Hypertension Clinical Trial
Official title:
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
Effective interventions that can address uncontrolled hypertension, particularly in
underrepresented populations that use the emergency department (ED) for primary care, are
critically needed. Uncontrolled hypertension (HTN) contributes significantly to
cardiovascular morbidity and mortality and is more frequently encountered among patients
presenting to the ED as compared to the primary care setting. EDs serve as the point of entry
into the health care system for many high-risk patient populations, including minority and
low-income patients. Based upon recent studies, the prevalence of uncontrolled/undiagnosed
HTN in patients presenting to the ED is alarmingly high.
Thus emergency department engagement and early risk assessment/stratification is a feasible
innovation to help close health disparity gaps in HTN.
This proposal involves a three-arm randomized controlled trial of 120 patients from the
Emergency Department at University of Illinois Hospital with elevated blood pressure (BP) and
no established primary care provider (PCP). The overarching goal is to improve follow-up
rates and transition to PCP care at a federally qualified community health center (FQHC). The
primary outcome will be blood pressure control. Secondary outcomes will be blood pressure
improvement, treatment adherence, and hypertension knowledge. The central hypothesis of the
proposal is that an ED-based screening, brief intervention, and referral for treatment
program for HTN (SBIRT-HTN) using existing ED resources, coupled with a follow-up visit to an
ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c), can be
impactful in a predominately underrepresented hypertensive population.
Effective interventions to address uncontrolled hypertension (HTN), particularly in
underrepresented populations that use the emergency department (ED) for primary care, are
critically needed. Uncontrolled HTN, which contributes significantly to cardiovascular
morbidity and mortality, is more frequently encountered among patients presenting to the ED.
EDs serve as the point of entry into the health care system for many high-risk patient
populations, particularly minority and low-income individuals. Our preliminary data from a
largely minority patient population presenting to the ED shows significant rates of
subclinical heart disease (diastolic dysfunction and left ventricular hypertrophy) in
patients with elevated blood pressure (BP). These early echocardiogram changes are reversible
with existing strategies for improving BP control.
The proposed project underscores that 1) The prevalence of uncontrolled/undiagnosed HTN among
ED patients from underrepresented groups who do not have a primary care physician (PCP) is
alarmingly high, and 2) ED engagement and early risk assessment/stratification with
facilitated PCP follow-up is a novel and feasible innovation to help address health disparity
gaps in HTN. The central hypothesis of the proposal is that an ED-based screening, brief
intervention, and referral for treatment program for HTN (SBIRT-HTN) using existing ED
resources, coupled with a follow-up visit to an ED pharmacist-initiated Post-Acute Care
Hypertension Transition Clinic (PACHT-c), will improve BP control through patient
empowerment, facilitating PCP follow-up rates, and consequently improving treatment
compliance in a predominately underrepresented hypertensive population. This proposal is
strengthened by the existing partnership between an academic urban ED and a Federally
Qualified Health Center (FQHC) as a model for integrating secondary cardiovascular prevention
in a population at high risk for complications due to uncontrolled/undiagnosed HTN. Moreover,
this proposal is innovative as a prospective randomized controlled trial in a high-risk ED
patient population with no established PCP and persistent elevated BPs.
Eligible patients are those with elevated BP and no established PCP (or no PCP contact in the
past year) who present to the University of Illinois Hospital & Health Sciences System (UI
Health) ED. The three arms are: 1) usual care (current practice of passive outpatient
referral for follow-up care), 2) an ED-based SBIRT-HTN program (patient empowerment tool)
using existing ED resources followed by assisted referral for usual care, and 3) the ED based
SBIRT-HTN coupled with a 48-hour follow-up visit to an ED pharmacist-initiated Post-Acute
Care Hypertension Transition Clinic (PACHT-c) followed by assisted referral for primary care.
The aims evaluate the effectiveness of the interventions (SBIRT-HTN & PACHTC-c) on
uncontrolled BP at 6 months. The primary outcome will be BP improvement. Based on the
demographics of the ED population at the study site (70% of the current UI Health ED
population are ethnic minorities), the majority of participants will be underrepresented
minorities (African-American and Hispanic/Latino) and low-income individuals. The
investigators propose the following specific aims and hypotheses:
Aim 1: Evaluate the effectiveness of an ED-initiated SBIRT-HTN program on BP control at 6
months post intervention compared to usual care.
H1: Early identification and initiation of a risk stratification algorithm that involves
non-invasive assessment (limited echocardiogram) for early subclinical cardiovascular disease
(combined with patient education regarding HTN & cardiovascular complications (patient
empowerment) at the point-of contact in the ED (arm 2) will result in greater BP control at 6
months compared to the usual care group (arm 1).
Aim 2: Evaluate the impact of the PACHT-c component with the ED-based SBIRT-HTN program on BP
control at 6 months post intervention compared to usual care and ED-SBIRT-HTN alone.
H2: The PACHT-c component (arm 3) will result in greater BP control compared to those
randomized to usual care (arm 1) or ED-based SBIRT-HTN alone (arm 2).
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