Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-30 @ 3:49 AM
Study NCT ID:
NCT06312332
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004636', 'term': 'Emergency Service, Hospital'}], 'ancestors': [{'id': 'D006748', 'term': 'Hospital Departments'}, {'id': 'D006739', 'term': 'Hospital Administration'}, {'id': 'D058016', 'term': 'Health Facility Administration'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D004632', 'term': 'Emergency Medical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'cluster-randomized stepped-wedge design with two or more sites assigned at each of four steps'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in proportion of patients discharged home from Emergency Department (ED)', 'timeFrame': '3 months Pre-intervention, Up to 18 months Post-intervention', 'description': 'Reported by participating center indicating the proportion of patients discharged home from ED'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency Department'], 'conditions': ['Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '40176133', 'type': 'DERIVED', 'citation': 'Smith SN, Greineder CF, Errickson J, Burns J, Seagull FJ, Kocher KE, Kline JA, Kullgren JT, Lanham MSM, Krein SL, Barnes GD. A stepped wedge cluster randomized implementation trial to increase outpatient management of low-risk pulmonary embolism from the emergency department - the MEDIC ALERT PE study. Implement Sci Commun. 2025 Apr 2;6(1):33. doi: 10.1186/s43058-025-00720-1.'}]}, 'descriptionModule': {'briefSummary': 'This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.', 'detailedDescription': 'The study team anticipates that there will be 5800 acute PE patients over multiple sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in MEDIC collaborative\n* Identified site physician champion\n* Annual volume of acute PE ≥80 (measured in 2022)\n\nExclusion Criteria:\n\n* Pediatric-only hospital/ED\n* No site physician champion identified\n* Annual volume of acute PE \\<80 (measured in 2022)\n* Existing formal clinical pathway for outpatient management of low-risk PE'}, 'identificationModule': {'nctId': 'NCT06312332', 'briefTitle': 'Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Michigan Emergency Department Improvement Collaborative (MEDIC) AltERnaTives to Admission for Pulmonary Embolism', 'orgStudyIdInfo': {'id': 'HUM00220089'}, 'secondaryIdInfos': [{'id': '1R01HL163438-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL163438-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDIC site', 'interventionNames': ['Behavioral: Pulmonary Embolism (PE) Care in Emergency Department (ED)']}], 'interventions': [{'name': 'Pulmonary Embolism (PE) Care in Emergency Department (ED)', 'type': 'BEHAVIORAL', 'description': 'Utilize implementation mapping to facilitate intervention development and evaluation that can be disseminated broadly in diverse settings. Intervention to include a structured education program for clinicians on home management of patients with low-risk PE led by regional/national leaders, the development of Clinician pre-commitment, point-of-care nudge including a clinical guideline integrated into an electronic health record clinical decision support, facilitated medication access, and dedicated outpatient rapid-follow up.', 'armGroupLabels': ['MEDIC site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Emergency Department Improvement Collaborative partners', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Geoff Barnes', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Geoffrey Barnes', 'investigatorAffiliation': 'University of Michigan'}}}}