Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT07159269
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac point-of Care Ultrasound Training Pathway for Emergency Department Advanced Practice Providers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D002305', 'term': 'Cardiac Tamponade'}, {'id': 'D010490', 'term': 'Pericardial Effusion'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019091', 'term': 'Critical Pathways'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aim 1: Assess the feasibility of implementing a just-in-time cardiac point-of-care ultrasound (POCUS) clinical training pathway for advanced practice providers (APPs) using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.', 'timeFrame': '1-2 years for each study site', 'description': 'Participants will complete a cardiac POCUS simulation session and a hands-on structured clinical skill exam post-training (OSCE) led by ultrasound-trained faculty. Then as part of standard clinical care, APPs will perform POCUS while supervised by EM attending physicians. The primary outcome assesses program feasibility and acceptability. Participants will complete a pre/post and 6-month post-survey and semi-structured interview. Survey questions are structured based on the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) survey tool. This is scored on a Likert scale from 1-5.'}, {'measure': 'Aim 1: Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)', 'timeFrame': '1-2 years for each study site', 'description': 'The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability.'}, {'measure': 'Aim 1: Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM)', 'timeFrame': '1-2 years for each study site', 'description': 'The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.'}, {'measure': 'Aim 1: Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool', 'timeFrame': '1-2 years for each study site', 'description': 'The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.'}], 'secondaryOutcomes': [{'measure': 'Aim 1: Feasibility of implementing a just-in-time cardiac point-of-care ultrasound (POCUS) clinical training pathway for advanced practice providers (APPs) using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework.', 'timeFrame': '1-2 years for each study site', 'description': 'Using a modified framework analysis approach, a team of 3-4 trained research assistants and the two emergency ultrasound fellows led by an implementation science expert will deductively analyze semi-structured interview content based on RE-AIM constructs with open inductive coding for data that does not fit into the framework. The investigators will perform a preliminary rapid qualitative deductive analysis based on audio recordings and meeting notes applied to the RE-AIM dimensions, to determine scope and saturation. Coding and categorization will be conducted with RE-AIM templated coding sheets and transferred to NVivo.'}, {'measure': 'Aim 2: Educational impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance', 'timeFrame': '1-2 years for each study site', 'description': 'Participants will complete a pre-, post-, and 6-month post-training knowledge assessment and technical skill test to assess the educational impact of the cardiac POCUS program, structured using the Ultrasound Competency Assessment Tool (UCAT), which is scored on a Likert scale from 1-5, where a higher score indicates greater competency.'}, {'measure': 'Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - number of clinical POCUSs performed', 'timeFrame': '1-2 years for each study site', 'description': 'To assess the advanced practice provider (APP) training program effectiveness, the investigators will collect pre/post-health record data on the number of clinical POCUS performed in the emergency department pre/post-intervention (from the Butterfly ultrasound archiving system, units in counts/percentages).'}, {'measure': 'Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - image quality', 'timeFrame': '1-2 years for each study site', 'description': 'To assess APP training program effectiveness, the investigators will collect pre/post-health record data on image quality review scores (determine by two ultrasound experts, Likert scale 1-5, where a higher score indicates greater quality).'}, {'measure': 'Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - diagnostic accuracy', 'timeFrame': '1-2 years for each study site', 'description': 'The investigators will collect data on diagnostic accuracy as compared to radiology studies (from ultrasound expert review, True Positive, True Negative, False Positive, False Negative, or Technically-limited study)'}, {'measure': 'Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - time to initial cardiology consult', 'timeFrame': '1-2 years for each study site', 'description': 'The investigators will collect electronic health record data on pre/post-intervention time to initial cardiology consult (both from the Epic electronic health record, units in hours).'}, {'measure': 'Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - emergency department length-of-stay', 'timeFrame': '1-2 years for each study site', 'description': 'The investigators will collect electronic health record data on pre/post-intervention ED length-of-stay (from the Epic electronic health record, units in hours).'}, {'measure': 'Aim 2: Impact of the training model on cost-effectiveness', 'timeFrame': '1-2 years for each study site', 'description': 'The investigators will collect pre/post-intervention POCUS revenue data for cost-effectiveness (from hospital billing data, units in dollars).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['point of care ultrasound', 'focused cardiac ultrasound', 'advanced practice provider training', 'medical education', 'implementation science'], 'conditions': ['Cardiovascular Disease Acute', 'Emergency Department Patient', 'Heart Failure Acute', 'Pulmonary Embolism (Diagnosis)', 'Point of Care Ultrasound (POCUS)', 'Cardiac Tamponade', 'Pericardial Effusion', 'Diagnostic Imaging', 'Medical Training', 'Implementation Science']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess emergency medicine physician and advanced practice provider (APP) knowledge and technical skill in performance of a point-of-care ultrasound simulation and just-in-time training pathway to determine the feasibility, acceptability, and usability of the ultrasound training program. By performing this study, we hope to create a standardized training model which could potentially facilitate point-of-care ultrasound (POCUS) clinical performance and thereby improve patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced practice providers (APPs) currently working in our ED, with additional APPs as they are hired (expected to be about 75 APPs total within the next 3 years due to expanding staffing needs and coverage models).\n\nExclusion Criteria:\n\n* non-APPs such as physicians, nurses, or other clinical staff'}, 'identificationModule': {'nctId': 'NCT07159269', 'briefTitle': 'Cardiac point-of Care Ultrasound Training Pathway for Emergency Department Advanced Practice Providers', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Cardiac Point-of-care Ultrasound Clinical Training Pathway Implementation and Impact Assessment for Advanced Practice Providers in the Emergency Department', 'orgStudyIdInfo': {'id': 'Pro00118464'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Advanced Practice Provider (APP) Cohort', 'description': 'Advanced Practice Providers (APPs) are nonphysicians essential to the emergency department workforce, especially in rural and community hospitals.', 'interventionNames': ['Behavioral: Cardiac point-of-care ultrasound (POCUS) training and clinical pathway']}], 'interventions': [{'name': 'Cardiac point-of-care ultrasound (POCUS) training and clinical pathway', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a cardiac POCUS simulation session and a hands-on observed structured clinical skill exam (OSCE) post-training led by ultrasound-trained faculty. Then as part of standard clinical care, advanced practice providers (APPs) will perform POCUS while supervised by emergency medicine (EM) attending physicians. To assess program feasibility and acceptability, participants will complete a pre/post and 6-month post-survey and semi-structured interview, as well as a knowledge and technical skills assessment.', 'armGroupLabels': ['Advanced Practice Provider (APP) Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca G Theophanous, MD, MHSc', 'role': 'CONTACT', 'email': 'rebecca.theophanous@duke.edu', 'phone': '919-681-0196'}], 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Rebecca G Theophanous, MD, MHSc', 'role': 'CONTACT', 'email': 'rebecca.theophanous@duke.edu', 'phone': '919-681-0196'}, {'name': 'Abha Singh', 'role': 'CONTACT', 'email': 'abha.singh@duke.edu', 'phone': '919-668-8700'}], 'overallOfficials': [{'name': 'Rebecca G Theophanous, MD, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}