Identifying Successful Strategies for Implementing Team-Based Home Blood Pressure Monitoring in Primary Care
Phase: NA
Conditions: High Blood Pressure, Hypertension
Sponsor: University of Rochester

Protocol Version Date: 06/15/2022
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Protocol
Title: Identifying Successful Strategies for Implementing Team-Based Home 
Blood Pressure Monitoring in Primary Care 
Principal Investigator/Advisor: Kevin Fiscella, MD MPH
1. Purpose of the Study:
The overall goal of this study is to identify and rigorously evaluate strategies 
for implementing and sustaining team-based home blood pressure monitoring 
(TB-HBPM) within primary care.
We have successfully accomplished aim 1 (a-c) for Phase 1 (R61) of the study.
 
The aims of phase 2 (R33) are as follows:
Aim 2: Deploy theorized implementation strategies using a type-2 hybrid 
stepped-wedge randomized cluster trial
Aim 3: Assess the impact of implementation strategies using specific metrics 
based on RE-AIM 
Aim 4: Test theoretical assumptions underlying the implementation strategies
2. Background:
Uncontrolled hypertension (HTN) is a major modifiable risk factor for CVD.1-3 
HTN is the single most important medically treatable CVD risk factor in the 
United States and the world.4 Uncontrolled HTN is the leading determinant of 
Black-White disparities in CVD morbidity and mortality,5,6 accounting for one 
third of CVD deaths among Blacks.7 HTN control is a key target for preventing 
CVD, for improving life expectancy in the U.S., and for healthy heart equity.8,9 
Yet, U.S. progress in addressing this key risk factor has stalled. African 
Americans continue to have worse HTN control than Whites.10,11 New models 
for HTN management are urgently needed.  
Evidence from systematic reviews show that home blood pressure monitoring 
(TB-HBPM), when supported by teams, improves HTN control.12-14 When 
appropriately implemented, TB-HBPM engages patients in self-management, 
fosters improved medication and lifestyle adherence, generates reliable and 
actionable data that can reduce clinical inertia (failing to intensify medication 
when indicated), and most importantly extends care beyond clinician-driven 

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office visits, yielding more frequent medication adjustments.12-14 A critical 
challenge is that TB-HBPM is a complex intervention where not all patients 
benefit all of the time. Successful TB-HBPM requires a prepared team who can 
support the patient in correct BP measurement and reliable transmission of 
readings in addition to promoting HTN lifestyle self-management. Busy 
primary care clinicians cannot do this alone.15 TB-HBPM is needed. TB-HBPM is 
cost-effective and critical to success.13,16,17
TB-HBPM is grounded in the evidence-based, Chronic Care Model (CCM)18,19 
and systematic reviews.13,20 Key elements of TB-HBPM include: 1) Practice 
level identification of patients with uncontrolled BP;21 2) Patient training in 
TBHBPM;22,23 3) Confirmation of HTN diagnoses using TB-HBPM (or 
ambulatory blood pressure monitoring [ABPM] for patients opting out of TB-
HBPM); 4) Optimized hypertension management and clinical decision 
support;24-26 5) Patient self-management support, including education 
regarding medication adherence and lifestyle changes;20,27 6) Optimized use 
of relevant clinical data by teams;28-30 and 7) Team-based management that 
includes clinical pharmacists and hypertension specialists, through in-person 
visits and/or eConsults (currently in use at these practices).31-35 TB-HBPM 
requires high functioning teams characterized by: effective leaders;36 shared 
goals, including common mental models;37,38 time to plan, delegate and 
coordinate activities;39 cohesive team identity and psychological safety;40,41 
and structures (time and place) and processes that support team learning, 
problem solving and adaptation to achieve goals through data on progress.42-
44 
3. Study Population:
Number Enrolled
1. A retrospective review of baseline data on approximately of 6,000 eligible 
patients that are diagnosed hypertension in addition to staff and primary care 
providers (PCPs) who may be impacted by this clinical initiative and/or by the 
collection of their de-identified data in relation to patients. 
2. Approximately 400 HFM clinicians and staff will be sent an email to a link 
with an information sheet and access to an anonymous/confidential Redcap 
survey. This surveys will be administered to clinicians and staff based on the 
assignment of their suite to the roll-out of TB-HBPM.
3. A subset group of patient participants (40), staff (20), and PCPs (20) will be 
formally consented for semi-structured key informant (KI) interviews.
Participants eligible for de-identified cohort (retrospective review of 
medical records [RRMR])

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Because this is a quality initiative involving the implementation of best 
practices for hypertension control using a practice wide team-based home 
blood pressure monitoring intervention and because we will rigorously evaluate 
the real-world impact of this initiative, we are requesting waivers of informed 
consent for patients, clinicians and staff to access their de-identified data on 
participants using encrypted IDs to assess changes in blood pressure and 
other measures over time and association with suites including their clinicians 
and staff. 
Patient participant inclusion criteria for de-identified cohort
Patients will be eligible for participation in the study based on: 1) age 18 and 
older; 2) Diagnosis of hypertension based on ICD-10 codes of I10-I15 and 2) 
at least one HFM visit and BP beginning no later than 7/1/2021. 
Patient participant exclusion criteria 
Documentation in the medical record that the patient died, transferred out of 
the practice or placed in long-term care or correctional facility prior to 
enrollment. Consistent with principles for pragmatic interventions, we will not 
exclude patients with most co-morbidities. Patient exclusion from the analytic 
cohort will include patients with pregnancy (O00-O9A), dementia (F01.x-F03, 
G30.x and G31.x), end-stage renal disease (Z99.2, N18.6), and hospice 
(Z51.5).
Staff and clinician participant inclusion criteria for de-identified cohort
All members of each of the eight suites are eligible participants for collection of 
study-relevant de-identified IDs that link them to patients. These participants 
include receptionist/medical secretaries, medical assistants (MAs), registered 
nurses (RNs), nurse practitioners, nurse practitioner residents, family 
physicians, family physician residents, clinical pharmacists and clinical 
pharmacist residents.
Exclusion criteria
None
Consented participants for key informant (KI) interviews and surveys
We will obtain informed consent from participants, whether they are patients, 
clinicians or staff, when we invite them to participate in selected surveys or 
qualitative interviews.
Patient inclusion criteria for KI interviews
Active family medicine patient age 18 and older during the project with 
diagnosis of hypertension. We will purposively select patients who did and did 

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not participate in the home blood pressure monitoring, in addition to 
purposively selecting based on age, sex, race, ethnicity, and insurance in order 
to ensure diversity in the sample
Patient Exclusion Criteria
Inability to speak or read the English language or to provide consent
Clinician and staff inclusion criteria for KI interviews and surveys
Any HFM employee (practice leaders, administrators, clinicians, or staff) that 
works with hypertensive patients during the study period, i.e. scheduling 
appointments, coordinating care, measuring blood pressure, responding to 
questions, and/or treating their blood pressure. 
Approximately 200-400 HFM clinicians and staff will be sent an email to a link 
with an information sheet and access to the anonymous/confidential Redcap 
surveys. These surveys will be administered to clinicians and staff based on 
the assignment of their suite to the roll-out of TB-HBPM.  
Clinician and staff exclusion criteria
None
All races and genders will be eligible to participate 
Supervisors are not involved in requesting participation in the study
4. Recruitment for de-identified cohort
The de-identified analytic sample will be generated using data extracted from 
eRecord by applying the eligibility criteria and creating a unique encrypted IDs 
for participants and for providers and other relevant staff that interact with the 
patient. 
 
