Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)
Phase: NA
Conditions: Hypertension, Cardiovascular Diseases, Vascular Diseases
Sponsor: University of Illinois at Chicago

TOUCHED_Protocol_Version 1.8, 05/10/2022 
1 of 28
Targeting of Uncontrolled Hypertension in the Emergency Department (TOUCHED) 
Principal Investigator: 
Heather M. Prendergast MD, MS, MPH, Professor 
Department of Emergency Medicine 
 
Co-Investigators: 
Renee Petzel Gimbar, PharmD 
Spyros Kitsiou, PhD 
Martha Daviglus, MD, PhD 
Sally Freels, PhD 
 
Study Location(s): University of Illinois Emergency Department 
1740 W. Taylor, Chicago, Il 60612 
 
Sponsor: National Institutes of Health (NIH) 
 
 
 
 
 
NCT03749499 
Version 1.8, Date:  May 10, 2022 
 
 
 
 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
2 of 28
1.0 
PROJECT SUMMARY/ABSTRACT 
 Effective interventions that can address uncontrolled hypertension, particularly in 
underrepresented populations that use the emergency department (ED) for primary care, are 
critically needed.[1, 2] [3] Uncontrolled hypertension (HTN) contributes significantly to 
cardiovascular morbidity and mortality and is more frequently encountered among patients 
presenting to the ED. [4, 5] EDs serve as the point of entry into the health care system for 
many high-risk patient populations, particularly minority and low-income individuals. 
Preliminary data from our research group, based on a largely minority patient population 
presenting to the ED, demonstrated significant rates of subclinical heart disease (diastolic 
dysfunction and left ventricular hypertrophy) in those with elevated blood pressures.[6] These 
early echocardiogram changes are reversible with existing strategies to improve blood pressure 
control making ED interventions within this population imperative. [7] [8]  
 
The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed 
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), medication adherence (as measured by the Modified Morisky Scale), 
and primary care engagement (measured by compliance with outpatient follow-up 
appointments), will also be assessed as part of this study. 
 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
3 of 28
2.0 BACKGROUND/SCIENTIFIC RATIONALE  
A. Background - EDs serve a high-risk population that is not readily captured in other clinical 
settings with many patients utilizing the ED as part of their primary care access. [3, 9] Moreover, 
patients who report using the ED as their usual site of care are disproportionately more likely to 
have poor cardiovascular outcomes relative to private doctor’s offices [10] 
Why Study Uncontrolled Hypertension in the Emergency Department Setting? It is estimated 
that the prevalence of uncontrolled/undiagnosed hypertension in the ED is as high as 45%. [11] 
Hypertensive patients presenting to the ED are a particularly high-risk group with >50% having 
stage II or higher hypertension (SBP > 160 or DBP >100).[4] Many cases of elevated blood 
pressures in the ED are incidental findings and not related to the patient’s chief complaints. 
Incidental hypertension represents a quandary for the emergency physician who cannot 
guarantee follow-up treatment.[12, 13] Thus identification and referral rates remain low in 
patients presenting to the ED with moderate BP elevations despite published outpatient 
guidelines. A recent study reported approximately 59% of men and 78% of women with elevated 
BP in the ED had continued elevated readings at outpatient follow-up after the ED visit. [14] 
Several studies have found that only 7-25% of ED patients with elevated BP are given 
instructions for outpatient BP follow-up. [12-14] Currently, there is no risk assessment or 
stratification based upon blood pressure assessment performed on hypertensive patients 
prior to discharge from the ED. All patients receive the same standard discharge instructions 
from the ED to follow up with a primary care provider (PCP). Recent emergency medicine 
literature suggests that if evidence-based guidelines were available for management of these 
patients and more assured follow-up mechanisms were in place, there would be greater 
compliance with referral guidelines and heightened awareness of secondary prevention 
interventions available to ED physicians. [11]  
In 2010, there were 128 million ED visits, and by 2012, this number had increased to 138 
million. [15] The proposed study is novel because it is initiated in the emergency department, is 
an innovative change to the current care delivery model, utilizes mobile health home BP 
monitoring, and can decrease the health disparity gaps associated with uncontrolled HTN. EDs 
serve as the point of entry into the health care system for many high-risk patient populations, 
particularly minority and low-income individuals, who are not readily captured in other clinical 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
4 of 28
settings because a significant number of these patients do not have a medical home and routinely 
utilize the ED as their source of primary care. EDs are well suited at the interface between 
inpatient and outpatient care and can contribute to reducing the health disparity associated with 
uncontrolled HTN in high-risk minority populations through focused engagement.  
3.0 OBJECTIVE/AIMS 
 The specific aims and hypotheses to be tested are:  
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 12-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 and baseline to 12-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 and 12-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.  
4.0 ELIGIBILITY 
The UI Health Department of Emergency Medicine serves a diverse population in Chicago and is 
a Level II trauma center located within the Illinois Medical District.  

TOUCHED_Protocol_Version 1.8, 05/10/2022 
5 of 28
All patient recruitment will be completed in the UI Health Department of Emergency Medicine 
(ED). ED study personnel will approach patients who meet inclusion criteria for the study. Study 
personnel will be available on rotating shifts (including days, nights, and weekends) in order to 
facilitate ongoing patient recruitment and enrollment. Individuals deemed eligible will be 
consented and sign a written consent with HIPAA authorization and have baseline data 
collection. The research assistants (RAs) will inform patients that the research is being conducted 
to improve hypertension knowledge and blood pressure control by facilitating primary care 
connections and to determine if the ED can help people reach goals of treatment. 
 
4.1 Inclusion Criteria:  
Inclusion criteria: Stage 1 Hypertension- Elevated Blood Pressure of  ≥140/90 and  ≤ 180/110 
at time of discharge from ED;  Verbal fluency in English or Spanish; Age 18 to 75 years. 
4.2 Exclusion Criteria: 
Exclusion criteria: Unable to verbalize comprehension of study or impaired decision making 
or documented dementia; Lives outside Chicago communities or plans to move from Chicago 
area within the next year; Pregnant or trying to get pregnant; COVID-19 positive. 
4.3 Vulnerable Populations:  
Study participants will be patients with uncontrolled/undiagnosed HTN in underrepresented 
groups presenting to the emergency department.  ED engagement and early risk 
assessment/stratification is aimed to be a cost-effective, feasible, and minimally invasive 
innovation to help close health disparity gaps in HTN.  
Collaborating Sites:  
There are no collaborating sites. 
 
