Point-of-care Ultrasound for Left Ventricular Hypertrophy
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Disqualifiers: Hypertension treatment, Cardiac disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The objective of the proposed project is to quantify the prevalence and disparities of undiagnosed left ventricular hypertrophy (LVH) in Emergency Department (ED) patients with persistently elevated asymptomatic BP, and to measure the effect of disclosure, education, and expedited referral on 3-month outpatient follow-up and treatment rates for ED patients with newly diagnosed LVH by POCUS. Additionally, investigators will create a database of annotated clips for future development of a machine learning algorithm for LVH detection on POCUS.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are actively being treated for high blood pressure or have active heart disease, you may not be eligible to participate.
What data supports the effectiveness of the treatment for Point-of-care Ultrasound for Left Ventricular Hypertrophy?
Research shows that providing clear discharge instructions and ensuring follow-up appointments can significantly reduce hospital readmissions for heart failure patients. This suggests that customized discharge and expedited referral instructions may help patients better manage their condition and reduce the need for rehospitalization.
12345How does point-of-care ultrasound differ from other treatments for left ventricular hypertrophy?
Point-of-care ultrasound is unique because it allows primary care physicians to quickly and accurately measure the heart's left ventricle using a small, portable device, which can improve the detection of left ventricular hypertrophy compared to traditional methods like electrocardiography that have lower sensitivity.
678910Eligibility Criteria
This trial is for Emergency Department patients with high blood pressure readings (over 140/90 mmHg) on two separate checks, who haven't been treated for hypertension or known heart enlargement in the last year and aren't currently under a cardiologist's care. It excludes those too ill to consent, admitted to the hospital, or suspected of having a hypertensive emergency.Inclusion Criteria
My blood pressure was over 140/90 mmHg in two separate checks.
Exclusion Criteria
Admission to the hospital
I am unable to give consent due to my severe health condition.
The doctor at the emergency room thinks you might have a serious problem with high blood pressure.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
POCUS Assessment
Participants undergo POCUS to assess for left ventricular hypertrophy (LVH)
Day 1
1 visit (in-person)
Intervention
Participants with LVH receive disclosure, counseling, and expedited referral
1 day
1 visit (in-person)
Follow-up
Participants are monitored for follow-up and treatment rates post-intervention
3 months
1-2 visits (virtual or in-person)
Data Collection for AI Development
Creation of a database of annotated clips for AI algorithm development
Concurrent with other phases
Participant Groups
The study aims to identify undiagnosed heart enlargement due to high blood pressure using point-of-care ultrasound (POCUS). Participants will receive education about their condition and expedited referrals for follow-up care. The impact on treatment rates after three months is being measured.
1Treatment groups
Experimental Treatment
Group I: Feasibility: Disclosure, customized discharge and expedited referral instructionsExperimental Treatment1 Intervention
Participants enrolled in the Aim 1 cohort with LVH on POCUS will receive the study intervention consisting of disclosure, counseling with set discharge instructions and expedited referral (communication to existing primary care physician OR referral to follow-up clinic if no existing primary care)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
References
Risk factor management after myocardial infarction: reported adherence and outcomes. [2009]Providing patients with documented discharge instructions is a performance measure of health care quality. It is not well known how often cardiac patients comply with the list of instructions or what their association is with health status outcomes after an acute myocardial infarction.
A Blueprint for the Post Discharge Clinic Visit after an Admission for Heart Failure. [2018]The immense symptom burden and healthcare expenditure associated with heart failure (HF) has resulted in hospital systems, insurance companies, and federal agencies playing close attention to systems of care delivery. In particular, there has been a large extent of focus on decreasing the frequency of HF readmissions through the development of hospital quality measures and the expansion of post discharge services to improve transitions of care from the inpatient to the outpatient setting. The post discharge clinic visit (PDV) serves an important role in this process as it acts as a fulcrum for the multi-disciplinary services available to HF patients, as well as an opportunity to fill any gaps that might have occurred in evidence based care of the patient. The objective of this review is to provide a blueprint for the PDV that will allow clinicians to construct the key elements of the PDV in a patient-centered fashion that is firmly rooted in the guidelines.
Predictors of delivery of hospital-based heart failure patient education: a report from OPTIMIZE-HF. [2022]Although recent heart failure (HF) management guidelines recommend delivery of patient education and discharge instructions, little is known about predictors of delivery of these materials or how such materials relate to outpatient disposition postdischarge. This report assesses the degree to which the full set of HF discharge instructions and education comprising the Joint Commission on Accreditation of Healthcare Organizations process-of-care measure (HF-1) was provided, identifies factors predictive of use of HF-1, and determines if HF-1 predicts postdischarge outcome disposition in a registry and performance improvement (PI) program for patients hospitalized for HF.
