Clinical trial NCT06121661: APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Official title: APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Wounds and Injuries
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Software session with error messages or critical software errors
timeFrame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation).
measure: Clinician surveys that the software negatively affected patient care
timeFrame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
measure: Clinician surveys that the software positively affected patient care
timeFrame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
measure: Clinician surveys that ongoing use of the software poses risks that exceeds benefits
timeFrame: From patient arrival in the Emergency Department through enrollment, protocol initiation, and protocol completion (which is typically 30 min after protocol initiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: Andrew Reisner, MD
role: PRINCIPAL_INVESTIGATOR
References: