APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System

Phase 1

Recruiting

• Conditions: Wounds and Injuries

• Registration Number: NCT06121661
• Lead Sponsor: Andrew Tomas Reisner

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-21
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2027-12-14
• Study Completion: 2028-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States