NCT06121661PHASE1Recruiting
APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Andrew Tomas Reisner
Start Date
2/21/2023
Completion Date
12/14/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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).
Interventions
DEVICE
APPRAISE Trauma Clinical Decision Support System
Conditions
Wounds and Injuries
Locations
Massachusetts General Hospital
Boston, Massachusetts 02460
United States