5. Recruitment for consented participants
Patient KI recruitment: The research staff will work with the HFM data manager 
to conduct outreach to potential patient KIs based on when their suite starts 
the project. Recruitment flyers will be posted throughout HFM for patients and 
clinicians that may be interested in completing a qualitative interview with the 
study coordinators to provide feedback on their experiences with at home BP 
monitoring. Our goal is to purposively recruit patients with a range of 

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characteristics, e.g. age, sex, race, ethnicity, insurance, and participation or 
not in the home blood pressure monitoring. We will track and monitor 
enrollment by obtaining patient characteristics such as reviewing their 
history/diagnosis of hypertension, demographics that include age, race, 
ethnicity, gender, DOB, education, insurance, and more that result from each 
of these strategies in order to inform the success of our “Reach.”  
Employee KI recruitment: For staff, we will purposively sample from clinicians, 
nursing staff, reception, and administrators. Similar to patient KIs, these will be 
conducted based on when their assigned suite started the project. All 
information obtained is stored on a secure URMC server where only the 
research team in the department and health practice involved will have access 
to it for analysis purposes. 
Survey recruitment: An anonymous/confidential Redcap survey will be 
administered broadly via email to Highland Family Medicine clinicians, faculty, 
and staff, approximately 250 people. If clinicians, faculty, and staff decide to 
participate in the anonymous/confidential Redcap survey, then their consent 
will be provided by having them personally read the information sheet and click 
the bottom of the screen to direct them into the RedCap survey. We have listed 
below the potential recruitment strategies that may be used:
•
Tele-remote
We will request that the HFM data manager with the assistance of the 
CTSI academic informatics unit, generate a list of HTN patients who 
meet study inclusion criteria using variables provided by the research 
team facilitating purposive sampling. The study research coordinator will 
call the patient and ask them if they are willing to participate in 
interview either now and/or at different time/day (see recruitment 
script). For patients who are interested, the research coordinator will 
meet with interested patients by phone or Zoom at time convenient to 
the patient, confirm eligibility criteria and consent patients who meet the 
inclusion criteria. Afterwards patients will receive relevant study 
documents and the Advarra Participant Payment System information 
sheet via postal mail.
•
On-site recruiting 
The on-site recruitment strategy will be in accordance with the University 
of Rochester’s research reboot guidance. We will remain vigilant about 
any additional changes that need to be made to study procedures if there 
are changes to the research reboot guidance in the future 

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(https://www.urmc.rochester.edu/coronavirus/coronavirusresearch/guida 
nce-for-researchers/human-subjects-research.aspx). 
Prior to meeting a study subject in person, the study coordinator 
will: 
•
Pre-screen all study subjects to see if they are symptomatic 
for COVID-19 (cough or shortness of breath, sore throat, 
fever, muscle aches, headache, new loss of taste or smell, 
repeated or shaking chills). We will suggest all individuals 
who have COVID-19 symptoms get tested and see their 
healthcare provider  
•
Defer study procedures or observations with any 
individual(s) testing positive
•
Social Distance – Maintain social distancing from all study 
subjects during the study activities. 
•
Protect study staff and subjects. Study staff and subjects 
will be required to wear a mask during the visit. 
•
The study coordinator will invite eligible subjects who meet 
the University of Rochester’s research reboot guidelines and 
that are willing to learn more about the study, to meet with 
the study coordinator in a location at HFM that allows for 
proper social distancing and privacy. 
HFM Employee KI recruitment: The research coordinator will work with practice 
leadership to identify employees from the different job categories who may be 
interested in providing feedback on the implementation of the TB-HBPM 
intervention at HFM. The research team will propose several methods of 
recruitment including Zoom, telephone (see recruitment script), and face-to-
face, where the purpose, rationale, design of the study and roles and 
responsibilities will be discussed, information regarding compensation will be 
shared, and interest in participating ascertained. 
• Sign-up sheet – The study coordinator will work with the 
HFM leadership to identify employees who may be interested 
in 
providing 
feedback 
on 
implementing 
a 
TB-HBPM 
intervention at the practice. Those whom are interested will 
be asked to provide their names and preferred contact 
information (name and phone number or email address) in 
order to schedule an interview with the study team.  This 
information will only be used to contact those whom are 
interested, and will not be used in the study analyses. 

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• Staff meeting outreach – study coordinators will work with 
practice leadership to deliver a lunch and learn session for all 
HFM employees. During the session, study coordinator will 
review study details and invite potential subjects to consent. 
One follow-up email may be sent to employees approximately 
2-weeks after the lunch and learn to gauge interest and 
schedule a time to consent and conduct the interview via 
telephone or Zoom.  
• Email outreach – RA’s already have access to the employee 
listserv through their HFM affiliation. The study coordinator 
will send an email via the listserv explaining the study and 
include contact information that employees can use to reach 
the research team. If the employee is interested, the study 
coordinator will schedule an appointment to confirm eligibility, 
obtain informed consent and conduct the interview via 
telephone or Zoom. The study coordinator will send one 
follow-up email two weeks after the initial email is sent. 
Use of E-mail in Research
Participants have the option to receive communications about this study via 
email by indicating so during this verbal consent process.  Email 
communications between participants and the study team may be filed in 
their personal research records.  
Emails will be used to send you Information Sheets about this 
study. It may also be used in order to receive payment for 
participating. 
Email communications may be sent or received in an unencrypted 
(unprotected) manner. Therefore, there is a risk that the content of the 
communication, including personal information, could be shared beyond 
you and the study team. The University of Rochester is not responsible for 
any interception of messages sent through email. The University of 
Rochester will make every effort to keep the information collected from 
participants private.  In order to do so all information collected be stored in 
a secure server where only the research team involved in this project has 
access. Sometimes, however, researchers need to share information that 
may identify you with people that work for the University, regulators or the 
study sponsor. If this does happen we will take precautions to protect the 
information you have provided. Results of the research may be presented 
at meetings or in publications, but names will not be used. Permission to 
use health information for this study will not expire unless told to cancel it. 

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The study team will keep the information we collect for seven years after 
the completion of the study at which point it will be destroyed. 
Consent: (Interview Portion)
Consent is an on-going process that starts when you first inform potential 
subjects about the study and ends when the subject’s study participation is 
completed. Informed consent will be obtained from employees (clinicians) and 
patients prior to conducting interviews. To ensure appropriate safety 
precautions when conducting in-person study procedures at the University of 
Rochester, the process for conducting in-person visits outlined in the Guidance 
for Human Subject Research will be followed45. In person consenting will take 
be in a quiet place, away from distractions and will provide the opportunity for 
participants to ask questions and they will take home copies of all study 
materials that includes the consent form and study information sheet. The 
method of authentication used when eConsenting will be a password 
verification based on already known information about the subject such as 
their DOB, middle name, street name, etc. When conducting remote consent 
via telephone, research staff will provide a Redcap eConsent and go through 
the form with the study participant. Upon remote consenting, participants will 
be mailed copies of all study materials including consent form and the study 
information sheet. Coercion will be minimized throughout the on-going 
consenting process by having participation be voluntary with the possibility to 
withdraw from the study at any time, without any penalty or loss of benefits 
to which employees and patients are entitled to at the health facility. 
Waiver of Documentation of Consent (survey portion)
We will provide an information sheet in REDCap for staff and clinician survey 
participants but will not require documentation of consent for completion these 
anonymous surveys that do not address sensitive topics.
Waiver of Informed Consent and waiver of HIPAA (RRMR portion)
As we have successfully done in other pragmatic trials approved by the 
University of Rochester (1R18HL117801), where the practice is the unit of 
intervention, we will request waivers of informed consent and HIPAA consent 
authorization for the RRMR portion of the study. The Common Rule allows 
Institutional Review Boards to "approve a consent procedure which does not 
include, or which alters, some or all of the elements of informed consent 
outlined in this section, or waive the requirements to obtain informed consent 
provided the [research ethics committee] finds and documents that: (a) The 
research involves no more than minimal risk to the subjects; (b) The waiver or 
alteration will not adversely affect the rights and welfare of the subjects; (c) 

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The research could not practicably be carried out without the waiver or 
alteration; and, (d) Whenever appropriate, the subjects will be provided with 
additional pertinent information after participation.”
Similarly, the Privacy Rule contains criteria for the waiver or alteration of the 
authorization requirement for Protected Health Information (PHI) (45 CFR 
§164.512(i) 1) by an IRB.135. These criteria, based on “minimal risk” 
principles, are similar to those in the Common Rule criteria for waiver of 
patient informed consent. They are: "(a) The use or disclosure of protected 
health information involves no more than minimal risk to the privacy of 
individuals, based on, at least, the presence of the following elements: (1) An 
adequate plan to protect the identifiers from improper use and disclosure; (2) 
An adequate plan to destroy then identifiers at the earliest opportunity 
consistent with the conduct of the research, unless there is a health or 
research justification for retaining the identifiers or such retention is otherwise 
required by law; and (3) Adequate written assurances that the protected 
health information will not be reused or disclosed to any other person or 
entity, except as required by law, for authorized oversight of the research 
study, or for other research for which the use or disclosure of protected health 
information would be permitted by this subpart.  (b) The research could not 
practicably be conducted without the waiver or alteration, and c) The research 
could not practicably be conducted without access to and use of the protected 
health information.”
As we detail above, this research poses minimal risk to subjects. The practice 
is undertaking the clinical intervention (TB HPBM). The study does not infringe 
on the rights or welfare of participants. From the patient vantage point, they 
will see clinicians who are better trained to collaboratively meet their needs 
including encouragement to follow-up more frequently for improved BP control 
and monitoring. Patients have the right to agree or not to this advice from 
their clinician and will provide clinical consent to home blood pressure 
monitoring. The proposed research could not be carried out without the waiver 
of informed consent due to an inability to fully shield patients from a practice-
wide QI initiative. Specifically, non-consenting patients (and clinicians or staff) 
will be nonetheless exposed to “trained clinicians.” Without a waiver of 
informed consent, there would be a loss of scientific relevance (selected 
enrollment undermines a central feature of a pragmatic trial - 
generalizability). Similarly, a waiver of the authorization requirement is 
needed to access existing PHI. An authorization from the patient would likely 
fundamentally alter the study in the same way a requirement for informed 
consent would – selected recruitment into the study with loss of external 
validity. Denial of either of these waivers would result in significant changes in 

