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

Study Title:  Reach Out: Randomized Clinical Trial of Emergency 
Department-Initiated Hypertension Behavioral Intervention Connecting 
Multiple Health Systems
Study Investigators:  William Meurer, MD, MS; Lesli Skolarus, MD, MS
NCT: NCT03422718
IRB Approval Date: 8/17/2022

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Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behav-
ioral Intervention Connecting Multiple Health Systems 
Study Investigators 
University of Michigan: Principal Investigators: William Meurer, MD, MS; Lesli Skolarus, MD, 
MS. 
Supported by: 
National Institutes of Health 
1 R01 MD011516-01A1 
Study Intervention Provided by: 
The Regents of The University of Michigan 
Sponsor of IND (IDE): 
Not applicable 
(Any modification to the protocol should be annotated on the coversheet or in an appendix.  The 
annotation should note the exact words that are changed, the location in the protocol, the date 
the modification was approved by the Executive Committee, and the date it became effective.) 

 
 
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Table of ContentsListing of changes ....................................................................................................................... 5 
SYNOPSIS ............................................................................................................................................................... 8 
1.1 
Primary Endpoint ........................................................................................................................................... 10 
1.2 
Primary Objective .......................................................................................................................................... 10 
1.3 
Secondary Endpoints ..................................................................................................................................... 10 
1.4 
Exploratory and Process Endpoints ............................................................................................................... 10 
2 
Background ................................................................................................................................................ 11 
2.1 
Rationale ....................................................................................................................................................... 11 
2.1.1 
Management of hypertension in, and following, the ED ..................................................................... 12 
2.1.2 
Mobile health technology offers ubiquity and scalability for hypertension treatment ...................... 12 
2.1.3 
Patient population ............................................................................................................................... 12 
2.1.4 
Relevance and priority for this study ................................................................................................... 13 
2.2 
Supporting Data (Preliminary studies) .......................................................................................................... 13 
2.2.1 
Reach Out-Flint Churches (HUM00082454) ........................................................................................ 13 
2.2.2 
Reach Out-ED (HUM00091668) ........................................................................................................... 14 
3 
STUDY DESIGN ............................................................................................................................................ 14 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ....................................................................................... 15 
4.1 
Inclusion Criteria ............................................................................................................................................ 15 
4.2 
Exclusion Criteria ........................................................................................................................................... 16 
4.3 
Study Enrollment Procedures ........................................................................................................................ 16 
4.3.1 
Identification of Cases ......................................................................................................................... 16 
4.3.1 
Consent procedures ............................................................................................................................. 16 
4.3.2 
Telephone Recruitment ....................................................................................................................... 17 
4.3.3 
Telephone Consent Procedures ........................................................................................................... 17 
4.3.4 
Eligibility phase .................................................................................................................................... 18 
4.3.5 
Randomization ..................................................................................................................................... 18 
5 
STUDY INTERVENTIONS .............................................................................................................................. 19 
5.1 
Intervention and strategy components ......................................................................................................... 19 
5.1.1 
Text messages ...................................................................................................................................... 20 
5.1.2 
Prompted BP self-monitoring .............................................................................................................. 21 
5.1.3 
Facilitated primary care provider appointment scheduling and transportation ................................. 21 
6 
Outcomes and EVALUATIONS ..................................................................................................................... 22 
6.1 
Outcome Assessments ................................................................................................................................... 22 
6.1.1 
Outcomes ............................................................................................................................................. 22 
6.1.2 
Tele-Outcomes ..................................................................................................................................... 23 
6.2 
Exploratory and Process Endpoints ............................................................................................................... 24 
6.2.1 
Incentives ............................................................................................................................................. 28 
6.3 
Estimation of resources necessary to implement protocol ............................................................................ 28 

 
 
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MANAGEMENT of adverse experiences ...................................................................................................... 28 
7.1 
Definition of Adverse Event and Serious Adverse Event and Scope of AE reporting ...................................... 28 
7.2 
Unexpected (Unanticipated) Adverse Event .................................................................................................. 29 
7.3 
Severity of an Adverse Event ......................................................................................................................... 29 
7.4 
Classification of an Adverse Event ................................................................................................................. 29 
7.5 
Relationship to Study Treatment ................................................................................................................... 29 
7.6 
Adverse Event Recording and Reporting ....................................................................................................... 30 
7.7 
Serious Adverse Event Recording and Reporting .......................................................................................... 31 
7.8 
Formal Definitions of Selected or Anticipated Adverse Events and Safety Outcomes ................................... 31 
8 
STATISTICAL CONSIDERATIONS ................................................................................................................... 31 
8.1 
Data analysis ................................................................................................................................................. 31 
8.2 
Endpoints ....................................................................................................................................................... 32 
8.3 
Sample Size and Accrual ................................................................................................................................ 32 
8.4 
Data Monitoring ............................................................................................................................................ 33 
9 
DATA COLLECTION, SITE MONITORING, AND ADVERSE EXPERIENCE REPORTING ....................................... 33 
9.1 
Records to Be Kept......................................................................................................................................... 33 
9.2 
Role of Data Management ............................................................................................................................ 34 
9.3 
Quality Assurance .......................................................................................................................................... 34 
10 
HUMAN PARTICIPANTS............................................................................................................................... 34 
10.1 
Risks .......................................................................................................................................................... 34 
10.1.1 
Data risks ......................................................................................................................................... 34 
10.1.2 
Vulnerable populations: pregnant women, prisoners, and children .............................................. 35 
10.2 
Adequacy of Protection Against Risk ........................................................................................................ 36 
10.2.1 
Physical risks ................................................................................................................................... 36 
10.2.2 
Psychological risks ........................................................................................................................... 36 
10.2.3 
Financial risks .................................................................................................................................. 36 
10.2.4 
Legal risks ........................................................................................................................................ 36 
10.3 
Institutional Review Board (IRB) Review and Informed Consent .............................................................. 37 
10.4 
Participant Confidentiality / Data Retention ............................................................................................ 37 
10.5 
Study Modification/Discontinuation ......................................................................................................... 37 
Appendix A – Flyer for taking your BP at Home ................................................................................................... 38 
Appendix B – Blood Pressure Informational flyers ............................................................................................... 39 
Appendix C – Recruitment flyer ........................................................................................................................... 40 
Appendix D – Sample text messages .................................................................................................................... 41 

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Appendix E – Flyer for Text Message Instructions ................................................................................................ 48 
Appendix F – Reach Out Feedback ....................................................................................................................... 49 
Appendix G – Comic Book .................................................................................................................................... 50 
Appendix H – Provider Authorization .................................................................................................................. 53 
Appendix I- Holiday Card Study Within A Trial ..................................................................................................... 54 
Appendix J- Holiday Card ..................................................................................................................................... 56 
Appendix K- Outcome Reminder .......................................................................................................................... 57 
Appendix L- Newsletter Outline ........................................................................................................................... 58 
Appendix M- Tele Outcome Reminder ................................................................................................................. 59 
Appendix N- Tele Outcome Guide ........................................................................................................................ 60 
Appendix O- Telephone Consent Script ................................................................................................................ 61 
Appendix P- Remote Recruitment Letter ............................................................................................................. 66 
Appendix Q- Supplement: Reach Out Cognition................................................................................................... 67 
Appendix R- Supplement: Telephone consent script ............................................................................................ 74 
Appendix S- Supplement: Feedback forms ........................................................................................................... 79 
Appendix T- Supplement: Instructions for taking your BP .................................................................................... 80 
Appendix U- Supplement: Instructions guide for tele-outcomes .......................................................................... 81 

 
 
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Listing of changes 
 
 
Ver-
sion 
No. 
Date 
Re-
viewer 
Details of changes 
IRB Status 
2.0 
9.19.2018 
MRD 
1. 
Uploading of instructions for BP and text messag-
ing which have been done by a graphic designer. 
(appendix A; appendix E) 
2. 
JNC-7 to JNC-88 outcomes based on recent revi-
sions to blood pressure guidelines (page 8; page 
19)  
Approved 
3.0 
12.3.2018 
MRD 
1. 
Added a sentence regarding the option to keep 
participants up to date on progress of the study. 
(page 15) 
2. 
 Deleted incomplete sentence “; we will accom-
plish this via the following specific aims.” (page 
10) 
3. 
Added clarification to consent process that the 
electronic pdf for may have the opportunity to be 
built into Redcap for more centralized and secure 
storage (page 14). 
Approved 
4.0 
4.1.2019 
MRD 
1. 
Added sentences and appendix describing use and 
purpose of Reach Out Feedback sheet and Comic 
Book. (Page 13) 
a. 
Appendix F (Page 44) 
b. 
Appendix G (Page 45-57) 
Approved 
5.0 
7.8.2019 
MRD 
1. 
Fix table of contents  
2. 
Change subjects to participants throughout proto-
col 
3. 
Correct provider transportation/appointment con-
trol standards from 140/90 to systolic 130.  
4. 
Add clarification that participants may be con-
tacted for technology checks after randomization 
if indications arise. (Page 18) 
5. 
Language allowing contact in the case of lost data 
or consent documentation (Page 17) 
Approved 
6.0 
8.13.2019 
MRD 
1. 
Add outcome sentence, “Outcomes may be built 
into REDCap. Outcomes may be visually modified, 
questions removed, rearranged, or re-worded as 
Approved 

 
 
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resources become available, but the messaging, 
and content will re-main consistent.” (Page 19).  
7.0 
9.12.2019 
MRD 
Adding explanation and appendix regarding provider appoint-
ment scheduling documentation if needed by provider office 
for scheduling permission.   
- 
Appendix H added (Page 48).  
- 
Sentence added “If a provider office indicates that 
they require proof of permission from participant 
regarding the ability to schedule appointments on 
their behalf, REACH OUT may provide that to them 
for their files, or complete the office’s specific per-
mission forms (Appendix H).”   (Page 19). 
Approved 
8.0 
12.5.2019 
MRD 
Adding FIM and AIM scales. Page 21 notes that general inter-
vention feedback may include validated scales, Acceptability 
of Intervention Measure (AIM), and Feasibility of Interven-
tion Measure (FIM). 
 
Added appendices to Pages 61-63 referencing a proposed 
study within the trial.  
Added Appendix I: Holiday Card Study within a Trial (Page 
61-62) 
Added Appendix J: Holiday Card (Page 63) 
 
Updated Table of Contents with new Appendices (Page 4) 
 
Approved 
9.0 
1.17.2020 
MRD 
Increase sample size estimates within the synopsis (Page 8) 
and the specific sample size section (Page 29).  
 
After accruing approximately 400 randomized participants, 
we noted lower than expected retention at 6 month visits. 
Therefore, we adjusted the maximum total number of enroll-
ments and randomizations upwards by 50% each. The overall 
intention is to achieve approximately 240 protocol complet-
ers (attendees at 12-month visit). We will continue to moni-
tor accrual and retention in order to achieve this target. 
Approved 
10.0 
2.13.2020 
MRD 
Adding description and appendix of 1) Outcome reminder let-
ter and 2) Newsletter outcome.  
 
Description of mailing of outcome reminder and newsletter 
added to Page 21.  
 
Added Appendix K: Outcome letter 
Added Appendix L: Newsletter 
 
Updated Table of Contents with new appendices.  
Approved 
11.0 
3.16.2020 
MRD 
Amendment for tele-outcomes given COVID recommenda-
tions.  
 
Detailing tele-outcome protocols and materials (Page 21). In-
cluding materials to make tele-outcomes more accessible to 
participants including a Tele-outcome reminder (appendix M) 
and a tele-outcome guide (appendix N), as well as a link to a 
video guide.  
Approved 
12.0 
4.14.2020 
MRD 
Supplemental appendix detailing extended 15 and 18 month 
outcomes with participant consent (appendix O).  
 
Addition of ability to do phone recruitment of ED patients. 
This involves calling ED patients (once discharged) that have 
Approved 

 
 
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met certain inclusion/ exclusion criteria for recruitment (page 
17).  
13.0 
10.8.2020 
MRD 
Supplemental Appendix changes (Appendix O) 
 
Clarification on where data will be stored regarding data-
bases. Language was changes for Reach Out Cognition from 
exclusively Redcap, to equivalent databases.  
 
The feedback forms (neuro-qol/ sage) regarding the enroll-
ment surveys will only be sent out to participants if they have 
completed the entire assessment. 
 
The mini MoCA was previously described as part of the en-
rollment, after the consent process. However, it seems most 
appropriate this is used as a screener prior to consent. A sec-
tion was added describing screening processes, and a screen-
ing consent verbal was created and submitted to IRB. 
Approved 
14.0 
08.1.2022 
MRD 
Adding subsection 3 of “Contemporary Control Group.” This 
is detailed as a retrospective contemporary control group of 
Hurley ED patients who had an outpatient follow-up visit.  
Pending 
 

 
 
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SYNOPSIS 
 
Study Title: 
 
Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behav-
ioral Intervention Connecting Multiple Health Systems 
 
Objectives 
 
Through Reach Out, a health system focused, multicomponent, health theory based, mobile 
health behavioral intervention to reduce blood pressure (BP) among hypertensive patients evalu-
ated in a safety net ED. We aim to determine which behavioral intervention components or 
‘dose’ of the components contribute to a reduction in systolic BP at one year (Aim 1). We will 
also determine the effect of primary care provider appointment scheduling and transportation on 
primary care follow up of hypertensive patients treated in an urban, safety net ED (Aim 2). Ulti-
mately, by connecting ED patients to primary care providers, Reach Out can serve as a model for 
safety net hospitals and Federally Qualified Health Centers to improve chronic disease manage-
ment in underserved communities. 
 
Design and Outcomes  
 
Reach Out is a health system focused, multicomponent, multiphase optimization strategy 
(MOST), health theory based, mobile health behavioral intervention to reduce BP among hyper-
tensive patients evaluated in a safety net ED. This trial will take place in Flint, Michigan, an ur-
ban, under-resourced, predominately African American community with which the researchers 
have long-standing partnerships. Reach Out consists of three components, each with two levels: 
1) healthy behavior text messaging (yes vs. no), 2) prompted home BP self-monitoring (weekly 
vs. daily), and 3) facilitated primary care provider appointment scheduling and transportation 
(yes vs. no). Participants will be randomized into one of the eight experimental arms and fol-
lowed for 12 months.  
 
The primary endpoint is the change in systolic BP from baseline to 12 months. By using multi-
variable modeling within the context of a 2x2x2 factorial design, we will learn about the relative 
contributions of each of the three components to BP reduction. Our overarching objective is to 
demonstrate that an ED initiated, multicomponent, health system intervention can meaningfully 
reduce BP in a traditionally underserved population. 
 
Interventions and Duration 
 
Reach Out consists of three, bi-level, mobile health components:  
 
1) healthy behavior text messaging (yes vs.no) 
2) prompted BP self-monitoring and associated tailored and targeted text messages (daily vs. 
weekly) 
3) facilitated primary care provider appointment scheduling and transportation (yes vs. no).  

 
 
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After demonstrating persistent hypertension and responsiveness to texting, participants will be 
randomized into this 2x2x2 factorial design and followed for 12 months. 
 
Sample Size and Population 
 
We originally planned to enroll approximately 960 patients into the eligibility phase. From this 
group, we estimate that 480 participants will report qualifying BPs and will be randomized to 
one of the eight intervention arms. We anticipate 240 participants will fully complete the 12 
month, in person follow up visits. However, after accruing approximately 400 randomized par-
ticipants, we noted lower than expected retention at 6 month visits. Therefore, we adjusted the 
maximum total number of enrollments and randomizations upwards by 50% each. The overall 
intention is to achieve approximately 240 protocol completers (attendees at 12-month visit). We 
will continue to monitor accrual and retention in order to achieve this target.

 
 
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STUDY ENDPOINTS AND OBJECTIVES 
1.1 
Primary Endpoint 
 
Reduction in systolic BP from baseline (median of three qualifying SBP from eligibility phase) 
to 12 months. 
 
1.2 
Primary Objective  
 
Estimate the expected change in 12-month SBP reduction associated with each level of the three 
interventions and determine the combination of elements that appears most promising for study 
in a future larger scale trial.  
 
1.3 
Secondary Endpoints 
• Time from ED visit to arrival at first primary care visit (in days). 
  
• Attendance at two or more primary care visits within 12 months of randomization.  
1.4 
Exploratory and Process Endpoints 
BP 
• Proportion of participants achieving BP control 
o JNC-8 targets for SBP/DBP 
o 2017 AHA guidelines targets for SBP/DBP 
• Change in DBP and mean arterial pressure 
• Change in 6 month SBP 
 
Process 
• Number of interactions (such as calls/texts) to schedule participant initial primary 
care visit 
• Number of interactions to schedule all other primary care visits 
• Proportion of BPs texted to the study team 
• Proportion enrolled but not randomized 
 
PCP 
• Establishment of a primary care providers among those without 
• Number and proportion of provider visits attended 
• Proportion of transportation vouchers used 
 
Utilization 
• Frequency of Hurley ED and other healthcare visits 
• Self-reported follow up of health system (Hurley, Hamilton, or other community clin-
ics) 

 
 
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• Follow up outside of health system (urgent care, outside clinics, outside EDs) 
 
Medications 
• Changes/escalation in antihypertensive regimen through patient self-report 
• Medication Adherence (Hill-Bone Scale, and modified Hill-Bone instrument asking, 
“How often do you forget to take your HBP medicine?”) 
 
Other 
• Social Cognitive Theory (SCT) measures  
o Modified one-question self-efficacy measure, “I am confident that I can 
take my blood pressure and text it to the Reach Out Team”) 
o Questions querying self-efficacy, motivation, social support and expertise.  
 I am confident that I can control my blood pressure 
 It is worthwhile for me to control my blood pressure 
 My friends and family care if I control my blood pressure 
 I know the right steps to take to control my blood pressure 
• General intervention feedback 
 
2 
BACKGROUND 
2.1 
Rationale 
Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading 
cause of mortality in the United States. African Americans have the highest prevalence of hyper-
tension of any race/ethnic group in the United States which largely contributes to their increased 
burden of stroke compared to non-Hispanic whites. In addition, uncontrolled hypertension is 
more common among socioeconomically disadvantaged populations than their counterparts.  
 
The Emergency Department (ED) represents a missed opportunity to identify and treat hyperten-
sion in difficult–to-reach populations. Currently, there are 136 million ED visits per year and 
nearly all have at least one BP measured and recorded. African Americans and socioeconomi-
cally disadvantaged patients are disproportionally represented in the ED patient population and 
both are increasing. In the age of electronic health records (EHR) and mobile health, the ED can 
feasibly become an integral partner in chronic disease management by programming the EHR to 
identify hypertensive patients and dispense a mobile health behavioral intervention. Facilitating 
ED follow up at primary care clinics is a key feature of the proposed intervention. Through lev-
eraging the strengths of the ED and its large patient volume of uncontrolled, difficult-to-reach, 
hypertensive patients, with the strengths of the primary care clinics’ continuity of care, we aim to 
improve community wide utilization of health services. 
 
We propose, Reach Out, a health system focused, multicomponent, health theory based, mobile 
health behavioral intervention to reduce BP among hypertensive patients evaluated in a safety 
net ED. This trial will take place in Flint, Michigan, an urban, under-resourced, predominately 
African American community with which the researchers have long-standing partnerships. 

 
 
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Reach Out consists of three components, each with two levels: 1) healthy behavior text messag-
ing (daily vs. none), 2) prompted home BP self-monitoring (weekly vs. daily), and 3) facilitated 
primary care provider appointment scheduling and transportation (yes vs. no). Participants will 
be randomized into one of the eight experimental arms and followed for 12 months.  
 
Our overarching objective is to demonstrate that an ED initiated, multicomponent, health system 
intervention can meaningfully reduce BP in a traditionally underserved population. 
2.1.1 
Management of hypertension in, and following, the ED 
 
Given variable ED hypertension management and low ED follow up rates, ED visits are missed 
opportunities for the identification and management of hypertension. Each year there are over 
130 million ED visits, of which hypertension is identified in about 45% (60 million visits). While 
ED guidelines recommend BP screening, the recommendations for management of asympto-
matic hypertension in the ED vary widely from no intervention, referral for primary care follow 
up, or initiation of antihypertensive to be followed by primary care. However, adherence with 
recommended primary care follow up by ED patients in the United States is low; ranging from 
26% and 56% depending on the community served. Strategies such as those proposed in Reach 
Out, which facilitate ED patient follow up with primary care providers via appointment schedul-
ing and transportation, are vital given the burden of hypertension and disproportionate ED use in 
disadvantaged populations, as well as low rates of primary care follow up after an ED visit. 
 
2.1.2 
Mobile health technology offers ubiquity and scalability for hypertension treat-
ment 
Mobile messaging is nearly ubiquitous—ninety-two percent of adult Americans have a mobile 
phone with over 80% using their devices to send or receive text messages. Overall, African 
Americans are more likely to own a mobile phone than non-Hispanic whites. Text messaging, or 
short-message service (SMS), is a widely used technology that sends messages of up to 160 char-
acters. Text messaging offers an appealing option for behavioral interventions given its popular-
ity in underserved populations, low cost, ease of adoption, scalability, and ability to reach people 
in real-time yet remain flexible and convenient. Text messaging does not require costly smart 
phones or expensive data plans—adding to the practicality and generalizability of Reach Out. 
2.1.3 
Patient population 
This trial will take place in Flint, Michigan, an urban, underserved, predominately African 
American community. Flint has a population of 102,434, of which 57% are African Americans; 
37% live below the poverty level. About 40% of Flint residents self-report hypertension.  
 
Hurley Medical Center is a 540-bed teaching hospital, and it is the only Level I Trauma Center 
and safety net hospital located in Flint (Genesee County). The Hurley ED cares for about 
110,000 visits per year and recently more than doubled in space. There is disproportionate bur-
den of hypertension among African Americans, those of low socioeconomic status, and working-
age Americans. These populations are high volume users of the ED. In fact, 20% of working age 
Americans had an ED visit in the last year. African Americans have nearly twice the ED visits 

 
 
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compared to non-Hispanic whites; and individuals with Medicaid have the highest ED visit rate 
of any type of insurance.  
 
Hamilton Community Health Network, a FHQC network in Flint, cares for over 30,000 patients, 
about 65% of whom are African American, in multiple clinics throughout the city.  
2.1.4 
Relevance and priority for this study 
Hypertension experts have called for evaluation of multilevel interventions addressing barriers to 
hypertension care. In line with this request and informed in part by the theory, Social Ecological 
Model, Reach Out intervenes at the individual patient, health system, and community levels. At 
the individual level, Reach Out will increase identification of hypertension through ED screen-
ing, providing BP self-monitors, and encouraging healthy behaviors, all of which are barriers to 
hypertension management in urban, under-resourced populations. At the health system level, 
Reach Out leverages the EHR to identify potential participants. Reach Out will work to reduce 
health system barriers by scheduling primary care provider appointments. Cost of medications is 
also a barrier that will be addressed in Reach Out. For participants who establish care with the 
FQHC, medications are provided on a sliding fee scale. Additionally, healthy behavior text mes-
sages will provide information about pharmacies with $4 generic drug programs in the area.  
2.2 
Supporting Data (Preliminary studies) 
 
The scientific premise of Reach Out is to test an innovative, mobile health, behavioral, health 
system intervention to reduce BP in hard-to-reach high-risk populations. 
 
An American Heart Association scientific statement on the use of mobile health for cardiovascu-
lar disease prevention found only 13 trials of which only three (all performed outside of the US) 
used primarily text messaging to promote BP control. Two of the three trials showed a reduction 
in BP but the results were limited by low participant retention and absence of intention- 
to-treat analysis. The American Heart Association scientific statement also identified limitations 
in trials with short duration of follow up, interventions less than 6 months, lack of information on 
the optimal intervention components and their delivery, and an absence of rigorous clinical trial 
design. Furthermore, the reductions in BP were small in many of the trials, suggesting that inter-
ventions that combine text messaging with other behavioral approaches, such as self- monitoring 
and novel strategies such as primary care provider scheduling and transportation assistance, may 
be needed in underserved populations. Reach Out will specifically address these limitations. 
 
Specifically, within our study team, in prior work, we have: 1) developed and tested health 
theory-based healthy behavior text messages and road map; 2) confirmed the feasibility of 
prompted BP self-monitoring; 3) created automated, real-time EHR alerts to identify possible eli-
gible ED patients; 4) established a recruitment strategy and protocol; and 5) conducted behav-
ioral clinical trials. 
2.2.1 
Reach Out-Flint Churches (HUM00082454) 
Using a community-based participatory research (CBPR) approach, several mobile health compo-
nents were developed including prompted BP self-monitoring, healthy behavior text messages, 

 
 
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and a text messaging roadmap. We then tested healthy behavior text messages and weekly 
prompted BP self-monitoring in three African American churches for 6 months. All text messages 
were delivered automatically through a text messaging platform developed by Mosio, who is also 
the vendor for this application.53 A total of 48 participants received the intervention with a mean 
age of 58 (sd=9.8) years, all of whom were African American. Notably, 15% of the participants 
did not have a primary care provider. Participants responded to BP prompts 587 (47%) of the 
available 1248 person-weeks. All (100%) participants reported satisfaction with the Reach Out 
intervention. Overwhelmingly, participants did not want the mobile health intervention supple-
mented with phone calls, workshops, cooking demonstrations or internet modules. 
2.2.2 Reach Out-ED (HUM00091668) 
This was a pilot trial of the healthy behavior text messaging and weekly prompted BP self-moni-
toring in the University of Michigan ED. In this study, we created real-time automated alerts using 
the EHR to identify potentially eligible participants. We also created procedures for recruitment 
of ED patients. Real-time automated EHR alerts identified patients with systolic BP ≥160 or a 
diastolic BP ≥100 (stage II hypertension) who were likely to be discharged from the ED. During 
the 7-month enrollment period, over 9,300 patients with elevated BP were identified through the 
alerts. Given that this was a pilot study that relied on volunteer undergraduate student research 
assistants, 163 patients were approached and 104 patients enrolled (64%), confirming the feasibil-
ity of automated real-time ED screening followed by research staff enrollment of eligible patients. 
Of the 104 enrolled participants, 55 had at least one elevated BP and were activated into the study. 
3 
CONTEMPORARY CONTROL GROUP 
To better understand how the intervention will or has affected Reach Out participants, we will 
retrospectively create a contemporary control group. This control group will encompass HMC 
ED patients who had follow-up visit (outpatient or ED) within 12 months of their ED visit.  Pa-
tients will be identified through review of the HMC EMR, during a similar period to when the 
Reach Out intervention was being conducted (March 2019-August 2020). If not possible to make 
adequate comparisons during the trial time period, it may be expanded. All data will be outgoing 
from HMC to the study team. We request a waiver of HIPAA authorization and waiver of con-
sent.  We will exclude all patients that were consented into the study, the contemporary control 
group will be de-identified following participant exclusion. We will collect the minimum amount 
of personal data possible to accomplish the comparison including similar variables to: 
 
- 
Stratifying variables (sex, age, antihypertensive use) 
- 
Demographics (race, ethnicity) 
- 
Date of ED visit 
- 
ED complaint 
- 
ED BPs 
- 
Date of follow-up 
- 
BPs at follow-up 
- 
Time to follow-up 
 
 

 
 
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4 
STUDY DESIGN 
 
As we did successfully through our two pilot studies (HUM00082454/ HUM00091668), we will 
integrate the two strategies together to now recruit participants from the emergency department 
of Hurley Medical Center in Flint, MI. We will conduct a randomized, controlled, 2x2x2 facto-
rial design clinical trial that will allocate participants to eight different combinations of mobile 
health components (Table 2). The proposed trial will identify which mobile health components, 
or ‘dose’ of the components (healthy behavior text messaging, prompted BP self-monitoring and 
facilitated primary care provider appointments and transportation) contribute to a reduction in BP 
among hypertensive participants recruited from Hurley Medical Center, an urban, safety net ED 
(Table 1). A baseline assessment will occur at enrollment. Outcome assessments will also occur 
at 6 months and 12 months.  
 
We will monitor the efficacy and resources required for the intervention using system level data 
obtained from the ED, the FQHCs, and clinics.  
 
Table 1: Reach Out Intervention Components to Decrease BP 
Texts 
Stratification 
Levels 
Tailoring varia-
bles 
Mechanism for BP Reduction 
Healthy behavior 
Daily vs. 
None 
No 
Decrease salt intake 
Increase physical activity 
Increase fruit and vegetable intake 
Medical provider 
BP medication 
Self-efficacy 
Discuss with provider  
Increase medication adherence 
Prompted BP self-mon-
itoring 
Daily vs. 
Weekly 
BP change (most 
recent self-re-
ported BP) 
BP control 
Participant activation 
Participant autonomy 
Participant competence 
Provider scheduling 
and transportation 
Yes vs. None 
Medical Provider 
BP control 
Improve access to medical care 
Opportunities for medication optimiza-
tion 
 
5 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
Participants will be recruited from Hurley Medical Center in Flint, MI by trained research assis-
tants who will be notified by real-time alerts from EPIC.  
5.1 
Inclusion Criteria 
• Age of 18 or greater 
• At least one BP with SBP ≥ 160 or a DBP ≥ 100 (criteria 1)  
• If the patient has repeated measurements after achieving Criteria 1, at least one of the re-
peat BP remains SBP ≥ 140 or a DBP ≥ 90 
• Must have cell phones with text-messaging capability and willingness to receive texts 

 
 
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• Likely to be discharged from the ED 
5.2 
Exclusion Criteria 
• Unable to read English (<1% at study site)  
• Prisoners 
• Pregnant 
• Pre-existing condition making one year follow-up unlikely  
o Terminal illness with death expected within 90 days 
• Current use of 3 or more antihypertensive agents 
• Patients with other serious medical conditions that prevent self-monitoring of BP 
• Critical illness with placement in resuscitation bay 
• Dementia/cognitive impairment 
5.3 
Study Enrollment Procedures 
5.3.1 
Identification of Cases  
As we did through EPIC at the University of Michigan in HUM00091668, we will implement an 
automated screening algorithm used by the electronic medical records of the ED, to identify pa-
tients with blood pressures over a threshold. The threshold for activation is established by a sys-
tolic 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. We will use this alert 
through their EMR to automatically notify the study team members to the presence of potentially 
eligible patients. 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. Auto-
mated identification of patients may commence up to 3 months prior to the opening of enroll-
ment to work out errors and optimize the EMR screening algorithm within Hurley.  
 
