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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.