Point-of-care Ultrasound and Treatment Disparities for Left Ventricular Hypertrophy
Study Details
Study Description
Brief Summary
The objective of the proposed project is to evaluate the feasibility and impact of Left Ventricular Hypertrophy (LVH) determination by Point-of-care Ultrasound (POCUS) on Emergency Department (ED) patients who are undertreated, and to quantify disparities in diagnosis and treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This study will aim to quantify LVH prevalence in ED patients with asymptomatic elevated blood pressure (BP) and treatment disparities for women and minority (African American, Hispanic) population, based on presence of LVH and no treatment.
This study will lay the groundwork for future research utilizing an effectiveness-implementation hybrid design randomized controlled trial to evaluate the impact of interventions informed by POCUS LVH assessment on hypertension control, referral, and cardiovascular outcomes, as well as effectiveness of implementation strategies.
Aim 1 will run concurrently with Aim 2 and utilize the same subjects. Methodologically, Aim 1 will be accomplished via a study design consisting of a prospective observational study evaluating the prevalence of LVH and differences in LVH prevalence and treatment between groups of subjects (women vs. men, black vs. other, Hispanic vs. non-Hispanic).
Aim 2 will be accomplished by utilizing a randomized controlled trial design. From the prospective cohort enrolled in Aim 1, after performing the POCUS study, we will randomize subjects with LVH on POCUS to usual ED physician driven care versus our intervention. Subjects without LVH on POCUS will also receive usual ED care. The intervention (described further below, Figure 2) will consist of set discharge instructions and expedited referral via communication to existing PCP or referral to hospital hypertension clinic and chart flag for follow-up nurse if the patient has no PCP. We will compare the rate of successful follow-up in the two groups (usual ED care and expedited follow-up). We will also calculate and report follow-up rates for the no LVH group, which we expect to be statistically comparable to the usual ED care arm. Aim 2 is the focus of this registration.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard of care Participants with LVH on POCUS will receive usual ED physician driven (standard of care) care |
|
| Experimental: Customized discharge and expedited referral instructions The intervention will consist of a set of customized discharge instructions and expedited referral via communication to existing primary care physician (PCP) or referral to hospital hypertension clinic and chart flag for follow-up nurse if the patient has no PCP. |
Behavioral: Customized discharge and expedited referral instructions
The intervention will consist of two elements: 1) customized discharge instructions addressing elevated blood pressure, hypertension, left ventricular hypertrophy and their diagnosis, risk for cardiovascular disease (such as development of heart failure, stroke), options for treatment and importance of follow-up; and 2) expedited follow-up plan, which will consist of one of two options, based on whether the subject has an established PCP or not: a) for subjects with a PCP, the research team will call the PCP office, inform the PCP of elevated BP, and make a follow-up appointment or b) for subjects without a PCP, the research team will flag the chart for our ED follow-up office staff to assist with care navigation, and refer patient to an existing hospital run clinic specifically design to evaluate and start treatment on patients with HTN.
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Outcome Measures
Primary Outcome Measures
- LVH point-prevalence [Day 1]
LVH point prevalence will be determined based on POCUS measurements of LV thickness and/or LV mass, expressed as percentage of total population enrolled in the study.
Secondary Outcome Measures
- Rate of no treatment in specific groups of subjects [up to 3 weeks]
Rate of no treatment in specific groups of subjects (women vs. men, black vs. other, Hispanic vs. non-Hispanic).
- Rate of successful follow-up in LVH usual care group [up to 3 weeks]
The rate of successful follow-up in the LVH group with usual ED care will be calculated. Successful follow-up defined as: a clinic appointment was made (either virtual or in-person) and subject presented to this appointment within 14 days of ED visit. Rate will be expressed as percentage of total subjects in each group with successful follow-ups.
- Rate of successful follow-up in LVH expedited follow-up group [up to 3 weeks]
The rate of successful follow-up in the LVH group with expedited follow-up care will be calculated. Successful follow-up defined as: a clinic appointment was made (either virtual or in-person) and subject presented to this appointment within 14 days of ED visit. Rate will be expressed as percentage of total subjects in each group with successful follow-ups.
- Rate of successful follow-up in no LVH group [up to 3 weeks]
The rate of successful follow-up in participants with no LVH will be calculated. Successful follow-up defined as: a clinic appointment was made (either virtual or in-person) and subject presented to this appointment within 14 days of ED visit. Rate will be expressed as percentage of total subjects in each group with successful follow-ups.
Eligibility Criteria
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
-
documented history of hypertrophic cardiomyopathy
-
documented history of left ventricular hypertrophy
-
documented history of diastolic heart failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06512 |
Sponsors and Collaborators
- Yale University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000034381