5.0 
SUBJECT ENROLLMENT 
In order to minimize the possibility of coercion or undue influence on potential subjects, 
subjects will only be approached for study consent after they have completed their evaluation 
in the emergency department and have been identified for discharge. Subjects will also be 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
6 of 28
informed that participation is voluntary and will not affect their relationship with the 
university/hospital if they decline to participate. Also, patients that are being cared for by the 
PI or key personnel will not be approached and consented by that individual but rather another 
member of the study team . Subjects will initially be identified by review of the tracking board 
listing in the department. The tracking board displays the patients' last name, room number, 
age, and vital signs. If patients meet the BP requirement (BP ≥ 140/90 and ≤180/110) and are 
slated for discharge from the emergency department, then a clinical EMT will approach the 
attending physician caring for the patient for preliminary review of exclusion criteria. Eligible 
participants will be approached by the clinical EMT with an iPad. The research assistant will 
communicate with the potential participant via the iPad. The consent form will be electronic 
to avoid possible contamination. Additionally, participants will be informed that a thank you 
letter will be mailed to their home after completion of the study. At no time will any 
information about refusals to participate be placed in the subjects' medical record.  All data 
will be entered into electronic database (REDCap). There will be no paper charts/data entry. 
This will minimize the potential for loss of information and breech of privacy.  All of this 
information will be handled in accordance with HIPAA guidelines. We do not expect subjects 
to experience discomfort with the collection of the minimally invasive clinical measures 
collected. 
6.0 
STUDY DESIGN AND PROCEDURES 
Human Subjects Involvement: The proposed study is a randomized, controlled trial focused 
on a high-risk ED population with evidence of moderately elevated blood pressures (≥140/90 
and ≤180/110). 770 ED patients (predominately African-American and Latino patients, based 
upon the demographics of the UI Health patient population) will be randomized to one of two 
arms: 1.) usual care (preprinted discharge instructions and a 48-72 hour referral to our FQHC 
program or assigned provider as appropriate) or 2) the ED-initiated Educational and 
Empowerment (E2) intervention and PACHTc intervention followed by 48-72 hour referral 
to our FQHC (or assigned health center). There will be 385 subjects in each arm.  
 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
7 of 28
Figure 1. Study Design 
 
The E2 intervention (arm 2) consists of a series of risk assessment tools (surveys, video, and 
minimally invasive bedside assessments) designed to be efficient, patient-centered and 
educational for participants in an emergency department setting. Through the intervention, 
participants will learn more about hypertension management and secondary complications 
associated with uncontrolled BP, such as subclinical heart disease.   
Subclinical heart disease refers to the presence of early echocardiogram changes seen on limited 
beside echocardiograms often as a result of uncontrolled hypertension. These changes include 
diastolic dysfunction and left ventricular hypertrophy. Many of these changes can be reversible 
with hypertension control. Study participants will not be diagnosed with subclinical heart disease 
in the ED. Instead participants will be shown limited bedside echocardiogram video clips of 
gender matched echocardiograms with subclinical changes as a part of an empowerment tool of 
the study. 
 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
8 of 28
Using Atherosclerotic Cardiovascular Disease (ASCVD) risk score calculators preloaded on 
study iPads, participants will have their risk score calculated by entering their age, tobacco status 
(Y/N), Systolic BP, Cholesterol/HDL, and BP treatment (Y/N). Point of care cholesterol/HDL 
measurement will be obtained using the Polymer Technology Systems CardioCheck PA 
Analyzer, which analyzes up to 4 cholesterol types with a single fingerstick of blood and is 
CLIA-waived and FDA approved. Trained nurse practitioners and emergency medical 
technicians will be performing the cholesterol tests. 
Additionally, all participants in arm 2 will receive a Post-Acute Care Hypertension Transition 
Consultation (PACHTC) with a clinical pharmacist or APN. To ensure consistency throughout 
the trial, the PACHTC will be standardized and interchangeable between the clinical pharmacists 
and APNs. During the day, the on-site ED clinical pharmacist will provide consultations. During 
evening and weekend hours, consultations will be provided by the APN located in the ED 
Clinical Decision Unit (CDU).   
Finally, all participants randomized to arm 2 will receive an FDA-approved HBPM kit that 
includes the Nokia wireless (self-inflating) BPM monitor and Health Mate mobile app. 
Participants without a mobile device will be provided one for the study.  
The app automatically launches when the patient slips on the cuff and turns on the monitor to 
measure his/her BP. All BP readings automatically sync with the app, which creates an easy-to-
understand chart of all the measurements and provides participants with instant color-coded 
feedback based on AHA recommendations for hypertension. Synced data are automatically 
uploaded from the mobile app to the iCardia server of our study.  
Participants will be shown how to use the BP monitor and app by a clinical EMT, view a 
standardized 2-minute instructional video, and asked to confirm/demonstrate that they 
understood how to use the device and app using the teach-back method prior to leaving the ED. 
Participants will be asked to check their BP at home, preferably daily but a minimum of twice 
per month, and use the mobile app to view their data. The EMT  will set-up daily or bi-weekly 
automatic reminders in each participant’s mobile app that will prompt them to measure their BP 
at a preferred time.  

TOUCHED_Protocol_Version 1.8, 05/10/2022 
9 of 28
In case of missed measurements for 1 consecutive week, participants will receive one text-
message per day through the iCardia platform for four consecutive days until they complete a BP 
measurement. In case of missed measurements for 14 consecutive days, participants will be 
contacted by phone by the RA’s. All data will be remotely monitored by the RA’s through the 
iCardia platform. The patient-centered benefit of HBPM monitoring has been repeatedly shown 
and is recommended as an important component of HTN management. HBPM has been shown 
to improve adherence to medications, induce healthy lifestyle changes, and aid in optimizing of 
treatment. In addition, use of the HBPM values will serve as a safety feature to avoid pushing BP 
too low in study participants.  
Additionally, participants will be sent behavioral change text messages. The text messages come 
from a pool of validated messages chosen by the investigators. They promote medication 
adherence and BP measurement adherence. The message database will be submitted along with 
this document. Participants will receive 3 behavioral text messages per week at a time of their 
preference, in addition to the app notifications they receive each day to monitor their blood 
pressure. Text messages will be programmed in iCardia by research staff. 
The Usual Care group (Arm 1) will received preprinted discharge instructions and an outpatient 
referral.  This group represents standard of care.  All other interventions in arm 2 are research 
activities. 
Table 1: Intervention Components by Arm * 
Arm 1: Usual Care (N=385) 
Arm 2: E2 Intervention (N=385) 
Intervention Components by Arm 
Baseline 
Quarterly 
Mid-point 
End 
Location 
ED 
Phone 
UI-Health 
Suite 1600 
UI-Health 
Suite 1600 
Time Point in Months (0=ED discharge) 
0   
1, 3, 5 
3 
6 
Duration  
10-20 min 
5 min 
10-20 min 
20 min 
BP Measured 
1, 2 
 
1, 2 
1, 2 
Clinical Data (from med chart) 
1, 2 
 
 
 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
10 of 28
Atherosclerotic Cardiovascular Disease 
(ASCVD) Risk Score 
1,2 
 
 
1,2 
Hypertension Knowledge Assessment 
1, 2 
 
 
1, 2 
Modified Morisky Scale 
1, 2 
1, 2 
1, 2 
1, 2 
Patient Activation Measurements Survey 
(PAM) 
1, 2 
1, 2 
1, 2 
1, 2 
Verify patient contact info 
1, 2 
1, 2 
1, 2 
 
Bedside Echocardiogram Education 
2 
 
 
 
Hypertension Education Video 
2 
 
 
 
PACT-Hypertension (Pharmacy) 
Consultation:  
2 
 
 
 
Home BP Monitoring Training and 
Reminders 
2 
2 
2 
 
*We may ask participants to return for a follow up at one year post-enrollment at which time all 
assessments and surveys performed at recruitment will be repeated.    
 