We will request a waiver of consent to maintain a screening log of patients that trigger the alert 
system, and also at times when completing remote recruitment, and through chart review collect 
demographics such as, age, gender, race/ ethnicity, reason for ineligibility or refusal and ED BP.  
 
Research assistants will be based in the Hurley emergency department, and thus familiar and 
comfortable with their system. Flyers/ announcements may be made to the emergency depart-
ment staff at events such as, staff meetings, or common area board, to notify them of study pur-
pose and recruitment (Appendix C). This document may be visually modified as resources be-
come available, but the messaging, and content will remain consistent.  
 
5.3.1 
Consent procedures 

 
 
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All adults meeting the inclusion/exclusion criteria will be approached for consent, if a study team 
member is available. Research staff will then perform in-person screening of these patients based 
on the remaining enrollment criteria (see inclusion/ exclusion criteria). Cognitive ability will be 
assessed through the question, “Are you able to stay home alone for 24 hours?” Patients will re-
ceive routine clinical care at the local emergency departments, and eligibility will be confirmed 
as previously described. We will use an informational flyer to help provide information about the 
study (Appendix C, Appendix E). If possible, the consent process will be performed in a private 
room or sectioned area as to provide the most privacy possible. This process will always be per-
formed in person, however we may use electronic pdf forms of the consent document (may build 
this into Redcap), and collect electronic signatures through a secure mechanism. A copy of the 
informed consent document with signature will still be supplied to the participant. Following 
consent, participants will receive a validated, automated, oscillometric BP monitor (XREXS Au-
tomatic Digital monitor or similar), and be asked to complete a baseline assessment. We will col-
lect baseline characteristics, including the data needed for targeting and tailoring the text mes-
sages. The research staff will teach the participant how to use the BP cuff and text the readings to 
the study team, including the timing of BP self-monitoring, body position, and resting prior to 
testing (Appendix A). Participants may also be given a comic book (Appendix G) to improve un-
derstanding of the study and hypertension, as well as a Reach Out BP Feedback sheet (Appendix 
F).  Additionally, these documents may be visually modified as resources become available, but 
the wording, and content will remain consistent. Participants will be given $20 in compensation 
for their time. We may have a study newsletter that is available to participants so they remain up-
dated on the study. 
5.3.2 
Telephone Recruitment 
As an alternative to in-person recruitment and consent procedures, remote recruitment may also 
be utilized instead of in-person. We may screen ER patients that meet age range and blood pres-
sure inclusion criteria via EMR, and then call to complete eligibility screening. The research staff 
will follow a phone screening and recruitment script for remote recruitment (Appendix O). We 
may also mail letters to these patients, letting them know if their potential eligibility (Appendix 
P). 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). 
5.3.3 
Telephone Consent Procedures 
If adults are found to be eligible by via telephone screening , we will proceed to a telephone con-
sent process, and will follow a phone consent script (Appendix O), this may be done with what-
ever means best possible for participant (telephone, video, etc). The research staff will ask for the 
last name, and month and year of birth as confirmation that we are speaking to expected patient. 
Only once confirmed, will the research staff begin the process of consent. The consent process 
will be performed by the research staff in a private environment to provide the most privacy pos-
sible The research staff will explain the study to participants during the consenting process. In-
terested participants will be enrolled in the study after providing verbal consent (for remote re-
cruitment). The research staff will discuss questions with the participant, and research would 
only begin after informed consent is obtained. 

 
 
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For feasibility reasons, within our already approved waiver of hipaa authorizing we add waiver 
of documentation of informed consent to allow for the study enrollment consenting to be ob-
tained in multiple ways (i.e., in-person when feasible, or verbal consent for those completing re-
motely). 
 
We will attempt to provide a copy of the consent to potential participant at beginning of obtain-
ing consent via email, text message to download, or texted link to website. If requested, we will 
give the participant a copy of the informed consent document via postal mail.  Following con-
sent, participants will be asked to complete a baseline assessment. We will collect baseline char-
acteristics, including the data needed for targeting and tailoring the text messages. The research 
staff will postal mail a validated, automated, oscillometric BP monitor (XREXS Automatic Digi-
tal monitor or similar), and will teach the participant how to use the BP cuff and text the readings 
to the study team, including the timing of BP self-monitoring, body position, and resting prior to 
testing (Appendix A). This training may be done after participant has receive BP cuff. Partici-
pants may also be mailed all training materials noted in the in-person consent process. Partici-
pants will be given $20 or cash equivalent in compensation for their time after informed consent 
is received by the research staff. We may have a study newsletter that is available to participants 
so they remain updated on the study. All following enrollment training discussed would then be 
done over the phone or through video services, and materials (incentive, blood pressure cuff, in-
structions sheet(s), swag, etc) would be either emailed, texted, or postal mailed to participant. 
5.3.4 
Eligibility phase 
Following consent, because some participants will have isolated hypertension in the ED, partici-
pants will undergo a 3-week eligibility phase (beginning after informed consent, and participant 
has received blood pressure cuff) to determine if they have persistently elevated BP. All partici-
pants enrolled in the study will be given an automated BP cuff, American Heart Association or 
American College of Cardiology information about high blood pressure (Appendix B), and re-
ceive a text message one day in a week asking to text in their own BP. If a participant has not re-
sponded by the end of week 2 of the eligibility phase, a study team member may contact up to 2 
times to assure it is not a technical issue. This is based on feedback from our previous studies, 
where participant’s primary reported reason for unresponsiveness was unaddressed technical 
complications.  
 
If participants have 1) persistent high blood pressure (any self-reported BP (SBP)≥140 or a BP 
(DBP)≥90), and 2) responded to texts at least once, they will be randomized into the trial. If par-
ticipants do not meet both criteria, they will receive no further communication from the study 
team following the eligibility phase. These participants may be texted a final text message thank-
ing them for participation.  
5.3.5 Randomization 
Table 2: Reach Out ED Intervention 
Arms 

 
 
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The overall study period will be approximately 12 
months. After the 3-week eligibility phase, as-
sessing for persistent hypertension and responsive-
ness to text messages, participants who meet all 
eligibility criteria will then be randomized.  
 
Participants will be randomized via 2x2x2 block 
randomization. Participants will be randomized 
into an experimental arm containing one of the two 
levels of the three interventions (eight unique com-
binations) (Table 2).  
 
Importantly, the intervention components may 
have important associations with participants’ 
baseline characteristics. We are most interested in 
three baseline characteristics: age, sex, and antihy-
pertensive use. Thus, to ensure scientific rigor, in 
randomization we will reduce imbalance within 
our treatment arms by stratifying randomization with these variables: 1) age (<64, ≥65); 2) sex, 
as reported by participant; 3) taking an antihypertensive within the last 6 months (yes vs. no).  
 
In the instance of any lost data, including but not limited to proof of consent through signature, 
participant responses, assessment data, or anything necessary for study procedures and/or IRB 
protocol, the participant will be contacted for completion. Because this is not an FDA regulated 
study, we desire to do what is least burdensome for the participant, the IRB, as well as most eq-
uitable as to not deprive the participant of the opportunity to have access to the study. If this in-
stance arises, and they chose, or the study team is not able to contact them in a reasonable time, 
we may consider them withdrawn and submit this to the IRB.  
 
6 
STUDY INTERVENTIONS 
6.1 
Intervention and strategy components 
 
As stated, Reach Out tests three intervention components: 1) healthy behavior text messaging 
(daily vs. none); 2) prompted BP self- monitoring (daily vs. weekly); 3) facilitated primary care 
provider scheduling and transportation (yes vs. no). Participants will be randomized into one of 
eight arms (Table 2) for the 12-month intervention. For example, in arm 1, the participants will 
not receive healthy behavior based texts. They will receive weekly prompted BP self-monitoring. 
Arm 1 is the lowest intensity group (weekly prompted self-monitoring and reporting of BP) and 
will serve as the effective control group. There is no “untreated” control group given the efficacy 
of prompted blood pressure self-monitoring and feedback from the community following the pre-
liminary studies. In all of these intervention groups, throughout the duration of the study, if a 
participants seems to be consistently unresponsive or responding in error, we may attempt to 
Arm Healthy 
Behavior 
Text 
Prompted 
BP self-
monitor-
ing fre-
quency 
Facili-
tated Pri-
mary 
Care ap-
pointment 
schedul-
ing and 
transpor-
tation 
1 
No 
Low 
No 
2 
Yes 
Low 
No 
3 
No 
High 
No 
4 
Yes 
High 
No 
5 
No 
Low 
Yes 
6 
Yes 
Low 
Yes 
7 
No 
High 
Yes 
8 
Yes 
High 
Yes 

 
 
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contact them via phone, text message, or their preferred means, to ensure they are not in need of 
technology or study assistance.  
 
Additionally, if any requests are sent in by the participant to modulate, pause, or stop any of their 
intervention components, we will give the participant the option if they may still be contacted for 
outcome assessments or appropriate other intervention components, if possible. Certain interven-
tion components deemed not possible because of coronavirus or institutional guidance, may not 
be able to be implemented. 
 
Figure 1 Reach Out Study Design and Incentives (within the  randomization  table, - boxes indicate low intensity, + boxes indi-
cate high intensity) 
6.1.1 
Text messages 
Text message frequency will be dependent on the randomization of the participant. Participants 
randomized to receive healthy behavior text messages will receive them daily. 
 
Text messages will be both tailored and targeted. Tailoring and targeting are health behavior 
strategies to increase the personal relevance and therefore the efficacy of behavioral interven-
tions. Targeting refers to the creation of materials focused on shared characteristics of a group of 
people. In contrast, tailoring refers to materials focused on characteristics of individuals. Studies 
have shown that tailored and targeted communications are more effective than generic messages. 
The messages address the most important lifestyle interventions to reduce BP such as, salt reduc-
tion, increased fruit and vegetable intake, and increased physical activity. Our team, partnering  
with the community, created the content for these text messages based on social cognitive theory. 
Appended are generic, targeted, and tailored text messages. Based on community and hospital 
feedback, additional text messages may be added, but they will be in the same participant and 
style of the appended messages.  
 
In addition to these generic health messages, tailored and targeted text messages-based on 
whether the participant takes an antihypertensive medication, medication adherence level, self-
efficacy level, and has a primary care physician will be used. For example, for participants taking 
The image part with relationship ID rId11 was not found in the file.

 
 
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antihypertensive medications, text messages will also address medication adherences (e.g., pill 
boxes, schedules, etc.).  
6.1.2 
Prompted BP self-monitoring 
All participants will have received a BP self-monitoring device at enrollment in the ED, and 
training for use and text-message response formatting. Participants will be randomized into ei-
ther a high intensity or low intensity.  
• The high intensity group will receive message reminders to check and text their BP back 
daily 
• The low intensity group will be asked to check and text it weekly  
 
By texting their BP, participants have a record of their BPs that they can bring to their primary 
care provider appointments. They may also be able to prompt the text messaging system to ac-
quire a list of their self-reported blood pressures from the text messaging system. Participants 
will receive a monthly picture graph of their self-reported blood pressures for feedback. Our plat-
form will allow the participants to provide preferences regarding the time of day for the BP re-
minders, and the ability to adjust these as needed.  
 
The text-messaging system may make up to a total of 3 attempts until the participant responds 
with a BP. Some messages for that week may then be tailored on that BP recording.  
 
Please note this will be the only Reach Out research specified outbound message that will be per-
missible from the participants to the research team. Otherwise, messages sent by the participant 
will trigger an automated response saying that the response is automated and that for emergen-
cies, the participant should call 911.  Participants who have a BP >180/120 will be sent an auto-
mated message telling them to call their doctor right away, as they likely need more or different 
medication, and if they have symptoms such as chest pain, weakness, difficulty talking, or confu-
sion to call 911.. Additionally, if a message is sent to the system that doesn’t make sense in the 
context of a BP reading, an automated error message will be sent back for them to resubmit their 
BP in the previously taught method. 
 
Participants will have the option to modulate their own reminder frequency by texting prompts to 
either receive daily BP message reminders, weekly message reminders, or setting them back to 
where they were assigned at baseline.  
6.1.3 
Facilitated primary care provider appointment scheduling and transporta-
tion 
Recognizing the importance of primary care provider visits and transportation, Reach Out will 
facilitate primary care provider appointment scheduling and transportation. Participants will be 
randomized to receive either facilitated scheduling and transportation, or passive reminders.  
 
Participants randomized to the facilitated group will be able to schedule appointments with their 
primary care provider via phone call or text capability, which may be facilitated by the research 
team depending on the capability of our scheduling system. If a provider office indicates that 
they require proof of permission from participant regarding the ability to schedule appointments 

 
 
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on their behalf, REACH OUT may provide that to them for their files, or complete the office’s 
specific permission forms (Appendix H).  
 
For participants without a primary care provider, medical care will be established at a Hamilton 
Community Health Center within about 6 weeks of discharge from the ED. After initial enroll-
ment, for all randomized participants, our research team will initially identify up to 3 available 
appointments that will be texted to the participant who will reply with his/her selected appoint-
ment. If a participant does not identify an available appointment time of the 3 selected, a member 
of the research staff may call to confirm availability and troubleshoot with participant by as-
sessing barriers.   
 
Preceding the appointment, automated text messages may be sent to the participant to remind 
him/her of the appointment. On, or prior, to the day of the appointment, a transportation credit 
will be issued to the participant via a driving service, which is most readily available in that tar-
geted neighborhood (taxi, public transportation, or ride share services are all possibilities). 
Though rare, a study team member may contact the participant (phone call or text message) 
through this process if necessary to clarify or complete appointment scheduling. 
 
These appointment and transportation procedures will occur monthly (on average) until BP con-
trol is achieved. Following BP control, which is defined by a certain number of instances of self-
reported <130 systolic, we will reduce the frequency of recommended provider visits. Following 
control, appointments will be scheduled about every 3 months thereafter.   
 
Participants who are not randomized to facilitated primary care provider appointment scheduling 
and transportation will receive text messages encouraging participants to contact their primary 
care provider to schedule an appointment. Transportation will not be provided. 
7 
OUTCOMES AND EVALUATIONS  
7.1 
Outcome Assessments 
7.1.1 
Outcomes 
A baseline assessment will occur at enrollment. Outcome assessments will also occur at 6 
months and 12 months. Outcome assessments will occur at a provider office to coincide with a 
scheduled provider appointment, in the ED research space, or a mutually convenient location 
(e.g. home, library, or restaurant). The primary endpoint is the change in systolic BP (SBP) from 
baseline to 12 months. At baseline, BP will be measured by the research team using a validated 
blood pressure cuff, in accordance with national standards for measurement. BP will also be 
taken with the participant’s home blood pressure cuff measurement and compared to the out-
come assessment measurements to assess accuracy of the home device. Participants will be given 
$25 for completing the 6 month outcome assessment, and $30 for completing the 12 month out-
come assessment. 
 