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the study and loss of external validity. We intend to share our findings with 
practices and encourage practices to post them in waiting rooms for all 
patients to view. We detailed steps below to protect patient identification 
through the use of a de-identified data set for analysis and by our 
commitment to destroy confidential linkages between study ID numbers and 
subjects and also linkages between patients, clinicians, and practices. Our 
data sharing plan makes a limited data set available once additional 
protections are taken, i.e. use of broad age categories, removal of any time 
variables, restriction to summary comorbidity scores,  absence of any 
hierarchical linkages, and obtaining a data use agreement (see data sharing 
plan below for further details).     
5. Study Activities
Aim 2: Deploy theorized implementation strategies using a type-2 hybrid 
stepped-wedge randomized cluster trial
The department of family medicine will roll out the clinical intervention (TB-
HBPM). To improve rigor in evaluation, the study biostatistician will use 
computer-generated numbers to randomly assign each of the eight suites to 
when they will begin the intervention during one of three wedges (Figure 1). 
We will randomize two suites in the first wedge and three each to the second 
and third wedge.
Description of TB-HBPM Clinical Quality Improvement Intervention
Table 2 describes key components of the TB HBPM, the Rationale and 
adaptations that are permitted.
Table 2. TB-HBPM Components, Description, Rationale and Permitted 
Adaptations
TB-HBPM 
Components
Description
Justification
Permitted 
Adaptations
The Team
The TB-HBPM team composition includes the 
clinician, 
MA 
or 
LPN, 
RN 
(shared), 
receptionist, 
Care 
Manager, 
Clinical 
Pharmacist (shared between teams), and 
specialist consultation through in-person or 
eConsult and lifestyle programs.
PCPs establish alerts, review reading from OH 
Dashboard 
and 
contacts 
patients 
for 
Teams are organized by 
each 
practice. 
Each 
member has a role: The 
PCP 
diagnoses, 
treats, 
counsels, 
and 
refers. 
Reception 
does 
phone 
outreach. 
RNs 
provide 
education and visits. MAs 
The 
roles 
of 
team members 
are 
adaptable. 
On some teams, 
PCPs 
and 
clinical 
pharmacists 
and/or RNs may 
Figure 1. Stepped Wedge Cluster Randomized Design in Involving Eight Suites.
M1-M12
M15-M20
M21-M26
M27-M32
M33-M38
M39-M44
M44-M49
Control
Rollout
TB-HPBM
TB-HPBM
TB-HPBM
TB-HPBM
Assess
Control
Control
Rollout
TB-HPBM
TB-HPBM
TB-HPBM
Assess
Control
Control
Control
Rollout
TB-HPBM
TB-HPBM
Assess

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medication adjustment. OH nursing personal 
contact PCPs when BP readings are out of 
range.
Clinicians request DFM care managers to work 
with patients whose BP remains uncontrolled 
after 60 days. PCPs are encouraged to refer 
patients with persistent SBP>160 to the clinical 
pharmacist for intensive management. 
Teams meet monthly to assess progress, 
problem-solve solutions, and assign tasks.
and LPNs conduct HBPM 
training, specialists provide 
expert input and clinical 
pharmacists 
work 
with 
patients needing intensive 
management.
co-lead 
group 
medical 
visits. 
MAs and LPNs 
may help with 
outreach. Care 
managers may 
help 
with 
training. 
RNs 
may 
conduct 
HTN 
visits. 
Specialists can 
provide 
eConsults
Population 
Management
and Outreach
Pro-active outreach to engage patients with 
past two BP readings > 140/90 or last BP > 
160/100 with no visit within 60 days.
Data from the practices 
show that 15% of patients 
with uncontrolled HTN have 
not been seen within the 
year. Nearly, one in four 
have 
BP 
> 
160/100.Population 
management is critical to 
reaching these patients.
Delegation 
of 
outreach 
to 
various staff to 
contact 
and 
engage 
the 
patient.
Optimal Office 
Blood 
Pressure 
Measurement
Use of automated office devices. Correct 
sitting position, cuff size, no talking and repeat 
taking of any elevated readings after >3 
minutes.
Accurate, 
reliable 
BP 
readings are critical to HTN 
management.38
Clinicians will be 
strongly 
discouraged 
from taking their 
patients 
BP 
themselves 
using 
manual 
devices.
Patient Self-
monitoring
The primary care clinician (PCP) explains 
the initiative to the eligible patients and elicits 
patients’ agreement to be contacted by the 
RPM vendor, OH and the clinician documents 
this in the medical record using a smartphrase. 
The clinician sends a secure message to OH 
with patient contact information (name and 
phone number).
Trained OH nursing personnel call the 
patient 
and 
formally 
consent 
interested 
patients. 
For 
consenting 
patients, 
OH 
personnel will obtain date of birth, address and 
additional 
relevant 
contact 
information, 
arrange for shipping of the device and provide 
phone education to the patient regarding 
appropriate procedures for measuring their 
blood 
pressure 
using 
the 
device. 
OH 
personnel will check on progress and provide 
additional education and support as needed 
for patients to engage in RPM of their blood 
pressure.
Patients take daily BP readings using the 
device that automatically transmits these 
readings to the OH Dashboard (server).
Patient skill proficiency is 
foundational to effective 
HBPM.39
PCP and HFM 
staff may over 
time 
assume 
responsibilities 
for 
formal 
consent, 
education.
Patient Self-
Management 
including 
RPM
Patient training in RPM will be provided by OH 
and/or 
DFM 
personnel 
depending 
on 
circumstance. 
Smart phrases for patient education include 
patients’ BP goal, reminders to use RPM and 
suggested lifestyle changes, and tips on 
improving medication adherence.
Smartphrases for referrals to the HFM clinical 
pharmacist
ACC/AHA 
and 
other 
guidelines emphasize the 
importance 
of 
lifestyle 
changes. 
Staff 
will 
be 
trained in how to assist 
patients in setting, tracking 
and 
following-up 
on 
achievable lifestyle goals 
and will be referred to 
internal 
and 
external 
The 
specific 
workflows will be 
decided 
by 
teams. 
Teams 
will 
be 
encouraged 
to 
permit the MA or 
LPN 
to 
invite 
patients 
to 
identify lifestyle 

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the Center for Community Healthy Living 
Program, 
the 
YMCA 
Hypertension 
program, 
and 
depression program.
Patients will be trained in home BP self-
management, including target BP goals, 
adherence and goal setting for lifestyle 
changes, i.e. physical activity, e.g. minutes of 
walking, DASH diet steps, e.g. reducing sugar 
and 
salt 
laden 
products 
and 
smoking 
cessation, including links to community 
resources for these.  
resources 
for 
more 
intensive counseling.
goals. Clinicians 
will 
assist 
patients 
or 
delegate 
care. 
Clinicians 
will 
make 
referrals 
and 
use 
smartphrase to 
summarize after 
visit information.
BP Device 
Integration
Validated digital BP devices that transmit data 
to the OH server will be used. These data will 
be integrated into the EPIC. The initial 
integration will involve transmission of PDF via 
direct messaging to each providers in basket. 
Subsequent integration will involve full scale 
EPIC integration of structured data. 
Device integration reduces 
errors in entering numbers 
and minimizes clinician and 
staff burden in viewing and 
responding 
to 
HBPM 
readings.40-43
FDA approved, 
validated, 
devices will be 
allowed 
for 
eRecord 
integration.
Clinical 
Decision 
Support  
(CDS)
Smartphrase that summarizes prior BPs and 
prompts PCP to invite patients with BP> 
140/90 to participate in RPM and document 
whether the patient agrees to participate and 
allow OH to contact them.
Smartphrase that prompts the PCP to check 
the target BP goal (<130/80) or indicate 
alternative targets and compare with mean 
recorded BPs over the last three readings. The 
smartphrase will pull in the RPM readings 
averaged over the prior five readings
Smartphrases will supports documentation of 
lifestyle counselling. 
Smartphrase will pull in 10-year ASCVD risk 
and prompts the PCP to consider statins.
Smartphrase will supports smoking cessation 
counselling and billing.
Team-based CDS permits 
delegation and sharing of 
actions to address gaps in 
care. Plan to address these 
gaps 
before 
the 
visit 
minimizes computer alert 
fatigue 
and 
distraction 
during visits.44,45
Teams will share 
design of these 
smart 
phrases 
and 
processes 
for 
addressing 
gaps
Audit and 
Feedback 
reports 
These 
monthly 
reports 
will 
summarize 
comparative 
performance 
by 
team 
and 
clinician and progress and include actionable 
data 
and 
practical 
suggestions 
for 
improvement.
1)
% patients with BP<140/90 and 
<130/80 by race/ethnicity and insurance
2)
Mean target BP and medication 
intensification
3)
% of patients engaged in RPM
4)
ASCVD 
10 
risk 
scores 
and 
prescription of statins
5)
BP >140/90 and no visit in 90 days
6)
% Current smokers and # quit in past 
month/year
Audit and feedback reports 
improve implementation of 
clinical practice guidelines 
(CGPs) including HTN.46,47 
They are more effective 
with 
actionable 
recommendations.48,49
Suites will have 
input 
into 
the 
formatting 
and 
content of these 
feedback 
reports.
Team 
Processes
These include monthly meetings for planning 
and 
delegation 
of 
tasks, 
team-based 
coordination and debriefing and meeting to 
review audit and feedback, to problem solve 
and adapt strategies.
These 
current 
team 
processes, coupled with 
critical 
interpersonal 
processes, 
i.e. 
psychological 
safety, 
conflict management and 
motivation are critical to 
team function.50 Notably, 
time for reflection, problem 
solving and co-learning are 
important.51,52
Mode and style 
for 
debriefing 
and approach to 
problem solving.
Training of 
clinicians and 
staff
1) Staff  will be trained  in correct blood 
pressure measurement using automated office 
Training 
will 
address 
identified 
gaps 
in 
Content will be 
modified based 