Details of ED Screening (risk assessment, both arms) 
BP Measurement: Prior to randomization all participants will be screened using a standardized 
5- point pain scale with 5 indicating severe pain and 0 no pain. Participants with moderate to 
severe pain (3-5) will not be randomized until their pain scale is improved (0-2). Participants will 
then have a standard BP measurement taken (as per AHA guidelines) to ensure consistency and 
standardization of BP measurements throughout the trial.  
The blood pressure measurements will be obtained using standard monitors currently available in 
our Emergency Department: Welch Allyn,  Model VSM 6000 series, Configuration Number: 
NIBP, Pulse Rate, SPO2, Temp, Hardware Version P3, Software Version 1.71.03.  
The blood pressure measurement protocol based on the AHA guidelines are as follow: 
1. The patient will be asked to remove all clothing that covers the location of cuff 
placement. 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
11 of 28
2. The individual will be comfortably seated, with the legs uncrossed, and the back and arm 
supported, such that the middle of the cuff on the upper arm is at the level of the right 
atrium (the mid-point of the sternum). 
3. The patient will be instructed to relax as much as possible and to not talk during the 
measurement procedure. The patient will be asked to sit quietly for 5 minutes before the 
first reading is taken. 
4. A minimum of three readings will be taken and the average of the last two readings will 
be used to record the measurement. There will be intervals of at least 1 minute between 
readings.  
5. If there is >4 mm Hg difference between the second and third readings, additional (one or 
two) readings will be obtained and then the average of the two closest readings will be 
used. 
Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score: Using ASCVD Risk Score 
calculators preloaded on study iPads, participants will have their risk score calculated by entering 
their age, tobacco status (Y/N), Systolic BP, Cholesterol/HDL, and BP treatment (Y/N). Point of 
care cholesterol/HDL measurement will be obtained using the Polymer Technology Systems 
CardioChek PA Analyzer, which analyzes up to 4 cholesterol types with a single fingerstick of 
blood and is CLIA-waived and FDA approved. 
Hypertension Knowledge Survey (all arms): 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.  
Modified Morisky Scale Health Survey and Patient Activation Measurement Survey (PAM) 
(all arms): The modified Morisky scale is a validated 4-item instrument to assess self-reported 
patient adherence related to antihypertensive medication. The modified Morisky scale provides a 
total score with a range of 0 to 4, with higher scores indicating lower adherence to medication. 
The scores of the modified Morisky scale can be classified as low compliers (3-4), medium 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
12 of 28
compliers (1-2) and high compliers (0) based on its criterion validity with BP control. The 
Patient Activation Measurement Survey (PAM) is a 10-item instrument that measures level of 
engagement (activation) and has been used and validated in HTN interventions with higher 
scores meaning better self-care behaviors. The surveys will be administered by RAs at the time 
of enrollment and at 3, 6, and 12 months during the in-person visit.  
Details of Intervention Components 
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. Based upon the 
existing literature overall HTN knowledge is extremely low among minority populations. 
Participants will review a 3-5 minute video on HTN, The customized video will be bi-lingual and 
culturally sensitive. After the video participants will complete a short touch-screen self-
assessment with real-time computerized feedback.  
Visual Echocardiogram Image Clips:  We are using visual images of gender-matched 
echocardiograms as a tool to educate and motivate patients to change their behavior to improve 
their BP.  We have found that the 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 a previous pilot study. (Figure 2) 
 
 
Figure 2. Images of a patient with mild to moderate diastolic dysfunction as evidenced by a normal E/A 
ratio, but an e’ lateral mitral valve annular velocity < 10 cm/s.  Patients are better informed about 
consequences of untreated HTN when they can visualize the effects of HTN on the heart. 
Smartphone-enabled BP monitoring Kit: All participants randomized to the intervention group 
will receive an FDA-approved home BP monitoring kit that includes the Nokia wireless (self-
inflating) BPM monitor and Health Mate mobile app. The app automatically launches when the 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
13 of 28
patient slips on the cuff and turns on the monitor to measure his/her BP. All BP readings 
automatically sync with the app, which creates an easy-to-understand chart of all the 
measurements and provides participants with instant color-coded feedback based on AHA 
recommendations for hypertension. Synced data are automatically uploaded from the mobile app 
to the iCardia server of our study. Participants will be shown how to use the BP monitor and app 
by RAs, view a standardized 2-minute instructional video and asked to confirm/demonstrate that 
they understood how to use the device and app using the teach-back method prior to leaving the 
ED. Participants will be asked to check their BP at home daily and use the mobile app to view 
their data. The EMT’s will set-up daily automatic reminders in each participant’s mobile app that 
will prompt them to measure their BP at a preferred time. In case of missed measurements for 
three consecutive days, participants will receive one text-message per day through the iCardia 
platform for four consecutive days until they complete a BP measurement. In case of missed 
measurements for 7 consecutive days, participants will be contacted by phone by the RA’s. 
Participants will also receive 3 behavioral text messages per week that are aimed at improving 
medication adherence and BP measurement adherence. All data will be remotely monitored by 
the RA’s through the iCardia platform. Participants will be informed that the Health Mate app is 
not a telemonitoring app and in the event the participant is experiencing a hypertensive crisis 
(>180/120) they must contact a physician immediately. The patient-centered benefit of home BP 
monitoring has been repeatedly shown and is recommended as an important component of HTN 
management. Home BP monitoring has been shown to improve adherence to medications, induce 
healthy lifestyle changes, and aid in optimizing of treatment. In addition, use of the home BP 
monitoring values will serve as a safety feature to avoid pushing BP too low in study 
participants. 
 
PACHT-c: All participants randomized to the E2 intervention will have a focused consultation 
with either a clinical pharmacist or an APN.  To ensure consistency throughout the trial, the 
PACHT-c intervention will be standardized and interchangeable between the clinical pharmacists 
and APNs. During the day, the on-site ED clinical pharmacist will provide consultations. During 
evening and weekend hours, consultations will be provided by the APN located in the ED 
Clinical Decision Unit (CDU).  The CDU is open 24 hours a day, 7 days a week. During this 
consultation, the pharmacist/APN repeats the BP measurement; reviews the screening 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
14 of 28
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 
regarding initiation of first-line antihypertensive medications.  Patients with BP ≥140/90 mmHg 
may be started on antihypertensive medications by the provider during the consultation if 
appropriate. All PACHT-c clinic notes will be accessible in the EMR, which is shared between 
both the ED and our FQHC, Mile Square Health Center. No tests will be ordered during the 
pharmacy follow-up. 
 
Based on our pilot trial (IRB Protocol # 2015-0323) the E2 intervention takes about 20-30 
minutes following randomization. Once patients are identified for discharge, the wait time before 
physically leaving the ED provides ample time to consent and complete the initial assessments 
based on participant randomization at the bedside without adding delays. Participants will be 
approached for study participation after they have been identified for discharge and BEFORE 
being physically discharged from the ED. 
 
Details of Additional Program 
Components:  
iCardia 
& 
Remote 
BP 
Monitoring: iCardia is a secure 
password-protected 
remote 
monitoring system hosted in a 
HIPAA-compliant server at UI 
Health. iCardia provides a user-
friendly environment for authorized personnel to view participants’ BP readings in real-time in the 
form of graphs and send personalized text-messages to participants’ cell phones (as needed) 
through the Twilio communication platform (Figure 3). RAs will receive training on iCardia and 
schedule messages for study participants regarding appointments, medications, and goals. Text 
messages can be sent immediately, recurrently (e.g. daily), or at a scheduled date/time to one or 
more participants. All communications utilize Transport Layer Security with encryption. 
Addressing “White Coat HTN”:  It has been suggested that a “white coat effect” (increase in BP 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
15 of 28
primarily in the medical care environment) can be present in as many as 20-33% of patients 
diagnosed with HTN. The use of wireless BP monitors with remote monitoring will address this 
issue and ensure that this is not a significant confounder in our study population. Following 
enrollment, subjects will be asked to check their BPs daily.  
Study Coordinator: The study coordinator will be responsible for overseeing the 48-72 hour HTN 
outpatient referrals for all study participants and track compliance with follow-up appointments 
using a combination of EMR review and participant self-report. The study coordinator will also 
assist with transportation concerns, fax PACHT-c letters to non-UI Health providers, and be 
trained to use the Open Access scheduling system for selected FQHCs to facilitate appointment 
scheduling.  
Illinois Video Interpreter Network (IVIN) (all arms): Translators versed in healthcare 
terminology are available by video 24 hours a day. In the rare circumstance that a Spanish-speaking 
study staff member is not available, the IVIN system will be employed to facilitate communication 
with the participant both at enrollment in the ED and during the PACHT-consultation.  
Patient In-Person Clinic Follow Ups (all arms): Following enrollment and randomization, there 
will be up to three additional in-person visits at 3 and 6-months for BP measurements. Staff 
will be blinded to study arm assignment.  These repeat visits will occur in the PACTH-c space 
(adjacent to the ED in Suite 1100 of the hospital) and be conducted by trained RAs using study 
protocols and the AHA guidelines. 
Participant Retention (all arms): Attrition is a challenge for follow-up data collection, particularly 
in underserved populations. We plan to use several strategies including: 1) monetary 
reimbursement for in-person data collection ($50 for their 3 month follow up and $50 for their 6 
month follow-up post-randomization); $50 will also be given to participants in the event they are 
asked to return in 1 year); $100 for participants that miss their 3 month follow-up but come in for 
their 6 month follow-up ($50 for missed 3 month and $50 for 6 month which is main outcome); 2) 
periodic phone calls to verify address and phone data (at 1, 3, 5, 6, 9, and 11 -months post-
enrollment); 3) use of secondary alternative contact information; 4) text messaging 24 hours prior 
to follow-up appointments; 5) mailing birthday/holiday cards; and 6) monthly newsletters 
containing recruitment updates. Co-Investigator Daviglus has demonstrated success in participant 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
16 of 28
retention in numerous studies involving high-risk populations with attrition rates between 8-10%. 
In our R56 trial (IRB protocol # 2015-0323), we had a final attrition rate of 25% (9-month follow-
up) due to transportation difficulties and loss of phone contact. To limit the attrition rate for this 
proposal, we will provide ride share, public transit, and parking vouchers as needed, and will 
provide smartphones to Arm 2 study participants without phones. Geocoding of our patient 
population demonstrated that the majority of individuals live within a 5-10-mile radius of UI 
Health. We are confident that these retention strategies will limit our attrition rate to no more than 
20%.  
Assessment of Impact of Intervention on the Racial Disparity Associated with Uncontrolled 
HTN and Mediating Factors (Aim 3): We will examine whether the intervention reduces racial 
disparities associated with uncontrolled HTN, i.e. is this intervention as effective in ethnic 
minorities as non-minorities. This will be an exploratory analysis and will primarily focus on 
changes in cardiovascular risk score. In addition, we will measure two potential mediating 
factors multiple times during the trial: 1) adherence to follow-up visits, and 2) the Modified 
Morisky Scale. All participants will receive phone calls at predetermined times to determine 
primary care engagement. All communication will be scripted and include: 1) whether follow-
up visits with the PCP have occurred or are scheduled; and 2) the Modified Morisky Scale to 
assess current HTN medication use and understanding. The appropriate surveys will be 
administered by RAs at the time of enrollment, by phone at 1 and 5 months, and at 3 and 6 
months during the in-person visit. Shorter calls will be made at 2, 5, and months to schedule the 
3 and 6-month appointments.   
Research Material:  
All research materials obtained during the course of this study will be for research purposes. The 
materials that will be obtained from the human subjects that participate in this study are blood 
pressure measurements, as well as assessments on medication adherence, HTN knowledge, and 
patient activation. 
New Data:  

TOUCHED_Protocol_Version 1.8, 05/10/2022 
17 of 28
Demographic data and blood pressure data, both provider-obtained and/or from patient-recorded 
home measures, will be obtained for all participants. New data will also include level of 
medication adherence, hypertension knowledge, and ASCVD risk score. 
Linkages to Subjects:  
All information collected in this study is confidential and all data will be transformed into 
anonymously-coded identifiers for each subject prior to analysis. We use a double coding system 
to maintain the confidentiality of information. Only Dr. Prendergast (PI) and study personnel 
will be able to link information to subjects. This is necessary because patients will be followed 
for a total of six months after discharge so participants will need to be tracked during this time.  
All data will be stored electronically on REDCap.  
For Specimen Collection Studies  
We will collect a single fingerstick of blood to measure HDL cholesterol levels for the ASCVD 
risk score.  
For Studies that Collect Existing or Prospective Data  
Prospective data to be collected from all subjects include blood pressure measurements. Subjects 
in the E2 intervention will have a series of risk assessment tools designed to be efficient, patient-
centered and educational for participants in an emergency department setting. Through the 
intervention, participants will learn more about hypertension management and complications 
associated with uncontrolled BP.   
Study data will be maintained for 7 years post study completion and then will be destroyed. 
7.0 
EXPECTED RISKS/BENEFITS 
 
