Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems
Phase: NA
Conditions: Hypertension
Sponsor: Northwestern University

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Title 
Reach Out 2: A Randomized Controlled Trial of a Text Message-Based Hypertension Intervention in a 
Safety-Net Emergency Department Population 
 
Introduction 
Background and rationale {6a} 
With 121.5 million (47%) adults with hypertension, the U.S. is facing a hypertension epidemic.1 Hypertension 
is the most important modifiable cardiovascular risk factor,2-7 while blood pressure (BP) treatment reduces 
cardiovascular disease and all-cause mortality.1,6 Approximately, 39% of hypertensive Americans are 
unaware that they have the conditiion.1 Even with widespread availability of effective treatment, 78% of 
Americans with hypertension are uncontrolled.1  
 
Racial and socioeconomical inequities are pervasive in hypertension.8 Black Americans have the highest 
prevalence of hypertension in the US and are among the highest in the world.1 By age 55 about 76% of 
Black individuals will have developed hypertension.9 Black men have one of lowest rates of blood pressure 
control of any racial or ethnic group.1 Hypertension disparities are also evident among those with low-
income, uninsured and working-age populations. People with low socioeconomic status have a 2-fold higher 
odds of hypertension.8 Uninsured Americans have a higher prevalence, less awareness, lower treatment 
rates, and lower control rates of hypertension than their insured counterparts.10 Similarly, working-age 
Americans are less likely to have their hypertension controlled and more likely to have missed appointments 
than their older counterparts.11-13  
 
One approach to addressing the hypertension epidemic is by going to where the people are in the 
community like barber shops and beauty salons,14,15 or expanding into non-traditional chronic disease 
management settings like the Emergency Department (ED). The ED is a cornerstone for health care in most 
communities. There are over 136 million ED visits annually,16 of which hypertension is identified in 45% of 
the individuals (60 million visits).17 The ED is uniquely suited for addressing hypertension among Black 
Americans, those of low socioeconomic status, and working-age Americans. First, these populations are 
high-volume users of the ED.18 19 Second, asymptomatic elevated BP during the ED visit is highly associated 
with persistent hypertension.20 Finally, an ED visit might be a teachable moment – a health event that might 
motivate individuals to adopt health-promoting behaviors to get control of their BP.21-23 ED guidelines 
recommend BP screening,24 and there is consensus that patients with asymptomatic hypertension should we 
referred for outpatient follow-up.25 While self-management and primary care are the mainstay of BP 
management, identifying hypertensive patients and initiating a mobile health (mHealth) program creates an 
opportunity for the ED to partner in BP management. 
 
Given the extent of the hypertension epidemic, scalable strategies are needed. Text messaging is nearly 
ubiquitous as 96% of adult Americans have a mobile phone, and over 80% use it for text messaging.26 Black 

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Americans are more likely to own a mobile phone than White Americans.27 Text messaging is an appealing 
option for behavioral interventions, given its popularity in historically marginalized populations, low cost, ease 
of adoption, scalability, and ability to reach people in real-time. Additional advantages include that it is a 
‘push technology’ intervention delivered without any effort from the individual, cannot be deleted, does not 
require upgrades, and the majority of people already use this technology.28 mHealth interventions are 
endorsed by the American Heart Association.29 A recent systematic review supports the promise of mHealth 
strategies for hypertension while also identifying limitations such as generalizability, short duration of follow-
up, lack of information on the optimal delivery, and absence of rigorous clinical trial design.30 Such limitations 
will be addressed in Reach Out 2. 
 
The Reach Out 2 trial builds upon the success of the Reach Out 1 trial, aiming to further investigate the 
impact of a text message-based hypertension intervention in a safety-net ED population. 
 
Objectives {7} 
Aim 1: To determine whether an mHealth intervention results in lower BPs and more initiation of BP 
management than usual care among hypertensive safety-net ED patients likely to be discharged 
home.  
 
Aim 2: Among participants randomized to the mHealth intervention, to assess BP control and long-
term engagement with prompted SMBP monitoring from 6 months up to 3 years post-enrollment. 
 
Aim 3: To contextualize Reach Out 2 findings, using real-world data and simulation analyses, we will 
explore the potential population-level reduction in myocardial infarction, stroke, and dementia 
associated with implementing Reach Out 2 across all eligible patients receiving care at individual 
safety-net EDs and across all safety-net EDs. 
 
Trial design {8} 
Reach Out 2 is a prospective, randomized open-, blinded-endpoint (PROBE) controlled trial. Patients will be 
recruited from the Hurley Emergency Department (ED). Participant will be randomized in the ED to the 
mHealth intervention or usual care (Table 1). There will be in-person, incentivized outcome visits at 3- and 6-
months. The primary outcome is a reduction in systolic BP at 6 months. Participants in the intervention arm 
will be followed from 6-months to 3-years in an extended follow-up observational cohort of prompted SMBP 
monitoring. 
 
As we did successfully through our previous studies (HUM00082454/ HUM00091668/ HUM00138470/ 
HUM00200541), we will integrate the various strategies together to now recruit participants and partners 
from the ED of Hurley Medical Center in Flint, MI.  
 
Table 1 

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Person 
Texts 
Frequency Levels 
dependent on BP 
Control 
Tailoring variables 
Participant 
Prompted BP self-monitoring  
and feedback (SMBP) 
Weekly vs. 3x/week 
BP change (most 
recent self-reported 
BP) 
Enrollment BP 
BP control 
Provider scheduling 
reminder and transportation 
None vs. Yes 
Medical Provider 
BP control 
Optional Partner 
Reminder for patient SMBP  
Weekly vs. 3x/week 
Participant text in BP  
Reminder for participant 
upcoming provider 
appointment  
None vs. Yes 
Participant BP 
control 
Participant medical 
provider 
 
 
Methods: Participants, interventions and outcomes 
Study setting {9} 
Patients will be recruited from the Hurley Medical Center ED by our team of research assistants.  
 