Protocol Version Date: 06/15/2022
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blood pressure devices, checklists and best 
practices.
2) Clinicians will be trained based on assigned 
wedge. There will be three one-hour trainings 
for each suite. The first will address HTN 
management including ACC/AHA guidelines. 
The 
second 
will 
address 
BP 
targets, 
smartphrase and monthly audit and feedback 
reports. The third session will address shared 
decision-making and lifestyle changes. In 
addition, suite teams will be trained in best 
team 
practices 
related 
to 
leadership, 
psychological safety, planning, executing and 
debriefing 
knowledge, skills and new 
resources.
on 
emerging 
data. T
Billing for 
RPM and 
chronic are 
management
Clinicians and staff will bill for set-up, 
monitoring, and management of HBPM using 
existing remote patient monitoring and chronic 
care management billing codes facilitated the 
vendor Twistle.
Insurance reimbursement 
for RPM is critical  financial 
sustainability. 
Templates and 
time 
stamped 
data 
will 
be 
adapted 
to 
support 
compliant billing
Key Informant Interviews
All KIs will be called upon to assist with informing the implementation process 
of TB-HBPM at HFM. The interview process will involve asking questions in 
person, via telephone, or via zoom that are tailored to the participant KI for 
addressing their use of home blood pressure monitoring devices, appropriate 
training of patients, use of the patient portal, and outreach to patients with 
uncontrolled blood pressure who have not been seen within three months. For 
example, we will ask clinicians about their experience with barriers and 
facilitators to patients conducting home blood pressure monitoring using 
bidirectional texting technology provided by the URMC approved vendor, 
Twistle. We will ask patients about barriers and facilitators they encountered 
when taking their blood pressure at home and sending readings to their 
clinician. We will similarly ask patient about their experience in taking their 
home blood pressure using the cuffs provided, transmission of readings, and 
communication with their health care team.
Steering Committee Minutes
A departmental steering committee will guide the process though Phase 2 with 
monthly meetings (weekly when required). The meeting minutes are 
conducted within a practice level and will include discussion on any study 
updates, and the planning of study processes throughout each year. No 
patient PHI is collected or discussed during these meetings. We de-identify the 
written minutes of the steering committee minutes and use these minutes as 
a data source.
Coding Analyses: 

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Our qualitative evaluation will be based on coding of open-ended questions 
from the interviews. We will be particularly attentive to themes relating to 
feasibility including time burden, disruption of routines, adaptions, comfort, 
trust, perceived value, which patients benefit and which did not. The location 
of the interviews will take place in a private setting at HFM or remotely at the 
preference of the KIs. Each interview will be conducted by a member of the 
research team.  
All interviews will be audio-recorded and then transcribed through a service called 
Rev.com which is a University of Rochester Qualified Supplier. If the interview is 
conducted using video, only the audio portion will be recorded using an audio-
recording device.  No personally identifiable information will be transcribed. The 
de-identified data will be stored in a password-protected file on a secure URMC 
shared drive housed in the Department of Family Medicine. Only the research 
team will have access to the de-identified data. 7 years after the completion of 
the study, the audio recordings will destroyed.
1. Several members of the research team will adopt a focused, rapid, 
qualitative, needs assessment using a priori codes based on the PRISM 
framework to identify barriers and facilitators for each of the five RE-AIM 
domains. Thus, we will assess internal and external context, practice 
infrastructure relevant to implementing and sustaining TB-HBPM and the 
views of recipients (HFM leaders, administrators, clinicians, staff and 
patients).
2. The codes will then be used to create a template for coding by the whole 
research team and applied to all of the transcripts. These will include 
identification of internal and external contextual issues that affect 
decision-making and its consequences.
a. The coding template will be pilot tested by members of the study 
team to ensure reliability and understanding. 
3. The coding process will be iterative; each transcript will be read by two 
coder(s) to generate a general understanding of the overarching themes 
and issues that evolved during a particular interview. The same coder(s) 
will read the transcript again, and code the transcript using the coding 
template noted in step 1 above. Additional codes will be applied as 
needed, by approval of the research team. 
4. Each transcript will be coded by at least 2 research team members to 
ensure concordance/agreement of themes. In the case of coder 
disagreement, the issue will be resolved via discussion with the research 
team. Each coder will enter their independent codes into a MAXQDA 
database where the codes can be summarized and collated for further 
analyses. 

Protocol Version Date: 06/15/2022
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MAXQDA is a URMC approved software that is designed for a 
qualitative and mixed methods data, text and multimedia analysis. 
The password -protected MAXQDA database is stored on the secure 
URMC shared network drive housed in the Department of Family 
Medicine. The MAXQDA database does not have personal access to 
the data stored within the system and will be protected according to 
institutional and HIPAA regulations. 
The transcripts from each KI and SC meeting will be given a 
randomly assigned ID number related to the person facilitating the 
group and not the subject. No personal identifiers will be included in 
the transcripts to link any of the subjects to the any of the KIs or 
SCs. The team members will not code any of the transcripts for the 
interviews they facilitated. We will triangulate the transcribed data 
from the KIs, SC meetings and field notes from the study coordinator 
to interpret the findings.
Payment
KI subjects will receive $50 either in-person or through the postal mail for 
completing the interview. For this study, we use a subject payment system 
called Advarra Participant Payments. The system allows three ways to 
provide payment. You can choose: a reloadable debit card; direct deposit; 
or mailed paper checks. The study team will help you create a “subject 
profile” in the system. In order to provide payment, we will need to enter 
your name and date of birth into your subject profile. Depending on which 
payment method you choose, you may also need to enter your email 
address and banking information. If you already have an Advarra account 
(because you are in another study that uses this system), your existing 
profile will be used to provide payment. See the ‘Information Sheet for 
Advarra Participant Payments” for additional information.  There will be 
no cost to you to participate in this study.
6. Risks and Benefits of Participation:
Risks:  This is a Minimal Risk study. The study activities are unlikely to pose 
harm or discomfort any greater than that ordinarily encountered in daily life. 
We will inform subjects that participation is voluntary. We do not anticipate 
that any questions will make patients uncomfortable. All participants will be 
advised they may decline to answer any questions. 