Heart sounds: a pilot randomised trial to determine the feasibility and acceptability of audio recordings to improve discharge communication for cardiology inpatients protocol. [2021]Ineffective hospital discharge communication can significantly impact patient understanding, safety and treatment adherence. This may be especially true for cardiology inpatients who leave the hospital with complex discharge plans delivered in a time-pressured discharge discussion. The goal of this pilot trial was to determine if providing supplemental audio-recorded discharge instructions is feasible and to explore its impact on cardiology patients' ability to understand and self-manage their care .
Reducing All-cause 30-day Hospital Readmissions for Patients Presenting with Acute Heart Failure Exacerbations: A Quality Improvement Initiative. [2020]Background Congestive heart failure (CHF) is the most common cause of hospitalization in the US for people older than 65 years of age. It has the highest 30-day re-hospitalization rate among medical and surgical conditions, accounting for up to 26.9% of the total readmission rates. We conducted a quality improvement project at our hospital with the objective to reduce the 30-day all-cause readmissions of patients with CHF by improving the transition of care and setting up scheduled follow-up appointments within two weeks of patient discharge. Method Retrospective data were collected to understand the pattern of admission for CHF during November 2017. Data on 30-day readmission post-discharge was also collected to understand readmission rates. Similarly, all patients who were admitted with acute CHF exacerbation to our hospital during the month of November 2018 were included in our intervention cohort. The 30-day readmission rates of these patients post-intervention were calculated and compared to the initial cohort. Results As part of our study, we ensured that 58% of the enrolled patients had a follow-up appointment scheduled within two weeks of discharge compared to only 30% in 2017. Also, 56% of the enrolled patients kept their follow-up appointments compared to 37% in 2017. The 30-day readmission rate of CHF patients was reduced in half after the implementation of our project, with a 14% readmission rate for our study patients compared to 28% in 2017. Conclusion Patient education and measures to augment post-discharge follow-up appointments can lead to substantial reductions in the readmission rates of heart failure (HF) patients.
Development and validation of a clinical score to identify echocardiographic left ventricular hypertrophy in patients with cardiovascular disease. [2016]Echocardiographic (echo) left ventricular hypertrophy (LVH) is an independent predictor of mortality. Despite this, screening for LVH in patients with overt cardiovascular diseases is not universally done. To help target echo screening for LVH in patient population, we developed and validated a simple clinical score to help identify those likely to have echo LVH.
Assessment of Primary Care Physicians' Use of a Pocket Ultrasound Device to Measure Left Ventricular Mass in Patients with Hypertension. [2016]Left ventricular hypertrophy (LVH) is common in primary care and is associated with increased morbidity and mortality. Treatment of underlying hypertension can reverse LVH and eliminate the associated risks. Electrocardiography is widely available and commonly used to screen hypertensive patients for LVH, but it is limited by low sensitivity. Limited echocardiographic measurement of the left ventricle is a method for screening with improved sensitivity; however, it is not currently widely used in the primary care setting. This study attempts to test the accuracy of primary care physicians' (PCPs) measurements of the left ventricle using a pocket-sized ultrasound (pUS) device after a brief training session.
Point-of-care screening for left ventricular hypertrophy and concentric geometry using hand-held cardiac ultrasound in hypertensive patients. [2021]The introduction of the hand-held cardiac ultrasound (HCU) may potentially increase detection of LV hypertrophy in hypertensive patients. However, whether point-of-care screening for LV hypertrophy and concentric LV geometry by HCU in hypertensive patients is feasible and comparable to that of standard state-of-the-art echocardiography (SE) evaluation remains to be elucidated.
[Echocardiography of left ventricular mass in patients with essential hypertension]. [2016]Patients with hypertension and left ventricular hypertrophy (LVH) are at increased risk of cardiovascular complications and the current guidelines recommend echocardiography for determination of left ventricular mass.
Prevalence of left ventricular hypertrophy in patients with mild hypertension in primary care: impact of echocardiography on cardiovascular risk stratification. [2019]Left ventricular hypertrophy (LVH) is an important predictor of cardiovascular risk, and its detection contributes to risk stratification. The aims of the present study were to estimate the prevalence of echocardiographic LVH and to evaluate the influence of echocardiography (ECHO) on cardiovascular risk stratification in hypertensive patients presenting in primary care.