Targeting of UnControlled Hypertension in Emergency Department

Hypertension Clinical Trial

— TOUCHED  

Official title:

Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749499
• Other study ID #: 2017-0118
• Secondary ID: 1R61HL139454-01A
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Emergencies
• Hypertension
• Vascular Diseases

Intervention

Other:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean systolic blood pressure (SBP) difference at 6 months post-intervention compared to usual care.	Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.	Baseline, 6 months after baseline
Secondary	Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) differences at 3 months post-intervention compared to usual care.	Blood pressure will be collected at two time points (baseline and 3 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.	Baseline, 3 months after baseline
Secondary	Diastolic blood pressure (DBP) difference at 6 months post-intervention compared to usual care.	Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.	Baseline, 6 months after baseline
Secondary	Change in cardiovascular risk score/profile.	As measured by the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator Plus at baseline, 3 months, and then at 6 months.; Atherosclerotic Cardiovascular Disease Risk Estimator Plus provides a patient's 10-year risk and a lifetime of developing atherosclerotic cardiovascular disease. The 10-year calculated ASCVD risk a quantitative estimation of absolute risk based upon data from representative population samples. The lifetime calculated ASCVD risk represents a quantitative estimation of absolute risk for a 50 year old man or woman with the same risk profile.; The estimator provides risk as a percentage, ranging from 0-100%. A higher percentage is considered a worse outcome.	Baseline, 3 months and 6 months after baseline
Secondary	Primary care engagement.	Measured by compliance with outpatient follow-up appointment at 1 month after baseline.	1 month after baseline
Secondary	Change in hypertension knowledge.	As measured by a validated HTN knowledge survey at baseline and then at 6 months.; The hypertension knowledge survey is a 10-item, validated tool developed to assess hypertension knowledge in low literacy patient populations. The scale assesses respondents' knowledge in defining hypertension, lifestyle, and behaviors that may affect BP levels, and the long-term consequences of HTN. The survey has been validated in an urban population that included a high proportion of black and Latino patients. Scores are categorized into tertiles that indicate low (=7), medium (8), or high (9-10) levels of HTN knowledge. The tool comes from: Shane S, Muntner P, Kawasaki L, Hyre A, DeSalvo K. Hypertension Knowledge Among Patients from an Urban Clinic. Ethnicity & Disease. 2008; 18: 42-47.	Baseline and 6 months after baseline