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

Phase 1RecruitingNCT06121661

Andrew Tomas Reisner20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Wounds and Injuries

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts