The PCORnet Blood Pressure Home Monitoring Study
Phase: NA
Conditions: Hypertension
Sponsor: University of California, San Francisco

 
Study Protocol and Statistical Analysis Plan 
 
 
Official Title 
The PCORnet Blood Pressure Home Monitoring Study (BP Home) 
NCT number 
NCT03796689 
IRB approval date 
4/28/2021 
Document Version 
Protocol v2.2 
 

 
 
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The PCORnet Blood Pressure Home Monitoring (BP HOME) Study 
Protocol 
 
Project Summary 
The PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized 
controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM) 
with versus without a linked Smartphone application (“app”) for helping patients with 
uncontrolled hypertension achieve a reduction in systolic blood pressure.  The trial will be 
conducted within the National Patient-Centered Clinical Research Network (PCORnet), which 
supports a research network that enables distributed querying of EHR data in a common data 
model.  It will also use the Eureka Research Platform, an online research platform hosted by 
UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs.  
Data from these two data sources will be used together to accomplish the study aims.  Given 
that HBPM is the guideline-recommended standard of care (without specification of 
Smartphone linkage), the HPBM devices and the app are all commercially available and 
currently in use, and that clinicians, with input from patients, will maintain full control of how 
BP is clinically managed, we believe participation in the project poses minimal risk to 
participants. 
 
Background and Significance 
Uncontrolled BP is the leading preventable cause of death in the US after smoking, causing 
nearly 400,000 deaths per year1.  While effective medications are available to control BP, 
multiple rounds of medication adjustment and intensification are typically required, and BP 
control is often not achieved2,3.  The usual configuration of healthcare delivery – periodic and 
relatively infrequent office visits with a physician – is not ideal for achieving BP control quickly 
and efficiently4,5.  One promising approach to enhancing clinic-based BP management is to 
support home BP monitoring by patients6.  Home BP monitoring technology has advanced 
substantially in recent years particularly in terms of linkage with Smartphones via Bluetooth, 
which enables use of associated Smartphone applications.  Smartphone applications enable a 
wide variety of functions potentially useful for BP goal attainment, including reminders to 
measure BP, recording and displaying measurements, interpretation of measurements (e.g., 
goal attained, BP dangerously high, etc), and facilitating communication of measurements with 
treating clinicians.  It is unclear, however, if this technological advancement helps patients 
achieve BP control.  The PCORnet Home Blood Pressure Monitoring (BP HOME) Study is an 
individual-level randomized controlled trial that will compare the effectiveness of Smartphone-
linked versus standard HBPM cuffs for helping patients with uncontrolled hypertension achieve 
a reduction in systolic blood pressure. 
 
Aims 
1) To compare the effectiveness of Smartphone-linked versus standard home BP monitors for 
helping patients with uncontrolled hypertension achieve a reduction in SBP.   
2) To assess patient-reported outcomes including satisfaction with the HBPM device and 
various aspects of BP management 
3) To assess the outcomes within subgroups based on age, sex and race/ethnicity. 
 

 
 
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Hypotheses 
Patients with uncontrolled hypertension who receive a Smartphone-linked HBPM will have a 
larger average reduction in SBP at 6 months compared to those who receive standard HBPM, 
and will be more likely to promote use of the device to a friend. 
 
 
Study Design 
We have designed a patient-level randomized controlled trial that will compare the 
effectiveness of Smartphone-linked versus standard HBPM for helping patients with 
uncontrolled hypertension achieve a reduction in their SBP, and patient satisfaction with the 
device.  We aim to enroll 2000 patients who will be randomized in a 1:1 ratio to receive a 
Smartphone-linked or standard HBPM.  We will use data from the electronic health record 
(EHR), an online patient portal, and the home BP monitor (in the Smartphone-linked arm) to 
collect outcome data for a period of at least 6 months (for the primary outcome), and up to 18 
months (for secondary outcomes, depending on enrollment date).  The primary BP control 
outcome will be reduction in SBP, by clinic measurements, at 6 months.  The primary patient 
satisfaction outcome will be the Net Promotor Score7,8, derived from self-reported likelihood of 
recommending the device to a friend, at 6 months. 
 
 
Study Subjects 
Target population 
Adults receiving medical care who have uncontrolled BP 
 
Accessible population  
Adults receiving medical care at a participating PCORnet institution who meet inclusion criteria, 
are willing to enroll in the study, and complete baseline surveys. 
 
Inclusion Criteria 
● Age ≥ 18 years 
● At least one ambulatory visit in one of the participating study sites during the past year  
● SBP > 145 mmHg at most recent clinic visit (may be treated with BP meds already or 
not), as reported by the participant  
● A self-reported commitment to “work on lowering your blood pressure by 10 points or 
more to reduce your risk of heart attack and stroke” 
● Owns a Smartphone (Android or iOS) and has an email address 
● Willing to receive text messages from the study  
● Can read/write English well enough to use English-based Smartphone apps and fill out 
online surveys in English 
 
Exclusion Criteria 
• Has an arm circumference <22 cm or >42 cm  
• Owns a functioning HPBM and has used it in the last 3 months 
 
Recruitment Plan 

 
 
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Participating sites will recruit patients via 2 basic methods. 
1)   
“High-Touch Methods”: Clinical or research staff at participating clinics will interact with 
patients directly to assess eligibility and interest in participation.  IRB-approved study 
materials will be available to support the patient interaction.  The materials will invite 
participants to register on the online portal, and they will be invited to enter their own special 
recruitment invitation code (“Golden Ticket Number”) to enable subsequent linkage between 
their EHR data and their data collected by the online portal.  Although those materials will be 
designed to be self-explanatory for patients, clinical or research staff can assist patients as they 
sign up on the portal.  Clinic staff will keep a list of interested and apparently-eligible patients to 
whom a Golden Ticket was provided, with their associated Golden Ticket Number, to enable 
EHR data linkage for patients that eventually enroll and consent to participate in the study.  
This option requires active participation by the patient’s treating clinical staff (though we hope 
it will be low-burden).  We are also planning follow-up calls to patients who were provided a 
Golden Ticket Number but who did not end up enrolling in the study, to remind them about 
signing up and provide any technical support they might require.  Our Phone Script is included 
in Attachment A.  
2)   
“Low-Touch Methods”: Patients appearing to meet criteria for enrollment according to 
their EHR data will be mailed, emailed, or otherwise contacted personally with an invitation to 
participate.  The invitations will include the Golden Ticket Number to enable linkage, as above.  
Participating sites will have their own approved methods and procedures to facilitate this 
recruitment approach (Attachment A), otherwise they will use only the in-clinic recruitment 
method.  This option does not necessarily require contacting of the patient’s treating physician; 
these issues will be governed by local policies and rules and addressed at each participating 
site.  These patients may also be called for follow-up (see Phone Script). 
 
Attachment A describes site-specific recruitment procedures and materials. 
 
Determination of Eligibility 
Eligibility will be checked: 
1) Preliminarily, by clinical or research staff and patients, using Recruitment Option 1 
above; 
2) Preliminarily, by EHR data review, using Recruitment Option 2 above; 
3) Finally, with confirmation from patients, when they enroll through the online portal 
 
Consent Process 
We will use the Eureka Research Platform to deliver an electronic consent process that consists 
of a landing page, a simple “pledge” page that outlines responsibilities of the study (e.g., keep 
your data safe) and the patient (e.g., completing follow up surveys), a more traditional informed 
consent form (with a link to the Eureka Privacy Policy and Data Security Measures), and an 
invitation to participate in the study.  All participants will also provide an electronic signature 
(collected via Docusign using our Eureka Research Platform) on a HIPAA Authorization form 
that will allow us to obtain their EHR data and link it with the other data collected via the 
platform.  Participants in the Smartphone-linked arm of the study will also be taken through a 
“device consent” in which they will be instructed to download the Smartphone app associated 
with the device, and link their device account to their study account. 
 

 
 
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Attachment B describes the online portal, eligibility check and enrollment procedures that all 
participants responding to recruitment efforts will use to register and consent to participate in 
the study. 
 
 
Study Interventions 
Overview: Participants enrolled in the study will be randomized in a 1:1 ratio to two study arms 
distinguished by the type of HBPM device they receive.  All participants will receive guideline-
based instructions on HBPM.   
 
Intervention arms: Participants will be randomized in a 1:1 ratio to: 
- 
Arm 1: Smartphone-linked HBPM with associated Smartphone app 
- 
Arm 2: Standard HBPM 
 
Attachment C describes the specific devices used in each arm of the study, and the Smartphone 
app used in Arm 1.   
 
Randomization plan: Randomization tables with stratification (by clinical site) and blocking 
(with randomly varying block sizes) will be generated and stored in the Eureka Research 
Platform.  Participants meeting eligibility criteria, consenting, and completing baseline data 
collection will be automatically assigned the first previously non-assigned randomization code, 
and will be notified immediately of their assignment (i.e., no blinding). 
  