Protocol Version Date: 06/15/2022
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The primary risk to subjects is breach of confidentially. In addition, there is a 
risk that employee KIs may feel coerced to take part in the study as KIs to 
maintain their employee status or benefits at the health center. 
We will minimize the risk of breach of confidentiality through appropriate 
training of all study personnel regarding confidentiality.  All study personnel 
have completed training and have obtained certification in clinical research. 
Subject data and audio-recordings will be securely stored on the Department 
of Family Medicine shared-drive. To protect HFM employees from feeling 
coerced into participating, no direct supervisors will approach potential 
participants. We will provide employees who would like more time to consider 
an information letter to take home, and ask them follow up with a research 
staff if they are interested in participating in the study. To minimize breaches 
in confidentiality, we will avoid names, transform actual dates, and convert 
Zip Codes to area-based measures, i.e. median income.
Benefits:  We do not anticipate any direct benefits to those who participate in 
this study beyond potential benefits from the clinical intervention, i.e. 
improved blood pressure. However, employees and patients may derive 
benefit if the intervention is successful. Potentially, these employees may have 
more effective clinical interactions and improve the level of care they provide 
their patients. 
7. Inclusion Criteria
(See section 3. Population for eligibility criteria for both the de-identified 
study cohort and consented participants
8. Data Measures and Analysis:
Aim 3: Assess the impact of implementation strategies using specific 
metrics based on RE-AIM 
Table 3 below describes the specific hypotheses being tested in addition to 
data source for this testing. The main hypotheses are being tested using de-
identified data extracted from the eRecord. Secondary and mediating 
hypotheses are based surveys that are administered. These include the 
Primary Care Team Dynamics Survey (PCTDS), Two 3 item surveys ( 
Acceptability Implementation Measure (AIM) and the Feasibility 
Implementation Measure (FIM)), the Quality Improvement Capacity 
Assessment survey (QICA) and the Teams Tool (TT)
Table 3. Primary, Secondary, and Exploratory Outcomes and Hypotheses
RE-AIM (Reach, Effectiveness, Implementation, Maintenance) Hypothesis reflecting the effect 
of TB-HBPM
Data
source
Reach 

Protocol Version Date: 06/15/2022
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R1: More than 50% of patients who are invited to engage in RPM for HBPM will consent.
EHR
R2: There will be a 50% reduction in patients with uncontrolled HTN with no follow-up reading within 90 
days
EHR
Effectiveness 
E1: HTN control rates (< 140/90 mm Hg) will improve by 6%,i.e. from 50% to 56% (Primary 
Outcome)
EHR
E2: Overall mean systolic blood pressures will improve (Secondary outcome)
EHR
E3: Improvements in HTN control will be similar by race, ethnicity, and insurance (Secondary 
outcome)
EHR
Adoption
A1: 70% of patients eligible for HBPM will be invited to consent by their clinician 
EHR
A2:  TB-HBPM will be viewed as acceptable and feasible by patients, staff, and clinicians
AIM, 
FIM** 
Implementation
I1:  More 50% of patients who consent to HBPM will transmit BP readings on >15 days/month
EHR
I2:  TB-HBPM elements will improve as measured by the QICA** scale
QIQA**  
scale
Maintenance
M1: HTN control will be sustained throughout the project
EHR
M2: Revenue from billing will exceed the costs of implementation and sustaining HBPM using RPM
Costs 
and 
billing 
Mediators (in the causal path between the intervention of TB-HPM and improved BP control)
Med 1:  Lower clinician BP targets 
Survey, 
EHR
Med 2:  More frequent patient HBPM readings transmitted 
EHR
Med 3:  More frequent clinician BP medication treatment intensification
EHR
Med 3: Team function (PCTDS*) l
PCTDS* 
scale, 
EHR
Exploratory 
Exp 1: LDL-C values and current smoking will decrease
EHR
Exp 2: Joy in practice, personal growth, and leadership and learning will improved based on the 
TT***
TT  
scale
Exp 3: Hypertension related ED visits will decrease 
EHR
PO= Primary Outcome. IPT=initial program theory, OR=Outreach using BP registry, GR=Gap Reports, A&F=Team 
and Clinician Audit & Feedback reports, CPGT=Clinical Practice Guideline Training, TT=Team Training and 
Coaching, *PCTDS=Primary Care Team Dynamics Survey, **AIM=Acceptability Implementation Measure, 
**FIM=Feasibility Implementation Measure ***QICA=Quality Improvement Capacity Assessment survey TT=Teams 
Tool. 
Notes on Surveys: *PCTDS is a 29-item survey that assesses core team dimensions: conditions, shared 
understanding, accountability, communication, conflict resolution, acting and feeling like a team and effectiveness, 
with α’s ranging from .75-.91.53 The **AIM and **FIM scales each contain 4 items with α’s of 0.85 and .89, with 
reasonable discriminant validity and test-retest reliability.54  The ***QICA assesses the extent to which the CCM for 
CVD prevention is implemented. It has been validated in primary care CVD prevention research.55 It was selected 
because its domains map to the TB-HBPM. The TT is the 14 item scale that has been developed using existing 
items and validated in primary care practices in CVD prevention.56 It includes three subscales: Joy in Practice 
(α=0.88), Personal Growth (α=0.81), and Leadership and Learning (α=.91).
Statistical Plan
We propose to use generalized linear mixed models to estimate the treatment 
and covariate effects in the SWCRT.  These methods are the conventional 
tools advocated in the statistics literature for this type of study design. Let 𝑌𝑖𝑗𝑘
be a Bernoulli (yes/no) outcome indicating controlled BP for the jth patient 
nested in the ith suite at the kth time point. We model the conditional 
probability of controlled BP given the jth patient and ith suite as:
𝑙𝑜𝑔𝑖𝑡[𝑃(𝑌𝑖𝑗𝑘= 1|𝛼𝑖,𝛼𝑗(𝑖))] = 𝜇+  𝛼𝑖+ 𝛼𝑗(𝑖) + 𝛽𝑘+ 𝑥𝑖𝑘𝜃

Protocol Version Date: 06/15/2022
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Where  is the background level of BP control (on the logit-scale), 
are fixed 
𝜇
𝛽𝑘
effects for time , 
 is a mean-zero Gaussian practice effect with variance 
, 
𝑡𝑘𝛼𝑖
𝜏21
 is a mean-zero Gaussian patient-level effect for the jth patient nested 
𝛼𝑗(𝑖)
within the ith suite independent from 
 and has variance 
. The 
 are time-
𝛼𝑖
𝜏22
𝑥𝑖𝑘
dependent treatment indicators (1=if the ith suite has begun the intervention 
rollout by time , 0=otherwise) and  is the treatment effect.  Our above 
𝑡𝑘
𝜃
model is an extension of the basic SWCRT model by Hussey and Hughes 
(2007) because our approach models patient-level heterogeneity within suite 
via the random effect 
. This random effect plays an important role in our 
𝛼𝑗(𝑖)
hierarchical model. We propose to use Satterthwaite’s method to adjust for 
the denominator degrees of freedom for small numbers of clusters. All the 
calculations will be conducted in SAS (i.e. GLIMMIX, NLMIXED in SAS, SAS 
Institute, Cary, NC).For secondary analyses, the mixed model regression 
framework above can be generalized to allow for additional covariate 
adjustments without difficulty.  
Sample size calculation
The study was designed to detect a 6% increase (e.g. 51 to 57%) in the 
population level of BP control (defined to be <140/90 for an office based 
reading or mean HBPM 135/85 based on most recent reading at the end of the 
study period).  We have selected this difference based on the following 
criteria. First, Kaiser Permanente improved control rates from 44 to 90% over 
13 years or an average 3.5 mm Hg/year improvement. Similar HTN control 
improvements, (i.e. 6%) have been obtained in safety net practice through 
adaptations of the Kaiser team-based approach by others, and by our team. 
Thus, we believe a 6% overall improvement in practice wide HTN control is 
achievable and clinically meaningful. There are eight practices and 
approximately 720 patients nested within practice for a total of 5805 patients. 
We used the above model to compute statistical power via Monte Carlo 
simulation study. To match the actual study setting as closely as possible, we 
let each practice have 10 providers apiece for a total of 80 providers (in fact, 
there are 83 providers). We assumed that each provider sees 72 patients for a 
grand total of roughly 5760 patients enrolled in the study The variance 
components 
 and 
 for the suite and patient-within-suite random effects, 
𝜏21
𝜏22
respectively, are unknown for this population and so we used reasonable 
values from some of our own studies conducted at the University of Rochester 
Medical Center.  We estimated parameters in the generalized linear mixed 
model using the ‘lme4’ package in the R statistical software.  If we set the 
standard deviations 
, then we estimated the statistical power to be 
𝜏1 = 𝜏2 = 4
95% for a two-sided test of the treatment effect at the nominal 5% level.  If 
we increased the patient-within-suite standard deviation to 
 but retained 
𝜏2 = 8
the suite-level standard deviation at 
, then the statistical power reduces 
𝜏1 = 4