Potential Risks: 
The potential risks associated with this study are: (1) The potential for loss of privacy or 
confidentiality of health information.  (2) Possible discomfort with assessments, however all  
measures are noninvasive with the exception of a single fingerstick of blood for the ASCVD risk 
score, so little discomfort is expected. (3) For the group that receives the Smartphone-enabled 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
18 of 28
Blood Pressure Monitoring Kit (group 2), participants may potentially feel annoyed or irritated 
with the frequency of notifications and/or text-message reminders they receive. For the app 
notifications, participants will have the option of turning off the notifications or change their 
frequency. The Research Assistants will show participants how to do this when they set up the app 
on the participant’s phone. For the text-messages, participants will have two options; the first 
option is to contact the research staff and ask them to reduce the number of text-messages they 
receive. The second option is to reply to one of the text-messages with the word “STOP”. Our 
system will automatically stop sending text-messages after that. However, if participants want to 
re-subscribe, they can reply with the word “START” and the text-messaging program will resume. 
 
Alternative Treatments/Procedures: 
Patients that decide not to enter this study will be informed that there is other care available, such 
as a referral to see a primary care doctor at the Mile Square Health Center. The study research 
assistant will discuss these options with the patient and let them know that they do not have to be 
in this study to be treated for hypertension. 
Potential Benefits of Proposed Research to Subjects and Others:  
Subjects may not directly benefit from participation in the research. Indirect benefits include 
expansion of risk assessment intervention to include emergency departments.  
 
Importance of the Knowledge to be Gained:  
Uncontrolled hypertension contributes significantly to cardiovascular morbidity and mortality and 
is more frequently encountered among patients presenting to the emergency department (ED), 
which serves as the point of entry into the health care system for many high-risk patient 
populations, particularly minorities.  If our results are as expected, our clinically relevant study 
has the potential to provide new insights into increasing motivation, follow-up rates, and 
consequently, treatment compliance and blood pressure control in a predominately underserved 
hypertensive population. 
 
8.0 
DATA COLLECTION AND MANAGEMENT PROCEDURES 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
19 of 28
Data Characteristics:  
All data forms will be initially developed and tested on paper; Spanish language versions of 
participant questionnaires will be prepared and back-translated to English prior to obtaining certified 
translations; after thorough pilot testing, paper forms are to be converted to equivalent electronic 
data entry forms with use of REDCap. REDCap (Research Electronic Data Capture) is a secure, 
web-based application designed to support data capture for research studies, providing: 1) an 
intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources.  At UI Health, REDCap is 
hosted on secure servers located in and supported by the Institute for Health Research and Policy 
(IHRP).  Project staff will be trained in the use of REDCap for entry of study data.  Appropriate logic 
and limits checking (including cross-form validity checks) will be implemented in REDCap to 
facilitate accurate and consistent data entry.  Where practical, study data will be directly entered into 
the REDCap database by clinical staff.  Alternatively, information can be captured on paper and 
entered into the system from the forms.  Routinely throughout the study the REDCap database will 
be downloaded into a secure virtual computing environment (virtual servers and virtual workstations 
secured behind software and hardware firewalls) available through the IHRP.  Study information 
within the virtual environment will be available for participant tracking activities such as production 
of result and reminder letters, scheduling of interim telephone contacts, and scheduling and tracking 
of follow-up visits.  Regular quality control and data cleaning/ error reports will be produced which 
identify missing, out of range, and questionable values.  These reports will be reviewed with study 
staff every two weeks.  Errors will remain on reports until they are resolved.  Statistical analyses 
prior to the 3, 6, and 12- month outcome evaluations will be limited to quality control, enrollment 
and drop out reporting and participant demographics.  No interim looks are anticipated but quality 
control and data entry errors and omissions will be continuously monitored and reported to staff for 
remediation.   
9.0 
DATA ANALYSIS 
Data Analysis will be performed by Dr. Ramon Durazo-Arvizu at the Institute for Minority 
Health Research at the University of Illinois Chicago and Dr. Sally Freels. 
 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
20 of 28
10.0/11.0 
QUALITY CONTROL AND QUALITY ASSURANCE & DATA AND 
SAFETY MONITORING 
The research project is a two-arm randomized clinical trial that includes a single site.  This is an 
uncomplicated, blinded trial, and the risk is considered to be minimal. The University of Illinois 
at Chicago (UIC) Institutional Review Board (IRB) will review and approve the research before 
the research is conducted and an IRB-approved data and safety monitoring plan will be 
documented.  Due to the vulnerable study population and the immediate public health impact, a 
Data Safety and Monitoring Board (DSMB) will be assembled to ensure the safety of the subjects 
and the validity and integrity of the data generated.   
Therefore, the PI and the PI’s research team have primary responsibility for monitoring subject 
safety. The PI is responsible for minimizing research-associated risk. This is done through 
continuous monitoring of the procedures and through weekly research team meetings. Three 
senior individuals with expertise in hypertension and clinical trials, external to the research team 
will serve on the DSMB. Dr. Prendergast, in consultation with the DSMB, will report any 
adverse events to the Funding Institute and Center. We will attempt to determine the cause of the 
adverse event and make a determination as to whether the adverse event was related to any 
study-related activity. When appropriate, we will make changes to the informed consent 
document and/or study protocol resulting from an adverse event.  The following is a list of 
Adverse Event descriptors that will serve as a guideline to notify IRB and DSMB review boards 
in the event any TOUCHED study participants experience abnormal symptoms or conditions.  
Table 2: Adverse events descriptors 
Study Related Adverse Events 
Symptoms or Condition 
Expanded Comments on Symptom or Condition 
Rash/itching 
Covers rash, itching, hives, flushing or similar change in 
skin.  Do not report if symptoms are related to contact with 
an allergen such as poison ivy or oak. 
Angioedema 
Covers swelling of the lips, face or tongue. 
Cough 
 
Use only for a new cough that is not related to a cold, other 
infection or seasonal allergy and that follows initiation of a 
new medication. 
Lower extremity edema 
Swollen legs or lower extremity edema that is new in onset 
or substantially worse than usual for the subject. 
Lightheadedness or passing 
out 
Lightheadedness, dizziness, passing out, or loss of 
consciousness  
Orthostatic hypotension 
Orthostatic hypotension (that is not chronic)  

