Recruiting
Phase 1

Observational Study

Sponsor:

Andrew Tomas Reisner

Code:

NCT06121661

Conditions

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

APPRAISE Trauma Clinical Decision Support System

Study Details

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.

Conditions

Wounds and Injuries

Study ID

NCT06121661

Start date

Feb 21, 2023

Status verified date

May, 2025

Completion date

Dec 14, 2028

Anticipated

Primary completion date

Dec 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: APPRAISE cases

Trauma patients for which APPRAISE system was used

Interventions

APPRAISE Trauma Clinical Decision Support System

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

Primary outcome measure

  • 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). ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Iain Kehoe

6177262241ikehoe@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02460

Contacts

Andrew T Reisner

617-726-2241areisner@mgh.harvard.edu

More Information

Sponsor

Andrew Tomas Reisner

Last update posted

May 8, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Tomas Reisner on 2025-05-08.