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

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.

Study Overview

• Status: Recruiting
• Conditions: Wounds and Injuries
• Intervention / Treatment: Device: APPRAISE Trauma Clinical Decision Support System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Iain Kehoe; Phone Number: 6177262241; Email: ikehoe@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02460
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Andrew T Reisner; Phone Number: 617-726-2241; Email: areisner@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).
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	From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
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	From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
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	From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)

Collaborators and Investigators

• Sponsor: Andrew Tomas Reisner
• Investigators: Principal Investigator: Andrew Reisner, MD, Mass. General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): December 14, 2028

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2022P001136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes