Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Simulation POCUS training, Clinical Practice Guidelines.
- Who it may be relevant to
- Registry conditions: Heart Failure Acute, Point-of-care Ultrasound, Simulation Training, Implementation Science. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Co-design and Implementation of a Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
Overview
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.
Detailed description
Cardiac disease is the leading cause of mortality worldwide, with over 6.7 million Americans with acute heart failure (AHF) presenting with 1 million annual emergency department (ED) visits. Point-of-care ultrasound (POCUS) is a critical bedside tool that can expedite diagnosis and treatment in AHF patients. However, gaps in POCUS training remain that limit clinical utilization. Simulation-based training reinforces technical skills for clinical application. Prior work achieved high procedural knowledge (70% passed, 18% SD) and technical skills (95%, 6% SD) in emergency medicine (EM) clinicians using a simulation nerve block model, with retention at 3-months post-intervention. The current proposed study builds on this work, using the Implementation Research Longitudinal Framework (IRLM) to translate knowledge into clinical skills through simulation-based POCUS training for EM physicians and Advanced Practice Providers (APPs) to improve time-to-diuretics and AHF patient clinical outcomes. Specific Aim 1 uses 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. Specific Aim 2 is the intervention assessment. We will assess pre-, post, and 6-month post-simulation participant POCUS skills using validated ultrasound self-efficacy scales, image interpretation tests (knowledge), and simulated scenario performance (technical skills). Specific Aim 3 evaluates the effectiveness of the cardiac POCUS simulation-based training and clinical practice guideline implementation. The investigators will perform a quasi-experimental pre-/post design by interrupted time series with one year of data before and after intervention implementation. We will perform a quasi-experimental pre-/post design interrupted time series with one year of data before and after intervention implementation in three diverse EDs. Our primary clinical outcome is time-to-diuretic dose in ED heart failure patients.11 PROCTOR-guided outcomes include effectiveness, provider adoption, and clinical POCUS uptake/utilization.
Interventions
- Behavioral Simulation POCUS training
Uses 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. - Behavioral Clinical Practice Guidelines
Clinical 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.
Primary outcome measures
- 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 frame: 12 months pre and 12 months post-intervention]
Secondary outcome measures (12)
- Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM) [Time frame: up to 6 months post-workshop]
- Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM) [Time frame: up to 6 months post-workshop]
- Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool [Time frame: up to 6 months post-workshop]
- Feasibility of implementing a cardiac point-of-care ultrasound (POCUS) simulation training and clinical practice guidelines for physicians and advanced practice providers (APPs) [Time frame: 12 months pre and 12 months post-intervention]
- Effectiveness of the simulation-based cardiac POCUS training implementation as measured by the number of clinical POCUS performed in the ED [Time frame: 12 months pre and 12 months post-intervention]
- Effectiveness of the simulation-based cardiac POCUS training implementation as measured by image quality review scores [Time frame: 12 months pre and 12 months post-intervention]
- Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by the time to initial cardiology consult [Time frame: 12 months pre and 12 months post-intervention]
- Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by emergency department length-of-stay [Time frame: 12 months pre and 12 months post-intervention]
- Clinical impact of the training model on heart failure patients as measured by the number of participants with serious cardiac outcomes [Time frame: 12 months pre and 12 months post-intervention]
- Ultrasound Self-efficacy Scale [Time frame: 6 months]
- Provider adoption as measured by the number of cardiac/lung POCUS exams performed by each participant for ED acute heart failure patients [Time frame: 12 months pre and 12 months post-intervention]
- Ultrasound image interpretation test [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners
Exclusion criteria
- ED nurses and technicians are excluded due to differing ultrasound training needs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07592598 · Pro00120135