported outcomes obviates the need for a new and costly infrastructure to track patient outcomes; (4) inclusion of large numbers of broadly representative patients in this study will be highly efficient with a waiver of informed consent. The design for this pilot proof-of-concept study will be a randomized clinical effectiveness trial. It will include a 6-month pre-intervention period during which time the ACT will be staffed but no alerts will be sent. This will allow for the training of controllers, refinement of alerts, and optimization of processes for obtaining and filtering information from diverse electronic sources. Following this period, the trial will begin and run for 12 months. On a daily basis during the study period (weekdays from 7am to 5pm), each operating room in Barnes-Jewish Hospital (BJH) will be eligible for randomization, which will occur using computer-generated assignment. Anesthesiology teams in ORs allocated to the experimental arm will receive the additional support of the ACT in the form of control-tower alerts that complement the AlertWatch® system. The outcomes of interest in this pilot study will be the usability and usefulness of the ACT, clinician adherence to recommendations for monitoring, documentation and therapeutic interventions, key physiologic variables such as temperature and blood pressure. We will also document patient outcomes including duration of postoperative hospital stay, incidence of postoperative morbidity (myocardial infarction, surgical site infection), functional recovery, and postoperative quality of life. Data on these endpoints will inform the design of a subsequent trial focused on clinically relevant outcomes, which will logically follow the current pilot randomized trial. All of the alerts included in this study will be chosen because they follow proven best intraoperative management practice and are in line with national metrics for quality and safety.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

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

  • On a daily basis during the study period (weekdays from 7am to 5pm), each operating room of Barnes-Jewish Hospital (BJH) will be eligible for randomization, which will occur at the level of the operating room using computer-generated assignment.

排除标准

  • 未提供

研究组 & 干预措施

Anesthesiology Control Tower Feedback

Experimental

Patients managed by anesthesia teams with feedback alerts from the ACT

干预措施: Anesthesiology Control Tower Feedback (Other)

Anesthesiology Control Tower Control

No Intervention

Patients managed by anesthesia teams without feedback alerts from the ACT

结局指标

主要结局

Compliance with recommendations for intraoperative temperature management

时间窗: 1 day

Proportion of patients with final recorded temperature in OR greater than 36 degrees Celsiustemperature, the target for this outcome was that the ACT intervention will increase the proportion of patients whose final recorded intraoperative temperature is above 36 degrees Celsius from 60% to 95%. For this calculation we assumed a standard deviation of core temperature of 0.9 degrees Celsius for both groups based on an unpublished EMR audit.

Compliance with recommendations for intraoperative blood glucose management

时间窗: 1 day

Proportion of cases with blood glucose \<=180 mg/dL upon arrival to the anesthesia recovery area

Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite

时间窗: 2 years

Usability and usefulness are key features of successful implementation of new information technologies 24,99,100. The success of the proof-of-concept ACT implementation and its perceived usefulness and usability depend on participation and support of the entire anesthetic team. Our usability testing procedure will explore the 5Es (effectiveness, efficiency, engagement, error tolerance, ease of learning) needed to develop a useful and usable resource.

次要结局

  • Antibiotic dosing(1 day)
  • Postoperative delirium(30 days)
  • Surgical site infection(30 days)
  • Ventilator management(1 day)
  • Intraoperative blood pressure management(1 day)
  • Temperature monitoring(1 day)
  • Intraoperative blood glucose management(1 day)
  • Train of four documentation(1 day)
  • Volatile anesthetic utilization(1 day)
  • Postoperative respiratory failure(30 days)
  • 30-day readmission(30 days)
  • Postoperative acute renal failure(30 days)
  • Postoperative atrial fibrillation(30 days)
  • Intraoperative awareness(30 days)
  • 30-day mortality(30 days)

研究者

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

Michael Avidan

Professor of Anesthesiology and Surgery

Washington University School of Medicine

研究点 (1)

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