TOUCHED_Protocol_Version 1.8, 05/10/2022 
21 of 28
Hypertensive urgency 
As indicated by the average blood pressure found at a study 
visit or a single BP found during a clinic visit that occurred 
since the last study visit 
Non-study Related Adverse Events 
Symptoms or Condition 
Expanded Comments on Symptom or Condition 
Fever 
 
Do not report if fever is related to a cold or viral infection. 
Rhythm disorder 
Covers any new rhythm disorder such as tachycardia or a 
racing heartbeat that is not typical for the subject. 
Chest pain 
Covers any new development or worsening of chest pain 
that does not reflect stable angina. 
Headache 
Do not report if subject has a history of frequent headaches. 
Other pain 
Other pain that is not related to an injury or chronic 
condition. 
Shortness of breath 
Covers shortness of breath, wheezes, stridor, and gasping 
for breath that is not typical for the subject. 
Weight gain 
Use for new and unintended weight gain with sudden onset, 
e.g., related to CHF. 
Kidney problem 
 
Covers a new or worsening kidney problem such as acute 
renal failure or a 20% increase in creatinine level; do not 
report a kidney infection. 
Liver problem 
Covers a new or worsening liver problem such as an 
increase in one or more liver function tests to > 2 times 
normal. 
Nausea or vomiting 
Do not report instances related to influenza, other infection 
or food poisoning. 
Other GI problem 
Use only for a new GI problem such as diarrhea, 
constipation, cramping or abdominal pain that is not related 
to influenza, other infection or food poisoning; do not use to 
report nausea or vomiting  
Neurological change 
Use only for a new or worsening neurological change, such 
as tingling in hands or feet 
Trouble walking or falls 
Trouble walking or falls 
Urinary problem 
Urinary problem such as urgency or frequency that is not 
related to infection 
Blood disorder 
Bleeding that is not related to or a blood dyscrasia such as 
leucopenia or thrombocytopenia 
Change in lab values 
Change in lab values related to a drug side effect such as a 
marked drop in potassium or sodium or a marked increase 
in serum creatinine. 
Weakness 
Covers new onset or worsening of weakness, fatigue, 
lethargy or other marked decrease in strength 
Other 
 
CHECK WITH HEATHER PRENDERGAST BEFORE 
USING THE ‘Other’ DESCRIPTOR 
In the event the “Other” descriptor is to be used to report a specific symptom that is not on the 
list above the Principal Investigator, Heather Prendergast, must be consulted. 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
22 of 28
 
The PI is also responsible for protecting the confidentiality of subjects’ data. All documents and 
information about this study will be kept confidential in accordance with federal, state, and local 
laws and regulations. Medical records and data generated by the study may be reviewed by the 
UIC Institutional Review Board, the Office for Human Research Protections, and the National 
Institutes of Health to assure proper conduct of the study and compliance with federal regulations. 
The results of this study will be published. If results are published, no subject will be identified by 
name. 
The following procedures are in place:  
• 
We do not collect any subject identifiers that we do not need.  
• 
We remove/destroy subject identifiers as soon as they are no longer needed.  
• 
We restrict physical access to any area or computer system that contains subject identifiers.  
• 
Restrict electronic access to any computer system that contains subject identifiers.  
• 
Subject identifiers are stored electronically via REDCap and will not be exported with research 
data that is analyzed. All information collected in this study is confidential and all data will be 
transformed into anonymously coded identifiers for each subject prior to analysis.  
• 
Subject identifiers and contact information are never distributed outside of University of Illinois 
at Chicago.   
 
12.0 
STATISTICAL CONSIDERATIONS 
Outcomes, Analysis Methods and Sample Size 
Statistical Analysis Plan: Outcome analyses will be conducted within the UIC Institute for 
Minority Health virtual environment. Descriptive statistics will be used to assess completeness of 
study data, normality of outcome measures, and potential covariates as well as to identify 
potential covariate imbalances between study arms. Based on our pilot study work and our 
protocol, which emphasizes repeated telephone contacts with participants’ post-baseline, we 
anticipate relatively low loss to follow up at 3 and 6 (at most 20%). For the primary analysis of 
each study hypothesis we will initially adopt an “intention to treat”, (ITT) modality. We will 
apply the independent samples t-test and Chi-squared test to compare key measures between 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
23 of 28
treatment arms to ascertain balancing of important measures that may have an influence on the 
outcome variables. All statistical analysis will be conducted using SAS 9.4 (SAS Institute Inc., 
Cary, NC, USA) and R version 3.3.1.A brief description of the analytical plan by specific aim 
follows: 
Aim 1: Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c intervention 
(arm 2) on the primary outcome of mean SBP difference at 6 -months post-intervention 
compared to usual care (arm 1). 
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 12-months and mean 
DBP differences at 6 months post-intervention compared to usual care. 
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 
 
Aim 1: We hypothesize that the mean change in SBP at 6 months after randomization will be 
higher in the intervention arm compared to usual care. Linear regression models will be used to 
compare change in continuous BP between treatment arms at 6 months; mixed effects linear 
regression models will be used to combine the two-time points into a single model. 
Aim 2: We hypothesize that the mean change in SBP and DBP at 3 and 12 months and mean 
DBP at 6 months after randomization will be higher in the intervention arm compared to usual 
care. Linear regression models will be used to compare change in continuous BP between 
treatment arms at 3 months and DBP at 6 months; mixed effects linear regression models will be 
used to combine the two-time points into a single model. 
Aim 3: Change in the cardiovascular risk score at 3 and 6 months will be analyzed to assess 
racial disparity by testing the interaction between a binary indicator of treatment group and a 
binary indicator of minority versus non-minority.  The distribution of change scores will be 
examined to determine whether linear regression is appropriate; if not, ordinal categories will be 
defined and proportional odds logistic regression will be used.  Models will be fit at each of 3 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
24 of 28
and 6 months, and mixed-effects models will be used to combine the two-time points into a 
single model. 
Handling Missing Data: For the missing data analysis an ITT will be implemented. Furthermore, 
missing data will be handled by using a mixed-effects model approach, which assumes that the 
data is missing at random and hence will not bias the analysis. If we determine that data may not 
be randomly missing and thus non-ignorable then two well accepted approaches to handle this 
situation will be implemented, namely selection models and pattern mixture models.  
Other Statistical Considerations: Sampling balance for the key predictors will be checked and 
adjusted for in the analysis, and their mediating and moderating effects will be examined if 
needed.  We address power for Aims 1 and 2 for unadjusted tests.  Adjustment for covariates will 
decrease power slightly by using up degrees of freedom, but the adjustment will also create more 
accurate estimates, so the expected power will be similar.  
 
