Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)

University of Illinois

Status: Completed

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Other: Post-Acute Care HTN Transition consultation (PACHT-c); Other: Visual Echocardiogram Image Clips; Other: Mobile Health and Remote BP monitoring; Other: HTN Educational Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03749499

1R61HL139454-01A1 (U.S. NIH Grant/Contract)

2017-0118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 574 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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574 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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)

Educational and Empowerment Intervention

Active Comparator group

Description:

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).

Treatment:

Other: HTN Educational Video

Other: Mobile Health and Remote BP monitoring

Other: Visual Echocardiogram Image Clips

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