This is a clinical trial of one-enrolling site (Hurley Medical Center), with multi-investigators from different 
sites. Other site involvement include Northwestern University, The University of Michigan, and Ohio State 
University. Drs. Skolarus (Northwestern University) and Meurer (University of Michigan) will each occupy the 
role of PI. Study staff and coordinators conducting participant recruitment at the site of enrollment will be 
employed by the University of Michigan.  
 
Hurley Medical Center 
- 
Site of Recruitment 
Northwestern University 
- 
Dr. Skolarus, multiple PI, will, along with Dr. Meurer, provide overall leadership to the entire project. 
Northwestern University is the primary grant recipient.  
Ohio State University 
- 
Dr. Burke’s primary role in the design and execution of aim 3 analyses. Dr. Lin will execute the trial 
analysis with the support of Drs. Meurer and Kidwell and assist in execution of the aim 3 under the 
support of Dr. Burke.. All of this will be de-identified data, no identifiable data will be shared with 
OSU.  
University of Michigan  
- 
Dr. Meurer, multiple PI, will, along with Dr. Skolarus, provide overall leadership to the entire project. 
IRBMED will also serve as the sIRB of record.  
 
 
Eligibility criteria {10} 
Inclusion Criteria for Main Trial Participants  

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While in the ED, the patient must meet all of the following:   
-Adult (≥18 y/o) 
-At least one BP with Systolic BP ≥160 or a Diastolic BP ≥100 (criteria 1) 
-If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains 
systolic BP ≥140 or a diastolic BP ≥90 
-Must have cell phones with text-messaging capability 
-Likely to be discharged from the ED 
 
Exclusion Criteria for Main Trial Participants: 
- Critical illness 
- Unable to read English (<1% at study site) 
- Incarcerated 
- Pregnant 
- Pre-existing condition making 6-month follow-up unlikely 
 
Inclusion Criteria for Partners (Partners are not research subjects, but will still only be possible partners with 
the following criteria) 
-Adult (≥18 y/o) 
-Must have cell phones with text-messaging capability 
Exclusion Criteria for Partners:  
- Critical illness 
- Unable to read English (<1% at study site) 
- Incarcerated 
- Pre-existing condition making 6-months unlikely 
 
Recruitment {15} 
As we did through Reach Out 1 in Hurley Medical Center’s EMR, we will utilize an automated screening 
algorithm used by the EMR of the ED, to identify patients with blood pressures over a threshold. The 
threshold for activation is established by a systolic BP (SBP)≥160, or a diastolic BP (DBP)≥100. We may 
adjust this screening threshold if the proportion of patients with persistent hypertension in follow up texting is 
towards either extreme (for example, less than 40% or above 80%).  This threshold activation will alert the 
study team member(s) a patient meets the BP eligibility criteria, and should be further screened.  
 
Patient BP is obtained during normal patient screening during any ED visit. If the alert system is not 
functional at any point, it may be supplemented by manual chart review of the daily ED patient log for 
recruitment and screening purposes. Automated identification of patients may commence up to 3 months 
prior to the opening of enrollment to work out errors and optimize the EMR screening algorithm. 
 

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We request a waiver of HIPAA authorization to maintain a 
screening log of patients that trigger the alert system, and also at 
times if ever necessary in completing recruitment (for example, 
virtual recruitment), and through chart review collect demographics 
such as, age, gender, race/ ethnicity, reason for ineligibility or 
refusal and ED BP. Medical records of the patients will only be 
used for these purposes. Alternative virtual recruitment protocols 
are noted in appendix K.  
 
Who will take informed consent? {26a} 
Adults meeting the inclusion/exclusion criteria will be approached 
for consent, if a study team member is available. Research staff will 
then perform screening of these patients based on the remaining 
enrollment criteria. 
 
If possible, the consent process will be performed in a private room 
or sectioned area as to provide the most privacy possible. For 
patients the process will be performed in person but we will either 
present paper informed consents, or utilize REDCap to present the 
approved informed consent document via electronic means 
(computer, tablet, or similar). We will configure REDCap to present 
the pages of PDF of the IRB-approved and stamped informed 
consent form. If for any reason the electronic system REDCap, is 
not function, we will utilize the identical approved paper informed 
consent document with the patient to complete the informed 
consent process. We will incorporate the informed consent 
document questions into redcap (for example, This study involves 
video and/or audio recording. If to participate in the post-study 
interviews/ groups you do not agree to be recorded, you can still 
take part in the study.Yes/No, etc). We will archive a PDF of the 
eConsent instrument, responses, and signature. A copy of the 
informed consent document will be offered to the participant 
through paper or electronic means. Examples are included as to 
how the eConsent is built into Redcap.  
   
Participants will be informed during the consent process that if they 
pay per text message with their cell phone company, regular text 
messaging costs apply. Additionally, doctor’s appointments are not paid for by the study team, and normal 
insurance, or coverage process will occur.  
 

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All consented, interventional participants will be given an Omron BP7 series or similar style validated BP 
cuffs. The blood pressure cuff is not the object of the study.  
 
All consented participants will receive $25 at enrollment. This will be given in cash or gift card equivalent.  
 
Pending study financial availability, we will also supply participants with pens, bags, magnets, or similar 
materials branded with study logo and/or pertinent study information like outcome timing. Alternative virtual 
consent protocols are noted in appendix K. 
 
 
Partners 
 
A participant does not have to include a partner, but may do so if they choose. Only intervention participants 
have the opportunity to have a partner. Partners will not complete consent as they are not research subjects, 
and no measures or outcomes are completed for partners. We will need to maintain the phone number of the 
partner, in order to send them the text messages. The research team will seek mutual understanding and 
agreement of partners to receive reminder text messages alongside consented participants. This mutual 
agreement will be sought for selected partners if they are present and available with the participant in the ER 
at the time of participant consent. The partner may or may not be present with the participant at the time of 
enrollment. One partner per participant will be chosen and participants have the option to not identify any 
partner. If a partner is chosen, they will be contacted (in-person or virtually) within about 1 week of 
enrollment of participant. The participant will provide first name, last name, age, gender, race, relationship to 
participant, and contact information (phone number, email, best time to contact, etc) for partner. If the partner 
declines the participant will be notified, and considering research assistant capacity, a participant may be 
offered the opportunity to include another partner. Regardless of partner involvement, the participant can still 
participate in the study, a partner is never necessary, simply optional.  
 
If the participant selects a partner that is not present and available with the participant in the ER at the time 
of participant consent, they will be contacted within about 2 weeks for a confirmation and conversation of 
agreement. This may be done with whatever means best possible (telephone, video, etc). For the partner, 
we will ask for relationship to the participant, first and last name (information will be known from participant, it 
may be possible the participant does not know the birthday of their selected partner), and contact information 
(phone number and email). The participant may be given an informational flyer that outlines partner 
involvement to help explain the partner support throughout the study. 
 
If at the end of the participant’s intervention, a partner is asked for Reach Out feedback through interview 
and/or focus groups, the partner will complete a process of informed consent in the same means and 
methods as already described for the participants (in-person or virtual).  
 
Randomisation  

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Randomization is at the participant level and will take place after consent and the baseline data collection. 
We will use three baseline factors for stratification: 1) race (Black vs. other); 2) sex; 3) taking an 
antihypertensive medication within the last 6 months (yes vs. no).  
 
Interventions 
Explanation for the choice of comparators {6b} 
Without a control group, Reach Out 1 findings were promising but may be, at least in part, due to regression 
to the mean or other temporal trends. Other hypertension interventions initiated in the ED also show potential 
to lower BP.36-40 Yet, these studies shared some of the limitations of Reach Out 1 including being limited by 
small sample size, lack of control group, unblinded assessments, and adaption of the intervention during the 
study. Thus, Reach Out 2 will include a usual care group.  
 
Intervention description {11a} 
Participants will be asked to provide an email address and cell phone number for texting and will be asked 
for permission to use these means of communication for scheduling the outcome assessment. We will also 
collect contact information for family member(s) and/or friend(s) as an alternative contact should we have 
difficulty reaching the participant.  
 
Participants randomized to the intervention group will have the option include a partner, friend, or family 
member with text-messaging capability who could support them on their BP journey. The partner will receive 
Reach Out materials and text messages to remind the participant to engage in SMBP and of their upcoming 
appointments.  
 
After consent but before randomization, participant BP will be measured by the research team using the 
Omron BP7 series or similar device, according to the research standards to ensure consistent technique 
across baseline and outcomes. Three consecutive BPs will be taken, and the 2nd and 3rd BP readings will 
be averaged to generate the baseline measurement unless they are over 10 mmHg apart in systolic. In that 
case a 4th BP will be measured, and the average taken of the 2 closest measurements. If it is not possible to 
physically take BPs with participants, ED BPs may be abstracted from the medical record. Additionally, 
baseline information will be abstracted from the medical record including ED BPs, age, sex, and current 
medications. We will ask additional information during baseline, such as race/ethnicity (self-report), gender 
(self-report), medical health literacy, self-rated health, hypertension awareness (prior diagnosis of 
hypertension, taking antihypertensive medications and medication adherence), health-related social needs, 
medications, whether they have a primary care provider, and recent health visits.  
 
Usual care group 
The usual care group is standard of care, they will receive the standard ED discharge materials available as 
recommended by their ED physician. These materials recommend lifestyle changes, dietary changes, 

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medication as directed, and follow-up with a PCP as directed. They will not receive the Reach Out 
intervention as described below.  
 
Intervention group 
Figure 
1  
 
BP 
monitoring skills session 
Participants will be given a validated, automated, oscillometric BP monitor (Omron BP7 series or similar). 
The research assistants will teach the participant how to use the BP cuff. They will also be taught how to text 
message their BP through Mosio. They will be given instructions for BP and texting, used in Reach Out 1 
(Appendix A and B). Participants will be given appropriate literacy-level, community hypertensive participant 
co-created materials (Appendix C).   
 
Given the fluidity of text message interventions and communication, we have thoroughly outlined the text 
message intention and content throughout the protocol. We also provide sample messages (Appendix D). 
Text message themes, content, and intent will remain consistent, text message wording may be changed, 
added or removed throughout the study as feedback or need arises. We will not submit IRB amendment 
unless significant messaging content is altered.  
 
Tailored Reach Out 2 mHealth components 
Prompted SMBP with tailored feedback and provider scheduling and transportation frequency will be tailored 
based on BP control (Figure 1). Control is defined as SMBP <135/85 based on the median of 3 most recent 
observations. We may adjust this definition of control if we find need. Reach Out 2 will begin with prompted 
SMBP monitoring 3 days/week and facilitated provider scheduling and transportation monthly. Every 4 
weeks SMBP measurements will be assessed and mHealth components will be escalated, de-escalated, or 
remain the same. If BP is controlled, SMBP prompts will be sent once a week and there will be no facilitated 
appointments. If BP is uncontrolled, SMBP prompts will be sent three times per week and facilitated provider 
scheduling and transportation will occur. Partners will be sent weekly or 2x/weekly text messages 
encouraging them to remind the participant to engage in SMBP and, if applicable, of their upcoming 

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appointments. The frequency of the partner’s text messages will match the frequency of the participant’s text 
messages. Depending on technological capability, the partner may also receive information about the 
participant’s SMBP responsiveness, and messages with ideas of support and connection. If participants are 
unresponsive meaning they do not have 3 observations or more and have not responded with at least 1 
observation in the last 4 weeks, we will do a technology check with the participant and potentially also with 
the partner. If the participant remains unresponsive after the technology check he/she will begin receiving the 
lowest intensity of the intervention (weekly SMBP prompts).  
 
A technology check involves the study team calling the participant or partner to help with any known or 
unknown barriers that may be present with SMBP engagement. Technology checks may be requested by 
the participant or partner, deemed helpful by the study team due to perceived SMBP confusion, or due to 
participant unresponsiveness as described previously. The technology check may include personalized text 
messages, phone calls, emails, or letters.  
 
Prompted SMBP with tailored feedback  
Participants will receive texts (administered through Mosio), prompting SMBP at their selected time of day 
and day of the week. After texting their BP, the participant receives automated feedback tailored on specific 
criteria. For example, whether their BP is elevated, have a PCP, and/or whether their BP is greater than or 
lower than their enrollment BP, among possible other tailoring 
features. Participants may also be texted monthly graphs of their BP 
so they can see their BP trends and can share with their PCP (Figure 
2).  
 
