[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07159269":3,"trial-entities:NCT07159269":126,"trial-summary:NCT07159269":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":29,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":39,"interventions":42,"primary_outcomes":49,"secondary_outcomes":63,"sex":88,"minimum_age":89,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":90,"std_ages":96,"locations":99,"central_contacts":115,"overall_officials":121,"references":124,"see_also_links":125},"NCT07159269","Pro00118464","Cardiac point-of Care Ultrasound Training Pathway for Emergency Department Advanced Practice Providers","Cardiac Point-of-care Ultrasound Clinical Training Pathway Implementation and Impact Assessment for Advanced Practice Providers in the Emergency Department","RECRUITING","2030-06-30","2026-06","2026-06-03","2025-11-13","Duke University","OTHER",true,"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.",null,[19,20,21,22,23,24,25,26,27,28],"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",[30,31,32,33,34],"point of care ultrasound","focused cardiac ultrasound","advanced practice provider training","medical education","implementation science","INTERVENTIONAL","DIAGNOSTIC",[38],"NA",{"count":40,"type":41},75,"ESTIMATED",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47},"BEHAVIORAL","Cardiac point-of-care ultrasound (POCUS) training and clinical pathway","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\u002Fpost and 6-month post-survey and semi-structured interview, as well as a knowledge and technical skills assessment.",[48],"Advanced Practice Provider (APP) Cohort",[50,54,57,60],{"measure":51,"description":52,"timeFrame":53},"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.","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\u002Fpost 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.","1-2 years for each study site",{"measure":55,"description":56,"timeFrame":53},"Aim 1: Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM)","The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability.",{"measure":58,"description":59,"timeFrame":53},"Aim 1: Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM)","The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.",{"measure":61,"description":62,"timeFrame":53},"Aim 1: Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool","The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.",[64,67,70,73,76,79,82,85],{"measure":65,"description":66,"timeFrame":53},"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.","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":68,"description":69,"timeFrame":53},"Aim 2: Educational impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance","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":71,"description":72,"timeFrame":53},"Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - number of clinical POCUSs performed","To assess the advanced practice provider (APP) training program effectiveness, the investigators will collect pre\u002Fpost-health record data on the number of clinical POCUS performed in the emergency department pre\u002Fpost-intervention (from the Butterfly ultrasound archiving system, units in counts\u002Fpercentages).",{"measure":74,"description":75,"timeFrame":53},"Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - image quality","To assess APP training program effectiveness, the investigators will collect pre\u002Fpost-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":77,"description":78,"timeFrame":53},"Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - diagnostic accuracy","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":80,"description":81,"timeFrame":53},"Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - time to initial cardiology consult","The investigators will collect electronic health record data on pre\u002Fpost-intervention time to initial cardiology consult (both from the Epic electronic health record, units in hours).",{"measure":83,"description":84,"timeFrame":53},"Aim 2: Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance - emergency department length-of-stay","The investigators will collect electronic health record data on pre\u002Fpost-intervention ED length-of-stay (from the Epic electronic health record, units in hours).",{"measure":86,"description":87,"timeFrame":53},"Aim 2: Impact of the training model on cost-effectiveness","The investigators will collect pre\u002Fpost-intervention POCUS revenue data for cost-effectiveness (from hospital billing data, units in dollars).","ALL","18 Years",{"inclusion":91,"exclusion":93,"raw_text":95},[92],"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).",[94],"non-APPs such as physicians, nurses, or other clinical staff","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",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":112},"Duke University Health System","Durham","North Carolina","27705","United States",[107],{"name":108,"role":109,"phone":110,"email":111},"Rebecca G Theophanous, MD, MHSc","CONTACT","919-681-0196","rebecca.theophanous@duke.edu",{"lat":113,"lon":114},35.99403,-78.89862,[116,117],{"name":108,"role":109,"phone":110,"email":111},{"name":118,"role":109,"phone":119,"email":120},"Abha Singh","919-668-8700","abha.singh@duke.edu",[122],{"name":108,"affiliation":13,"role":123},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":127,"biomarkers":131},[24,128,129,25,130],"Cardiovascular Disorder","Heart Failure","Pulmonary Embolism",[],{"nct_id":4,"found":15,"summary":133,"prompt_version":17},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This interventional study plans to enroll about 75 advanced practice providers (APPs). It is designed to assess the feasibility, acceptability, and appropriateness of a training pathway.","completed","Cardiac POCUS Training for Emergency Department APPs","This study is testing a training program for advanced practice providers (APPs) in the Emergency Department on how to use cardiac point-of-care ultrasound (POCUS). POCUS is a type of ultrasound done at the patient's bedside to quickly check the heart. The goal is to see if this training program is practical, acceptable, and easy to use for APPs. Participants will complete a POCUS simulation and a hands-on exam after training, then perform POCUS on patients under supervision as part of their regular work. This study aims to improve patient care by creating a standard training model for APPs. About 75 APPs working in the Emergency Department are expected to join this study.","The feasibility, acceptability, and appropriateness of the intervention will be measured at 1-2 years for each study site.",112,"Participants will complete a cardiac POCUS simulation session and a hands-on observed clinical skill exam after training. They will then perform POCUS on patients as part of standard clinical care, supervised by emergency department faculty.","Not stated in the trial record.",[]]