Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT06441760
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation Trial of Telemedical Support for Paramedics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D013226', 'term': 'Status Epilepticus'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participants will be blinded to the simulated transport scenarios.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single blind, parallel arm, multicenter simulation RCT of prehospital teams from 9 Pediatric Emergency Care Applied Research Network (PECARN) and non-PECARN sites'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Serious Safety Events', 'timeFrame': 'Post treatment usually 4 hours', 'description': 'Serious safety events are defined as clinical care actions that reach the patient and have the potential to cause moderate-to-severe harm or death. An investigator developed predefined serious safety event checklist developed for each simulated transport scenario will be used to record serious safety events. Serious safety events will be scored as: present, absent, or not observable.'}], 'secondaryOutcomes': [{'measure': 'Composite team score', 'timeFrame': 'Post treatment usually 4 hours', 'description': "The composite team performance score is calculated from the modified Lammer's simulation checklist tool as the percentage of completed actions that can be observed during the simulation by either video review or in person observation. This checklist tool contains 171 items across 3 simulated transport scenarios that represent critical actions expected for optimal care performance."}, {'measure': 'Error in medication choice', 'timeFrame': 'Post treatment usually 4 hours', 'description': "Errors in medication choice are measured by specific items within the modified Lammer's simulation checklist tool. These will be any incorrect type of medication used by a team during simulation, including unanticipated medication choices which raters feel was not indicated or potentially harmful by consensus opinion. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to medication choice."}, {'measure': 'Error in weight-based medication dosing', 'timeFrame': 'Post treatment usually 4 hours', 'description': "These are measured by specific items within modified Lammer's simulation checklist tool. These will be any error in pediatric weight-based dose calculation, including error in volume of administered drug. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to weight-based medication dosing."}, {'measure': 'Equipment size error', 'timeFrame': 'Post treatment usually 4 hours', 'description': "These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error in size of equipment used during each case. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to equipment sizing"}, {'measure': 'EMS protocol error', 'timeFrame': 'Post treatment usually 4 hours', 'description': "These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error observed omission, error, or deviation in offline and online EMS treatment protocols that could result in patient harm. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to selection of appropriate EMS protocols."}, {'measure': 'Equipment Use Error', 'timeFrame': 'Post treatment usually 4 hours', 'description': "These are measured by specific items within the modified Lammer's simulation checklist tool. These will be any error in equipment usage during each case. This will be reported as the proportion or percentage of items scored as incomplete over all possible items related to equipment use."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehospital emergency care', 'Emergency medical services (EMS)', 'Paramedics', 'Infant simulator mannequins', 'Telemedical support', 'Critically ill infants and children', 'Pediatric emergencies'], 'conditions': ['Emergencies', 'Cardiopulmonary Arrest', 'Acute Respiratory Failure', 'Status Epilepticus']}, 'descriptionModule': {'briefSummary': 'In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.\n\nThe purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies.\n\nThe two specific aims for this research are:\n\n* Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups\n* Aim 2: To compare two safety event detection methods, medical record review, and video review'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response.\n* Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible.\n* The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience.\n\nExclusion Criteria:\n\n* EMS personnel providing interfacility transport and/or pediatric specialty transport\n* Resident physicians-in-training\n* Non-physician providers'}, 'identificationModule': {'nctId': 'NCT06441760', 'acronym': 'R01', 'briefTitle': 'Simulation Trial of Telemedical Support for Paramedics', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Efficacy of Teleconsultation to Improve Prehospital Patient Safety for Critically Ill Infants and Children - A Multicenter, Simulation-based Randomized Control Trial', 'orgStudyIdInfo': {'id': 'H-44972'}, 'secondaryIdInfos': [{'id': '1R01HD115574-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD115574-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teleconsultation video arm with PEM physicians', 'description': 'Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians.', 'interventionNames': ['Other: Video teleconsultation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Audio support arm with EM physicians', 'description': 'EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians.', 'interventionNames': ['Other: Audio support']}], 'interventions': [{'name': 'Video teleconsultation', 'type': 'OTHER', 'description': 'Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while PEM physicians will provide medical direction remotely using video to communicate with EMS personnel via tablet devices.', 'armGroupLabels': ['Teleconsultation video arm with PEM physicians']}, {'name': 'Audio support', 'type': 'OTHER', 'description': 'Each team will participate in 4 video-recorded simulated transports in fully equipped ambulances. Each team will provide resuscitative care in 4 simulated high-risk pediatric transports. EMS personnel will provide care in the ambulance while EM physicians will provide medical direction remotely using audio to communicate with EMS personnel via tablet devices.', 'armGroupLabels': ['Audio support arm with EM physicians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kathleen Adelgais, MD', 'role': 'CONTACT', 'email': 'kathleen.adelgais@childrenscolorado.org', 'phone': '303-724-1055'}], 'facility': "Children's Hospital Colorado, University of Colorado Denver Anschutz Medical Campus", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Auerbach, MD', 'role': 'CONTACT', 'email': 'marc.auerbach@yale.edu', 'phone': '203-785-4688'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tehnaz Boyle, MD PhD', 'role': 'CONTACT', 'email': 'tehnaz.boyle@bmc.org', 'phone': '617-414-3682'}], 'facility': 'BostonMedical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bradley Barney, PhD', 'role': 'CONTACT', 'email': 'bradley.barney@hsc.utah.edu', 'phone': '801-581-3655'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Tehnaz Boyle, MD PhD', 'role': 'CONTACT', 'email': 'tehnaz.boyle@bmc.org', 'phone': '617-414-3682'}, {'name': 'Divya Gumudavelly, MPH', 'role': 'CONTACT', 'email': 'divya.gumudavelly@bmc.org', 'phone': '248-787-0876'}], 'overallOfficials': [{'name': 'Tehnaz Boyle, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bosotn Medical Center, Pediatrics Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}