Facilitated PCP appointments and transportation  
For participants without a PCP our research team will assist in establishing medical care at Hamilton 
Community Health Network. Our research team will inquire through text message(s) of participants if they 
would like assistance scheduling PCP appointments. Our research team will identify available appointment 
times with the participant’s provider or with Hamilton, for those without a provider, that will be texted to the 
participant. If a participant’s provider requires additional permissions for scheduling, we will complete and 
provide the provider’s officer with an authorization form (Appendix E). If a provider’s office requires their own 
specific authorization form, we will work with them and the participant to have that completed, these specific 
forms will not be uploaded to the IRB. Participants will communicate their desired time and the research staff 
will complete the appointment scheduling. Preceding the appointment, automated text reminder messages 
may be sent to the participant and/or partner. Prior to the appointment, a transportation ride or voucher may 
be sent to the participant and/or partner (to assist participant). Participant who have declined or are 
unresponsive to PCP appointment scheduling may still be offered a transportation ride or voucher. These 
may be implemented through Rides to Wellness, Uber, Uber Health, Lyft, Taxi services, or any similar 
available transportation company. Participants may decline this particular aspect of the intervention , and still 
be considered a part of the interventional group.  
 
Figure 2 –Participant SBP graph   

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Extended observational cohort of prompted SMBP monitoring 
After the 6-month intervention, participants in the intervention group will have to option to enter a longitudinal 
cohort.  They may be asked at the outcome assessment or via text message. Participants opting to continue 
will receive weekly prompted SMBP monitoring and tailored feedback for up to 3 years, based on when they 
enrolled in the trial. Partner messages may also continue. When the longitudinal cohort is ending, all will 
receive a text message indicating text messages will end.  
 
Participant Retention 
We will maintain contact with participants throughout the trial and will include phone calls and/or texts at 
about 1, 3, 6 months post-enrollment to update contact information and schedule outcome visits, and 
various other informational updates such as a welcome card, seasonal greetings, quarterly newsletters 
and a study website. These materials are available in Appendix F and G. We may also contact 
participants through phone call, text message, or letters, to assess any perceived technological 
difficulties or troubleshooting, as needed or requested.  
 
A sample contact guide and material outline can be seen in Table 2.  
 
Table 2 
 
Timepoint 
(Months)  
0 
Enrollment 
1 
2 
3 
5 
6 
Other time-
points 
Materials 
Participant 
• 
OMRON Cuff 
• 
Welcome card 
• 
Newsletter 
• 
Study website 
• 
BP instructions 
• 
Texting 
instructions 
 
• 
Comic 
book 
• 
Newsletter 
• 
Mailed 
outcome 
reminder 
 
• 
Newsletter 
• 
Mailed 
outcome 
reminder 
 
• 
Seasonal 
greetings 
• 
Technology 
assistance 
• 
Newsletter 
Partner 
• 
Welcome card 
 
• 
Newsletter 
• 
Mailed 
outcome 
reminder 
• 
Newsletter 
• 
Mailed 
outcome 
reminder 
• 
Seasonal 
greetings 
 
 
Criteria for discontinuing or modifying allocated interventions {11b} 
Participants may withdraw from the study by any means (for example, phone call, text message). If a 
participant withdraws from the study, the partner’s text messages will  be stopped. Additionally, if any 
requests are sent in by the participant to modulate, pause, or stop their text messages or any other 
intervention components, we will still contact the participant for outcome assessments or appropriate other 
intervention components. Partners are not research subjects, and thus are not considered with withdrawals. 
They may stop their messages about participants by any means (for example, phone call, text message). 
 

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Outcomes {12} 
Data will be collected in several ways. Prior to outcomes, we will attempt to schedule and remind participants 
of outcomes assessments, this may include letters, text messages and/or phone calls. Reminder messages 
may be sent the few days before and the day of the outcome assessment. Outcomes may be built into 
REDCap or similar secure platform. Outcomes may be visually modified, questions removed, rearranged, or 
re-worded as resources become available, but the messaging, and content will remain consistent. To 
increase retention for outcomes, we may also be mailing outcome reminders (Appendix H), and/or 
newsletters (Appendix G) periodically. Some aspects of the outcomes may be tailored. For example, some 
specific questions may be asked to participants who are unresponsive, and others to participants who are 
responsive to better understand each individual’s experience. These materials are included as appendices in 
the protocol, and will be submitted to the IRB as outlines of materials. However, the dates, time sensitive 
information, and content may change as needed to better communicate and stay up to date with participants. 
For example, within the newsletters that may be periodically sent out and updated, it will always contain 
topics such as recruitment updates, outcome visit information, study staff spotlights, end of study 
instructions, and any other relevant, time-sensitive informational updates. Given the topics and theme of the 
content will remain consistent, we will not submit changes to the IRB unless there are significant additions or 
deviations from topics. 
 
In-person outcome assessments will occur at 3- and 6-months. These assessments will occur at a provider 
office to coincide with a scheduled provider appointment, in the ED research space, at a convenient location 
or home visit. BP will be measured by the research team with the same devices and technique as at 
enrollment in accordance with national standards for measurement. Participants will also complete brief 
research assistant administered surveys (Table 3). Medications will be collected via interview, with the 
possibility of a home phone call or text message for participants to read their pill bottles to the research 
assistant if needed at 3- and 6-months. To understand PCP establishment and utilization we may utilize 
study team provided transportation and vouchers as confirmation of PCP attendance, and may utilize 
records from Hamilton Community Health Network EMR for patient provider appointments. Transportation 
with voucher, ride share, public transit, or parking vouchers will be provided as previously described and/or 
needed. Participants will be compensated with cash or gift card equivalent of $25 for the 3-month 
assessment and $50 for the 6-month assessment.  
 
SMBP data will be captured in REDCap (or similar) and Mosio. All participant BPs texted through the Mosio 
text messaging system flow to the Reach Out database via API integration. Key participant variables will also 
be outgoing to Mosio (such as phone number, participant ID, tailoring variables). SMBP, updated tailoring 
variables and phone numbers will also be available within the participant text history and profile in Mosio to 
facilitate text messaging. If at any point the API integration is not functional between Mosio and REDCap, we 
will facilitate this connection through direct secure upload and/or download of variables.    
 
The primary endpoint is the systolic BP at 6 months. We will adjust for baseline systolic BP and compare 
these systolic BPs at 6 months to the control group. Using the 6-month systolic BP (with adjustment for 

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baseline), as opposed to change, is preferred in clinical trials. Of note, the baseline BP is the median value 
of the research assistant measured BPs as previously described.  
 
Here we describe secondary and exploratory outcome examples, these may not fully encompass all 
outcomes and endpoints that will be analysed.  
 
Secondary Outcomes 
• 
Diastolic BP at 6 months 
• 
Proportion of participants with controlled BP at 6-months 
 
Exploratory Outcomes and Processes 
• 
BP control defined as BP less than 140/90 mmHg  
• 
Collect additional BP measurements both from surveys and via the EHR 
• 
Initiation of antihypertensive medication 
• 
Change in antihypertensive medication 
• 
Establishment of primary care  
• 
Hypertension awareness, diagnosis, treatment of hypertension  
• 
BP medication adherence  
• 
Health care utilization at other health care sources (urgent care, outside clinics, outside EDs)  
• 
Continued engagement with and impact of SMBP monitoring 
• 
Engagement- Proportion of participants who continue SMBP monitoring after 6-months (threshold for 
success is greater than 50%).  
• 
Impact- Proportion of SMBP monitoring responses that are controlled (threshold for success is 80%). 
• 
Adherence with SMBP monitoring- Proportion of BPs received after a BP prompt 
• 
Self-reported use of ‘GRAPH’ link 
• 
Completed facilitated provider appointments  
• 
Rides to medical appointments 
• 
Satisfaction and perceptions of the acceptability and appropriateness of Reach Out 2  
• 
Open-ended questions of participants’ experience 
 
To assess participant and/or partner feedback and satisfaction with the Reach Out intervention and 
messaging, we will conduct interviews and/or focus groups of up to 40 participants and partners. We will 
choose the best format (individual or group) for our study population. We anticipate the interviews or groups 
will last about 30-60 minutes and will be conducted at a location convenient to the participants or virtually via 
secure means provided by the University of Michigan 
(https://safecomputing.umich.edu/dataguide/?q=home). The interview or groups will be based on a semi-
structured interview guide. Given this is minimal risk, and conversational, this will be submitted to the IRB as 
a guide. During this team members will assist in taking structured notes and may be recorded. This will be 
consented for during the initial consent process, and the up to 40 participants will be contacted after 
completion of the Reach Out Intervention. We will have a conversation to ensure continued interest and 
consent to participate. Participants will be given $25 in appreciation of their time. 
 

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Table 3 
  
Baselin
e 
Control 
Assessmen
t 
Control 
Assessmen
t 
3-Month 
Outcome 
Assessmen
t 
Control 
Assessmen
t 
Control 
Assessmen
t 
6-Month 
Outcome 
Assessmen
t 
Extended 
Observatio
n 
Time 
point 
Week
s 
0 
4 
8 
12 
16 
20 
24 
6-months 
to 36 
months 
Range 
  
  
  
(+/- 30 
days) 
  
  
(+/- 30 
days) 
  
Measures to be 
collected 
  
  
  
  
  
  
  
  
Enrollment:  
Contact 
Information 
X 
x 
 
x 
 
 
x 
 
Motivational Text 
Message 
Creation 
X 
 
 
 
 
 
 
 
Questions/ Assessments:  
Demographics 
X 
  
  
  
  
  
  
  
Medical History 
x 
  
  
  
  
  
  
  
Physical Activity 
X 
 
 
 
 
 
 
 
Diet 
X 
 
 
 
 
 
 
 
Study taken BP 
measurement 
x 
  
  
x 
  
  
x 
  
Self-rated Health 
Evaluation 
x 
  
  
  
  
  
  
  
HTN Awareness 
x 
  
  
x  
  
  
x 
  
HTN Treatment 
x 
 
 
x  
  
  
x 
 
BP Medication 
Adherence 
x 
 
 
x  
  
  
x 
 
Medical Literacy 
x 
  
  
  
  
  
  
  
Health-Related 
Social Needs 
x 
  
  
  
  
  
  
  
Healthcare 
Utilization 
x 
  
  
x 
  
  
x 
  
Establishment of 
PCP 
x 
  
  
x 
  
  
x 
  
Assessment of 
SMBP 
  
x 
x 
 x 
x 
x 
x  
  
Medications: 
Medications 
X 
 
 
 
 
 
 
 
Changes in anti-
hypertensive 
treatment 
x 
  
  
x 
  
  
x 
  
Medication 
Review 
x 
  
  
x 
  
  
x 
  
Antihypertensive
s 
x 
  
  
x 
  
  
x 
  
Process Measures: 
Sustained 
engagements 
with SMBP 
monitoring 
  
  
  
  
  
  
  
x 
SMBP 
monitoring 
adherence 
  
  
  
x 
  
  
x 
  
Pcpt 'GRAPH' 
link utilization 
  
  
  
  
  
  
x 
  
Transportation 
vouchers used 
  
  
  
 X 
  
  
x 
  
PCP Utilization 
  
  
  
  
  
  
x 
  
Intervention 
Feedback 
  
  
  
  
  
  
x 
  

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Qualitative 
interviews  
  
  
  
  
  
  
  
x 
Acceptability 
Outcome 
 
 
 
 
 
 
x 
 
 
 
Participant timeline {13} 
Table 4 
  
Baseline 
 
 
3-Month 
Outcome 
Assessment 
 
 
6-Month 
Outcome 
Assessment 
Extended 
Observation 
Time 
point 
Weeks 
0 
4 
8 
12 
16 
20 
24 
6-months to 
36 months 
Range 
  
  
  
(+/- 30 
days) 
  
  
(+/- 30 
days) 
  
 
Informed consent 
x 
  
  
  
  
  
  
  
Randomization 
x 
 
 
 
