Wounds and Injuries
Conditions
Brief 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.
Interventions
DEVICEAPPRAISE Trauma Clinical Decision Support System
Real-time bedside decision-support system for trauma patient management
Sponsors
Andrew Tomas Reisner
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Software session with 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). | 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. |
| Clinician surveys that the software negatively affected patient care | From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation) | Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement |
| Clinician surveys that the software positively affected patient care | From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation) | Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement |
| Clinician surveys that 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) | Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits |
Countries
United States
Contacts
Primary ContactIain Kehoe
Outcome results
None listed