Duke University Health System
Durham, North Carolina, 27705, United States
Location status: Recruiting
NCT Number: NCT07159269
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1-2 years for each study site
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.
Time frame: 1-2 years for each study site
The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability.
Time frame: 1-2 years for each study site
The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
Time frame: 1-2 years for each study site
The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness.
Time frame: 1-2 years for each study site
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.
Time frame: 1-2 years for each study site
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.
Time frame: 1-2 years for each study site
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).
Time frame: 1-2 years for each study site
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).
Time frame: 1-2 years for each study site
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)
Time frame: 1-2 years for each study site
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).
Time frame: 1-2 years for each study site
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).
Time frame: 1-2 years for each study site
The investigators will collect pre/post-intervention POCUS revenue data for cost-effectiveness (from hospital billing data, units in dollars).
Contact information is provided by the study sponsor or research team.
Abha Singh
CONTACT
Rebecca G Theophanous, MD, MHSc
CONTACT
Duke University
Other
Cardiac Point-of-care Ultrasound Clinical Training Pathway Implementation and Impact Assessment for Advanced Practice Providers in the Emergency Department
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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