Heart Failure Acute, Implementation Science, Point-of-care Ultrasound, Simulation Training
Conditions
Keywords
acute heart failure, point-of-care ultrasound, simulation training, implementation science
Brief summary
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
BEHAVIORALSimulation 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.
BEHAVIORALClinical 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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 months pre and 12 months post-intervention | Time-to-diuretics (units in minutes) in patients with a clinical diagnosis of acute heart failure with reduced or preserved ejection fraction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Intervention as measured by the Acceptability of Intervention Measure (AIM) | up to 6 months post-workshop | The AIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater acceptability. |
| Appropriateness of the Intervention as measured by the Intervention Appropriateness Measure (IAM) | up to 6 months post-workshop | The IAM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness. |
| Feasibility of the Intervention as measured by the Feasibility of Intervention Measure (FIM) survey tool | up to 6 months post-workshop | The FIM is scored on a Likert scale from 1 to 5, where a higher score indicates greater appropriateness. |
| Feasibility of implementing a cardiac point-of-care ultrasound (POCUS) simulation training and clinical practice guidelines for physicians and advanced practice providers (APPs) | 12 months pre and 12 months post-intervention | 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. |
| Effectiveness of the simulation-based cardiac POCUS training implementation as measured by the number of clinical POCUS performed in the ED | 12 months pre and 12 months post-intervention | To assess the cardiac POCUS simulation 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). |
| Effectiveness of the simulation-based cardiac POCUS training implementation as measured by image quality review scores | 12 months pre and 12 months post-intervention | To assess cardiac POCUS simulation 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). |
| 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 | 12 months pre and 12 months post-intervention | 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). |
| Clinical impact of the training model on point-of-care ultrasound (POCUS) use and diagnostic performance as measured by emergency department length-of-stay | 12 months pre and 12 months post-intervention | 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). |
| Clinical impact of the training model on heart failure patients as measured by the number of participants with serious cardiac outcomes | 12 months pre and 12 months post-intervention | The investigators will collect pre/post-intervention 30-day serious cardiac outcomes including 30-day mortality, ventilation, new dialysis, myocardial infarction (from the Epic electronic health record, units in counts/percentages). |
| Ultrasound Self-efficacy Scale | 6 months | Post-workshop assessments will assess participant skills via validated Ultrasound Self-efficacy Scale, which is reported on a scale of 1 to 5. A higher score indicates greater self-efficacy. |
| Provider adoption as measured by the number of cardiac/lung POCUS exams performed by each participant for ED acute heart failure patients | 12 months pre and 12 months post-intervention | — |
| Ultrasound image interpretation test | 6 months | Post-workshop assessments will assess participant skills via validated ultrasound image interpretation tests (knowledge assessment survey, 11 questions multiple choice). Scores range from 0 to 11, where a higher score indicates greater knowledge. |
| Ultrasound Competency Assessment Test (UCAT) | 6 months | Post-workshop assessments will assess participant skills via validated ultrasound simulated scenario performance and technical skills using the UCAT. The score ranges from 1 ("I had to do", total supervisor intervention) to 5 ("I did not need to be there", independent). Higher scores indicate greater competency. |
| Cost-effectiveness as measured by POCUS (Point-of-Care Ultrasound) revenue | 12 months pre and 12 months post-intervention | Number of dollars billed at a flat rate for each procedure type from the Butterfly enterprise and hospital clinical billing data archive, units in dollars. |
Contacts
CONTACTRebecca Theophanous, MD, MHSc
CONTACTMaria Manson
PRINCIPAL_INVESTIGATORRebecca Theophanous
Duke University
Outcome results
None listed