Clinical trial NCT03749499: Targeting of UnControlled Hypertension in Emergency Department
Official title: Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Vascular Diseases
Keywords: Emergency Department
Minorities
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-11-21
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care.
timeFrame: Baseline, 6 months after baseline
Secondary outcomes:
measure: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care.
timeFrame: Baseline, 3 months after baseline
measure: Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care.
timeFrame: Baseline, 6 months after baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Heather Prendergast, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prendergast HM, Petzel-Gimbar R, Kitsiou S, Del Rios M, Lara B, Jackson M, Heinert S, Carter BL, Durazo-Arvizu RA, Daviglus M. Targeting of uncontrolled hypertension in the emergency department (TOUCHED): Design of a randomized controlled trial. Contemp Clin Trials. 2021 Mar;102:106283. doi: 10.1016/j.cct.2021.106283. Epub 2021 Jan 20.