Delivery of study devices and instructions: After randomization, UCSF-based study staff will 
confirm contact information and ship the assigned device to participants free of cost, and follow 
up via electronic survey, text message and/or phone calls to make sure the device is received.  
Upon receipt of their device, participants in Arm 1 (Smartphone-linked) will be asked to 
connect their device account to their study account, which will enable the study to receive BP 
measurement data from their device.  Participants in both arms of the study will be provided 
guidelines for HBPM (using publicly-available materials developed by the American Medical 
Association and American Heart Association for their Target: BP Program), and told to continue 
interacting with their treating physician as usual for BP medication management, etc. 
 
 
Measurements 
Overview: Measurements will be obtained via online survey through our online portal, from the 
participant’s EHR accessed via PCORnet, and from the Smartphone-linked HBPM device for 
participants randomized to Arm 1.  Online survey data will be elicited at pre-specified time 
points; participants will receive a variety of reminders to complete surveys, possibly including 
but not limited to email, text, and personal phone calls.  EHR data will be extracted for enrolled 
participants using PCORnet queries, and analyzed to evaluate baseline medical conditions and 
outcomes.  All available BP measurements, encounter data and other EHR data from those 
queries, along with all BP and heart rate measurements extracted from Smartphone-linked 
HBPM for participants in Arm 2, will be used in analyses as per outcome definitions described 
below. 
 

 
 
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The following table describes the measurements we plan to obtain on enrolled participants: 
 
 
 
 
 
 
Baseline 
1m 
3m 
6m 
12m 
18m 
Online survey data 
Baseline BP and eligibility  
X 
Basic demographics  
 
X 
Subjective Social Status Scales9 
X 
HBPM use 
 
 
 
 
 
X 
X 
X 
X 
X 
HBPM satisfaction 
 
 
 
 
X 
 
X 
Net Promoter Score7,8 
 
 
 
 
 
X 
Satisfaction with BP management X 
 
 
 
X 
X 
X 
Quality of shared decision-making10   
 
 
 
X 
X 
X 
Patient Activation11  
 
 
 
 
 
X 
  
Attachment D provides the text of the online surveys we will administer. 
 
EHR data (all available data through end of follow-up will be extracted in the following domains) 
Basic demographics  
 
 
Diagnoses 
 
 
 
 
 
 
 
 
 
 
Encounter characteristics 
 
 
 
 
 
 
 
 
Provider characteristics 
 
 
 
 
 
 
 
 
Blood pressure 
 
 
 
 
 
 
 
Medications  
 
 
 
 
 
 
  
Lab results 
 
 
 
 
 
 
 
  
Death indicator 
 
 
 
 
 
 
  
 
The EHR data analysis section, below, provides additional detail. 
 
HBPM device data (all available measurements made during follow up, for Arm 1 only)  
Blood pressure 
Heart rate  
 
Primary BP control outcome: The following pre-specified outcome will be used for the primary 
test of comparative effectiveness: 
1) Reduction in SBP at 6 months.  Reduction is defined by the absolute difference between 
the eligibility SBP (collected from the patient at the time of eligibility assessment), and 
the SBP measured at the most recent outpatient clinical encounter 6 months after 
enrollment.  If more than 1 measurement is recorded during a single clinical encounter, 
the lower/lowest will be used. 
 
Primary patient satisfaction outcome: The following pre-specified outcome will be used for the 
primary test of patient satisfaction: 
2) Net Promotor Score.  This score is assessed by asking a single question about likelihood 
of recommending the device to a friend, with options from 1-10 (10 being extremely 
likely).  As per published methods7,8, persons indicating 9 or 10 are considered 
“Promotors”; persons indicating 7 or 8 are “Passives”; and persons indicating 1-6 are 

 
 
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“Detractors”.  The score is calculated by taking the percent of Promotors and subtracting 
the percent of Detractors, yielding a score for each group ranging from -100 to 100.  Note 
that an identical score could theoretically be produced for a group with either a 
relatively high proportion of Promotors and Detractors, or a relatively low proportion of 
both. 
 