Sample Size: The primary 
hypothesis of the study is 
that the difference in 
systolic blood pressure from 
baseline to month 6 is 
different across the two 
treatment arms. Testing this 
hypothesis amounts to 
testing difference in mean 
systolic blood pressure 
between the two treatment 
groups at 6 months, due to 
randomization (since the 
mean SBP at baseline is the 
same across groups). Thus, 
sample size estimation is 
determined by comparing 
the mean SBP at 6 months using a two-sample, two-sided, 5% significance t-test with 80% and 
Effect Size 
80% Power 
85% Power 
 
Standardized 
mmHg* 
Sample Size 
Sample Size 
 
DBP SBP 
N 
N** 
N 
N** 
0.20 
2.40 
4.20 
786 
1049 
898 
1198 
0.25 
3.00 
5.25 
504 
673 
576 
769 
0.30 
3.60 
6.30 
350 
467 
400 
534 
0.35 
4.20 
7.35 
258 
345 
294 
393 
0.40 
4.80 
8.40 
198 
265 
178 
238 
0.45 
5.40 
9.45 
156 
209 
178 
238 
0.50 
6.00 
10.5 
126 
169 
144 
193 
*Effect size is defined as difference in means divided by 
standard deviation. From our pilot study: DBP Standard 
deviation 12 mmHg; SBP Standard Deviation 21 mmHg. 
**25% attrition is assumed and thus required sample size, 
N**, is obtained by dividing calculated sample size, N, by 
0.75. 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
25 of 28
85% statistical power. Sample size is calculated first to detect a pre-determined effect size 
(difference in means divided by standard deviation) and then converted to blood pressure units, 
namely mmHg.  Data from out pilot study resulted in estimates of DBP standard deviation of 12 
mmHg and SPB standard deviation of 21 mmHg. For example, the required sample size to detect 
an effect size of 0.25 (0.25*12 = 3 mmHg in DBP, and 0.25*21 = 5.25 mmHg in SBP) is 504 for 
80% power and 576 for 85% power, using a two-sided, two-sample 5% significance t-test. An 
attrition-adjustment to the calculated sample size give 673 and 770 patients for 80% and 85%, 
respectively. 
 
The statistical analysis: Mean BPs will be compared across groups using a two-sample, two-
sided, 5% significance t-test. The analysis will be then extended to gain statistical power by 
adjusting the comparison by baseline BP levels. An intention-to-treat analysis will be 
undertaking by using mixed effects models so that all the available information on each patient is 
used for the analyses. Further analyses using maximum likelihood estimators for data imputation 
and weighting will be implemented to better account for missing data. Moreover,  
key variables (age, sex, race/ethinicity) will be compared across treatment groups and if different 
will be used in a multivariate mixed effects model. 
 
Patient Accrual: Using the UI Health Enterprise Data Warehouse (EDW), a report was 
developed to estimate how many patients seen in the ED had elevated BP (Stage 1 ≥140/90 
mmHg). The sampling was conducted from April 1, 2014 to December 31, 2014 (9 months). 
During the sampling period, 8,021 patients had BP readings of at least 140/90 mmHg (29.16 
patients per day) as the final ED BP measurement. Approximately 69% of these patients were 
discharged. The proposed study requires enrollment of 13.9% (770/5534) of potentially eligible 
UI Health patients over a 4-year period. We are confident that we can meet our recruitment 
goals. 
 
Data Management: Electronic data entry will utilize REDCap (Research Electronic Data 
Capture). REDCap is a secure, web-based application providing data quality control through 
validation options, audit trails and user access controls. Study information within the virtual 
environment will be available for participant tracking activities. Data quality related to the entry 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
26 of 28
process can be controlled by programming REDCap validation options. Tracking reports will be 
reviewed with study staff every two weeks. Statistical analyses prior to the 3, 6, and 12-month 
outcome evaluations will be limited to quality control, enrollment and dropout reporting, and 
participant demographics. No interim looks are anticipated, but quality control and data entry 
errors and omissions will be continuously monitored and reported to staff for remediation. Many 
of the needed REDCap forms for the TOUCHED proposal were already developed for use for 
the R56 pilot study. 
 
 
13.0 
REGULATORY REQUIREMENTS 
13.1 
Informed Consent  
Written informed consent will be obtained from all subjects who present to the ED with 
eligibility criteria, namely elevated blood pressure consistent with stage I hypertension 
(≥140/90).  Patients will be shown a consent video to better streamline and standardize 
explanation of the study.  Consent will be obtained from all subjects interested in participating 
after the entire study and its risks and hazards have been discussed and all of the subject's 
questions have been answered.  Consent will only be obtained by study staff who have 
completed Human Subject Research Protection training.  In order to minimize the possibility of 
coercion or undue influence on potential subjects, subjects will only be approached for study 
consent after they have completed their evaluation in the emergency department and have been 
identified for discharge.  Subjects will also be informed that participation is voluntary and will 
not affect their relationship with the university/hospital if they decline to participate. Also, 
patients that are being cared for by the PI or key personnel will not be approached and consented 
by that individual but rather another member of the study team. Subjects will initially be 
identified by review of the tracking board listing in the department. The tracking board displays 
the patients' last name, room number, age, and vital signs. If patients meet the BP requirement 
(BP ≥140/90) and are slated for discharge from the emergency department, then the study 
personnel will approach the attending physician caring for the patient for preliminary review of 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
27 of 28
exclusion criteria. At no time during enrollment will any information be placed in the subjects' 
medical record. 
 
All information collected in this study is confidential and all data will be transformed into 
anonymously-coded identifiers for each subject prior to analysis. We use a double coding system 
to maintain the confidentiality of information. Only Dr. Prendergast (PI) and study personnel will 
be able to link information to subjects. This is necessary because patients will be followed for a 
total of one year after discharge so participants will need to be tracked during this time. All data 
will be stored electronically on REDCap.  
Data Characteristics:  
All data forms will be initially developed and tested on paper; Spanish language versions of 
participant questionnaires will be prepared and back-translated to English prior to obtaining 
certified translations; after thorough pilot testing, paper forms are to be converted to equivalent 
electronic data entry forms with use of REDCap. REDCap (Research Electronic Data Capture) 
is a secure, web-based application designed to support data capture for research studies, 
providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data 
manipulation and export procedures; 3) automated export procedures for seamless data 
downloads to common statistical packages; and 4) procedures for importing data from external 
sources.  At UI Health, REDCap is hosted on secure servers located in and supported by the 
Institute for Health Research and Policy (IHRP).  Project staff will be trained in the use of 
REDCap for entry of study data.  Appropriate logic and limits checking (including cross-form 
validity checks) will be implemented in REDCap to facilitate accurate and consistent data entry.  
Where practical, study data will be directly entered into the REDCap database by clinical staff.  
Alternatively, information can be captured on paper and entered into the system from the forms.  
Routinely throughout the study the REDCap database will be downloaded into a secure virtual 
computing environment (virtual servers and virtual workstations secured behind software and 
hardware firewalls) available through IHRP.  Study information within the virtual environment 
will be available for participant tracking activities such as production of result and reminder 
letters, scheduling of interim telephone contacts, and scheduling and tracking of follow-up visits.  
Regular quality control and data cleaning/ error reports will be produced which identify missing, 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
28 of 28
out of range, and questionable values.  These reports will be reviewed with study staff every two 
weeks.  Errors will remain on reports until they are resolved.  Statistical analyses prior to the 3 
and 6-month outcome evaluations will be limited to quality control, enrollment and drop out 
reporting and participant demographics.  No interim looks are anticipated but quality control and 
data entry errors and omissions will be continuously monitored and reported to staff for 
remediation. 
13.2 Subject Confidentiality 
The PI is responsible for protecting the confidentiality of subjects’ data. All data will be entered 
into electronic database (REDcap). There will be no paper charts/data entry. This will minimize 
the potential for loss of information and breech of privacy.  All of this information will be 
handled in accordance with HIPAA guidelines.  
Patient confidentiality will be maintained through secured, password protection computerized 
data collection.  All documents and information about this study will be kept confidential in 
accordance with federal, state, and local laws and regulations. Medical records and data 
generated by the study may be reviewed by the UIC Institutional Review Board, and The 
Office For Human Research Protections, to assure proper conduct of the study and 
compliance with federal regulations. The results of this study will be published. If results are 
published, no subject will be identified by name. 
 