At these 6 and 12 month assessments, text messages and/or phone calls will be sent to all partici-
pants to facilitated the outcome assessment scheduling of the 6 and 12 month. Reminder text 

 
 
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messages may be sent the 2 days before and the day of the outcome assessment. In striving for 
equity within our study population, we may also offer transportation credit to participants via a 
driving service, which is most readily available in that targeted neighborhood (taxi, public trans-
portation, or ride share services are all possibilities), to be able to assess our primary outcomes of 
BP in person. Outcomes may be built into REDCap. Outcomes may be visually modified, ques-
tions removed, rearranged, or re-worded as resources become available, but the messaging, and 
content will remain consistent. Outcomes will be assessing such topics as contact/tailoring infor-
mation, provider topics, medication, medication adherence, hospital use, the impact of corona-
virus, and Reach out study feedback/ utilization. To increase retention for outcomes, and as al-
ready addressed within our enrollment process with participants, we may also be mailing 6/12 
outcome reminders (Appendix K), and/or newsletters (Appendix L). Outcome reminders will be 
updated for either 6 or 12 month outcomes as needed. 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, 6/12 outcome visit infor-
mation, 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. 
7.1.2 
Tele-Outcomes 
Given recent COVID-19 precautionary contact recommendations or when unable or not recom-
mended to conduct in-person 6 and 12 month outcome assessments, we have devised tele-out-
comes to mitigate in-person contact. These outcome assessments would replace in-person assess-
ments during COVID-19 precautions. We may resume in-person outcomes once COVID-19 rec-
ommendations are lifted. 
 
We would ask participants to send a picture or video confirmation that they are taking their blood 
pressure with their blood pressure cuff. Around these 6 and 12 month assessments, text messages 
and/or phone calls will be sent to participants to facilitated the tele-outcome assessment schedul-
ing. Participants may be mailed a reminder, and instructions sheet of how to complete this as-
sessment appropriately, with the least amount of PHI possible (Appendix M and N). These mate-
rials may be mailed out by a HIPAA compliant mail service. Participants may also be directed to 
a video through text message link or website which is demonstrating how to take a picture of 
cuff, and sending it in (https://www.youtube.com/channel/UCup3LoqlxtMw9sYHQEX7AIA 
available at reachouted.com). These resources may be visually modified, rearranged, or re-
worded as resources or COVID-19 standards change, but the messaging, and content will remain 
consistent. These materials are included as appendices or links in the protocol, and will be sub-
mitted to the IRB as outlines of materials. However, time sensitive information, and content may 
change as needed to better communicate and stay up to date with participants. 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.  
 

 
 
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In these tele-outcomes, participants may complete outcome assessments in the following ways. 
We may ask the participant to include a picture, or video of themselves taking their blood pres-
sure when they text in their BP. This could be texted, emailed, postal mailed, or another means 
available to the participant, as we are attempting to be equitable between participants according 
to their availability for method. We will utilize all secure means to assist in these outcomes and 
promote equity in completion between participants (this may include phone, text, facetime, blue-
jeans, text link to youtube tutorial, etc). Participants will also be instructed to text message in 3 
consecutive measures and adhere to the American Heart Association best practices for measuring 
blood pressure. Reach Out will attempt to complete the outcome survey via phone, mail, or simi-
lar means. If participants are unable to send pictures based on their phone service, we may use 
methods such as mailing a disposable camera with returned mailing for their use, or having them 
ask a friend to text it to us.  
 
Once outcome is completed, we will send a confirmation of completion to participants, and ask 
them to confirm their current mailing address. Incentives may be mailed or texted (link to equiv-
alent value for gift card) out upon receiving these tele-outcomes.  
 
7.2 
Exploratory and Process Endpoints 
BP 
• Proportion of participants achieving BP control 
o JNC-8 targets for SBP/DBP 
o 2017 AHA guidelines targets for SBP/DBP 
• Change in DBP and mean arterial pressure 
• Change in 6 month SBP 
 
Process 
• Number of interactions (such as calls/texts) to schedule participant initial primary 
care visit 
• Number of interactions to schedule all other primary care visits 
• Proportion of BPs texted to the study team 
• Proportion enrolled but not randomized 
 
PCP 
• Establishment of a primary care providers among those without 
• Number and proportion of provider visits attended 
• Proportion of transportation vouchers used 
 
Utilization 
• Frequency of Hurley ED and other healthcare visits 
• Self-reported follow up of health system (Hurley, Hamilton, or other community clin-
ics) 
• Follow up outside of health system (urgent care, outside clinics, outside EDs) 
 

 
 
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Medications 
• Changes/escalation in antihypertensive regimen through patient self-report 
• Medication Adherence (Hill-Bone Scale, and modified Hill-Bone instrument asking, 
“How often do you forget to take your HBP medicine?”) 
 
Other 
• Social Cognitive Theory (SCT) measures  
o Modified one-question self-efficacy measure, “I am confident that I can 
take my blood pressure and text it to the Reach Out Team”) 
o Questions querying self-efficacy, motivation, social support and expertise.  
 I am confident that I can control my blood pressure 
 It is worthwhile for me to control my blood pressure 
 My friends and family care if I control my blood pressure 
 I know the right steps to take to control my blood pressure 
• General intervention feedback 
o Acceptability of Intervention Measure (AIM) 
o Feasibility of Intervention Measure (FIM) 
 
 
 
 
 

 
 
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Baseline 
Screening 
Randomization 
Tech 
F/U 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
6 
month 
follow-
up 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
Med/ 
PCP 
Survey 
12 
month 
follow-
up 
Close-
out 
Time point 
0 
1 
2 
3 
4 
6 
8 
12 
16 
20 
24 
28 
32 
36 
40 
44 
48 
52 
56 
 
 
 
 
 
 
(+/- 7d) 
Monday 
 
 
 
 
 
 
(+/- 6 
weeks
) 
 
 
 
 
 
 
(+/- 
30d) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Measures to be 
collected 
 
ENROLLMENT: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ID ED “user” status 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility screen 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Incentive 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Cognitive screen 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ED Measured BPs 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Competence w/BP 
cuff 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Competence with 
text messaging 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ASSESSMENTS: 
 
Contact Information 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tobacco/ Alcohol 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Insurance Status 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Transportation 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SCT measures 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Self- efficacy 
modified  
 
 
 
 
 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
 
SCT modified  
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Self- reported BP 
measurement 
 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study taken BP 
measurement  
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
PCP: 
 
PCP 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
First PCP visit time 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
PCP attendance 
X 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 

 
 
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Transportation 
vouchers used 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Utilization: 
 
Frequency of ED 
visits 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Frequency of hos-
pitalizations 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Medications: 
 
Changes in anti-hy-
pertensive treat-
ment 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Medications 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Antihypertensives 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Pill text 
 
 
 
 
 
 
 
 
 
 
 
X (+1 
day) 
 
 
 
 
 
 
X (+1 
day) 
 
Hill-Bone 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
X 
 
Hill-Bone modified 
 
 
 
 
 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
 
Intervention Feed-
back (AIM/ FIM) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Qualitative inter-
views  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 

 
 
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BP medication adherence will be assessed using several different methods: 1) Hill-Bone and 
one-question modified Hill-Bone question; 2) pharmacy and provider notes; 3) text participants 
to message pictures of their medication prior to the 6 and 12 month follow-ups. We will also ask 
participants to bring their medication to the 6 and 12 month follow-ups. For participants that 
have not done either, they will be reminded at the follow-up appointments, and texted once more 
afterwards. In an attempt to further monitor medication adherence, we will look for medication 
fill rates within the Hurley EHR, and Hamilton pharmacy records, and if there are linkages to 
commercial pharmacy, we will scan electronic record to assess. We will evaluate the impact of 
the interventions, and a brief survey regarding participant feedback on the specific intervention 
components they received (will be added in a future amendment).  
7.2.1 
Incentives 
In appreciation of participants’ time all participants will be given a blood pressure cuff at enroll-
ment (about $20 value), and $20 at the completion of baseline data collection. Participants will 
be given $25 for completing the 6 month outcome assessment and $30 for completing the 12 
month outcome assessment.  
 
Participants randomized to receive facilitated primary care provider appointment scheduling will 
also be provided transportation for their necessary appointments (about $15-30/ ride). All partici-
pants will be offered facilitated transportation in order to reach outcome assessment appoint-
ments. We will track all incentives allocated to participants through the intervention.   
 
Participants may be given a variety of items designed to help promote enthusiasm and obvious contact 
information for the project including nominal gifts such as pens, a project t-shirt, and other assorted 
“stuff” with the Reach Out logo. The additional project stuff is pending available funds. 
 
7.3 
Estimation of resources necessary to implement protocol 
We will track the operational aspects of conducting the intervention. This will include: 1) the 
number of contacts to providers for the research team to schedule the appointments; 2) time re-
quired from the research team to schedule follow up; 3) optimal methods to contact participants 
to schedule follow up. In addition, our research team will actively develop and optimize our 
manual of procedures and the design of the subsequent follow up study. 
8 
MANAGEMENT OF ADVERSE EXPERIENCES 
Several types of safety issues and serious adverse events may occur in REACH-OUT and partici-
pants will be monitored for these regularly throughout the study. 
8.1 
Definition of Adverse Event and Serious Adverse Event and Scope of AE reporting  
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally 
associated with the use of a medical treatment or procedure regardless of whether it is considered 
related to the medical treatment or procedure (attribution of unrelated, unlikely, possible, proba-
ble, or definite). Each AE is a unique representation of a specific event used for medical docu-
mentation and scientific analysis.  
 

 
 
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A serious adverse event (SAE) is an AE that is fatal or life threatening, is permanently or sub-
stantially disabling, requires or prolongs hospitalization, results in a congenital anomaly, requires 
intervention to prevent permanent impairment or damage, or any event that the treating clinician 
or internal medical monitor judges to be a significant hazard, contraindication, side effect, or pre-
caution. Reporting serious adverse events (SAEs) are based on the guidelines of the International 
Conference on Harmonization (ICH).  
 
We will only track adverse events definitely, probably, or possibly related to the intervention. 
8.2 
Unexpected (Unanticipated) Adverse Event 
An unexpected AE is defined as an event that is not anticipated or known to occur as an estab-
lished risk of either the study intervention or the participant’s underlying medical condition. Ex-
pected events include, but are not limited to, those specifically identified and described or listed 
in the study protocol and/or informed consent document. 
8.3 
Severity of an Adverse Event 
‘Severity’ is not the same as ‘serious.’ Serious is based on patient/event outcome or action crite-
ria usually associated with events that pose a threat to a patient’s life or health. The term ‘severe’ 
is often used to describe the intensity (severity) of a specific event (as in mild, moderate, severe 
myocardial infarction); the event itself, however, may be of relatively minor medical significance 
(such as severe headache). Seriousness (not severity) serves as a guide for defining regulatory 
reporting obligations. Most AEs include clinical criteria that describe patient/event outcomes or 
indicated interventions to more clearly substantiate seriousness.  
8.4 
Classification of an Adverse Event 
All serious adverse events occurring during study participation will be documented on the AE 
case report form. Adverse events will be documented using the NCI Common Terminology Cri-
teria for Adverse Events Version 3.0 (CTCAE). The CTCAE provides descriptive terminology 
that will be used for recording and reporting adverse events that occur. The CTCAE provides a 
grading (severity) scale for each AE term and AEs are listed alphabetically within categories 
based on anatomy or pathophysiology. The CTCAE (v 3.0) displays Grades 1-5 with unique clin-
ical descriptions of severity for each AE based on this general guidance: 
•          Grade 1:        Mild AE 
•          Grade 2:        Moderate AE 
•          Grade 3:        Severe AE 
•          Grade 4:        Life-Threatening or Disabling AE 
•          Grade 5:        Death related to AE 
Note: Severity is not equivalent to seriousness. A serious adverse event (SAE) would be any 
event in category 4 or 5, and any event in category 3 that required or prolonged hospitalization.   
8.5 
Relationship to Study Treatment 
At the time that an AE is reported, the PI is responsible for designating the likelihood that the AE 
is caused by the study intervention. This determination requires clinical judgment, but for pur-
poses of this study, an algorithm is used to help the investigator report in a manner that is con-
sistent across the trial and done as objectively as possible. 

 
 
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Modified for Reach Out, based upon: Adverse Events Reporting Requirements SOP (NIH-
NIAID http://www.niaid.nih.gov/ncn/sop/adverseevents.htm, accessed 11-30-04).  
 
Not related: The temporal relationship between treatment exposure and the adverse event is  
unreasonable or incompatible and/or adverse event is clearly due to extraneous causes (e.g., un-
derlying disease, environment) 
 
Unlikely: May have reasonable or only tenuous temporal relationship to intervention. Must meet 
both of the following conditions: 
• 
Could readily have been produced by the participant’s clinical state, or environmental or 
other interventions. 
• 
Does not follow known pattern of response to intervention. 
Possibly: Must meet any 2 of the 3 following conditions 
• 
Has a reasonable temporal relationship to intervention. 
• 
Could not readily have been produced by the participant’s clinical state, environmental, 
or other interventions. 
• 
Follows a known pattern of response to intervention. 
Probably: Must meet all 3 of the following conditions 
• 
Has a reasonable temporal relationship to intervention. 
• 
Could not readily have been produced by the participant’s clinical state or have been due 
to environmental or other interventions. 
• 
Follows a known pattern of response to intervention. 
Definitely: Must meet all 3 of the following conditions 
• 
Has a reasonable temporal relationship to intervention. 
• 
Could not possibly have been produced by the participant’s clinical state or have been 
due to environmental or other interventions.  
Follows a known pattern of response to intervention. 
8.6 
Adverse Event Recording and Reporting 
We will only record AEs and SAEs that are possibly, probably, or definitely related to the study 
interventions.  
 
All AEs reported to the research team and all serious adverse events (SAEs) occurring until par-
ticipation in the study has ended are recorded on the AE case report form. The PI or Study Coor-
dinator 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 on the electronic AE 
CRF 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 

 
 
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addition to performing protocol specified follow up, the participating PI must review all previ-
ously reported ongoing AEs to evaluate the status. If an AE that was previously reported on the 
Adverse Event CRF fully resolves and then recurs later, the second occurrence is considered a 
new AE and a new Adverse Event CRF must be completed. Likewise, if an SAE that was previ-
ously reported and subsequently fully resolved later recurs at a level requiring expedited report-
ing, the SAE must be reported as a new SAE on the Adverse Event CRF. 
 
Upon completion of the study protocol by the participant, premature withdrawal from the study 
by the participant, or participant’s death, all information regarding each AE must be completed, 
if not already done so. 
8.7 
Serious Adverse Event Recording and Reporting  
All Serious Adverse Events (SAEs) occurring during a participant’s study participation will be 
recorded. These will be reported to the IRB per their policy preferences.  
8.8 
Formal Definitions of Selected or Anticipated Adverse Events and Safety Outcomes 
Our team does not anticipate any specific adverse events related to the study intervention. 
9 
STATISTICAL CONSIDERATIONS 
9.1 
Data analysis 
The primary analysis (aim 1) will fit a linear regression model with the outcome of SBP change 
(baseline minus 12 months) and main effect-coded binary predictors of healthy behavior texts 
(yes vs. no), prompted BP self-monitoring frequency (high vs. low), and primary care provider 
visit scheduling and transportation (active vs. passive). Initial analyses will focus on the main ef-
fects. Additional analyses will include all the two-way interactions of the three intervention com-
ponents (only considering interactions where at least one of the factors in the interaction demon-
strates a sufficiently large main effect). As the goal of this exploratory trial is to find interven-
tions and combinations with activity, we will use an alpha level of 0.10 for all main effects and 
0.20 for interactions. We plan to include elements meeting that bar for statistical significance in 
the subsequent multicenter trial. If significant interactions exist (i.e. the combination of facili-
tated transportation and high frequency home BP monitoring), we plan to implement the combi-
nation of elements that has the highest expected reduction in SBP – assuming we achieve signifi-
cance at the p=0.1 (main effects) or 0.2 (interaction) level for the components. In the event of an 
overall “null” trial, we would examine the expected change in SBP for arm 1, which would be 
represented by the intercept. If this was significantly greater than 0 at the p=0.1 level we would 
propose a very simple subsequent multi-center trial using only weekly prompted BP self- moni-
toring. 
 