Exploratory outcomes: The following pre-specified secondary outcomes will also be measured 
and analyzed.  These include alternative measures of BP control, other patient-reported 
outcomes, and process measures intermediate along the causal pathway to BP control. 
3) Documented attainment of a 10 mmHg reduction in SBP from baseline to 6 months, as 
defined above.   
4) Documented attainment of a 10 mmHg reduction in SBP at 6 months, as in Outcome 1, 
but assessed using home BP measurements, when available.  As per guidelines, a set of 
12 or more home measurements (counting no more than 2 in the morning and 2 in the 
evening of each day) within any given 1 week time period will count as a completed 
Home Measurement Protocol12.  The average SBP and DBP measurements within the 
most recent completed Home Measurement Protocol within 180 days of the index date 
(e.g., 6 months after enrollment) will then be used as the attained BP, regardless of 
subsequent clinic measurements or subsequent random home measurements.  If no 
completed Home Measurement Protocol is available within 180 days of the index date, 
the most recent clinic measurement will be used.  Note that a documented Home 
Measurement Protocol can only be attained in Arm 1, as home measurements will not be 
accessible in Arm 2.   
5) Other BP Control outcomes defined as ((SBP<140 mmHg and DBP<90 mmHg) OR 
(SBP<130 and DBP<80) OR 10 mmHg reduction), assessed using the baseline 
measurement (self-reported OR last clinical measurement prior to randomization from 
the electronic health record) and subsequent measurements (clinical measurements OR 
clinical + home measurements) at a specified time-point (6 OR 12 OR 18 months) or 
using a time-to-control approach. 
6) Patient reported outcomes including various aspects of satisfaction with the HBPM 
device and BP management, including quality of shared decision-making and patient 
activation. 
7) Visit frequency.  We will analyze the number of ambulatory care visits during the 6 
month follow up period; we will also analyze the number of visits made before 
attainment of the first in-control BP. 
8) Medication intensification.  We will analyze the proportion of clinical visits with high BP 
(SBP>140 mmHg or DBP>90 mmHg) after which a BP medication was added. 
 
Pre-specified subgroups: The following subgroups are pre-specified: 
- 
Baseline Age: 20-44 vs 45-64 vs. 65+ years 
- 
Sex: Male vs. Female vs. Other vs. Missing 
- 
Race/Ethnicity: Non-Hispanic White vs. Non-Hispanic Black vs. Non-Hispanic Asian vs. 
Hispanic (any race) vs. Other/Multiple vs. Missing  
- 
Subjective Social Status, measured through online survey at baseline, using MacArthur 
Scale for SES (not the “Community” version)9: Upper vs. Middle vs. Lower tertile, defined 
within our recruited sample of participants 

 
 
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Analysis Plan 
Overview: Our primary analyses will test two independent hypotheses: that SBP reduction 
(outcome 1, defined above) differs by study arm, and that promotion of the HBPM device 
(outcome 2) differs by study arm.  Subgroup analyses and exploratory outcomes will also be 
analyzed, as described below. 
 
Primary BP control analysis: For analysis of this outcome, which is continuous (defined above), 
we will use a random effects linear model, including a random effect for clinic and a fixed effect 
for a 3-level variable that indicates whether the clinic is participating in a concurrently-running 
cluster-randomized quality improvement trial (Not participating vs. Full Support MAP 
intervention13,14 vs. Self-Guided MAP intervention13,14). 
 
Primary patient satisfaction analysis: The Net Promoter Score (NPS) is calculated from the 
proportions of Promoters and Detractors, as described above.  To assess the influence of 
treatment assignment and other exposures on the NPS, we will first define the 3-level outcome 
classifying each participant as a Promoter, a Passive, or a Detractor, then fit a random effects 
multinomial logistic model for the independent effect of the exposure on this outcome.  The 
model will include the same random and fixed effects specified for the primary BP control 
analysis.  Expected proportions in each outcome group by treatment assignment will then be 
obtained using standardization.  Finally, the NPS scores for each group, as well as the between-
group difference in the score, with 95% confidence intervals for each, will be calculated as 
linear combinations of the adjusted proportions, and a p-value calculated assuming a null 
hypothesis of no between-group difference in the NPS. 
 
Subgroup analyses: We will produce subgroup-specific analyses of the primary outcomes for 
each of the pre-specified subgroups, and test for heterogeneity by including the appropriate 
interaction terms in the models described above, with an omnibus test for each of the 4 
grouping variables.  Subgroups that include fewer than 100 study participants or with missing 
values for the subgrouping variable will be omitted from the omnibus test and results 
presentation.  P-values for within-subgroup treatment effects will be reported only if the 
omnibus test is statistically significant at P<0.05. 
 
Exploratory analyses: We plan to analyze many additional outcomes, including alternate 
methods of defining BP control, alternate time-points, and additional endpoints including 
patient-reported outcomes and BP control process measures.  These analyses are not planned 
for testing of the primary hypotheses, but are important for describing the experience of BP 
control using the two different device types and for generating hypotheses for future study.  
Our general approach to these analyses will be similar to how we approach the primary and 
secondary analyses, but we may use other methods that are not pre-specified. 
 
EHR data analyses:  We plan to analyze the EHR data obtained from each partner site.  Each 
partner’s EHR information is standardized to the PCORnet Common Data Model (CDM) to 
collect data from the EHR systems.  The PCORnet CDM is a HIPAA Limited Data Set and quality 
checks of the EHR data are performed using procedures and algorithms that PCORI established 

 
 
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for its clinical data research network sites.  Among other things, it standardizes laboratory tests 
and results using LOINC for laboratory tests and medication data using RxNorm.   
 
Queries will be sent to the sites asking for the following data: 
- Ambulatory Clinic information, including: 
- Basic demographic and visit information 
- Diagnoses 
- Medication orders 
- Blood pressure and pulse measurements 
- Lab Reports relevant to blood pressure 
- Vital Status 
 
To obtain the information above, we will use the following tables from the PCORnet CDM: 
- DEMOGRAPHIC 
- ENCOUNTER 
- PROCEDURE 
- VITAL 
- PRESCRIBING  
- DIAGNOSIS 
- LAB_RESULT_CM 
- DEATH 
- DEATH_CAUSE 
 
Please note that the research team will NOT request release of information pertaining to drug 
and alcohol abuse, diagnosis or treatment; HIV/AIDS testing; genetic testing; or mental health 
diagnosis or treatment. 
 
Attachment E summarizes the steps required for the OneFlorida Data Trust to obtain data for 
the queries.    
 
 
Enrollment prediction modeling: 
In response to PCORnet’s emphasis on ensuring access to health care interventions for 
vulnerable populations, we plan an exploratory post-hoc analysis examining any disparities in 
enrollment in BP HOME, particularly by race and ethnicity. Black and Hispanic/Latinx patients 
are underrepresented in clinical trials and health care research generally, and specifically 
within hypertension research. This is particularly worrisome given that these subgroups 
experience disproportionate burdens of negative sequelae of hypertension, including coronary 
artery disease, stroke, and chronic kidney disease. Further, the interaction between social 
determinants of health (SDH), Black race and Hispanic ethnicity, and participation in 
interventional trials is not well understood. 
 
We plan to study the interaction between self-identified race, self-identified ethnicity, and 
various indicators of social determinants of health, measured at both the census tract and 
individual patient level, to understand their effects upon enrollment in BP Home.  To 
accomplish this, participating BP Home sites will analyze all persons invited to join BP Home 

 
 
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and analyze predictors of enrollment.  BP Home sites will consider different predictors 
depending on their availability; e.g., OCHIN may consider social determinants of health they 
have specified based on patient address and also at the individual patient level, while other 
sites may have different types of predictors.  Sites will generally keep individual-level data on 
non-enrolled patients local and do analyses through their honest broker teams, sharing only 
model results (aggregated). 
 
Multiple hypothesis testing: The intervention will likely be regarded as successful by clinicians 
if it is shown to be both efficacious and acceptable (that is, both co-primary outcomes are 
positive), so no penalty for multiple testing is needed to support this conclusion.  In any case, 
the results of both hypothesis tests will be reported.  No formal penalization for multiple 
hypothesis testing is planned for the subgroup or exploratory outcome analyses, which will be 
treated as exploratory and hypothesis-generating. 
 
Multiple imputation for missing data: Our general approach to missing data will be multiple 
imputation.  While our primary BP control outcome is defined to minimize loss to follow up and 
missing data, it is still possible that follow up will be missing if EHR linkage fails.  If this occurs 
(and in general for other analyses), we will use a multiple imputation strategy.  This approach 
will be optimized by the requirement for completion of baseline surveys before randomization 
occurs.  It is likely that our primary patient satisfaction outcome will be missing in a sizable 
proportion of patients, since it will require patients to log back into our system and fill out an 
additional survey.  Again, we will handle this situation with multiple imputation.  In addition to 
multiple imputation under the standard assumption that data are missing at random 
(conditional on observed covariates and outcomes), we will also implement sensitivity analyses 
using imputation under plausible missing-not-at-random scenarios. 
 
Data and Safety/Interim Monitoring: Given the minimal risk nature of the intervention (both 
arms are considered standard of care), no formal interim monitoring is required.  All study staff 
are CITI-trained, and will be on the alert for unanticipated adverse effects; if such effects are 
identified, UCSF study staff will notify our IRB and all study sites as needed to minimize risk for 
participants in the study. 
 
Sample size justification: With 2000 patients randomized (1:1 ratio, 1000 standard vs. 1000 
Smartphone-linked), we will have 80% power to distinguish very small standardized treatment 
effects of only 0.125 standard deviations (SDs).  For example, if the standard deviation of SBP 
reduction is 8, we would have 80% power to distinguish a reduction of 11 mmHg from 10 
mmHg in SBP reduction between the two groups.  We have not attempted a power analysis for 
the Net Promotor outcome given the complexity of the calculated score. 
 
 
 
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