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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121661
• Other study ID #: 2022P001136
• Status: Recruiting
• Phase: Phase 1
• Start date: February 21, 2023
• Est. completion date: December 14, 2028

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: Iain Kehoe
• Phone: 6177262241
• Email: ikehoe[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 14, 2028
• Est. primary completion date: December 14, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Wounds and Injuries

Intervention

Device:
• APPRAISE Trauma Clinical Decision Support System
Real-time bedside decision-support system for trauma patient management

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Tomas Reisner

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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)
Primary	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)