Targeting of UnControlled Hypertension in Emergency Department

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT03749499
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HTN Educational Video — 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 — 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 — 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) — 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.

Study Details

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.

Key Dates

Start date
Feb 19, 2019
Status verified
Jun 2025
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023

Study Design

Enrollment
574 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • No Intervention: 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)
  • Active Comparator: 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).

Primary Outcome Measure

Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care. [ Time Frame: Baseline, 6 months after baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612-

Find similar trials in Chicago, IL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Illinois at Chicago· Chicago, IL

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