APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Study Details
Study Description
Brief Summary
This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the
System"). The specific objections are as follows:
-
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);
-
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;
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Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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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
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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).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Andrew Tomas Reisner
Investigators
- Principal Investigator: Andrew Reisner, MD, Mass. General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022P001136