Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
The aim of this study is to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians and evaluate the effectiveness of the cardiac point-of-care ultrasound (POCUS) simulation-based training (CPST) and CPG implementation. By performing this study, the investigators hope to improve diagnostic processes and time-to-diuretic dosing for acute heart failure (AHF) patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners
Disqualifiers
ED nurses and technicians are excluded due to differing ultrasound training needs
Trial design
Design model
Sequential
Treatments tested in this trial
Simulation POCUS training
BehavioralUses adaptive Experience-Based Co-design (EBCD) to co-design a cardiac POCUS simulation training intervention and implementation strategy for EM clinicians. The cardiac POCUS training workshop and reinforcement sessions will be co-designed with ED leadership, ultrasound faculty, and key stakeholders. Participants will then perform cardiac and lung POCUS using standardized clinical practice guidelines (CPG) in AHF patients as part of clinical care.
Clinical Practice Guidelines
BehavioralClinical practice guidelines will instruct clinicians on how to perform POCUS, save the images, complete worksheets on the archiving platform, and signed so that images are saved to the patient's chart and billed.
Treatment groups
175 Participants
are divided into 1 treatment groupGroup A: Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Effectiveness of the simulation-based cardiac POCUS (Point-of-Care Ultrasound) training implementation as measured by time-to-diuretic dose in ED (Emergency Department) heart failure patients
Time-to-diuretics (units in minutes) in patients with a clinical diagnosis of acute heart failure with reduced or preserved ejection fraction.
Time frame
12 months pre and 12 months post-interventionSecondary outcomes
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.
Time frame
up to 6 months post-workshop2
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.
Time frame
up to 6 months post-workshop3
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.
Time frame
up to 6 months post-workshop4
Feasibility of implementing a cardiac point-of-care ultrasound (POCUS) simulation training and clinical practice guidelines for physicians and advanced practice providers (APPs)
Using a modified framework analysis approach, a team of 3-4 trained research assistants and ultrasound faculty led by an implementation science expert will deductively analyze semi-structured interview content based on IRLM constructs and PROCTOR outcomes, with open inductive coding for data that does not fit into the framework. A preliminary rapid qualitative deductive analysis will be performed based on audio recordings and meeting notes applied to the PROCTOR dimensions, to determine scope and saturation. Coding and categorization will be conducted with PROCTOR-templated coding sheets and transferred to NVivo.
Time frame
12 months pre and 12 months post-interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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