APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
NCT ID: NCT06121661
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2023-02-21
2028-12-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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APPRAISE cases
Trauma patients for which APPRAISE system was used
APPRAISE Trauma Clinical Decision Support System
Real-time bedside decision-support system for trauma patient management
Interventions
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APPRAISE Trauma Clinical Decision Support System
Real-time bedside decision-support system for trauma patient management
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Andrew Tomas Reisner
OTHER
Responsible Party
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Andrew Tomas Reisner
Principal Investigator; Associate Prof. of Emergency Medicine
Principal Investigators
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Andrew Reisner, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022P001136
Identifier Type: -
Identifier Source: org_study_id
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