Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT06121661
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2023-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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).', 'description': '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.'}, {'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)', 'description': 'Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement'}, {'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)', 'description': 'Each time the software is used, clinicians are surveyed whether the software negatively affected patient care, in their professional judgement'}, {'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)', 'description': 'Each time the software is used, clinicians are surveyed whether ongoing use of the software poses risks that exceeds benefits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wounds and Injuries']}, 'descriptionModule': {'briefSummary': 'This is a pilot evaluation of the APPRAISE trauma decision-support software system ("the System"). The specific objections are as follows:\n\n1. 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);\n2. 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;\n3. Collect pilot data to allow for a statistical power analysis to design a future clinical trial evaluating efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18 yrs) Emergency Department (ED) patient\n* 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).\n* 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).\n\nExclusion Criteria:\n\n* Prisoners\n* Patients known to be pregnant, based on patient report, physical exam, or bedside ultrasound\n* Patients wearing an "EFIC Opt-Out" bracelet\n* 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).'}, 'identificationModule': {'nctId': 'NCT06121661', 'briefTitle': 'APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'APPRAISE 2.0: Live Trial of the APPRAISE Trauma Decision Support System', 'orgStudyIdInfo': {'id': '2022P001136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APPRAISE cases', 'description': 'Trauma patients for which APPRAISE system was used', 'interventionNames': ['Device: APPRAISE Trauma Clinical Decision Support System']}], 'interventions': [{'name': 'APPRAISE Trauma Clinical Decision Support System', 'type': 'DEVICE', 'description': 'Real-time bedside decision-support system for trauma patient management', 'armGroupLabels': ['APPRAISE cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02460', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew T Reisner', 'role': 'CONTACT', 'email': 'areisner@mgh.harvard.edu', 'phone': '617-726-2241'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Iain Kehoe', 'role': 'CONTACT', 'email': 'ikehoe@mgh.harvard.edu', 'phone': '6177262241'}], 'overallOfficials': [{'name': 'Andrew Reisner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrew Tomas Reisner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator; Associate Prof. of Emergency Medicine', 'investigatorFullName': 'Andrew Tomas Reisner', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}