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

NCT06121661 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 2022P001136
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:

1. 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. 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. 3.Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

APPRAISE cases

EXPERIMENTAL

Trauma patients for which APPRAISE system was used

Device: APPRAISE Trauma Clinical Decision Support System

Interventions

APPRAISE Trauma Clinical Decision Support System DEVICE

Real-time bedside decision-support system for trauma patient management

APPRAISE cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Andrew Tomas Reisner: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02460, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Andrew Reisner, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iain Kehoe

CONTACT

6177262241; ikehoe@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Associate Prof. of Emergency Medicine

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 8, 2023
• Study Start: February 21, 2023
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): December 14, 2028
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)