Protocol Version Date: 06/15/2022
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to 87% for two-sided tests at the 5% level. This power will allow us to explore 
interactions between HTN control and patient demographic factors, i.e. age 
(<65 vs >65), sex (M vs F), race (Black vs White), ethnicity (Hispanic vs non-
Hispanic) and insurance (Self pay vs any and Medicaid vs Commercial). We 
will use a similar approach to examining the second primary outcome, i.e. 
improvement in patients transmitting HBPM readings.
Outcomes and Analyses
Primary outcome
We will adopt the prototypical SWCRT mixed-effects model and analysis 
described above for the primary binary, BP control outcome (E1). We will use 
the most recent BP from either office or HBPM to define control (BP < 140/0 
mm Hg) at month 44. Because HBPM readings are systematically 5 mm Hg 
lower than office readings,62 we will add 5 mg to the SBP and DBP for HBPM 
readings to ensure comparability with office readings.
Secondary RE-AIM outcomes
Similarly, we will adopt the prototypical SWCRT mixed effects model and 
analysis above for the secondary RE-AIM outcomes (R1, R2, E2, E3, A1, A2, 
I1, I2, M1, M2).
Cost Analyses (M2: Revenue from billing will exceed the costs of 
implementation and sustaining TB-HBPM).
The cost analysis will be performed with respect to both the health system and 
patients. We will consider the net impact based on the marginal revenue 
minus the marginal costs.
Marginal revenue will be based on billing using RPM and CCM CPT codes for a 
diagnosis of hypertension, e.g. ICD-10 110.x, in addition to CPT codes for 
visits for the cohort. We will capture all types of visits including traditional 
office visits, telehealth visits, and patient group visits. Office visits will be 
identified based on CPT codes, e.g. 99213, 99214 etc. Telehealth visits involve 
use of modifiers, e.g. 95 for video and 93 for phone visits. Group patient visits 
will be identified based on standardized smart phrases. Thus, CPT codes and 
billing data will allow us to calculate corresponding marginal changes in 
revenues for the cohort 
The first cost item will be based on OH charges for enrollment, training, and 
coordination of care. These are monthly per-patient charges that will be 
estimated based on the total months. HBPM will be included in current team 
meetings. We will flag these HTN-related meetings (and trainings), capture 
attendance, duration, and frequency of meeting/training based on clinician 
and staff type. This will allow us to estimate costs of the personnel attending 

Protocol Version Date: 06/15/2022
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based on salary/benefits ($/hour) multiplied by time. RPM time for HTN (which 
can be converted into costs based on the clinician type) will be estimated 
using the time audits on the OH dashboard that tracks time use. Depending on 
clinician workflows, we may need to impute time (for clinicians who choose 
not to use the dashboard and/or communicate with patients outside the OH 
platform where time is not tracked). This could be estimated based on time 
use among clinicians and staff who use the platform and based on prior 
studies on clinician time in reviewing BP data and communicating with 
patients. Time required for communicating with patients is tracked using the 
OH platform (when used), and we will record clinician time spent in patient 
group visits and study-specific training. Patient costs will include time required 
to measure BP according to frequency (times/day x number of days per month 
x months). We will adopt a similar approach for assessing patient time to that 
taken for assessing clinician time. Specifically, we will record patient time 
spent in patient group visits. We will also measure the marginal change in 
clinic visits, whether in-person, telehealth, individual or group.  Clinic visits for 
patients may increase as patients are monitored more closely, or they may 
decrease as care switches to group visits and OH. Thus, we will record all clinic 
visits and associated diagnosis and CPT codes and compare clinic visits to 
historical averages (or time off study) to determine the marginal cost, which 
could be positive or negative. Additional medication costs can be estimated 
based on mean changes in the number of antihypertensive medications with 
estimates of both the medication costs, both average wholesale price (payer 
perspective) and out-of-pocket costs (patient perspective). We will conduct 
sensitivity analyses that consider costs based on hypertension-related 
emergency department visits using data from the exploratory analyses 
described below. 
Mediating analyses
Mediation analyses for SWCRT have not been well-developed.63 The strategy 
that we aim to employ is the method by Baron and Kenny.64 In general, our 
strategy to assess mediation will be to fit 3 regression models: (a) regress the 
BP control outcome on the HBPM intervention in a SWCRT, (b) regress the 
mediator on the HBPM intervention, and (c) regress the BP control outcome on 
the HBPM intervention in a SWCRT while also adjusting for the mediator. For 
the sake of the mediation analysis plan, we assume that HBPM intervention 
significantly affects both the outcome (via (a)) and potential mediator (via 
(b)). The Baron-Kenny method is to infer complete mediation if the statistical 
significance of the HBPM intervention disappears in the adjusted model (c) 
after having adjusted for the potential mediator; one infers partial mediation if 
the statistical significance if the statistical significance is weakened but does 
not completely disappear.  If there is a statistically significant effect of the 
intervention on the mediators, we will next assess whether changes of these 

Protocol Version Date: 06/15/2022
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mediators (e.g. BP targets, intensification), are associated with changes in 
improved BP.  If necessary, we will explore structural equations models.63 
Exploratory analyses
We will adopt the SWCRT model and mixed model analysis above for the 
exploratory outcomes in Exp 1, Exp 2, and Exp 3
The key variables will be extracted from the eRecord (Table 4 below) at 
baseline and at the end of the study to assess changes.
Table 4. Limited Data Set
Variable
Source for data
Patient eMRN (converted to a unique 
ID)
Demographic File
Primary Care Practitioner (PCP) Name
(converted to a unique ID)
Care team
Continuity Care Practitioner (CCP) 
Name (converted to a unique ID)
Care team
HFM Suite Number
Care team
Age  DOB will be adjusted to de-
identify
Demographic File
Sex (birth)
Demographic File
 Male 
 Female 
 Other
 Missing 
Sex (legal)
Demographic File
 Male
 Female
 Other
 Missing
Race  %(N)
Demographic File
 Asian/Pacific Islander
 Black
 Indigenous/American Indian
 White
 Other
 Missing
Hispanic ethnicity
Demographic File

Protocol Version Date: 06/15/2022
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 Yes
 No
 Missing
Marital Status/partner%(N)
Demographic File
 Divorced
 Legally Separated
 Life partner
 Married 
 Significant other
 Single
 Widowed
 Unknown/missing
Employed
Demographic file
 Yes
 No
 Missing
Level of Education/Degree Completed
Demographic file
 Years
 Missing
Social Determinants of Health
Social Determinants file
 Financial Resource Strain
 Transportation Needs
 Stress
 Intimate Partner Violence
 Housing Instability
 Food Insecurity
  Physical activity
  Social Connections
Illiteracy
  Missing 
Language preferred 
Demographic file
 Language e.g English, Spanish, ASL
 Missing
Interpreter Needed 
Demographic file
 Yes/No
 Missing 
Insurance
Demographic file
Commercial/other

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Medicare
Medicaid
Other
No insurance/self-pay
Missing
Residence Zip Code
Demographic file
Smoker
Substance and Sexual Activity
 Current 
 Never
 Former
 If former, how many years ago
 Missing
% Current smokers counseled to quit  
<12 months CPT codes 99406,99407
CPT codes from any office visit beginning 4/1/2021
Alcohol use
 Never
 Former
 Current
 Drinks/week
 Missing
BMI  including Ht and Wght, dates
Vital (most recent).
Comorbidities %(N)
Problem list most recent and billing ICD-10 codes 
including Z codes
PHQ-9
  Values
Values/dates from 4/1/2021
   Missing
10-year ASCVD risk Score
Smart phrases that include ASCVD 
 Missing 
Hypertensive Medications
Medication list beginning 4/1/2021
  Name frequency and dose
New antihypertensive stated since 4/12021
  None 
  New/Change in antihypertensive from 
4/1/2021
Taking statin 
Current medication list 
  Name dose
  None
Taking other lipid lower medication
Current medication list
  Name dose
  None

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Labs
Most recent lab values and dates
 Lipid panel 
 Total  cholesterol
 HDL  cholesterol 
 LDL  cholesterol
 Triglyceride
 Missing
A1c (%) %(N)
Most recent lab including POCT values and date
 Missing
Most recent value and date
eGFR Black and Caucasian
Most recent value and date
Potassium, serum
Most recent values including missing and date
Urine Microalbumin
Most recent value and date
Office Blood pressures 
Vitals All readings with dates/location beginning 
4/1/2021
Blood pressures from 
eRecord/MyChart
Values/dates/ begin 4/1/2021 exclude dialysis
EKG
CV procedures date (no restriction on lookback)
24-hour ambulatory blood pressure 
monitor
CV procedures date (no restriction on lookback)
Enrolled in MyChart
URMC MyChart Administration
 Yes
 No
 Missing
Used MyChart (ever or # of times in 12 
months?)
URMC MyChart Administration
 Yes
 No
 Missing
Mean# Office visits 12 months by Last 
BP
All office visits date/BP beginning 4/1/2021
Recent HFM office or telehealth visits
Visit dates, blood pressure reading from 4/1/2021
Referral to Healthy Lifestyle (CCH)
Date of referral 
Referral to YMCA Hypertension 
program
Date of referral
Cardiology encounters
Visit dates, blood pressure reading from 4/1/2021
# No shows HFM encounters
# No show
# No show any encounter
# No show
ED visits in prior 12 mths HTN ICID-10 
codes
Dates, I10.x begin 4/1/2021