The main secondary analyses (aim 2) will use time-to event (Cox Proportional Hazards) and lo-
gistic regression. For the endpoint of interest, (either time to first primary care visit, or the binary 
variable indicating attendance at two or more primary care visits within 1 year of randomiza-
tion), we will fit an adjusted regression model. The main predictor of interest for these models is 
assignment to the active primary care provider scheduling and transportation arm (50% of all 

 
 
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participants randomized in the trial), while adjusting for the assignment into other groups similar 
to aim 1 (healthy behavior text messages and prompted BP self-monitoring).  
 
We will conduct additional exploratory analyses using the stratification factors (age, sex, and an-
tihypertensive use) as covariates. As uncertainty exists on the distribution of enrolled participants 
within these strata (e.g.  young men taking antihypertensive medication), we cannot estimate the 
preliminary statistical power for these exploratory aims. Thus, we will estimate the power based 
on the strata sizes prior to conducting the exploratory analyses. Interaction terms (e.g. age with 
behavioral interventions, sex with behavioral interventions, etc.) will be utilized to determine if 
specific groups respond well to specific intervention elements. Baseline BP may also play an im-
portant role. We will examine its impact by dividing the cohort into tertiles. We will repeat the 
above primary and exploratory modeling within each of the three initial BP strata to determine if 
there is heterogeneity of effect (e.g. do patients with the highest baseline BPs get the most bene-
fit from the intervention components?). We will similarly assess the impact of the intervention 
components on the exploratory and process outcomes using linear, Poisson, logistic, or ordinal 
regression depending on the distributions. In addition, we will conduct longitudinal analyses that 
include all BP measurements over time (including those by text and at the in-person visits) to as-
sess the temporal profiles of response in the intervention components. 
9.2 
Endpoints 
• Average change in systolic BP from baseline to 12 months 
• Time from ED visit to arrival at first primary care visit (in days)  
• Attendance at two or more primary care visits within 12 months of randomization 
9.3 
Sample Size and Accrual 
 
We originally planned to enroll approximately 960 patients into the eligibility phase. From this 
group, we estimate that 480 participants will report qualifying BPs and will be randomized to 
one of the eight intervention arms. We anticipate 240 participants will fully complete the 12 
month, in person follow up visits.  
 
However, after accruing approximately 400 randomized participants, we noted lower than ex-
pected retention at 6 month visits. Therefore, we will adjust the maximum total number of enroll-
ments and randomizations upwards by 50% each. The overall intention is to achieve approxi-
mately 240 protocol completers (attendees at 12-month visit). We will continue to monitor ac-
crual and retention in order to achieve this target. 
 
In the work by Collins and others, methods for sample size estimations for factorial design, 
MOST based interventions, have previously been reported. It is important to note, that the pri-
mary hypotheses driven by these designs is not in the pairwise comparisons of each of the inter-
ventions, but instead is the overall estimate of the effects of each of the individual intervention 
components, and their combinations. This smallest standardized effect size of 0.35 corresponds 
to a BP change of 1 mm Hg and standard deviation of 2.8 mm Hg for each parameter. We be-
lieve this is the minimal clinically significant change for each component; and to achieve im-
provements of 3-4 mm Hg over the course of a year, our chosen regimen for the next phase 

 
 
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would need a component or combination of components to perform better than an expected 1 
mm Hg change. For 80% power to detect the smallest main expected effect of 0.35 based on the 
Collins method of a 3-factor experiment analyzed using a second order model (i.e. main effects 
and 2-way interactions), we require 196 participants. Assuming 480 randomized participants, and 
allowing an additional 50% loss to follow up after the eligibility phase, we expect at least 240 
participants, exceeding 80% power with an alpha level of 0.10 (inflated to reduce likelihood of 
dismissing active components with modest BP reducing effect) – we used the FactorialPower-
Plan SAS macro to calculate power. For the secondary analyses, considering an alpha of 0.05 
and a baseline proportion attending 2 or more primary care provider visits within one year of 
40%, with a total sample size of 240 evenly distributed between the active appointment schedul-
ing and passive appointment, we have 87% power to detect an increase to 60% attending 2 or 
more visits. The time to event analysis (considering an alpha of 0.05, power of 99%, and 240 
participants enrolled over 720 days, followed for 30 days) can detect a change from 20% of par-
ticipants in the non-facilitated group to 20.4% of participants in the facilitated group. This high 
power allows ample room to adjust for covariates and loss to follow up. Sample size calculations 
for secondary outcomes performed with STPLAN (version 4.5). 
 
The challenges of recruiting racial minorities and people with socioeconomic disadvantage for 
clinical research studies are well documented. Reach Out participant recruitment will be facili-
tated by several factors: 1) the study is no more than minimal risk; 2) culturally and community 
sensitive recruitment materials were created using a CBPR approach; 3) enrollment in an urban, 
safety net ED; and 4) monetary incentives.  
 
9.4 
Data Monitoring 
 
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 Reach  
Out IMM will be an expert in the care of hypertension and may either be an emergency medicine  
physician or a primary care physician. 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 meet-
ings, in which to advise about study progress and performance, and to make recommendations 
regarding study continuation and protocol changes.  
 
10 
DATA COLLECTION, SITE MONITORING, AND ADVERSE EXPE-
RIENCE REPORTING 
10.1 Records to Be Kept 
Some data may be abstracted from the medical record into the participant’s research chart. Iden-
tifying information will be collected for each individual in the study (phone numbers, name, age, 
address and additional contact information). This will be used to coordinate the outcome assess-

 
 
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ments and text message tailoring. We will maintain a link between the study dataset and the pa-
tient identifiers to monitor for recurrent events and potential pharmacy information. This linkage 
file will be retained until the end of data analysis.  
 
Limited access, HIPPAA compliant databases on secure servers will be utilized for all data stor-
age and collection. Every effort will be made to protect the confidentiality of participants en-
rolled in this study.  HIPAA regulations will be followed. Each patient will be assigned a unique 
study identification number, which will be used on all data collection forms. All identifying in-
formation recorded on paper will be stored in individual research files for each participant and 
will be kept in a locked file that is accessible only to study staff. All data stored electronically 
will be maintained in databases stored on a password protected network drive. 
 
10.2 Role of Data Management 
A subset of study participant data outcomes will undergo additional review to assess data quality. 
A second assessor, will review a random subset. Range checks and content validation will be uti-
lized in the database to ensure high quality data entry.  
10.3 Quality Assurance 
When applicable, source documents will be uploaded for remote verification. Based on the re-
sults of the additional review, retraining of the abstractors will occur if issues with accuracy 
arise. 
11 
HUMAN PARTICIPANTS 
In general, the research team will adhere to the following principles: 
• We will protect and safeguard HIPAA defined Protected Health Information.  
• We will respect the confidentiality of the medical providers and health care facilities. 
• There will not be public disclosure of identifiable medical provider performance. 
• There will not be disclosure or publication of identifiable hospital level performance. 
• Identities (patient, provider, and hospital) will be coded in research databases with the 
linkage file being removed after data analysis.  
11.1 Risks 
11.1.1 Data risks  
The main potential risk to patients in this study is breach of confidentiality of medical records 
and survey responses that could result in psychological distress. The likelihood of this risk is es-
timated to be rare. The seriousness to the participant is estimated to be low. We have methods in 
place to prevent this occurrence. Data obtained for participants will be held strictly confidential 
in locked facilities and password protected computers. Trained abstractors will enter pertinent 
information into the database using REDCAP or similar secure online database. Each abstractor 
is restricted to only the data they collect or have a need to access. Reach Out will use a secure, 
password-protected web-based application to enter necessary contact information. The text mes-
sages are within a SSL encrypted web-based application with secure log-ins to access. A DUA is 

 
 
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in process. We have also obtained a Certificate of Confidentiality from the National Institutes of 
Health. The Certificate can be used to legally refuse to disclose information that may identify a 
participant. 
11.1.2 Vulnerable populations: pregnant women, prisoners, and children  
We are not enrolling vulnerable populations (pregnant women, children, and prisoners). Hyper-
tension is a different disease in pregnancy and in childhood. Prisoners will not generally have ac-
cess to text messaging, a BP monitoring cuff, or appointments with outside primary care physi-
cians and thus they would not be able to participate or benefit from the study interventions. 
 
All patients of childbearing age will be screened for pregnancy at the time of enrollment. For 
those who may be pregnant, a pregnancy test may be performed in the Emergency Department 
(ED) as part of their routine medical care. We are performing research procedures and screening 
patients in the ED who are visiting for a variety of medical problems and cannot mandate that the 
clinical care teams perform pregnancy tests. However, in the screening and enrollment process, 
our research staff will ask potential participants if they could be pregnant. If pregnancy testing 
has not been done by the clinical team, the research team will inform the clinical team that the 
patient may be pregnant. The research team will not enroll this patient unless there is a negative 
pregnancy test. The study would not be dangerous for a pregnant woman; however, the results 
would not be scientifically relevant. 
 
Once enrolled, participants of childbearing age will be instructed to notify the research team if 
they become pregnant. Additionally, we will ask participants whether they might be pregnant 
during the research visits. If the research team learns the participant is pregnant at the research 
visits or is notified at other times during the intervention, the intervention elements would be dis-
continued, and we will work with their usual medical care provider to help them establish pre-
natal care. This will be done because hypertension management differs in pregnancy. In general, 
by the intention to treat principle, we will keep pregnant women in our cohort to monitor and 
collect outcomes; we will not use the active intervention components. 
 
Enrolled patients may become prisoners while in our study. The study team will not actively 
screen for this, however if we learn this during the course of participation we will place study 
procedures on hold while the patient is a prisoner. We may resume their participation after the 
period of incarceration, assuming the one-year follow up period has not been expended. We will 
not extend the follow up window in these cases.  
 
While not a traditionally defined vulnerable population, the people of the city of Flint have faced 
unique challenges recently given the water crisis. The University of Michigan Department of 
Emergency Medicine has a long-standing relationship with Hurley Medical Center and the city 
of Flint. Our faculty group has staffed the emergency department there for almost 20 years. We 
have an active research infrastructure there and work to reduce the burden of substance abuse 
and violence in this community. We anticipate that the community will be distrustful of govern-
ment-funded research, and we will be extremely diligent including working with our community 
advisory board and employing research staff sensitive to diverse populations. In fact, the re-
search assistants will be part of Dr. Cunningham’s infrastructure at Hurley Medical Center and 

 
 
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thus have extensive experience recruiting and enrolling this patient population and setting. This 
research proposal involves limited risks to the community and is truly designed to provide meth-
ods of getting better access to hypertension treatment, so it should not be controversial. 
 
11.2 Adequacy of Protection Against Risk  
11.2.1 
Physical risks  
The BP cuffs could cause skin irritation or bruising – this is unlikely given the FDA approved 
devices used and will most likely be of low seriousness. In addition, it is possible that the partici-
pants will experience a medical emergency and elect to text the research number instead of seek-
ing care. All text messages sent into the Reach Out system will receive a standard message simi-
lar to, “Remember: this is an automated messaging system, and texts other than your BP are not 
read. If you have questions, ask your Dr. If this is an emergency call 911.”  
 
If BP received is outside of parameters, participants will receive something akin to the following 
message, “You sent a BP that is very high or low. If this is right, please contact a Dr. very soon 
to check your BP. If you sent it by accident, please text us a new BP.” 
11.2.2 
Psychological risks 
We do not anticipate our intervention will induce psychological risks. We provide positive text 
messages and referrals to primary care providers. There is a small risk that our study team will 
lose or release private personal health information and that this could induce psychological harm. 
We are not collecting sensitive health information that could lead to psychological harm if dis-
closed to unauthorized individuals. 
11.2.3 
Financial risks 
Text-messaging charges could create a financial burden on participants. We plan to minimize 
this risk by specifically discussing this during the enrollment process. In addition, our previous 
work demonstrates that the majority of eligible patients will have unlimited text messaging plans. 
We do not use any sort of app or data (which is more likely to incur costs for participants). Addi-
tionally, we believe it will be unlikely that anyone will have limited minute mobile voice plans, 
and thus it will be unlikely that our study protocol will induce overage fees for participants. Ad-
ditional financial risks would include identity theft due to the loss of sensitive information by the 
study team; we are minimizing the personal data that we collect to what is necessary for our re-
search strategy so this should be unlikely. 
11.2.4 
Legal risks 
We are not collecting location-based data relating to text messages and we do not anticipate that 
our research protocol will induce any additional legal risks for participants. Alternative proce-
dures that may confer less risk: we are conducting a prospective, clinical trial of several low risk 
interventions to improve BP. Alternatives to our research strategy would generally be for the par-
ticipants to self-monitor their BP and follow up with their doctors outside of our protocol. This 
will be included as an alternative to participation during the informed consent process. 

 
 
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11.3 Institutional Review Board (IRB) Review and Informed Consent 
 
This protocol and the consent and any subsequent modifications will be reviewed and approved 
by the IRB or ethics committee responsible for oversight of the study.   
11.4 Participant Confidentiality / Data Retention 
 
All records will be kept in a locked file cabinet or on secure computer systems.  Clinical infor-
mation 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 cre-
ate a permanent de-identified, public use database. We will remove linkages to protected health 
information, hospital identifiers and patient 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.  
 
11.5 Study Modification/Discontinuation 
 
The study may be modified or discontinued at any time by the IRB, the NIMDH, or other gov-
ernment agencies as part of their duties to ensure that research participants are protected. 
 
 
 
 
 

 
 
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Appendix A – Flyer for taking your BP at Home 
 
 
 

 
 
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Appendix B – Blood Pressure Informational flyers 

 
 
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Appendix C – Recruitment flyer 
 
 
 
 
 

 
 
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Appendix D – Sample text messages 

 
 
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Theory 
Construct  
Category 
Subcategory 
Text Message 
1. 
Social Cog-
nitive The-
ory (SCT) 
COGNITIONS 
(Knowledge/Skills) 
DIET 
Substitutions 
If you’re trying to limit your sugar, try switching soda, lemonade, and other 
juices for water!  Carrying a water bottle throughout the day can help you 
drink more! 
2. SCT 
COGNITIONS 
Knowledge/Skills 
DIET 
Substitutions 
Canned products can have a lot of salt! Look for “lower sodium” or “salt-
free” varieties at the grocery store instead! 
3. SCT 
COGNITIONS 
Knowledge/Skills 
DIET 
Culinary Knowledge 
Rinsing canned veggies and beans with water after you open them can help 
remove extra salt! 
4. 
SCT 
COGNITIONS 
Self-Efficacy 
DIET 
Eating/ 
Ordering out 
Salads are a healthy option especially when eating out.  Beware of the extra 
toppings though and try asking for the dressing and cheese on the side so 
you can choose how much to add! 
5. SCT 
COGNITIONS 
Self-Efficacy 
DIET 
Planning 
Planning your meals can be a great way to help you stay on track!  Start with 
planning one of your meals for the week like lunch or dinner! 
6. SCT 
COGNITIONS 
Self Efficacy 
DIET 
Eating/ 
Ordering Out 
Try asking your server when out restaurants if you can substitute steamed 
vegetables or fruit for French fries and chips 
7. 
SCT 
COGNITIONS 
Self Efficacy 
DIET 
Snacks 
We all have cravings once in a while.  Try a piece of fruit or yogurt with gran-
ola as a healthy substitute for ice cream or cookies! 
8. 
SCT 
COGNITIONS 
Self Efficacy 
DIET 
Eating/ 
Ordering Out 
Find yourself struggling to find healthy options at fast food restaurants?  Try 
to choose baked or grilled options over items that are fried to keep calories 
from fat down!   
9. 
SCT 
COGNITIONS 
Outcome Expecta-
tions 
DIET 
Eating/ 
Ordering Out 
Portion sizes at restaurants can be really large.  Try asking your server to box 
up half of your meal before it gets to the table! 
10.  
COGNITIONS 
Outcome Expecta-
tions 
DIET 
Food Access 
If you find fruits and veggies going bad before you use them, opt for buying 
frozen ones! Frozen has the same amount of nutrients as fresh!   

