Targeting of UnControlled Hypertension in Emergency Department

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

574 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-19

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension Cardiovascular Diseases Vascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.

Study Groups

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Usual Care

Participants randomized to usual care will receive preprinted discharge instructions on HTN and a 48-72-hour referral to our FQHC (or other community health center if pre-assigned though Illinois Medicaid) to schedule their follow-up appointment (current standard of care)

Group Type NO_INTERVENTION

No interventions assigned to this group

Educational and Empowerment Intervention

Participants receive:

1. HTN Educational Video about high BP, how it is diagnosed, and importance of treatment to prevent secondary complications.
2. Visual Echocardiogram Image Clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change behavior and improve their BP.
3. Mobile Health and Remote BP monitoring- participants receive an FDA-approved home blood pressure monitoring (HBPM) kit that includes the Nokia wireless BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
4. A Post-Acute Care HTN Transition consultation (PACHT-c) with a clinical pharmacist or advanced practice nurse (APN).

Group Type ACTIVE_COMPARATOR

HTN Educational Video

Intervention Type OTHER

The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.

Visual Echocardiogram Image Clips

Intervention Type OTHER

Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.

Mobile Health and Remote BP monitoring

Intervention Type OTHER

All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.

Post-Acute Care HTN Transition consultation (PACHT-c)

Intervention Type OTHER

All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.

Interventions

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HTN Educational Video

The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.

Intervention Type OTHER

Visual Echocardiogram Image Clips

Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.

Intervention Type OTHER

Mobile Health and Remote BP monitoring

All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.

Intervention Type OTHER

Post-Acute Care HTN Transition consultation (PACHT-c)

All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BP\>=140/90 and \<=180/110 mm Hg at time of discharge from ED
* Verbal fluency in English or Spanish
* Age 18-75 years

Exclusion Criteria

* Unable to verbalize comprehension of study, impaired decision-making or documented dementia
* Plans to move from Chicago area within the next year
* Pregnant or trying to get pregnant
* COVID-19 positive within the past 14 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No