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9. Data Storage and Confidentiality:
The study protocol will be monitored by the PI for safety via weekly contact 
with the research staff, with resolution of any safety issues that arise. The 
protocol will be monitored by means of REDCap tracking the status of 
activities of all key phases of the study such as recruitment, enrollment, and 
interviews. The files will be kept for a total of 7 years (from the completion of 
the study), at which point they will be destroyed according to institutional and 
HIPAA regulations. SC and KI contact information (name and phone number 
or email address) will be destroyed once the interviews are complete and the 
subject no longer needs to be contacted by the study team. Only the key 
investigators, project coordinator and research assistants will have access to 
individually identifiable Key Informant data. The data will be entered into a 
password protected spreadsheet stored on the study team’s fire-wall protected 
REDCap database. 
All research material will be maintained in locked files at the University of 
Rochester. As noted above, the files will be kept for a total of 7 years (from 
the completion of the study), at which point they will be destroyed according 
to institutional and HIPAA regulations.
All audio recordings will be stored in a secure protected electronic database. 
The audio recorded interviews will be kept until they have been transcribed. 
Once transcription is complete the recordings will be destroyed according to 
institutional and HIPAA regulations. 
10. Data and Safety Monitoring Board (DSMB) and Charter and Safety 
Monitoring Plan
Background 
TB-HPBM (Team-Based Home Blood Pressure monitoring) is a Stepped Wedge 
Cluster Randomized Trial Design (SWCRT) to assess implementation of the 
Chronic Care Model for Hypertension with HPBM. TB-HPBM will support 
patients with diagnosed with hypertension (HTN) with HBPM and other self-
management support. Core implementation strategies involve contracting with 
remote monitoring vendor (RPM), billing codes, creation of HTN registry, 
monthly feedback reports, EPIC smartphrases, patient outreach and training 
in HTN management, measurement and team care for HTN. The leadership of 
the Department of Family Medicine at the University of Rochester is adopting 
Hospitalized in prior 12 mths/ HTN ICD-
10 codes
Dates I10.x  begin 4/1/2021 

Protocol Version Date: 06/15/2022
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this model with support from the research team. The research team will 
rigorously evaluate implementation using the RE-AIM framework using an 
SWCRT design.
This Charter describes the roles and responsibilities of the Data Safety 
Monitoring Board (DSMB), including the timing of meetings, methods of 
communicating information to the DSMB, frequency and format of meetings, 
and statistical issues and reporting relationships. 
Roles and Responsibilities 
The intervention, including home blood pressure monitoring, the Chronic Care 
Model for TB-HPBM and the implementation strategies are widely used in 
different ways in clinical care.  Thus, we anticipate that the risk posed to 
participants (patients, staff and clinicians) are minimal, i.e. no greater than 
the risk associated with the management of HTN in routine practice. The aims 
of the DSMB are to assure that appropriate procedures are in place to monitor 
the safety of the study, ensure the protection and privacy of participants and 
monitor the overall conduct of the trial. The DSMB will act in an advisory 
capacity to the TB-HBPM Steering Committee, and if needed will provide 
reports to the funded institution the University of Rochester. Dr. Kevin 
Fiscella, MD, MPH, the TB-HPBM PI chairs the trial’s Steering Committee. The 
full voting membership of the Steering Committee is listed below. 
TB-HBPM STEERING COMMITTEE
Co-Chairs 
Kevin Fiscella, M.D, MPH PI  (Kevin_Fiscella@urmc.rochester.edu)
Matt Devine, M.D., Chief Medical Office and Site PI Co-Chair 
(Matt_Devine@urmc.rochester.edu)
 
Members
University of Rochester
Brent A. Johnson, Ph.D. (Co-I)
Tziporah Rosenberg, Ph.D (Co-I)
Mechelle Sanders, PhD (Co-I)
Soumya Sridhar, M.D., M.P.H. (Co-I)
Emma Strujo, M.P.H (Project Director)
Marie Thomas
Highland Hospital 
Marsay Houston
Katie Lashway, R.N.

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Stacey Makubire, BSN, NE-BC
Amy Thein, Pharm.D., BCGP
University of Michigan
John D. Bisognano, M.D., Ph.D (co-I)
University of Iowa
Linnea A. Polgreen. M.A., Ph.D.
Oxford University
Geoff Wong, MA MBBS MD(Res) MRCGP FHEA
The initial function of the DSMB will be to review and approve the protocol 
prior to starting this implementation trial. This will include reviewing 
procedures for patient enrollment, data management, and safety and 
adaptations.
After this approval, the DSMB will meet at periodic intervals during the course 
of the trial to: 

Review any changes in the research protocol; 

Evaluate the progress of the trial, including assessments of data quality 
and completeness; participant accrual; participant risk versus benefit; 
performance of the trial; and other factors that can affect study outcomes;

Consider factors external to the study when relevant information becomes 
available, such as scientific or therapeutic developments and contextual 
factors that may have an impact on the safety of the participants or the 
ethics of the trial; 

Review and assess any treatment harm (e.g. severe adverse events) 
reported for trial participants and potential impact on the participants and 
the trial; monitor compliance with previous DSMB recommendations; and

make recommendations to the Steering Committee and URMC (and 
indirectly to NIH NHLBI) concerning continuation without modification, 
continuation with modification, or termination of the trial based on data 
quality, study progress, or the observed adverse effects of the treatment 
under study. (Modifications may include but are not limited to changes in 
inclusion/exclusion criteria and alterations in study procedures)
The DSMB will consist of three members. Two members will constitute a 
quorum.  DSMB members must be completely independent of the trial and 
have no financial, scientific, or other conflict of interest with the trial.  
11. DSMB COMMITTEE

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Members
Gbenga Ogedegbe, M.D. M.P.H., New York University (Chair)
Valy Fontil, M.D., MAS  University of California, San Francisco
Daniel Tancredi, Ph.D., University of California, Davis
Collectively the DSMB members provide expertise in: clinical trials 
methodology, biostatistics/epidemiology, primary care, hypertension, and 
blood pressure and vitals monitoring. The NIH NHLBI Program Officer, Dr. 
Keith A. Mintzer, will be invited to participate in DSMB as a non-voting 
member.   
Dr. Gbenga Ogedegbe will serve as DSMB Chair.  In this capacity, he will 
develop meeting agendas in consultation with the PI/Study Chair, oversee the 
conduct of DSMB meetings, and review and approve the draft minutes from 
each meeting.  
Staff from URMC will provide administrative and logistical support for the 
DSMB, including taking minutes of all DSMB meetings and reimbursing DSMB 
members for expenses and honoraria.   They will strive to ensure that suitable 
meeting dates are selected to enable all DSMB members to attend.  Members 
will participate by teleconference.  If the DSMB is considering recommending 
major action after a meeting without a quorum, the DSMB Chair should talk 
with absent members as soon possible after the meeting to check if they 
agree, and if they do not, a conference call will be arranged for the full DSMB.  
DSMB members will receive an honorarium of $500 for each meeting 
attended.  In addition to the initial meeting during project year 1, the DSMB is 
expected to meet 4-5 additional times during the course of the study.  
Organization of DSMB Meetings
Meetings are attended by the study PI, Dr. Kevin Fiscella, study program 
manager (Emma Strujo), and other steering committee/TB-HPBM 
investigators and staff members as appropriate. 
The format for DSMB meetings consists of: 
a) an open Session, 
b) a closed Executive Session,
c) a debriefing Session.
The closed Executive Sessions are attended only by the voting members of the 
DSMB and, if requested by the DSMB, the PI/Study Chair.  The purpose of 
these sessions is to discuss the report presented to the DSMB, highlight any 
issues requiring attention or resolution, and formulate recommendation(s) 

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related to the trial progress and continuation.  The first optional Executive 
Session is typically used for early input about key issues of concern. Every 
effort should be made for the DSMB to reach a unanimous decision.  If the 
DSMB cannot decide unanimously, a vote may be taken, although details of 
the vote should not be included in the report to avoid conveying information 
about the state of the trial.  Implications (ethical, practical, financial, 
statistical, etc.) should be considered before recommendations are made.  
Should the DSMB decide to issue a termination recommendation, a full vote of 
the DSMB will be required and a majority vote will rule.  A minority report may 
be prepared at the discretion of the DSMB members not supporting a 
termination recommendation. 
The Open Session may be attended by the PI/Study Chair and other study 
staff.  Issues discussed at Open Sessions will include the conduct and progress 
of the study, including patient accrual, compliance with the protocol, problems 
encountered, intervention process data, and safety monitoring data.   
As with the initial Open Session, the Debriefing Session may be attended by 
the PI/Study Chair and other study staff as appropriate.
DSMB Communications
Meeting materials: Trial monitoring reports are generally distributed to the 
DSMB 1 week prior to a scheduled meeting.  The contents of the report are 
determined by PI/Study Chair in consultation with the DSMB Chair. Additions 
and other modifications to these reports may be requested by the DSMB at 
any time.   
Minutes: The PI/Study Chair will provide draft minutes from DSMB Open 
Sessions and Debriefing Sessions to the DSMB Chair within 1 week of the 
DSMB meetings.  The DSMB Chair will review these minutes with the other 
DSMB members and send finalized minutes to the Study Chair within 4 weeks 
of receipt of the draft minutes.  The Study Chair will then circulate these 
minutes to the full Steering Committee and to the Project Officer at NHLBI.
Study staff will file an IRB DSMB report within 10 days of meeting. 
Confidentiality: All materials, discussions, and proceedings of the DSMB are 
completely confidential and should not be discussed outside of the DSMB 
meetings. DSMB members also should properly dispose of all trial monitoring 
reports after each meeting. 
12. Safety Monitoring and Stopping Rules
The TB-HPBM is considered a minimal risk study.  It is designed to compare 
commonly used and recommended methods (or those practiced by care as 
usual) of BP measurement and hypertension treatment, augmenting 
implementation in several key ways.  The primary risk is breach of 