 
 
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11.
SCT 
SOCIOENVIRON-
MENTAL 
Social Support 
DIET 
Encouragement 
Stress can make it hard to eat healthy and exercise, try talking with friends 
and family about your health goals to help keep you on track!   
12. SCT 
SOCIOENVIRON-
MENTAL 
Social Support 
DIET 
Food Access 
 
Check out your local farmers market for fresh fruits and veggies!  Follow this 
link to find the closest market to your home – 
13. SCT 
SOCIOENVIRON-
MENTAL 
Social Support 
DIET 
Food Access 
Did you know some farmers markets accept SNAP EBT vouchers?  Check with 
your local market and vendors to see if you can use your benefits to buy 
fresh produce! 
14. SCT 
BEHAVIORAL 
Reinforcement 
DIET 
Encouragement 
Eating healthy is hard! You are doing a great job, keep at it!   
15. SCT 
BEHAVIORAL 
Reinforcement 
DIET 
Culinary Knowledge 
Cooking at home not only helps you save money, but is generally healthier 
than eating out because you decide how much sugar, salt and fat to add! 
16. SCT 
Reinforcement 
DIET 
Encouragement 
All of us here on the REACH OUT team are proud of the progress you have 
made.  Keep up the great work!   
17. SCT 
Reinforcement 
DIET 
Encouragement 
Stress can make eating healthy seem overwhelming and hard.  Keep at your 
health goals and try to take it one day at a time!   
18.
SCT 
BEHAVIORAL 
Reinforcement 
DIET 
Eating/ 
Ordering Out 
Eating healthy at restaurants can be challenging. Most restaurants have their 
menus available online so try checking these out beforehand so you can plan 
for success even when eating out!   
 
19.
SCT 
Reinforcement 
PHYSICAL ACTIVITY 
Exercising regularly is hard! You are doing a great job, keep at it!   
20.
SCT 
Social Support 
PHYSICAL ACTIVITY 
Accountability helps with sticking to eating healthy and being active! Find a friend, family member, or signifi-
cant other that you can share your goals with to help keep you on track! 
 
21.
SCT 
Social Support 
PHYSICAL ACTIVITY 
Work days are long and exhausting!   Try turning your lunch hour into a daily walk!  Bring along a co-
worker and turn it into a social hour! 
 

 
 
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22. SCT 
Knowledge 
PHYSICAL ACTIVITY 
An easy way to get more steps into your day is by opting to take the stairs over the elevator when you 
can! 
23. SCT 
Outcome Expecta-
tions 
PHYSICAL ACTIVITY 
Weight loss can be challenging!  But maintaining a healthy weight can make it easier to do things like 
cook, work, and even play with your kids/grandkid!   
24. SCT 
Knowledge 
PHYSICAL ACTIVITY 
Winter can make getting outside challenging.  If you find yourself struggling to be active outdoors, con-
sider trying a new winter activity with friends like skiing, ice skating, or snow shoeing! 
25.
SCT 
Outcome Expecta-
tions 
PHYSICAL ACTIVITY 
If your job involves a lot of sitting, try to schedule 15 minutes every couple of hours to walk around! Take 
the longer route to the bathroom, the stairs, or even a lap around the building! 
 
26. SCT 
Reinforcement 
PHYSICAL ACTIVITY 
Stress can make exercise seem overwhelming and hard.  Keep at your health goals and try to take it one 
day at a time!   
27. SCT 
Knowledge 
PHYSICAL ACTIVITY 
Try using commercial breaks while watching TV as a time to get up and get moving! Try doing some, 
lunges, jumping jacks or jogging in place! 
28.
SCT 
Knowledge 
PHYSICAL ACTIVITY 
Don’t forget that being active can be more than going for a run or hitting the gym!  Try gardening, biking, 
or even a walk to get yourself up and moving! 
 
 
1. 
SCT 
MEDICATION ADHER-
ANCE 
 
It is very important to regularly take your BP medication, get help by asking people close to you to remind 
you. Often the more support you have the better! 
2. SCT 
MEDICATION ADHER-
ANCE 
Don’t forget to regularly take your BP meds, and do not stop any medications without talking to your health 
care provider first. Consistency is very important! 
3. SCT 
MEDICATION ADHER-
ANCE 
Remember to take your BP meds every day. If you don’t feel like your meds are making a difference, or 
you’re having side-effects, your Dr can help, go see them! 
4. 
SCT 
MEDICATION ADHER-
ANCE 
Often cost of BP meds are a challenge, but there are discount, BPmeds at many stores, such as Kmart, Mei-
jer, Walmart, CVS, and Walgreens.  
 
5. 
SCT 
MEDICATION ADHER-
ANCE 
Many stores like Kmart, Meijer, Walmart, CVS, and Walgreens provide discounted BP meds. Save money by 
checking to see if your BP meds are cheaper there. 
 

 
 
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6. 
SCT 
MEDICATION ADHER-
ANCE 
 
If you find yourself having trouble remembering to take your BP meds, use a beeping alarm or watch to re-
mind you when a dose is due, and to keep consistency! 
 
 
1. SCT 
Med Encouragement 
It’s not always easy to decide when it’s time to start taking BP meds, but most people need meds in addition 
to exercise and diet to lower their high BP.  
2. SCT 
Med Encouragement 
Often cost of BP meds are a challenge, but there are discount, generic meds at many stores, such as Kmart, 
Meijer, Walmart, CVS, and Walgreens.  
3. 
SCT 
Med Encouragement 
 
Think about how important it is to you to lower your BP, then start taking small steps towards change. One 
important step may be beginning BP medication.  
4. 
SCT 
Med Encouragement 
 
If your healthy habits aren’t enough to bring your BP below 140/90, you may need to take BP medication, 
and this is something a Dr can help you decide.  
5. 
SCT 
Med Encouragement 
 
It is important to consider talking about BP meds with a Dr. Most people who take pills for high BP need to 
take 2 or more kinds of pills that work together.   
6. SCT 
Med Encouragement 
If you are like most people with high BP, meds can play a major part in lowering your BP. It is between you 
and a Dr to determine the right plan.  
7. SCT 
Med Encouragement 
Though healthy life changes are key to lower your BP, it may also be key to take BP meds with a Dr. If you 
don’t have one, you can call Hamilton 810-406-4246. 
8. SCT 
Med Encouragement 
 Many stores like Kmart, Meijer, Walmart, CVS, and Walgreens provide discounted BP meds. Save money by 
checking to see if your BP meds are cheaper there. 
9. 
n/a 
Coronavirus Impact 
Have you been diagnosed with COVID-19 (i.e., coronavirus infection)? 
Have any of your family or friends been diagnosed with COVID-19 (i.e., coronavirus infection)? 
Have you had fevers, cough, runny nose, shortness of breath, cold-like symptoms, or flu-like symptoms in 
the last week?  
Have you received your flu shot this year? 

 
 
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Special Messages 
Welcome to REACH 
OUT- first text sent 
out to everyone 
156 
Welcome to REACH OUT! You will text in your BP once a week and get feedback/tips on how 
to better manage your high BP. Save this number into your contacts!  
Weekly BP Survey 
Collection 
157 
 
This is your weekly reminder to take your BP and reply back to this message. If you have ques-
tions see your BP cuff instructions, and the REACH OUT handout.  
 
Not real BP number- 
an unrealistic number 
was sent in.  
153 
The BP you sent in does not seem to be right. Your BP should setup like xxx/xxx. Refer to your 
BP cuff instructions, and the home BP measurement handout.  
Reminder: Did not 
text in BP reading 
(After waiting 3 
hours) 
124 
Remember to text in your weekly BP reading so we can create personalized messages for you 
this week based on your progress.  
152 
Don’t forget to text in your BP this week. If you have any questions about taking your BP see 
your BP cuff guide, and the REACH OUT handout we gave you. 
159 
 
 
Remember to text in your BP reading so we can create personalized messages for you this week 
based on your progress. This is your last reminder for this week.  
Text something other 
than BP 
160 
Remember: this is an automated messaging system, and texts other than your BP are not read. If 
you have questions ask your Dr.  If this is an emergency call 911 
Success Response: 
what to send back 
159 
REACH OUT has received your BP of $current-blood-pressure. Thank you for your response, 
now you can get personal messages on your most current BP for the week! 

 
 
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when they do enter a 
valid BP 
BP greater than 
180/110  
148 
You recently reported a BP greater than 180/110, which is very high. Please contact a Dr. soon 
(at least within a few days) to have your BP checked. 
 
 
Note: Bottom number (diastolic) larger than top number (systolic) 
 
Parameters: 
top number (systolic) less than 70 or greater than 250 
Bottom number (diastolic) less than 50 or greater than 140 
 
If they were outside 
the BP parameters 
158 
You sent a BP that is very high or low. If this is right, please contact a Dr very soon to check 
your BP. If you sent it by accident, please text us a new BP. 
 
If diastolic bigger 
than systolic 
159 
The BP you sent in does not seem to be right. Your BP should be like xxx/xxx. Refer to your BP 
cuff instructions, and the home BP handout. Please text new BP.  
 
If they text back the 
same number 
 
155 
You recently sent a BP that is extremely high or low. If this was the actual reading given by the 
machine, please contact a Dr very soon to check your BP.  
 
Closing 
 
You have been in the research study, REACH OUT, for about 4 months. Please send in your fi-
nal blood pressure through text message!  
 
 
 
 
 
 
 

 
 
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Appendix E – Flyer for Text Message Instructions 
 
 
 
 

 
 
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Appendix F – Reach Out Feedback 
 
 

 
 
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Appendix G – Comic Book 

 
 
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Appendix H – Provider Authorization 
 
 
 
 
 
 
 
 
 

 
 
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Appendix I- Holiday Card Study Within A Trial 
Introduction and Background  
 
Holiday cards are frequently sent to research participants, yet the impact of this practice 
is not clear. The intended result is to maximize retention and maximize the amount of 
follow up data collected from participants on protocols. The trials group at the University 
of York, UK has organized the Christmas Card study within a trial (SWAT). Professor 
David Torgenson is the lead investigator. This SWAT has been registered as “SWAT 
82: Sending Christmas cards to trial participants to improve retention – studies within tri-
als (SWATs)” and has the Prometheus reference MR/R013748/1/SWAT 82 and was ap-
proved by the Yorkshire & The Humber – Leeds West Research Committee under pro-
ject ID 27054.   
 
Within the main protocol of REACH-OUT, sending retention materials is allowable. We 
propose to use this SWAT methodology to send holiday cards (Appendix J) to a random 
sample of participants currently active on the REACH-OUT protocol.   
 
No data with protected health information or personal identifiers will be transferred out-
side of the REACH-OUT. Aggregate response rates per arm of the SWAT will be shared 
to the organizers of the SWAT in York.  
 
Design  
 
Inclusion:  
 
The launch date is pending approval of this amendment, but we anticipate sending the 
cards in Winter 2020. All subjects currently active on the REACH-OUT protocol are eli-
gible.  
 
Exclusion:  
 
Participants who have withdrawn from follow up visits.   
 
Intervention:  
 
We will create a randomization list of the current REACH-OUT participants, stratified by 
randomization group assignment (groups 1-8 will each have 1:1 randomization to holi-
day card versus no holiday card). In addition, within each of the 8 treatment groups, we 
will further stratify randomization of the holiday card by gender and age (<65 versus 
>65). Cards will be mailed.   
 
Analysis – From SWAT:  
 
The primary endpoint is retention – defined attendance at the next follow up visit. The 
secondary endpoints are cost per participant retained and response rate.  

 
 
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Subgroups will be identified for reporting, including those with an appointment within 30 
days of expected delivery of the card, those who have 1st or 2nd visit next, and those 
who did not return the previous 4-week survey.   
 
We will report proportions and differences in proportions with 95% confidence intervals 
for the primary endpoint and repeat this for all subgroups, including gender and age.  
  
Analysis – Additional Specific to REACH-OUT  
 
We will estimate additional subgroups using the defined stratification variables of 
REACH-OUT  
 
The REACH-OUT specific primary endpoint is text-messaging engagement. This is a 
count variable, which for the 4 weeks prior to and after the expected card delivery is de-
fined as the number of blood pressures reported by text over the number of blood pres-
sures that were requested. Participants near the beginning (less than 4 weeks in) or end 
(less than 4 weeks from final visit) of REACH-OUT will be excluded from this analysis.   
The main analysis of this will be using repeated measures binary logistic regression with 
a random effect. Each participant will have a line of data for each eligible blood pressure 
request. We will include an indicator variable for REACH-OUT assigned frequency of 
texts (weekly versus every other day) and SWAT group assignment (will be one in par-
ticipants who were sent a card, for the eligible BPs that occurred after estimated receipt 
of card, and will be zero in all participants not randomized to card, and will be zero for 
all pre-delivery texts in the group randomized to card.) A random intercept for individual 
will be included. In addition, we will add a variable to account for the number of weeks 
before or after the estimated delivery of the card. Depending on model fit and number of 
observed outcome events, we will add in adjustment for the other two main REACH-
OUT interventions (healthy behavior texts versus none, PCP facilitated transportation 
versus none), along with the gender, age, and pre-existing hypertension medications 
baseline stratification variables from the main REACH-OUT study.    
 
 
 

 
 
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Appendix J- Holiday Card 
 
 
 
 
 
 
 

 
 
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Appendix K- Outcome Reminder 
 

 
 
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Appendix L- Newsletter Outline 
 
 
 

 
 
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Appendix M- Tele Outcome Reminder 
 

 
 
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Appendix N- Tele Outcome Guide 
 

 
 
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Appendix O- Telephone Consent Script 
Screening Phone Recruitment Script: 
 
 
Hello, my name is __________ from the University of Michigan and Hurley Medical Center. 
Am I speaking to ____________?  
 
I’d like to tell you about a research study that uses text messaging to help you lower your blood 
pressure (BP), and then ask you a few questions to see if you are interested and eligible to partic-
ipate in the study.  
 
Taking part in this study is completely voluntary.  You do not have to take part if you don't want 
to.  Your medical treatment will not be affected in any way if you choose not to take part. You 
may also leave the study at any time.  If you leave the study before it is over, you will not lose 
any benefits to which you are owed.  
 
