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NCT Number: NCT06121661

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.

Recruiting

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Key information

Conditions

Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02460, United States

Location status: Recruiting

Location contact

Andrew T Reisner

CONTACT

[email protected]

617-726-2241

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

APPRAISE Trauma Clinical Decision Support System

Device

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

Primary outcomes

  1. Software session with 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).

    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.

  2. Clinician surveys that the software negatively affected patient care

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

    Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement

  3. Clinician surveys that the software positively affected patient care

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

    Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement

  4. Clinician surveys that 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)

    Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits

Study contacts

Contact information is provided by the study sponsor or research team.

Iain Kehoe

CONTACT

[email protected]

6177262241

Sponsors and collaborators

Lead sponsor

Andrew Tomas Reisner

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Nov 8, 2023
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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