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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Andrew Tomas Reisner
Study ID
NCT06121661
Phase
PHASE1
Status
Recruiting
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Conditions

  • Wounds and Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 21, 2023
Status verified
May 2025
Primary completion
Dec 14, 2027
Completion
Dec 14, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: APPRAISE cases
    Trauma patients for which APPRAISE system was used

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02460
Andrew T Reisner
[email protected]
617-726-2241

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By research site
Massachusetts General Hospital· Boston, MA

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