(Purpose of the study) We are asking you to be in this study because you were a patient in the 
ER of Hurley Medical Center recently, and while you were there, had elevated BP. Many people 
have high blood pressure. We are doing this study because we want to know if sending text mes-
sages and reminding people to check their blood pressure can help people to lower their blood 
pressure. People who volunteer to be in this research study will be asked to complete some sur-
veys about yourself, and you’ll be asked to take your own blood pressure throughout the study 
while receiving text messages.  
 
Would you be interested in hearing more about our study and how you can help? [If yes, con-
tinue with script. If no, thank the patient and code him/her as a screen refusal] 
Great! 
 
I have a few simple questions to ask to first.  
 
Can you confirm your last name? And the month and year you were born? 
 
Thank you! 
 
[If PT gives information that matches the medical record, continue with script. If the information 
does not match/ the person on the phone is NOT the patient, ask the person on the phone if they 
know the patient, and a better time or way to contact them]  
 
Are you 18 year of age or older?  
[If yes, continue with script. If no, thank the patient and code him/her as ineligi-
ble] 
Do you have a cell phone with the ability to text-message and willingness to receive 
texts?  

 
 
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[If yes, continue with script. If no, thank the patient and code him/her as ineligi-
ble]  
Are you able to stay home alone for 24 hours?  
[If yes, continue with script. If no, thank the patient and code him/her as ineligi-
ble]  
 
 
Unable to read English  
 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
Prisoners 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
Pregnant 
 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
Pre-existing condition making one year follow-up unlikely  
 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
Current use of 3 or more antihypertensive agents 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
Any other serious medical conditions that prevent self-monitoring of BP 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
Dementia/cognitive impairment 
[If no, continue with script. If yes, thank the patient and code him/her as ineligi-
ble] 
 
 
You qualify for the study, are you interested in hearing more?  
 
Informed Consent Phone Script: 
(Information about Study Procedures) If you agree to participant in the study, you will start by 
completing a survey telling the research team about yourself.  
Once in the study, you will also be given materials about BP. A BP monitor will be given to you 
to use to take your BP at home. You will be taught how to take your own BP using the monitor 
given, and how to text these results back to the study team 
On a weekly basis for 3 weeks you will receive text messages reminding you to take your BP. 
You will then take your own BP and to text the results back to the study team. If during the 3-
week period you still have high BP, the REACH OUT Program will start. There are three differ-
ent types of text messages you could receive while participating in the REACH OUT program 1) 
healthy behavior texts; 2) reminder texts to take your BP at home; 3) texts to help with primary 
care provider appointment scheduling and transportation. 

 
 
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It is possible that you might receive all of the types of text messages, or only one type. The type 
of texts and how often you receive them will depend on what grouping you have been randomly 
assigned to. You may receive several messages from the study team in one day.  
Follow-up visits will occur at 6 months and 12 months and may be in-person or virtual. At these 
visits, your BP will be measured by the REACH OUT team. You will also be asked to complete 
additional surveys.  
At the end of the study period, some participants may be asked to participate in a focus group so 
we can learn about your opinions on REACH OUT. We may ask you by telephone, or in person 
to participate. We may record and will write down notes about what is said during these inter-
views so that we have a record and can accurately remember your opinions about Reach out. 
This program does not replace your usual health care. If you have a problem or question about 
your blood pressure or medical problems, you will still need to contact your healthcare team. 
 We expect the amount of time you will participate in the study will be about 12 months. 
(Risks and Potential Benefits of the Study) There can be risks associated with joining any re-
search study. For this study, some of these risks may include asking you about your current rec-
orded BP. The messages are meant to be motivational, but there is a small chance you may be 
distressed by them. You do not need to answer any question that you don’t want to, and you can 
stop the text messages at any time. There is a small chance that participants in this study could 
have information about their health status, such as information about their BP levels, or general 
health activities, given to people they don’t want to know.  
You also need to understand that all information received from you will be confidential and will 
be kept under lock and key or secure, password protected documents and computers. Your name 
will not be kept with your answers. Your name will not appear in any reports.  
As with any research study, there may be additional risks that are unknown or unexpected. 
This study may not offer any benefit to you , but may benefit others in the future by helping us 
gain important information about how to help people manage their high BP. 
(Financial Information) You will be given an automated BP cuff and $20 at your enrollment. 
You will be given $25 after completion of your 6-month follow-up visit, and $30 after comple-
tion of your 12-month follow-up visit. REACH OUT will provide transportation, if needed, to 
the 6 month and 12 month visits. Some participants may also be provided transportation to their 
primary doctor for REACH OUT appointments. Participants asked to participate in the focus 
groups may receive food and up to $20 following completion of the session. Payments will be in 
the form of cash or a gift card. 
(Confidentiality) You may be worried about the confidentiality of your information. We won’t share 
answers with anyone except the researchers of this study. The risks to participating are minimal, but 
there is risk associated with transmitting data, including loss of confidentiality.  
 
Taking part in this study will involve collecting private information about you. If there are physi-
cal copies of your information, it will be stored in a locked area, accessible only to research 
staff, and will not be made part of your medical record. Your research information will be en-
tered into a password protected computer and your name will be separated from the data. We will not 
share data that identifies you with anyone outside of the study. The study uses a SSL encrypted web-
based application with secure log-ins to access. There is a very small risk that someone could obtain 
your contact information from the study website.  

 
 
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To help us protect your privacy, we have obtained a Certificate of Confidentiality from the Na-
tional Institutes of Health. The researchers can use this Certificate to legally refuse to disclose 
information that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other proceedings, for example, if there is a court subpoena. You should under-
stand that a Certificate of Confidentiality does not prevent you or a member of your family from 
voluntarily releasing information about yourself or your involvement in this research, or for any 
purpose you have consented to in this informed consent document. 
 
Consenting to this form gives the researchers your permission to obtain, use, and share infor-
mation about you for this study, and is required in order for you to take part in the study. Medical 
information and billing records are protected by the privacy regulations of the federal Health In-
surance Portability and Accountability Act of 1996 (HIPAA). This type of information is called 
protected health information (PHI). PHI about you may be obtained from any hospital, doctor, 
and other health care provider involved in your care, including:  
 
• Hospital/doctor's office records, including test results and dental records  
• Any records relating to condition, the treatment received, and response to the 
treatment  
• Demographic information  
• Personal identifiers  
 
The results of this study could be published in an article, but would not include any information 
that would let others know who you are.  
(Contact Information) I will provide you with our study cell phone, email and other direct contact 
information if you have any questions about the study or if you want to withdraw from the study.  
I will also provide you with contact information for the University of Michigan Institutional Re-
view Board and Hurley Medical Center’s Institutional Review Board if you have any questions 
about your rights and responsibilities as a research participant.  This contact information is on the 
copy of the Consent form which has been texted, emailed, or mailed to you.   
(Consent) Do you have any questions, comments or concerns?  Remember, your participation is 
voluntary.  
 (If patient consents to participate in the study with no further questions, pursue consent) 
Great, so the final thing is getting your consent as documentation that you have heard the in-
formed consent for this study, and are agreeing to participate.  
If you agree to participant in this study, please reply “yes” to the question. I will record your an-
swer. 
(If patient says yes, record answer; legal name; date; time) 
Please answer the following questions. I will record your answer.  
I have had the opportunity to ask questions and have those questions answered to my satisfaction. 
(Record answer) 
I would like to receive follow-up newsletters and information regarding Reach Out after completion of 
the study.  
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If asked to participate in the post-study focus group, I agree to being recorded during discussion. 
(Record answer) 
How would you prefer to receive a copy of this consent document (email, postal mail, etc)?  
(If patient says email, record this email address and send consent form to participant. If patient 
says address, record this address and send consent form to participant)  
 
 
 

 
 
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Appendix P- Remote Recruitment Letter 
 
 
 

 
 
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Appendix Q- Supplement: Reach Out Cognition  
  
Introduction and Background  
 
We propose Reach Out Cognition which will extend Reach Out data collection past the current 
12 months to 15 and 18 months. During Reach Out Cognition, we aim to assess novel ap-
proaches to mobile health (mHealth) self-administered cognition and blood pressure (BP) meas-
urements. These approaches may include cognitive assessments via mobile applications (apps) 
and Web-based surveys, and wireless BP measurements via Bluetooth-enabled blood pressure 
cuffs and apps. The launch date is pending approval of a supplement and/or amendment and par-
ticipant completion of the parent study 12-month outcome assessment (we anticipate July 2020).   
 
Design  
 
Recruitment:  
 
The study population for Reach 
Out Cognition will be drawn from 
Reach Out participants who com-
plete the Reach Out intervention 
and are defined as: participants 
who complete the 12-month out-
come assessment. We anticipate 
about 240 participants will have 
completed Reach Out’s 12-month 
outcome assessment and will be 
eligible for Reach Out Cognition. 
At the time of the final (12-
month) outcome assessment, par-
ticipants will be introduced to the 
opportunity of continuing for an-
other ~6 months with the added 
mHealth measures.  
 
Inclusion:  
 
Participants of the Reach Out protocol that are no more than 6 months after completion of their 12-month 
outcomes are eligible. A subset of Reach Out participants will not have smartphones. However, our goal 
is inclusivity and generalizability and will allow for inclusion of all cell phones with the capability to send 
picture text-messages. Thus we designed Reach Out Cognition with the capability to include these partici-
pants, albeit outcome assessments procedures will differ.  
 
Exclusion:  
 
Participants who have withdrawn or not completed follow up visits.   
 

 
 
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Screening:  
 
Prior to consent, participants may be screened for baseline cognition via the mini-Montreal Cognitive 
Assessment (MoCA) or similar. This would be preceded by verbal screening consent (Appendix 
V). Participants may either be given a feedback sheet in person, via postal mail, or text message 
to link regarding their MoCA score if fully completed (Appendix S). If score <11, or similar test 
specific cognitive threshold, we will state the MoCA suggested response to this range, and par-
ticipant will not be consented for the study. It will be suggested that participant may wish to 
share the MOCA score with their doctor to discuss memory and thinking.  Participant’s doctor 
will be able to answer questions and decide whether more testing or treatments are right. These 
tests are not diagnostic.  
 
Consent:  
 
If 12-month outcome is in-person, and the participant agrees to continued participation, an in-
formed consent will be signed (may be electronic and built into redcap as previous informed con-
sent) by the participant before any study procedure is done.  
 
However, in the time of COVID-19, the consent process and subsequent surveys may also be 
done virtually, if performing a 12-month outcome via tele-outcome per Reach Out protocol. In 
this circumstance, we would perform remote recruitment and consent. The research staff will fol-
low a phone consent script (Appendix R), this may be done with whatever means best possible 
for participant (telephone, video, etc). The research staff will ask for the last name, and month 
and year of birth as confirmation that we are speaking to expected patient. Only once confirmed, 
will the research staff begin the process of consent. The consent process will be performed by the 
research staff in a private environment to provide the most privacy possible. The research staff 
will explain the study to participants during the consenting process. Interested participants will 
be enrolled in the study after providing verbal consent (for remote recruitment). The research 
staff will discuss questions with the participant, and research would only begin after informed 
consent is obtained. 
 
 
For participants who are within 6 months of their 12 month visit but have completed their 12 
month outcome visit prior to approval of this amendment, we may attempt to re-contact them to 
perform remote recruitment and consent.  
 
For feasibility reasons, within our already approved waiver of hipaa authorization, we add 
waiver of documentation of informed consent to allow for the study enrollment consenting to be 
obtained in multiple ways (i.e., in-person when feasible, or verbal consent for those completing 
remotely). 
 
 
We will give the participant a copy of the informed consent document. Given this is a study of 
no more than minimal risk of harm, and seeking in-person written consent may prove more 
harmful to participants, we will also seek a waiver of documentation of consent in the case tele-
outcomes are being done. In this circumstance, we would read an informed consent script over 
the phone, discuss questions with the participant, and research would only begin after participant 

 
 
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verbally consents. All following enrollment training discussed would then be done over the 
phone or through video services, and materials would be either emailed, texted, or postal mailed 
to participant.  
 
 
Enrollment:  
 
After enrollment participants may complete a brief survey assessing their eHealth literacy via the 
eHealth Literacy Scale or similar and baseline cognition via the Self-Administered Gerocogni-
tive Exam (SAGE). Participants will either be given a feedback sheet in person, via postal mail, 
or text message to link regarding score, which may only be sent out if the survey is fully com-
plete, or it is determined than an appropriate score can be calculated based on missing values 
(Appendix S). If score <17, we will state the SAGE suggested response to this range. It will be 
suggested that participant may wish to share the SAGE score with their doctor to discuss 
memory and thinking.  Participant’s doctor will be able to answer questions and decide whether 
more testing or treatments are right. These tests are not diagnostic.  
 
Participants will receive a BP arm cuff and incentives for completing the outcome assessments. 
They may also receive materials helpful in technology assistance and instructions. These may be 
mailed or emailed to participants if performing tele-outcomes.  
 
At enrollment, participants will undergo about a 60-minute technology introduction tailored to if 
they have a smart phone or a feature phone. Reach Out Cognition assessments will differ based 
on whether the participant has a feature phone or smartphone (Table 1). If participant phone ca-
pabilities change throughout the duration of the study, we will work with them to re-train on 
their new phone.  
 
• 
Feature phones include capabilities such as built-in cameras.  
• 
Smartphones, in comparison, have touch-input and advanced computing software, in 
addition to built-in cameras, apps, and Web-browsers.  
 
Participants will re-
ceive a Bluetooth-
compatible BP moni-
tor, the Omron Evolv 
Wireless Upper Arm 
Home BP Monitor or 
similar model which 
may depend on phone 
capability.   
 
We will review procedures and trainings for all groups and phone capabilities.  Those with 
smartphones may download the necessary app associated with the Bluetooth-compatible BP 
monitor. This will allow participants’ blood pressures to directly sync the BP cuff to the app. 
Table 1: Overview of Reach Out Cognition and BP Assessments 
Data 
Smartphone 
Feature Phone 
SAGE 
Texted survey for phone-
use 
Texted survey URL for 
browser-use 
Neuro- 
QoL 
Texted survey for phone-
use 
Texted survey URL for 
browser-use 
BP 
App and Bluetooth BP 
cuff 
Texted BP with photo-
graph 

 
 
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Participants with feature phones will be trained on how to photograph the process of obtaining 
BP measurements and how to submit the picture via text to the study team. While, ideally it 
would include the BP measurement, we are most interested in confirming the BP cuff is on the 
participant’s arm as a measure of validity of the measurement. The picture does not have to in-
clude the persons face or any identifiers. 
 
We will also review best practices for BP measurements. Participants will receive a text to an 
online survey link for survey questions. This link can be used directly, or typed into a web-
browser. The participant and the study coordinator may complete a mock round of cognitive and 
BP measures in the practice environment to identify and solve any technological issues. If enroll-
ment is not able to be done in-person, training would then be done over the phone or through 
video services, and materials would be either emailed, texted, or postal mailed to participants. 
We will have participants download the app (if able) while we are communicating with them, so 
we may train them in set-up and use of both app, text messages. We will postal mail the blood 
pressure monitor to participants, and then may also have another virtual training with participant 
in blood pressure monitor use.  
 
We will also have resources and trainings available on the Reach Out website (reachouted.com) 
accessible to participants (for example, Appendix T and Appendix U).  
 
