APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System

Study Overview
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Brief Summary
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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.

Official Title
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APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: APPRAISE Trauma Clinical Decision Support System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APPRAISE cases<br>Trauma patients for which APPRAISE system was used | Device: APPRAISE Trauma Clinical Decision Support System<br>* Real-time bedside decision-support system for trauma patient management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Software session with error messages or critical software errors | 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. | From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation). | 
| Clinician surveys that the software negatively affected patient care | Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement | From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation) | 
| Clinician surveys that the software positively affected patient care | Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement | From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation) | 
| Clinician surveys that ongoing use of the software poses risks that exceeds benefits | Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits | From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation) |