Heart Failure AcuteNCT07592598
Simulation-Based Cardiac Point-of-Care Ultrasound Program to Improve Clinical Outcomes in Acute Heart Failure Patients
A study testing Simulation POCUS training and Clinical Practice Guidelines in people with Heart Failure Acute and Point-of-care Ultrasound, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure Acute, Point-of-care Ultrasound, Simulation Training
- What is being tested?
- Simulation POCUS training and Clinical Practice Guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners
Who cannot join
- ED nurses and technicians are excluded due to differing ultrasound training needs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure Acute, Point-of-care Ultrasound, Simulation Training, Implementation Science
- Being tested
- Simulation POCUS training, Clinical Practice Guidelines
- Keywords
- acute heart failure, point-of-care ultrasound, simulation training, implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation POCUS trainingBehavioural
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.
Clinical Practice GuidelinesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs) | Experimental | Co-designed simulation training intervention and clinical practice guidelines implemenation Receives: Behavioral: Simulation POCUS training; Behavioral: Clinical Practice Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months pre and 12 months post-intervention
Secondary outcomes (14)
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.
Measured: up to 6 months post-workshop
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.
Measured: up to 6 months post-workshop
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.
Measured: 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)
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.
Measured: 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
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).
Measured: 12 months pre and 12 months post-intervention
Effectiveness of the simulation-based cardiac POCUS training implementation as measured by image quality review scores
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 12 months pre and 12 months post-intervention
Ultrasound Self-efficacy Scale
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.
Measured: 6 months
Provider adoption as measured by the number of cardiac/lung POCUS exams performed by each participant for ED acute heart failure patients
Measured: 12 months pre and 12 months post-intervention
Ultrasound image interpretation test
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.
Measured: 6 months
Ultrasound Competency Assessment Test (UCAT)
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.
Measured: 6 months
Cost-effectiveness as measured by POCUS (Point-of-Care Ultrasound) revenue
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.
Measured: 12 months pre and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure AcuteStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Theophanous, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592598
- Sponsor's protocol ID
- Pro00120135
- Status last verified
- May 2026
- First submitted
- 19 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be collected in hospital secured platforms including Duke REDCap, the current clinical Butterfly Enterprise POCUS archiving system, and Epic electronic health records. All data will be de-identified at the collection step and kept as de-identified data for our research purposes. Data will be collected in digital format and stored using standardized file types such as .csv, .txt, .docx, .mp3. The total data volume will cover about 175 participants across 2-3 hospital sites. The research community will have access to data when the award ends. As required by NHLBI, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available and have digital object identifiers (DOI) to aid in findability. The investigators will include the DOI in relevant publications. NHLBI will make decisions about how long to preserve the data.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07592598
- Acronym / sponsor ID
- Pro00120135
- Conditions
- Heart Failure Acute, Point-of-care Ultrasound, Simulation Training, Implementation Science
- Keywords
- acute heart failure, point-of-care ultrasound, simulation training, implementation science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs) | Experimental | Behavioral: Simulation POCUS training, Behavioral: Clinical Practice GuidelinesCo-designed simulation training intervention and clinical practice guidelines implemenation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency medicine provider practicing at the study site, including physician assistants and nurse practitioners
Key exclusion criteria (1 listed)
- ED nurses and technicians are excluded due to differing ultrasound training needs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation POCUS trainingUses 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. | Behavioural | Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs) |
| Clinical Practice GuidelinesClinical 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. | Behavioural | Duke University Hospital emergency medicine physicians and Advanced Practice Providers (APPs) |
Primary outcome
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
Time-to-diuretics (units in minutes) in patients with a clinical diagnosis of acute heart failure with reduced or preserved ejection fraction.
14 secondary outcomes
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
Ultrasound Competency Assessment Test (UCAT)
Time frame: 6 months
Cost-effectiveness as measured by POCUS (Point-of-Care Ultrasound) revenue
Time frame: 12 months pre and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. All data will be collected in hospital secured platforms including Duke REDCap, the current clinical Butterfly Enterprise POCUS archiving system, and Epic electronic health records. All data will be de-identified at the collection step and kept as de-identified data for our research purposes. Data will be collected in digital format and stored using standardized file types such as .csv, .txt, .docx, .mp3. The total data volume will cover about 175 participants across 2-3 hospital sites. The research community will have access to data when the award ends. As required by NHLBI, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available and have digital object identifiers (DOI) to aid in findability. The investigators will include the DOI in relevant publications. NHLBI will make decisions about how long to preserve the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Theophanous principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Simulation POCUS training and Clinical Practice Guidelines in people with Heart Failure Acute and Point-of-care Ultrasound, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Theophanous, MD, MHSc (9196848111, rebecca.theophanous@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.