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confidentiality. Less serious issues involve potential anxiety about high BP 
from frequent monitoring.  Thus, the study protocol does not include any 
provision for formal interim monitoring (and stopping rule) for efficacy. 
However, the DSMB may recommend early termination for safety or lack of 
ability to meet study goals (due to inadequate recruitment or participant 
inability to complete study protocols).  To that end, the Steering Committee 
has adopted a formal Data and Safety Monitoring Plan (DSMP) which will be 
submitted to the URMC IRB and NIH NHLBI.  The study investigators will also 
track and report on participant and provider complaints related to the study, 
breaches of confidentiality, and any protocol violations that occur during the 
course of the study.
Post-Trial Reporting
Following completion of the trial, the DSMB will have the opportunity to review 
trial findings and to read and comment on the main outcomes paper before 
submission.  
Changes to the Charter
Following initial approval of this Charter, changes to it may be approved by a 
simple majority vote of DSMB members.  A historical record of changes to the 
Charter will be maintained by staff. 
DATA AND SAFETY MONITORING PLAN
A. Confidentiality 
1. Protection of Subject Privacy: During this study, blood pressure data will 
be recorded. Data will be kept in strict confidence. No information will be 
given to anyone without permission from the subject, and confidentiality 
will be protected by use of randomly generated identification code 
unique to the subject. Health Information Portability and Accountability 
Act (HIPAA) guidelines will be followed. 
2. Database Protection: Data will be secured with password protection. 
3. Confidentiality during AE Reporting: Adverse event (AE) reports and 
annual summaries will not include subject-identifiable material. Each will 
include the identification code only.
B. Adverse Event Information 
1. Definition: An adverse event (AE) is any untoward medical occurrence in 
a subject temporally associated with participation in the clinical study. 
An adverse finding can include a sign, symptom, abnormal assessment 
(laboratory test value, vital signs, etc.) or any combination of these.  For 
this study, we will be routinely monitoring all home blood pressure 
readings collected during the trial, with clear safety follow-up for 
patients recording very low or very high BP values. Clinicians will be 

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trained to establish alerts based on BP thresholds as part of sound 
clinical practice. Clinical team members will contact patients about these 
readings, assess patient symptoms and the situation and take 
appropriate action.  We also may uncover other patient-reported 
adverse events through regular communication with participants (e.g., 
symptoms reported to pharmacist, clinician, or staff during the study, or 
self-reported AE on the follow-up study survey) and will track and 
review them using a standardized documentation tool via RedCAP.  
2. Classification of AE Severity: AEs will be labeled by the study team 
according to severity which is based on their impact on the patient, per 
this Event Grading Scale:
Grade 1 Mild                                                                                                               
Transient of mild discomfort; no limitation in activity; no medical 
intervention/therapy required
Grade 2 Moderate                                                                                                      
Mild to moderate limitation in activity – some assistance may be needed; no 
medical intervention/therapy required. 
Grade 3 Severe                                                                                                          
Marked limitation in activity, some assistance usually required; medical 
intervention/therapy required, hospitalizations possible. 
Grade 4 
Life Threatening                                                                                                        
Extreme limitation in activity, significant assistance required significant 
medical intervention/therapy required, hospitalization or hospice care 
probable. 
3. AE Attribution Scale: AEs will be categorized according to the likelihood 
that they are related to the study intervention. Specifically, they will be 
labeled either definitely, probably, possibly or unrelated to the study 
intervention.
4. Expected Risks: Expected risks to the subject are mild given that the 
trial will be conducted as integrated into routine primary care practice.  
Risks are considered to be minimal and are addressed in the protocol 
and consent form. Participants will have a contact number to report any 
potential adverse events that occur in between scheduled study visits. 
They will also have an opportunity to privately discuss any physical 
complaints due to remote blood pressure monitoring when they visit 
their provider.
5. SAE Reporting: SAEs that are unanticipated, serious (grades 3 and 4), 
and/or possibly related to the study intervention will be reported to the 
IRB and NIH in accordance with requirements. Anticipated SAEs or those 
unrelated to the study intervention will be reported in accordance with 

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requirements. We plan to proactively identify SAEs specific to 
hospitalizations by setting an alert within our Epic EHR to capture in 
real-time hospital encounters for study participants, which will be 
categorized and followed up directly.  
C. Data Quality and Safety Review Plan and Monitoring 
1. Data Quality and Management 
a. Description of Plan for Data Quality and Management – The PI will 
review all data collection forms on an ongoing basis for data 
completeness and accuracy as well as protocol compliance. A 
statement reflecting the results of the review will be sent to the 
NIH in the annual report. The EHR is the primary data source. EHR 
data quality will be assessed using extreme outlier data, missing 
data for outcome variables (i.e. office or transmitted blood 
pressure readings, dates of visits, participant ID), and loss to 
follow-up (no data for the participant appears in EHR, e.g. due to 
relocation, left practice etc). Note:  clinical staff will conduct 
outreach to all participants as part of sound clinical practice.  
Regular data checks and data cleaning will be deployed to optimize 
data quality. Multiple imputation methods will be used as 
necessary to address missing data as described in the statistical 
analysis.
Measure                                 Goal                    
Acceptable Value
Outlier for EHR key data
3%
5% of participants
Missing data for outcome variables   
5%
10% of participants
Participant loss-to-follow-up
10%
20% of participants
b. Frequency and Review
For each measure listed above, we will summarize annually from study 
tracking database (in REDCap).  
2. Subject Accrual and Compliance
a. Measurement and reporting of subject accrual, adherence to 
inclusion/exclusion criteria – Review of the rate of subject accrual 
and adherence to inclusion/exclusion criteria will occur annually 
during the entire recruitment phase. Note:  practice and patient 
participant accrual is passive through EHR and it is expected that 
75% of the total accrual will occur during the first three months of 
the trial. 
b. Measurement and reporting of participant compliance to treatment 
protocol 

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Data on compliance to the treatment protocol will be collected via the home 
BP monitoring devices. Compliance on the part of participants will be 
evaluated for participants’ home BP readings on a weekly basis. Participants 
who are not recording home BP readings will be automatically reminded via 
text messaging, with follow-up phone call if they continue to have gaps in 
their home BP readings.  On a quarterly basis, the Steering Committee will 
review these data and determine if there are any concerns about whether 
compliance has reached a level that might inhibit the ability of the study to 
test its primary hypotheses. If there are concerns, these will then also be 
raised to the DSMB.   
3. Stopping Rules – This study will be stopped prior to its completion if: (1) 
study recruitment or retention is too low for the study to provide 
meaningful results; (2) any new information becomes available during 
the trial that necessitates stopping the trial; and (3) other situations 
occur that might warrant stopping the trial. Given that the trial 
intervention is relatively safe, we will not monitor efficacy and will not 
stop the trial prior to planned completion for unexpected efficacy.  
Furthermore, even if the intervention is efficacious at 6 months, it will 
still be important to continue data collection to determine the extent to 
which its benefits are maintained at 1 year as planned and whether 
benefits accrue to disparity groups, e.g. African American patients, 
those without insurance, and older patients.  The trial will be stopped 
early if the DSMB finds that the harm to study participants outweighs 
the benefit of the scientific evidence to be accrued by continuing the 
trial. Finally, the trial will be stopped early if the DSMB finds that new 
information from sources outside the trial provides definitive information 
that the intervention is effective or harmful. 
D. Safety Review Plan
Study progress and safety will be reviewed monthly by the PI. Progress 
reports, including patient recruitment, retention/attrition, and adverse events 
will be provided to the DSMB annually for independent review. An annual 
report will be compiled and will include a list and summarization of adverse 
events. In addition, the annual report will address (1) reason for dropouts 
from the study; (2) whether continuation of the study is justified on the basis 
that additional data are needed to accomplish the stated aims of the study. 
The annual report will be forwarded to the appropriate IRB and NIH contacts 
on an annual basis.

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