13.3 Unanticipated Problems  
Any unanticipated problems will be addressed immediately by the PI and brought to the 
DSMB. Any unanticipated problems will also be reported and documented in written 
document to the IRB and sponsor (if applicable). 

TOUCHED_Protocol_Version 1.8, 05/10/2022 
29 of 28
14.0 REFERENCES 
 
1. Bonds, D.E., et al., A multifaceted intervention to improve blood pressure control: The 
Guideline Adherence for Heart Health (GLAD) study. American heart journal, 2009. 157(2): p. 
278-84.  
2. Racial/Ethnic disparities in the awareness, treatment, and control of hypertension - United 
States, 2003-2010. MMWR. Morbidity and mortality weekly report, 2013. 62(18): p. 351-5.  
3. Begley, C.E., et al., Emergency room use and access to primary care: evidence from Houston, 
Texas. Journal of health care for the poor and underserved, 2006. 17(3): p. 610-24.  
4. Levy, P.D. and D. Cline, Asymptomatic hypertension in the emergency department: a matter 
of critical public health importance. Academic emergency medicine : official journal of the 
Society for Academic Emergency Medicine, 2009. 16(11): p. 1251-7.  
5. Preston, R.A., et al., Clinical presentation and management of patients with uncontrolled, 
severe hypertension: results from a public teaching hospital. Journal of human hypertension, 
1999. 13(4): p. 249-55.  
6. Prendergast, H., Colla ,J., Patel, N., Del Rios, M., Marcucci, J.,Scholz R., Ngwang, P., 
Cappitelli, K.,Daviglus, M., Dudley, S., Correlation between Subclinical Heart Disease and 
Cardiovascular Risk Profiles in an Urban Emergency Department Population with 
Asymptomatic Hypertension: A Pilot Study, in submitted for publication.  
7. Kupferman, J.C., et al., BP Control and Left Ventricular Hypertrophy Regression in Children 
with CKD. Journal of the American Society of Nephrology : JASN, 2014. 25(1): p. 167-74.  
8. Aljaroudi, W.A., et al., Prognostic Value of Diastolic Dysfunction: State of the Art Review. 
Cardiology in review, 2013.  
9. Berenson, J. and A. Shih, Higher readmissions at safety-net hospitals and potential policy 
solutions. Issue brief, 2012. 34: p. 1-16.  
10. Ndumele, C.D., et al., Cardiovascular disease and risk in primary care settings in the United 
States. Am J Cardiol, 2012. 109(4): p. 521-6.  
11. Baumann, B.M., D.M. Cline, and E. Pimenta, Treatment of hypertension in the emergency 
department. Journal of the American Society of Hypertension : JASH, 2011. 5(5): p. 366-77.  
12. Baumann, B.M., et al., Evaluation, management, and referral of elderly emergency 
department patients with elevated blood pressure. Blood pressure monitoring, 2009. 14(6): p. 
251-6.  
13. Baumann, B.M., et al., Provider self-report and practice: reassessment and referral of 
emergency department patients with elevated blood pressure. American journal of hypertension, 
2009. 22(6): p. 604-10.  
14. Tanabe, P., et al., Increased blood pressure in the emergency department: pain, anxiety, or 
undiagnosed hypertension? Annals of emergency medicine, 2008. 51(3): p. 221-9.  
15. Statistics, N.C.f.H., Health, United States, 2013: With Special Feature on Prescription 
Drugs. 2014, Hyattsville, MD.  
16. Chobanian, A.V., et al., Seventh report of the Joint National Committee on Prevention, 
Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension, 2003. 42(6): p. 
1206-52.  
17. Gu, Q., et al., High blood pressure and cardiovascular disease mortality risk among U.S. 
adults: the third National Health and Nutrition Examination Survey mortality follow-up study. 
Annals of epidemiology, 2008. 18(4): p. 302-9.  

TOUCHED_Protocol_Version 1.8, 05/10/2022 
30 of 28
18. Gu, Q., et al., Association of hypertension treatment and control with all-cause and 
cardiovascular disease mortality among US adults with hypertension. American journal of 
hypertension, 2010. 23(1): p. 38-45.  
19. Burt, V.L., et al., Trends in the prevalence, awareness, treatment, and control of 
hypertension in the adult US population. Data from the health examination surveys, 1960 to 
1991. Hypertension, 1995. 26(1): p. 60-9.  
20. Chobanian, A.V., et al., The Seventh Report of the Joint National Committee on Prevention, 
Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA : the 
journal of the American Medical Association, 2003. 289(19): p. 2560-72.  
21. Kramer, H., et al., Racial/ethnic differences in hypertension and hypertension treatment and 
control in the multi-ethnic study of atherosclerosis (MESA). Am J Hypertens, 2004. 17(10): p. 
963-70.  
22. Ferdinand, K.C. and A.M. Armani, The management of hypertension in African Americans. 
Critical pathways in cardiology, 2007. 6(2): p. 67-71.  
23. Guzman, N.J., Epidemiology and management of hypertension in the Hispanic population: a 
review of the available literature. American journal of cardiovascular drugs : drugs, devices, and 
other interventions, 2012. 12(3): p. 165-78.  
24. James, P. A., Oparil, S., Carter, B. L., Cushman, W. C., Dennison-Himmelfarb, C., Handler, 
J., . . . Ortiz, E. (2014). 2014 Evidence-Based Guideline for the Management of High Blood 
Pressure in Adults. Jama, 311(5), 507. doi:10.1001/jama.2013.284427