跳至主要内容
临床试验/NCT02933840
NCT02933840撤回不适用

Using a Remote Patient Monitoring Alert System to Improve Care in Geriatric Orthopedic Trauma Patients

Massachusetts General Hospital0 个研究点开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Transfer to the ICU

研究概览

简要总结

The purpose of this study is to determine the efficacy of a remote patient monitoring platform and alert system in reducing adverse events for hospitalized geriatric orthopedic trauma patients.

详细描述

Geriatric orthopedic trauma patients are a particularly vulnerable cohort due to their age and medical complexity. These patients are often admitted to a floor unit with high physician-to-patient and nurse-to-patient ratios, especially during hours of low staffing intensity (eg, nighttime and weekend hours). As a result, during hours of low staffing intensity the potential for acute deterioration with delayed reaction from the care team is significant. The investigators aim to test the efficacy of a remote patient monitoring platform to reduce adverse events in this population during hours of low staffing intensity. The platform is a software called AlertWatch. It takes laboratory and vital sign data that has been reported in the medical record and determines whether it meets a cut-off value that is concerning for patient deterioration. If the value meets that cut-off, it sends a page to a recipient clinician. The investigators will have a physician trained in intensive care receive these alerts and respond to them by evaluating the patient and, in a consultative capacity, assist the primary team, namely the orthopedic surgery service, in taking care of the patient.

Patients will be randomized to intervention and control arms at the outset of their hospitalization. Patients in the intervention arm will receive standard of care monitoring and the primary team responsible for the care of the patient will remain the orthopedic surgery service, however, in addition, the AlertWatch software will be implemented and the intensive care physician will be involved in the patient's care when there is an alert. Patients in the control arm will receive standard of care monitoring and the orthopedic surgery service will be the primary team responsible. The Investigators will measure whether the intervention reduces adverse events in the study population compared with control patients.

All patients will be enrolled consecutively at the time of admission to the hospital. The AlertWatch platform (510(k) FDA clearance K15335) has the ability to automatically detect whether a patient admitted to a bed on the orthopedic surgery service meets inclusion criteria. The platform will automatically randomize patients into the active arm or the control arm of the study. For patients randomized to the active arm, the platform will provide alert monitoring.

The Investigators will also be enrolling intensive care physicians to participate in this study. Physician participation is optional. In advance of the start of the study, they will be provided information regarding the study and an informed consent document.

The AlertWatch platform has the ability to send an alert when it detects abnormalities, particular trends, or combinations of abnormalities or trends. In this study, the Investigators will use specific threshold values to alert for abnormalities and concerning trends in patient data. When an alert is made, it will be sent to the in-house intensive care physician's regular pager. The page will display the data. Orthopedic interns will continue to monitor for patient data in the standard fashion.

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
None

入排标准

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

入选标准

  • Admitted to Massachusetts General Hospital or Brigham and Women's Hospital
  • Admitted to orthopedic trauma surgery service
  • Admitted to a non-ICU bed (patients initially admitted to an ICU and then transferred to the non-ICU bed will be included)

排除标准

  • Admitted to service other than orthopedic trauma surgery

研究组 & 干预措施

AlertWatch

Experimental

Patients will receive standard monitoring and in addition the AlertWatch software will alert the intensive care physician if there is a value that meets criteria for alerting. The care team will be the orthopedic surgery team in addition to the intensive care physician being involved as a consultant if he/she receives an alert.

干预措施: AlertWatch (Device)

No AlertWatch

No Intervention

Patients will receive standard monitoring without the AlertWatch software. The care team will be the orthopedic surgery team without the intensive care physician being involved as a consultant.

结局指标

主要结局

Transfer to the ICU

时间窗: One year

Whether the patient is transferred from a floor unit to the intensive care unit during their hospitalization.

Mortality

时间窗: One year

Whether a patient experiences death during their hospitalization.

Cardiac arrest

时间窗: One year

Whether the patient experiences a cardiac arrest during their hospitalization.

Rapid response team called

时间窗: One year

Whether the a rapid response team is called to assess the patient during their hospitalization.

次要结局

  • Time to improvement of sodium(One year)
  • Time to improvement of potassium(One year)
  • Time to ordering of diuretics, NIPPV, or intubation(One year)
  • Time to ordering to discontinue foley catheter(One year)
  • Time to improvement of blood pressure(One year)
  • Time to improvement of hemoglobin(One year)
  • Time to ordering of appropriate fluids(One year)
  • Time to improvement of heart rate(One year)
  • Time to ordering of blood(One year)
  • Time to ordering of nodal blocking agent(One year)
  • Time to ordering of insulin(One year)
  • Time to improvement of glucose(One year)
  • Time to ordering of fluids or vasopressors(One year)
  • Time to ordering of diuretics or insulin/D50(One year)
  • Time to improvement of oxygen saturation(One year)

研究者

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

Aalok Agarwala

Division Chief of General Surgery Anesthesia, Associate Director of Quality and Safety

Massachusetts General Hospital

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