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Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy

Primary Purpose

Left Ventricular Hypertrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized discharge and expedited referral instructions
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Left Ventricular Hypertrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Two blood pressure measurements greater than 140 mmHg systolic and greater than 90 mmHg diastolic on two separate vital sign checks obtained as part of routine ED care Exclusion Criteria: Subjects in extremis or lacking capacity to consent Active treatment of hypertension within the last year History of/known left ventricular hypertrophy Active cardiac disease under the care of a cardiologist within last year Suspicion for hypertensive emergency by treating ED physician Admission to the hospital

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility: Disclosure, customized discharge and expedited referral instructions

Arm Description

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)

Outcomes

Primary Outcome Measures

Prevalence of LVH by POCUS
LVH point prevalence will be determined based on ultrasound measurements of left ventricular wall thickness and/or left ventricular mass, expressed as percentage of total population enrolled in the study.

Secondary Outcome Measures

Prevalence of LVH stratified by race, ethnicity and gender
Prevalence of LVH stratified by race, ethnicity and gender, if sample size allows this. LVH point prevalence by subgroups will be expressed as percentage of patients meeting LVH criteria of total enrolled population in that subgroup (eg men, women, African American, etc).
Rate of successful follow-up in group of subjects with LVH on POCUS
Rate of successful follow-up in group of subjects with LVH on POCUS at 3 months post intervention, expressed as percentage of total subjects with successful follow-ups. Successful follow-up is defined as: a clinic appointment was made (either virtual or in-person) and subject presented to this appointment.
Rate of treatment in group of subjects with LVH on POCUS
Rate of treatment in group of subjects with LVH on POCUS at 3 months post intervention. Treatment is defined as new medication prescribed for blood pressure management following the ED visit where enrollment occurred.

Full Information

First Posted
February 6, 2023
Last Updated
September 1, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT05730309
Brief Title
Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy
Official Title
Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
The rationale for the proposed project is that, through bedside LVH detection, ED POCUS can be leveraged to identify those high-risk patients with asymptomatic hypertension (HTN) and improve disease prevention equity, while also ultimately decrease cardiovascular disease burden. The objective of the proposed project is to evaluate the feasibility and impact of LVH determination by POCUS on ED patients with elevated BP, and to quantify disparities in diagnosis and treatment. This study has 3 Aims: Aim 1: To quantify the prevalence and disparities of undiagnosed LVH in ED patients with persistently elevated asymptomatic BP. The investigators will enroll a prospective cohort of ED patients with BP > 140/90mmHg on two measurements who will receive POCUS to assess for LVH. The investigators hypothesize an overall LVH prevalence of at least 30%. Aim 2: 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. In a single arm feasibility clinical trial, subjects 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 a follow-up clinic if no existing primary care). The investigators hypothesize a 50% follow-up rate and a 40% treatment rate. Aim 3: To create a database of annotated clips for development of an artificial intelligence (AI) algorithm for LVH detection on POCUS. A collection of annotated clips would support subsequent training, validation, and eventual integration into POCUS technology to facilitate larger scale screening and referral efforts. Aim 1 will have a prospective observational study design. Aim 2 will occur sequentially based on results of POCUS performed as part of Aim 1. Aim 3 will follow a repository creation protocol utilizing the ultrasound clips obtained during Aim 1. This study will lay the groundwork for future research to evaluate the impact of interventions informed by LVH assessment by POCUS on hypertension control, referral, and cardiovascular outcomes, as well as effectiveness of implementation strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Hypertrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
From the prospective cohort enrolled in Aim 1, after performing the POCUS study, we will offer subjects with LVH on POCUS the three-element intervention (disclosure regarding presence of LVH, pre-specified discharge instruction and referral). Subjects without LVH on POCUS will receive usual ED care and pre-specified discharge instructions about high blood pressure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feasibility: Disclosure, customized discharge and expedited referral instructions
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Customized discharge and expedited referral instructions
Intervention Description
The intervention for subjects with LVH on research POCUS will consist of three elements: 1) disclosure of presence of LVH to subject, ED team and primary care physician (PCP) (if applicable); 2) educational discharge instructions describing high BP, HTN, LVH, implications for development of cardiovascular disease (such as development of heart failure, stroke), options for treatment (lifestyle, medications) and importance of follow-up; A preliminary version will be refined prior to the start of the trial by feedback from ED physicians and patients. Refinement will target content, phrasing, and literacy level. 3) referral to outpatient care, consisting of one of two options, based on whether the subject has an established PCP. For subjects with existing PCP, the study team will call the office, inform about study participation, LVH findings, and secure a follow-up appointment. For those with no PCP, study team will arrange for follow-up to special clinic.
Primary Outcome Measure Information:
Title
Prevalence of LVH by POCUS
Description
LVH point prevalence will be determined based on ultrasound measurements of left ventricular wall thickness and/or left ventricular mass, expressed as percentage of total population enrolled in the study.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Prevalence of LVH stratified by race, ethnicity and gender
Description
Prevalence of LVH stratified by race, ethnicity and gender, if sample size allows this. LVH point prevalence by subgroups will be expressed as percentage of patients meeting LVH criteria of total enrolled population in that subgroup (eg men, women, African American, etc).
Time Frame
through the end of the study, approximately 6 months
Title
Rate of successful follow-up in group of subjects with LVH on POCUS
Description
Rate of successful follow-up in group of subjects with LVH on POCUS at 3 months post intervention, expressed as percentage of total subjects with successful follow-ups. Successful follow-up is defined as: a clinic appointment was made (either virtual or in-person) and subject presented to this appointment.
Time Frame
3 months post-intervention
Title
Rate of treatment in group of subjects with LVH on POCUS
Description
Rate of treatment in group of subjects with LVH on POCUS at 3 months post intervention. Treatment is defined as new medication prescribed for blood pressure management following the ED visit where enrollment occurred.
Time Frame
3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Two blood pressure measurements greater than 140 mmHg systolic and greater than 90 mmHg diastolic on two separate vital sign checks obtained as part of routine ED care Exclusion Criteria: Subjects in extremis or lacking capacity to consent Active treatment of hypertension within the last year History of/known left ventricular hypertrophy Active cardiac disease under the care of a cardiologist within last year Suspicion for hypertensive emergency by treating ED physician Admission to the hospital
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiana Baloescu, MD, MPH
Phone
(203) 737-2644
Email
cristiana.baloescu@yale.edu
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy

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