Targeting of UnControlled Hypertension in Emergency Department
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- STATUS
- Recruiting
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- End date
- Feb 6, 2023
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- participants needed
- 570
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- sponsor
- University of Illinois at Chicago
Summary
The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2) ED engagement and early risk assessment/stratification is a cost-effective, feasible innovation to help close health disparity gaps in HTN. This proposal involves a two-arm randomized controlled trial of up to 770 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure (BP). The primary objective is to determine the effectiveness of an emergency department-initiated Educational and Empowerment (E2) intervention with a Post Acute Care Hypertension Consultation (PACHT-c) intervention (arm 2) on the primary outcome of mean systolic blood pressure (SBP) differences between the two trial arms at 6-months post intervention. Secondary objectives include evaluating the effectiveness of this ED education and empowerment intervention on mean SBP and diastolic blood pressure (DBP) differences at 3-months, and mean DBP differences at 6-months. Additionally improvement in cardiovascular risk score (as measured by the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score), medication adherence (as measured by the Modified Morisky Scale), primary care engagement (measured by compliance with outpatient follow-up appointments), and HTN knowledge improvement (as measured by a validated HTN knowledge survey).
Description
The study is a single-site randomized controlled trial (RCT) focused on a high-risk ED population with evidence of moderately elevated BP (140/90 mmHg) at discharge. ED patients will be recruited and randomized into two arms: 1) usual care (preprinted discharge instructions and 48-72 hour referral to a federally qualified health center (FQHC) or assigned provider as appropriate); 2) ED-initiated E2 intervention program followed by 48-72 hour referral to a FQHC (or assigned health center). Based on the ED population demographics (70% ethnic minorities), the majority of participants will be underrepresented minorities (NHB and Hispanic) and low-income individuals. The investigators propose the following specific aims and hypotheses:
Aim 1: Evaluate the effectiveness of an ED-based E2 + PACHT-c intervention (arm 2) on the primary outcome of mean SBP difference at 6-months post-intervention compared to usual care (arm 1).
H1: The mean SBP difference (from baseline) will be significantly greater in the E2+ PACHT-c group (arm 2) compared to the usual care group (arm 1) at 6- months post-randomization, i.e., SBP change in arm 2 > arm 1 at 6-months post-randomization.
Aim 2: Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the secondary outcome of mean SBP and DBP differences at 3-months, and mean DBP differences at 6 months post-intervention compared to usual care.
H2: The mean SBP and DBP differences from baseline to 3- months post-intervention and mean DBP at 6-months post intervention will be significantly greater in the ED-based E2 intervention compared to the usual care group, i.e., SBP and DBP change in arm 2 > arm 1 at 3 -months post-intervention and DBP change in arm 2 > arm 1 at 6 -months post-intervention.
Aim 3: Examine if the E2 intervention reduces racial disparities. Specifically, if the intervention is as effective in racial minorities as non-minorities. This will be an exploratory analysis and will primarily focus on changes in cardiovascular risk score/profile. Also included will be an assessment of intervention mediators: primary care engagement, medication adherence, and HTN knowledge in these same patients at 3 and 6-months post randomization-intervention.
Details
| Condition | vasculopathy, cardiovascular diseases, Cardiovascular Disease, vascular disease, Diabetes and Hypertension, High Blood Pressure (Hypertension - Pediatric), vascular disorder, arterial hypertension, cardiovascular disease (cvd), High Blood Pressure (Hypertension), Hypertension, Vascular Diseases, Elevated Blood Pressure, high blood pressure, cardiovascular disorders, vasc, cardiovascular system diseases |
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| Treatment | HTN Educational Video, Visual Echocardiogram Image Clips, Mobile Health and Remote BP monitoring, Post-Acute Care HTN Transition consultation (PACHT-c) |
| Clinical Study Identifier | NCT03749499 |
| Sponsor | University of Illinois at Chicago |
| Last Modified on | 6 December 2021 |
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