Targeting of UnControlled Hypertension in Emergency Department
Condition: Hypertension; Cardiovascular Diseases; Vascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases; Emergencies
Study type: Interventional

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), primary care engagement (measured by compliance
      with outpatient follow-up appointments), and HTN knowledge improvement (as measured by a
      validated HTN knowledge survey).
    

Detailed 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.
    

Intervention name(s): HTN Educational Video; Visual Echocardiogram Image Clips; Mobile Health and Remote BP monitoring; Post-Acute Care HTN Transition consultation (PACHT-c)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Emergency Department; Minorities