Targeting of UnControlled Hypertension in Emergency Department
TOUCHED
2 other identifiers
interventional
574
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Feb 2019
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedStudy Start
First participant enrolled
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedResults Posted
Study results publicly available
June 18, 2025
CompletedJune 18, 2025
June 1, 2025
4.1 years
November 19, 2018
June 14, 2024
June 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care.
Baseline, 3 months after baseline
Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care.
Baseline, 6 months after baseline
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants 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 COMPARATORParticipants 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- BP\>=140/90 and \<=180/110 mm Hg at time of discharge from ED
- Verbal fluency in English or Spanish
- Age 18-75 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Related Publications (2)
Prendergast H, Kitsiou S, Petzel Gimbar R, Freels S, Sanders A, Daviglus M, Kotini-Shah P, Carter B, Del Rios M, Heinert S, Khosla S. Emergency Department-Based Education and mHealth Empowerment Intervention for Hypertension: The TOUCHED Randomized Clinical Trial. JAMA Cardiol. 2025 Jul 1;10(7):657-665. doi: 10.1001/jamacardio.2025.0675.
PMID: 40266598DERIVEDPrendergast 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.
PMID: 33484897DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Recruitment and retention during the pandemic posed challenges to the study.
Results Point of Contact
- Title
- Heather M. Prendergast MD, MS, MPH, Professor, Department of Emergency Medicine
- Organization
- University of Chicago Illinois
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Prendergast, MD, MPH, MS
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor (CT), Associate Head for Academic Affairs, Resident Research Director, Emergency Medicine
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
February 19, 2019
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
June 18, 2025
Results First Posted
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- The TOUCHED data set will be submitted to the NHLBI Program Officer, no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first.
The TOUCHED data sets will be submitted to the NHLBI Data repository, and will include the following: * Data Information collected and recorded from study participants, including baseline, interim visit, ancillary data, outcome data, laboratory measurements not otherwise summarized, blood pressure measurements; quantitative results from survey assessments; clinical event surveillance and follow-up contacts. * Study documentation: Descriptive information regarding the conduct of the study and collection of Data, including study protocol, manual of operations/procedures, annotated data collection forms, codebooks /data dictionary, and descriptions of data derived from procedures. In the preparation and delivery of the Data to the NHLBI Data Repository, all personal identifiers will be eliminated. A summary of all proposed modifications and deletions to be made to a data set will be submitted to and approved by the NHLBI Data Repository representative prior to their implementation.