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

Purpose

This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows: 1. 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); 2. 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; 3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.

Condition

  • Wounds and Injuries

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
APPRAISE cases 		Trauma patients for which APPRAISE system was used
  • Device: APPRAISE Trauma Clinical Decision Support System
    Real-time bedside decision-support system for trauma patient management

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02460
Contact:
Andrew T Reisner
617-726-2241
areisner@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Andrew Tomas Reisner

Study Contact

Iain Kehoe
6177262241
ikehoe@mgh.harvard.edu