 
 
 
 
Contact 
Information 
x 
 x 
  
x  
  
  
x  
  
Participants randomized to intervention 
Training with BP 
cuff 
x 
  
  
  
  
  
  
  
Training with 
Text Messages 
x 
  
  
  
  
  
  
  
Optional Partner 
X 
 
 
 
 
 
 
 
SMBP Control 
Assessment 
 
X 
X 
X 
X 
X 
 
 
SMBP graph 
 
X 
X 
X 
X 
X 
X 
 
Intervention dependent on SMBP uncontrolled 
PCP 
Appointment 
Scheduling 
X 
X 
X 
X 
X 
X 
 
 
PCP 
Transportation 
X 
X 
X 
X 
X 
X 
 
 
 
Sample size {14} 
A total sample size of 500 (assuming 25% loss to follow up from recruitment of 670 participants) is needed to 
find a comparison of group means of 134 and 130mmHg, assuming a SD of 15, 84.6% power, and alpha of 
0.05. Due to the pandemic, in Reach Out 1, outcome BP data were often based on home monitoring 
readings, which were substantially more variable compared to the more precise measurements we currently 
propose. Furthermore, attrition was 50% in Reach Out 1 mostly due to the COVID-19 pandemic which 
caused major disruption in the Flint community, as with most communities around the world. We estimate 
attrition in Reach Out 2 to be 25%. 
 
Assignment of interventions: allocation 
Sequence generation {16a} 

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We will use three baseline factors for stratification: 1) race (Black vs. other); 2) sex; 3) taking an 
antihypertensive medication within the last 6 months (yes vs. no). Within each of these eight baseline 
characteristic strata, we will create randomization sequences in randomly permuted blocks of two, four, and 
six, balanced to the two arms. Some strata may be less common than others; however, this strategy should 
limit imbalance of potentially important prognostic factors. We successfully employed a similar procedure in 
Reach Out 1.  
 
 
Implementation {16c} 
The statistician will generate the randomization sequences. These allocation sequences will be uploaded to 
a secure web-based randomizer like CSCAR’s randomization application (https://trial-
randomize.appspot.com/ ), or similar. The project manager will then input stratification variables and 
generate a randomization assignment. This randomization assignment will be assigned to pre-populated 
participant forms into REDCap or similar. From here, research assistants will utilize these in sequence as 
they recruit participants from the ED. This or a similar implementation method will be utilized.  
 
Assignment of interventions: Blinding 
 
Procedure for unblinding if needed {17b} 
Unblinding may occur under specific circumstances, and approved and overseen by the Independent 
Medical Monitor. To request unblinding, the principal investigators and medical monitor, must provide a clear 
and compelling justification for the unblinding request to the statistician. Reasoning will be based on potential 
medical management or safety of a participant. Upon approval, the statistician will disclose the relevant 
information while maintaining confidentiality. 
 
Statistical methods 
Statistical methods for primary and secondary outcomes {20a} 
The primary analysis will be intent-to-treat where BP measured at the 6-month visit is the outcome variable 
and baseline BP is a covariate. The analytic plan for the differences between arms will use a linear 
regression model (transformation of outcome if needed) with an indicator variable for the treatment arm 
controlling for age, and stratification variables of sex, race, and being on antihypertensive medication in the 6 
months prior to baseline.  
 
Demographic and clinical characteristics of participants with and without missing data will be compared for 
any missingness patterns. Multiple imputation will be conducted under missing at random assumptions. If we 
observe statistical evidence that the data are not missing at random, we will stratify the participants into 

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subgroups that share the same missing data pattern and estimate the statistical model separately for each 
missing data pattern. The results of all missing data analyses will be presented, and the sensitivity of our 
inference to the assumptions and approaches will be included in the interpretation of results.  
 
Hypothesis 1b: Participants randomized to the mHealth intervention will have a lower diastolic BP and will be 
more likely to have BP control (<130/80) at 6 months than participants who receive usual care (secondary).  
 
Across the 8 groups from Reach Out 1, we observed a mean change in diastolic BP of -3.7 mmHg (95% CI, 
-5.7 to – 1.7 mmHg) with SD ranging from 9 to 15 mmHg. We have 79.7% power with a total sample size of 
500 and alpha of 0.05 to find a difference in group means of 90 and 87 mmHg, assuming a SD of 12.  
The model for this analysis mirrors that for the primary analysis but with diastolic BP measured at the 6-
month visit as the outcome and baseline diastolic BP as a covariate.  
 
Our main secondary analysis of efficacy will evaluate a 2-arm comparison of the proportion of participants 
whose BPs are controlled (i.e., < 130/80). From Reach Out 1, the proportion of controlled BPs across the 8 
treatment groups ranged from 6-31% at 6 months. Assuming a baseline rate of 15% control of BP in our 
usual care group, we will have approximately 91% power (alpha = 0.05) to detect an absolute difference in 
proportion of controlled BPs between the two groups of 12%, assuming 500 observations. This difference 
represents approximately the difference between the median group and the arm with the best control in 
Reach Out 1. We provide power under alternative scenarios in our statistical design and power plan. The 
analysis will employ a logistic regression model for control vs. no control adjusting for the covariates 
mentioned in above analyses plus baseline diastolic BP.  
 
Hypothesis 1c: Participants randomized to the mHealth intervention will be more likely to initiate an 
antihypertensive medication and establish primary care than participants who receive usual care 
(exploratory).  
 
Our exploratory analyses will examine between group differences in initiation of antihypertensive medication 
among participants who did not initially take antihypertensive medication and establishment of primary care 
among participants without a PCP at baseline. We will fit a logistic regression model exploring the 
association of initiation of antihypertensive medication with an indicator for the treatment group and adjust for 
race and sex. We will fit another logistic regression model exploring establishing primary care with an 
indicator for treatment group and adjust for race and sex.  
 
Aim 2: To assess the long-term engagement with prompted SMBP monitoring and the effect on BP control  
 
Baseline demographics and 3-and 6-month BP outcomes will be compared between participants randomized 
to the intervention group who continue vs. those who do not continue with SMBP monitoring. Propensity 
scores will be developed via logistic regression to account for selection bias in models of long-term BP 
control. Joint longitudinal survival models will estimate the association between BP measurements over time 

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and time to discontinuation of SMBP responses. We expect 80% of self-reported BPs among participants 
continuing past 6 months to be controlled and that 50% of participants will continue prompted SMBP 
monitoring to the end of the study period (6 months – 3 years depending on initial enrollment date). We will 
calculate 95% CIs for these proportions. We will declare this exploratory aim promising if the confidence 
intervals for the proportions include those stated performance criteria (80% BP control, 50% continuing 
monitoring). Additional details are in statistical design and power plan. 
Methods in analysis to handle protocol non-adherence and any statistical methods to 
handle missing data {20c} 
 We will complete intention to treat and per protocol analyses. We will also conduct a sensitivity analysis with 
multiple imputation to handle missing data.  
Oversight and monitoring 
Composition of the coordinating centre and trial steering committee {5d} 
We will have frequent steering committee meetings and input from community advisor board.   
Composition of the data monitoring committee, its role and reporting structure {21a} 
The trial does not employ formal efficacy or futility stopping rules. An independent medical monitor (IMM) will 
be appointed with responsibility to monitor data and oversee participant safety. IMM will be approved by the 
NIMHD to provide oversight of the trial. The frequency of IMM meetings will be determined by the IMM, IC, 
and PI. Given the planned period of data collection we anticipate about 8-10 meetings, in which to advise 
about study progress and performance, and to make recommendations regarding study continuation and 
protocol changes. 
 
Adverse event reporting and harms {22} 
We will only record AEs and SAEs that are possibly, probably, or definitely related to the study interventions.  
 
All of these recorded AEs and SAEs will be reported to both the University of Michigan and Hurley Medical 
Center.  
 
All AEs reported to the research team and all serious adverse events (SAEs) occurring until participation in 
the study has ended are recorded. The PI or Study Coordinator or designee is responsible for entering any 
and all AEs and SAEs into the database as soon as he/she becomes aware of the event and updating the 
information (e.g., date of resolution, action taken) in a timely manner. All non-serious AEs must be recorded 
within 5 days from the time it was discovered by the study personnel. All SAEs and non-serious AEs must be 
entered by the end of study for that participant. These will be reported to the IRB per their policy preferences.  
 
The PI is responsible for the monitoring and follow-up of AEs until resolution or the end of study for that 
participant, and appropriate documentation in the participant research record. In addition to performing 

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protocol specified follow up, the participating PI must review all previously reported ongoing AEs to evaluate 
the status. If an AE that was previously reported fully resolves and then recurs later, the second occurrence 
is considered a new AE. Likewise, if an SAE that was previously reported and subsequently fully resolved 
later recurs at a level requiring expedited reporting, the SAE must be reported as a new SAE. 
 
 
Funding {4} 
National Institute on Minority Health and Health Disparities: 1R01MD019124-01   
 
Availability of data and materials {29} 
All records will be kept in a locked file cabinet or on secure computer systems.  Clinical information will not 
be released without written permission of the participant, except as necessary for monitoring by IRB, the 
FDA, or the NIMDH. In accordance with NIH regulations, we may create a permanent de-identified, public 
use database. We will remove linkages to protected health information, hospital identifiers and participant 
identifiers. The purpose of the retention of this data is for future research and to comply the NIH regulations 
for datasets created during the conduct of NIH funded research grants. 
 
Ethics approval and consent to participate {24} 
This protocol and the consent and any subsequent significant modifications will be reviewed and approved 
by the IRB responsible for oversight of the study.   
 
 
 
 

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Appendix A : 
 
 
 

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Appendix B : 
 
 
 

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Appendix C :  

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Appendix D :  
Triggers 
Participant 
Action 
Category 
Proposed Message 
Open/Closing 
 
 
Initial message 
WELCOME 
Welcome to REACH OUT! Save this number to your contacts so you can text in 
your blood pressure once a week and get feedback/tips on how to better manage 
your BP! 
Final Message 
6 MONTH 
END 
Thank you for being a part of REACH OUT this past year!  Healthy BP is very 
important for your brain health. If you have questions please reach out to our team 
:) 
Continuance 
6 MONTH 
END 
As we reach the end of REACH OUT, you could continue receiving texts from 
REACH OUT. Its your choice! Reply YES to continue or NO to end as anticipated. 
Thank you for being a part of REACH OUT!  
Final Message 
CONT END 
Thank you for being a part of REACH OUT!  This is your final message. Healthy 
BP is very important for your brain health. If you have questions please reach out 
to our team :) 
UMreachweeklyBPsurve
y 
Initial message 
Weekly BP 
Survey 
Today is the day to check your blood pressure. Reply to this text with your blood 
pressure. 
NL feedback 
response 
Weekly BP 
Response 
One of your recent blood pressures was %recent_bp% and in a healthy range. 
Great job! Keep up the great work :) 
SBP too high 
feedback response 
Weekly BP 
Response 
One of your recent BP's was %recent_bp%. Your top BP # is high but your bottom 
# is OK. Meds, eating healthy and physical activity can lower that top #! 
DBP too high 
feedback response 
Weekly BP 
Response 
One of your recent BP's was %recent_bp%. The bottom BP # is high but the top # 
is OK. Meds, eating healthy and physical activity can help lower the bottom #! 
SBP and DBP too 
high 
Weekly BP 
Response 
One of your recent BP's was %recent_bp%. Both the top and bottom #s are high. 
Keep working to lower your BP with meds, eating healthy and physical activity 😊 
Monthly 
Graph Out Survey 
Normal 
Range 
Your most recent blood pressure is in a healthy range! You are doing an awesome 
job! 
Graph Out Survey 
High BP 
Your most recent BP is high meaning that you have high blood pressure. Talk to a 
doctor about meds. Physical activity and eating healthy can help lower your BP! 
Graph Out Survey 
Emergency 
BP 
Your blood pressure is very high. If you have symptoms like chest pain, call 911. 
See a Dr. soon to get your blood pressure down! 
PCP 
Scheduling 
Controlled BP 
Monthly 
Passive 
Reminder 
This is a reminder to make an appointment with your doctor to talk about your 
blood pressure.  Call Hamilton if you need to find a doctor (810) 406-4246 
Uncontrolled BP 
Monthly 
PCP 
Schedule 
REACH OUT can help schedule appts with your Dr. If you would like, reply YES! 
Reach Out will also provide free rides to one of your primary care Dr. appts this 
month! Please let us know by texting, or call (810)-337-8399 
Uncontrolled BP 
Monthly 
PCP 
Schedule 
OK, thanks for letting us know! If you would like to schedule appts with your Dr, or 
rides to your PCP appointment in the future please let us know by texting, or call 
(XXX)-XXX-XXXX.  
Uncontrolled BP 
Monthly 
PCP 
Schedule 
Your Dr. has an opening at XX:XX XXXXX. Please reply YES within 24 hours if 
you would like this appt. If reply NO, we will send you another appt option. If you 
have questions call REACH OUT at (810)- 337-8399. 
Uncontrolled BP 
Monthly 
PCP 
Schedule 
Your Dr. has an opening at XX:XX XXXXX. Please reply YES within 24 hours if 
you would like this appt. If reply NO, we will send you another appt option. If you 
have questions call REACH OUT at (810)- 337-8399. 
Uncontrolled BP 
Monthly 
PCP 
Schedule 
Your Dr. has an opening at XX:XX XXXXX. Please reply YES within 24 hours if 
you would like this appt. If reply NO, we will call you to see what options may 
generally work for you. If you have questions call REACH OUT at (810)- 337-8399. 
Blood 
Pressure 
Response/ 
Errors 
Not real BP number- an unrealistic 
number was sent in 
  
The BP you sent in does not seem to be right. Your BP should setup like xxx/xxx. 
Look at your BP cuff instructions and the home BP measurement handout. 
Reminder: Did not text in BP 
reading (After waiting 3 hours) 
Remember to text in your blood pressure reading so you can know how you are 
doing! 
Follow-up message x2 
  
This is a reminder to take control of your health and reply to this text with your 
blood pressure. Keeping track of your blood pressure helps keep you healthy! 
Text the following day if still no 
response (THURSDAY) 
  
Don’t forget to text in your blood pressure this week. Questions about taking your 
BP? Look at your BP cuff guide and the REACH OUT handout for help! 
Text something other than BP 
  
Remember: this is an automated system. For questions about REACH, call the 
study team. For questions about your BP, ask your Dr. If this is an emergency, call 
911. 
Safety Measures - BP too high 
  
You recently sent a BP where one or both of your numbers were greater than 
180/110, which is very high. If you have symptoms like chest pain, call 911. See a 
Dr. soon to get your BP down! 
Safety Measures - BP too low 
  
You recently reported a BP where one or both of your numbers were less than 
90/60 which is low. If you have symptoms like dizziness call 911 or go to the 
hospital.  See a Dr. soon for your BP health! 
If not a biological BP 
  
The BP you sent in does not seem to be right. Your BP should be like xxx/xxx. 
Look at your BP cuff instructions and the BP handout. Reply with your new BP.  
 

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Appendix E : 
 
 
 

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Appendix F : 

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Appendix G : 
 
 
 

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Appendix H : 

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Appendix I : 

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Appendix J :
 
 

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Appendix K : Alternative Implementation Plans 
We intend for these alternative implementation strategies to not be utilized as primary means of 
enrolment, and instead be utilized as exceptions. We anticipate, if utilized, we may include statistical 
strategies to account and acknowledge participant difference. We anticipate instancing of utilizing 
may include in the case of a public health emergency, large electronic system down ages, etc. 
 
Virtual recruitment 
 
If in-person recruitment is not feasible, virtual recruitment may also be utilized. We may screen ER patients 
that meet age range and blood pressure inclusion criteria via EMR, and then call the patient to complete 
eligibility screening. The research staff will follow a phone screening and recruitment script for virtual 
recruitment (Appendix I). We may also mail letters to these patients, letting them know of their potential 
eligibility (Appendix J). We will attempt to call ER patients once they are discharged home, within the next 
week, given patients often do not have their own telephone in the ER. The research staff will contact the 
patient via the contact information available in HMC’s ED medical records (same records viewed as during 
in-person recruitment). 
 
Virtual Consent procedures 
 
As stated, if in-person recruitment is not feasible, virtual recruitment may also be utilized. If patients are 
found to be eligible by virtual recruitment, we will proceed to a virtual consent process utilizing the informed 
consent document, this may be done with whatever means best possible for patient (telephone, zoom, etc). 
This will not be recorded. 
 
The research staff will ask for the last name, and month and year of birth as confirmation that we are 
speaking to expected patient (information will be known through EMR screening). Only once confirmed, will 
the research staff begin the process of consent. Interested patients will be enrolled in the study after 
providing consent. The research staff will discuss questions with the individual, and research would only 
begin after informed consent is obtained. The study team will have a conversation with the participant 
regarding informed consent. Verbal consent will be received and will be documented by the study team. 
 
We will attempt to provide a copy of the consent to potential participants prior to obtaining consent. This will 
be done in whatever way best preferred by potential participant such as via email, text message to 
download, or texted link. If requested, we will give the participant a copy of the informed consent document 
via postal mail.  Following consent, patients will be asked to complete a baseline assessment. The research 
staff will postal mail a validated, automated, oscillometric BP monitor, and will teach the participant how to 
use the BP cuff (Appendix A) and text the readings to the study team (Appendix B), including the timing of 
BP self-monitoring, body position, and resting prior to testing. This training may be done after participant has 
receive BP cuff. Participants may also be mailed all training materials noted in the in-person consent 
process, and provided a link to the reach out website (reachouted.com) which has these materials along with 

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videos of blood pressure monitoring.  
 
All enrollment training discussed would be done over the phone or through video services, and materials ( 
blood pressure cuff, instructions sheet(s)) would be either presented through reachouted.com, emailed, 
texted, or postal mailed to participant. The $25 incentive will be cash or gift card equivalent. It will either be 
mailed, emailed, or texted, depending on participant preference. We will ensure the preference of the 
participant.