Intervention  
 
Participants who agree to continue in Reach Out Cognition will continue to receive the Reach 
Out intervention at a moderate intensity; this may include daily healthy behavior text messages 
and weekly prompted blood pressure self-monitoring. We elected to forego facilitating the pri-
mary care appointment scheduling and transportation as that was not automated and thus requires 
substantial study team resources and is not consistent with Reach Out Cognition’s solely 
mHealth intervention.  
 
 Reach Out Cognition, will extend data collection to include 15 and 18 month assessments +/- 45 
days for contact for outcomes. These assessments may include mHealth cognition and blood 
pressure assessments (Figure 1). Cognitive measures may be assessed using two different vali-
dated measures (or similar methods): 1) SAGE; and 2) Neuro-QoL-Cognition (Quality of Life in 
Neurological Disorders). Self-reported blood pressure outcomes will be based on either pictures 
or a Bluetooth-enabled BP cuff. 
 
 
Outcomes (smartphone and feature phones) 
 
At around 15 and 18 months, participants will receive reminder text message(s) and/or email(s) 
to complete a survey link and/or variations of computer adaptive assessment, or paper copies of 
survey, to either be mailed back or take a pictures and text/ email to return. In either scenario, the 
survey information does not contain sensitive information, and our attempt is to be flexible in re-
ceiving outcomes as is preferable and feasible from participants. The survey link may directly 
import data into RedCap or another equivalently secure database. Participants may also be 

 
 
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mailed and called as reminder(s) for these outcomes, and to assist with technology troubleshoot-
ing.   
 
Participants with smartphones will be sent a reminder text message to complete a Bluetooth ena-
bled BP measurement. In order to get the data, we will train participants on how to download 
their data via the Bluetooth app, and send the data to the study team either text or email to a se-
cure study team email. If the sending of data method is unavailable, or is found to be too difficult 
for participants, the study team will conduct an in-person or virtual outcome visit to download 
final blood pressures from the Bluetooth app or collect BP measurements over the phone.  
 
Participants with feature phones will be sent a reminder text message prompting the photograph 
blood pressure procedure. We will ask the participant to include a photograph of themselves tak-
ing their blood pressure when they text in their BP. We will instruct participants to send the pic-
ture, and text message 3 blood pressure measurements. Participants will be instructed to take 3 
consecutive measures and adhere to the American Heart Association best practices for measuring 
blood pressure. This will be done via secure texting via Mosio. If the sending of data method is 
unavailable, or is found to be too difficult for participants, the study team will conduct an in-per-
son or virtual outcome visit to for assistance or collect BP measurements over the phone.  
 
Participants who do not respond to outcome requests or indicate technical difficulties, may be 
contacted by the study team via phone or text to troubleshoot.  
 
Participants may be contacted to invite them to participate in other mHealth or stroke prevention 
trainings, if interested. 
 
Throughout the duration of the intervention, the study team will attempt to support and connect 
with the participants as able. All resources, materials, and methods of contact are included as ap-
pendices or standards in the protocol, and will be submitted to the IRB as outlines. However, 
time sensitive information, and content may change as needed to better communicate and stay up 
to date with participants, especially given COVID-19, and the changing standards of interactions. 
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 or methods. 
 
Data Security 
 
Reach Out will use a secure, password-protected web-based application, REDCap and/or qualtrics, for 
data collection and surveys. The text messages and picture messages are within a SSL encrypted web-
based application with secure log-ins to access. The Bluetooth app is subject to the terms and conditions 
of the particular company, which will be presented to the participant. The data being utilized on these 
apps (blood pressures) will only be connected with personal information if the participant chooses to use 
their name and email in the profile description and sharing capability. Regardless, additional personal 
identifiable information will not be associated with the blood pressures or the app from Reach Out. Addi-
tionally, any data submitted by participants via direct download from BP app and sent to study team by 
email correspondence will be through a secure study team email. Only Reach Out study team members 
will have access to the study email account. All data submissions received on the study email account will 

 
 
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be transferred to the password-protected database. All Reach Out study team members will receive data 
security training.  
 
 Outcomes  
 
We will measure acceptability, feasibility and satisfaction which are necessary for large scale use 
of mHealth BP and cognition measures. We will use these scales or similar validated measures of 
acceptability, feasibility and satisfaction.   
 
Acceptability is the perception among participants that the mHealth assessments are achievable 
and agreeable. Acceptability will be assessed by the proportion of Reach Out 12-month outcome 
participants who continue into Reach Out Cognition.  
 
Feasibility is the extent to which the mHealth assessments can be successfully carried out. Feasi-
bility will be assessed by the proportion of participants who complete the mHealth cognitive as-
sessment and the BP assessments separately. We will declare feasibility if greater than 50% of 
participants provide at least one cognitive measure. 
 
Satisfaction is the perception that upon completion of the mHealth assessments participants 
found them agreeable. Satisfaction will be measured with a text survey to all participants. The 
satisfaction survey is 4-item, written at a 5th grade reaching level and takes less than 5 minutes to 
complete. Responses are a 5 item likert scale. In addition, we may invite a subset of participants 
to participate in a focus group. 
 
Focus Groups 
 
To assess participant satisfaction with mHealth self-administered cognitive and blood pressure 
measures, we may conduct up to 4 focus groups of about 10 participants each of Reach Out Cog-
nition. We anticipate the focus group to last about 60 minutes and will be conducted at a location 
convenient to the participants or virtually via secure means provided by the University of Michi-
gan (https://safecomputing.umich.edu/dataguide/?q=home). Focus groups will be based on a 
semi-structured interview guide. Given this is minimal risk, and conversational, this will not be 
submitted to the IRB. During the focus group team members will assist in taking structured 
notes. Participants will be given $25 in appreciation of their time. 
 
Analysis 
 
Descriptive statistics will be used to evaluate acceptability, feasibility and satisfaction. The de-
nominator is the number of Reach Out participants who complete the 12 month assessments. Re-
garding feasibility, we will separately determine the feasibility by mHealth measure (i.e. cogni-
tion vs. BP), phone type (i.e. smartphone vs. feature phone) and operating system type (iOS vs. 
Android vs. Windows) as a continuous and dichotomous (>50% completion of each assessment 
type) measure. The satisfaction scale will be assessed for all participants. Given the difference in 
procedures by phone type, we will compare satisfaction between the smartphone and feature 
phone users using a Kruskal-Wallis test.  
 

 
 
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Minorities and women: Per NIH policy, the primary outcomes will be analyzed for evidence of 
differential treatment effects in subgroups determined by sex/gender, race, and ethnicity. 
 
Upon recruitment during the parent study final outcome visit, we may collect a Montreal Cogni-
tive Assessment (MoCA). We anticipate that approximately 10-20% of our participants will have 
previously undiagnosed mild cognitive impairment. In addition, using the Neuro-QOL cognition 
battery, we will determine how much the Reach-Out Cognitive cohort differs from the expected 
values for the patient reported outcomes. Using existing data on trajectory of change in MoCA 
based on age, we will develop estimates of the likely cognitive status of ED patients with hyper-
tension 12 months prior to enrollment in Reach Out Cognitive (i.e. at the time initially seen in 
ED and enrolled in the parent Reach Out trial). 
  
 
 

 
 
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Appendix R- Supplement: Telephone consent script  
Screening Phone Recruitment Script: 
 
 
Hello, my name is __________ from the University of Michigan and Hurley Medical Center. Am I speak-
ing to ____________?  
 
I’d like to tell you about a way that you could continue to participate in Reach Out for about another 6 
months. In this research study, you will continue to receive some texts from Reach Out and will be asked 
to take your blood pressure weekly.  
 
(Purpose of the study) The purpose of this study is to see whether mHealth (mobile health) interven-
tions can help lower blood pressure.  High blood pressure, can lead to a stroke and heart attack and af-
fects about 78 million Americans. We are asking you to be in this study because you were a participant 
in Reach Out.  
 
People who volunteer to be in this research study will be asked to complete some surveys about them-
selves, and to take their blood pressure using a Bluetooth blood pressure cuff or by taking a picture of 
your blood pressure cuff. They will also receive text messages.  
 
Would you be interested in hearing more about our study and how you can help? [If yes, continue with 
script. If no, thank the patient and code him/her as a screen refusal] 
Great! 
 
I have a few simple questions to ask to first.  
 
Can you confirm your last name? And the month and year you were born? 
 
Thank you! 
 
[If PT gives information that matches the medical record, continue with script. If the information does 
not match/ the person on the phone is NOT the patient, ask the person on the phone if they know the pa-
tient, and a better time or way to contact them]  
 
Do you have a cell phone with the ability to send picture text messages? 
[If yes, continue with script. If no, thank the patient and code him/her as ineligible]  
 
You qualify for the study, are you interested in hearing more?  
 
 
(Information about Study Procedures)  After consent, you willcomplete a baseline survey about your-
self, your knowledge of technology, and how you process through thoughts and decisions (cognition).  

 
 
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Once in the study, you will continue to receive some of the text messages and reminders to take your 
blood pressure that you received during Reach Out.  
 
If you have a smart phone, you will receive a new bluetooth-compatible blood pressure cuff and will be 
asked to download the blood pressure cuff app to your cell phone and trained on how to use the app.  
You will be asked to take your blood pressure weekly using the new bluetooth-compatible blood pres-
sure cuff.  
 
At around 3 and 6 months, you will receive reminder text message(s) to complete a survey link. You may 
also be mailed and called as reminder(s) for these outcomes, and to assist with technology trouble-
shooting.   
 
If you have a smartphone, you will be sent a reminder text message to complete a Bluetooth enabled BP 
measurement. In order to get the data, we will train you on how to download data via the Bluetooth 
app, and send the data to the study team either via email or a similar secure means. If unavailable, the 
study team will conduct an in-person or virtual outcome visit to download final blood pressures from the 
Bluetooth app. 
 
Participants without apps or Bluetooth capable phones will be sent a reminder text message prompting 
a photograph blood pressure procedure.  
 
Please note- this program does not take the place of your doctor. Doctors will not be evaluating all of 
the information participants report during their automated text messaging system, and no one will be 
reviewing blood pressure or survey data in real-time. If you have any urgent questions, health problems, 
or dangerous BP levels they should be addressed with your doctor, or call 911.   
 
You may be contacted to be invited to participate in other mHealth or stroke prevention trainings, if in-
terested. 
 
You may also be asked to participate in a focus group.  
 
We expect the amount of time you will participate in the study will be about 6 months. 
 
(Risks and Potential Benefits of the Study) There can be risks associated with joining any research 
study. The type of risk may impact whether you decide to join the study. For this study, some of these 
risks may include:  
(1) 
Discomfort with monitoring or potentially sending a picture of your blood pressure.  
(2) 
You will receive survey links to complete questionnaires, directly connected to secured data-
base(s). Reach Out will use a secure, password-protected web-based application for data 
collection and surveys.  
(3) 
Depending on your phone capability you may transmit your BP over Bluetooth app. The risks 
associated with these apps are stated in their terms and conditions, as with any app you 
download. You should read these terms and conditions. The app may collect data and infor-
mation including account information, user data, usage information, cookie information, 

 
 
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third party services for basic services, third party services for data sharing, third party data, 
and additional information provided to app.  Some of these features can be changed in ac-
count settings. This is not Reach Out, but company data and privacy policies.  
(4) 
This study contains risks associated with transmitting data online, including loss of confiden-
tiality. We have protections in place to minimize these technical risks. 
 
 
You also need to understand that all information received from you will be confidential and will be kept 
under lock and key or secure, password protected documents and computers. Your name will not be 
kept with your answers. Your name will not appear in any reports.  
 
 
As with any research study, there may be additional risks that are unknown or unexpected. 
 
This study may not offer any benefit to you not, but may benefit others in the future by helping us gain 
important information about how to help people manage their high BP. 
  
 (Financial Information) You will be given a blood pressure cuff and $20 after completing 3-month 
outcome, and $30 after completing the 6-month. Participants asked to participate in the focus groups 
may receive food and up to $20 following completion of the session. Payments will be in the form of 
cash or a gift card. 
 
 (Confidentiality) You may be worried about the confidentiality of your information. We won’t share 
answers with anyone except the researchers of this study. The risks to participating are minimal, but 
there is risk associated with transmitting data, including loss of confidentiality. 
 
Taking part in this study will involve collecting private information about you. This information will be 
protected in the following ways. If there are physical copies of your information, it will be stored in a 
locked area, accessible only to research staff, and will not be made part of your medical record. Your re-
search information will be entered into a password protected computer and your name will be sepa-
rated from the data.  We will not share data that identifies you with anyone outside of the study. The 
study uses a SSL encrypted web-based application with secure log-ins to access. There is a very small risk 
that someone could obtain your contact information from the study website. 
 
The research team will have printed terms and conditions available for the apps that are asked to be 
downloaded to your phone, so that you may understand the policies of those specific apps, which are 
not created or supported by Reach Out. The app is possibly partnered with selected third party services, 
in which thye   
 
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Insti-
tutes of Health. The researchers can use this Certificate to legally refuse to disclose information that 
may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other pro-
ceedings, for example, if there is a court subpoena. You should understand that a Certificate of Confi-
dentiality does not prevent you or a member of your family from voluntarily releasing information about 

 
 
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yourself or your involvement in this research, or for any purpose you have consented to in this informed 
consent document. 
 
Consenting to this form gives the researchers your permission to obtain, use, and share information 
about you for this study, and is required in order for you to take part in the study.  
 
Medical information and billing records are protected by the privacy regulations of the federal Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected 
health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health 
care provider involved in your care, including:  
 
• Demographic information  
• Personal identifiers  
 
The results of this study could be published in an article, but would not include any information that 
would let others know who you are.  
(Contact Information) I will provide you with our study cell phone, email and other direct contact infor-
mation if you have any questions about the study or if you want to withdraw from the study.  I will also 
provide you with contact information for the University of Michigan Institutional Review Board and Hurley 
Medical Center’s Institutional Review Board if you have any questions about your rights and responsibili-
ties as a research participant.  This contact information is on the copy of the Consent forms.   
(Consent) Do you have any questions, comments or concerns?  Remember, your participation is voluntary.  
 (If patient consents to participate in the study with no further questions, pursue consent) 
Great, so the final thing is getting your consent as documentation that you have heard the informed 
consent for this study, and are agreeing to participate.  
If you agree to participant in this study, please reply “yes” to the question. I will record your answer. 
(If patient says yes, record answer; legal name; date; time) 
Please answer the following questions. I will record your answer.  
I have had the opportunity to ask questions and have those questions answered to my satisfaction. 
(Record answer) 
I would like to receive follow-up newsletters and information regarding Reach Out after completion of 
the study.  
(Record answer) 
If asked to participate in the post-study focus group, I agree to being recorded during discussion. 

 
 
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(Record answer) 
How would you prefer to receive a copy of this consent document (email, postal mail, etc)?  
(If patient says email, record this email address and send consent form to participant. If patient says ad-
dress, record this address and send consent form to participant)  
 
 
 

 
 
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Appendix S- Supplement: Feedback forms 
 
 
 
 

 
 
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Appendix T- Supplement: Instructions for taking your BP 
 
 
 
 

 
 
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Appendix U- Supplement: Instructions guide for tele-out-
comes 
Feature phone:  
 

 
 
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Smart phone: