Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT06065761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2023-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 17459}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with serious adverse events', 'timeFrame': '30 days from index ED visit', 'description': 'Serious adverse events include mortality, cardiopulmonary resuscitation (CPR), intubation/ventilation, new end-stage renal disease (ESRD), balloon pump placement, or percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG)'}, {'measure': 'Number of patients with all-cause mortality', 'timeFrame': '30 days from index ED visit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency Department', 'Risk Prediction'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The primary goal is to build and test a previously developed and validated risk model and clinical decision support tool embedded within the electronic health record to improve risk stratification of emergency department (ED) patients with acute heart failure (AHF).', 'detailedDescription': 'The study team will build an electronic health record-embedded clinical decision support tool using a recently developed risk prediction model that curates patient-specific data in real-time, accurately estimates short-term patient risk, and presents tailored clinical recommendations. This will be a regional implementation study in which the tool is turned on at 21 emergency departments (ED) across Kaiser Permanente Northern California (KPNC). The study team will validate risk predictions and study key clinical outcomes as part of this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients presenting to KPNC emergency departments with eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18y) KPNC members treated in the ED for presumed acute heart failure\n\nExclusion Criteria:\n\n* Children (\\<18y).\n* Patients who left against medical advice or eloped prior to ED physician evaluation.'}, 'identificationModule': {'nctId': 'NCT06065761', 'briefTitle': 'Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Improving Risk Stratification of Emergency Department Patients With Acute Heart Failure: Building and Testing a Machine-learning Platform for Personalized, Accurate, Real-time Risk Prediction', 'orgStudyIdInfo': {'id': '1719171'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comprehensive ED heart failure management tool', 'type': 'OTHER', 'description': 'The investigators plan a regional implementation of an electronic health record-based heart failure decision support tool across 21 EDs of Kaiser Permanente Northern California (KPNC).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94531', 'city': 'Antioch', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Antioch Emergency Department', 'geoPoint': {'lat': 38.00492, 'lon': -121.80579}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Fremont Emergency Department', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Fresno Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95337', 'city': 'Manteca', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Manteca Medical Center', 'geoPoint': {'lat': 37.79743, 'lon': -121.21605}}, {'zip': '95356', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Modesto Medical Center', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '94611', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Oakland Emergency Department', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Redwood City Emergency Department', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94801', 'city': 'Richmond', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Richmond Emergency Department', 'geoPoint': {'lat': 37.93576, 'lon': -122.34775}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Roseville Emergency Department', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '95823', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente South Sacramento Emergency Department', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Sacramento Emergency Department', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Francisco Emergency Department', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Jose Emergency Department', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Leandro Emergency Department', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94903', 'city': 'San Rafael', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Rafael Emergency Department', 'geoPoint': {'lat': 37.97353, 'lon': -122.53109}}, {'zip': '95051', 'city': 'Santa Clara', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Santa Clara Emergency Department', 'geoPoint': {'lat': 37.35411, 'lon': -121.95524}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Santa Rosa Emergency Department', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94080', 'city': 'South San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente South San Francisco Emergency Department', 'geoPoint': {'lat': 37.65466, 'lon': -122.40775}}, {'zip': '95688', 'city': 'Vacaville', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Dana R Sax, MD, MPH', 'role': 'CONTACT'}], 'facility': 'Kaiser Permanente Vacaville Medical Center', 'geoPoint': {'lat': 38.35658, 'lon': -121.98774}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Dana R Sax, MD, MPH', 'role': 'CONTACT'}], 'facility': 'Kaiser Permanente Vallejo Medical Center', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Walnut Creek Medical Center', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'centralContacts': [{'name': 'Dana R Sax, MD, MPH', 'role': 'CONTACT', 'email': 'dana.r.sax@kp.org', 'phone': '510-891-3400'}, {'name': 'Adina S Rauchwerger, MPH', 'role': 'CONTACT', 'email': 'adina.s.rauchwerger@kp.org', 'phone': '510-891-3400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}