APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
ConditionWounds and Injuries
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrew Tomas Reisner
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
APPRAISE Trauma Clinical Decision Support System
DeviceReal-time bedside decision-support system for trauma patient management
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: APPRAISE casesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).2
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
Time frame
From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)3
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
Time frame
From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)4
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
Time frame
From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrew Tomas Reisner
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov