APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinician surveys that the software negatively affected patient care
研究概览
简要总结
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:
- Evaluate the robustness of the System (i.e., whether the software performs in real-time in accordance with a priori technical specifications during real-time clinical use);
- Evaluate whether the real-time display of the System causes distraction or confusion to clinicians treating the trauma patient such that its risks exceed its benefits;
- Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Adult (≥18 yrs) Emergency Department (ED) patient
- •Triaged to the "Acute" area of the ED. (The "Acute" area is the designated area for ED patients with potential or established critical illness. Triage to Acute is a routine ED operation that is performed based on departmental guidelines and the professional judgement of an experienced triage nurse).
- •Clinical concern for acute injury (based on either an explicitly chief complaint of acute injury, or clinical team with documented concern for acute injury as a relevant part of patient presentation).
排除标准
- •Prisoners
- •Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound
- •Patients wearing an "EFIC Opt-Out" bracelet
- •Any concern about the suitability of the software system for a specific patient by any clinician involved in the patient's ED care, or by the patient themselves (or by any LAR [lawfully authorized representative] of the patient).
研究组 & 干预措施
APPRAISE cases
Trauma patients for which APPRAISE system was used
干预措施: APPRAISE Trauma Clinical Decision Support System (Device)
结局指标
主要结局
Clinician surveys that the software negatively affected patient care
时间窗: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement
Software session with error messages or critical software errors
时间窗: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).
Each time the software is used ("session"), a log file is generated. We will quantify how many sessions generate error messages or critical software errors.
Clinician surveys that the software positively affected patient care
时间窗: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement
Clinician surveys that ongoing use of the software poses risks that exceeds benefits
时间窗: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits
次要结局
未报告次要终点
研究者
Andrew Tomas Reisner
Principal Investigator; Associate Prof. of Emergency Medicine
Massachusetts General Hospital