Improving Recognition and Management of Hypertension in Youth: Comparing Approaches for Extending Effective CDS for Use in a Large Rural Health System
Phase: NA
Conditions: Hypertension
Sponsor: HealthPartners Institute

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Improving Recognition and Management of Hypertension in 
Youth: Comparing Approaches for Extending Effective CDS for 
use in a Large Rural Health System
IRB Protocol Version: v1.8
IRB Study Acronym: Peds & TeenBP
National Clinical Trial (NCT) Identified Number: 05126082
Principal Investigator(s): Catherine Benziger, MD, Essentia Health
Elyse Kharbanda, MD, HealthPartners Institute
Sponsor: HealthPartners Institute
Grant Number: 1R18HS027402-01A1
Project Period: 09/30/2020 - 07/31/2025
Funded by: Agency for Healthcare Research and Quality (AHRQ)
 2025-03-06

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Table of Contents
1
PROTOCOL SUMMARY ......................................................................................................................................3
1.1
Synopsis..................................................................................................................................................3
1.2
Schema...................................................................................................................................................5
1.3
Schedule of Activities .............................................................................................................................6
2
INTRODUCTION.................................................................................................................................................7
2.1
Study Rationale ......................................................................................................................................7
2.2
Background ............................................................................................................................................7
2.3
Risk/Benefit Assessment......................................................................................................................10
2.3.1
Known Potential Risks ......................................................................................................10
2.3.2
Known Potential Benefits .................................................................................................11
2.3.3
Protection against Risk .....................................................................................................11
2.3.4
Vulnerable subjects ..........................................................................................................11
3
OBJECTIVES AND ENDPOINTS .........................................................................................................................12
4
STUDY DESIGN.................................................................................................................................................13
4.1
Approach to Adaptation and Implementation.....................................................................................13
4.1.1
Phase 1 – Organizational Engagement and Pilot Testing..................................................13
4.1.2
Phase 2 – Full Intervention...............................................................................................13
4.1.3
Phase 3 – Analyses............................................................................................................14
5
STUDY POPULATION........................................................................................................................................14
5.1
Inclusion Criteria ..................................................................................................................................15
5.2
Exclusion Criteria..................................................................................................................................15
6
STUDY INTERVENTION(S) ................................................................................................................................16
6.1
Study Intervention(s)............................................................................................................................16
6.1.1
Description of CDS Intervention .......................................................................................16
6.2
Randomization Strategy.......................................................................................................................18
7
TRAINING REQUIREMENTS..............................................................................................................................18
7.1
Overall Training approach....................................................................................................................18
8
STATISTICAL CONSIDERATIONS.......................................................................................................................18
8.1
Statistical Hypotheses ..........................................................................................................................18
8.2
Sample Size Determination..................................................................................................................19
8.3
Populations for Analyses......................................................................................................................20
8.4
Statistical Analyses...............................................................................................................................21
8.4.1
Analysis of the Secondary Endpoint(s) .............................................................................22
9
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ......................................................22
9.1
Regulatory, Ethical, and Study Oversight Considerations ....................................................................22
9.1.1
Informed Consent Process................................................................................................22
9.1.2
Key Roles and Study Governance .....................................................................................23
9.1.3
Safety Oversight................................................................................................................24
9.1.4
CDS Quality Assurance and Testing ..................................................................................24
9.1.5
Data Handling and Record Keeping ..................................................................................24
9.1.6
Publication and Data Sharing Plan....................................................................................26
9.2
Abbreviations and Special Terms .........................................................................................................27
9.3
Protocol Amendment History ..............................................................................................................27
10
REFERENCES....................................................................................................................................................28
11
APPENDIX 1 – Assessment of Risk Factors ......................................................................................................33

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1
PROTOCOL SUMMARY
1.1
SYNOPSIS 
Title:
Improving Recognition and Management of Hypertension in Youth: Comparing 
Approaches for Extending Effective CDS for use in a Large Rural Health System
Grant Number:
AHRQ 1R18HS027402-01A1
Study Description:
This research project will adapt the PedsBP clinical decision support (CDS) tool for use at 
Essentia Health and measure the implementation processes and outcomes. This minimal 
risk, pragmatic trial will randomize up to 45 Essentia clinics in a 3-arm, cluster-
randomized trial. Clinics will be randomly allocated in a 1:1:1 allocation ratio to usual 
care, low-intensity implementation, or high-intensity implementation of the PedsBP 
CDS. Study-eligible patients will be allocated to the study arm assigned to the clinic at 
which the patient has an index visit when blood pressure (BP) is measured. Clinic 
providers and rooming staff will be interviewed and surveyed to assess experience and 
satisfaction with the CDS.
Objectives:
Identify optimal intervention implementation strategies for the PedsBP CDS tool. 
Post-implementation comparisons of high- plus low-intensity implementation versus 
usual care and high- versus low-intensity implementation will be conducted for the 
primary endpoints of BP remeasurement at the index visit (for patients with an elevated 
first BP), and BP recognition within 6 months of the index visit (for patients newly 
meeting HTN criteria).
Endpoints:
There are two primary outcomes. One is repeat BP measurement during the same clinic 
visit, of an initial BP that is ≥95th percentile for children 6-12 years or ≥130/80 mmHg 
for adolescents 13-17 years. Repeat BPs can be measured by providers or rooming staff 
but will only contribute to this outcome if recorded in the vitals section of the EHR. The 
other primary outcome is clinical recognition of HTN within 6 months of meeting criteria 
for HTN.  Clinical recognition will include a new diagnosis of HTN (ICD-10: I10) or 
elevated BP (ICD-10: R03), adding HTN or elevated BP to the problem list.
Secondary outcomes will describe management within 6 months of meeting criteria for 
HTN including: lifestyle counseling, dietitian referrals, subspecialty referrals, initiation of 
antihypertensive medications and receipt of diagnostic imaging (echocardiogram or 
renal ultrasound). BP control at 12 months following the index date meeting criteria for 
HTN will be an exploratory outcome.
Study Population:
To participate in this study, primary care providers must practice at one of the 
participating EH clinics and meet these additional eligibility criteria: (a) be a pediatric or 
family medicine care provider (pediatrician, family physician, nurse practitioner or 
physician assistant), and (b) provide ongoing clinical care for children and adolescents.
Patients enrolled will be 6-17 years with BP, height and weight recorded. We estimate 
patients will have an average of 2.02 visits per patient over the study period. Similar to 
demographics of the region, the population is 90% white, non-Hispanic. 

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Description of 
Sites/Facilities Enrolling 
Participants:
Pilot - Two Essentia Health primary care clinics
CDS control & intervention - up to 45 Essentia Health primary care clinics
Description of Study 
Intervention/Experimental 
Manipulation:
Up to 45 community-based, Essentia Health primary care clinics with the largest number 
of visits among youth 6-17 years will be balanced and randomly allocated in a 1:1:1 
allocation ratio to usual care, low-intensity implementation, or high-intensity 
implementation of the PedsBP CDS.
Study Duration:
Pilot testing and interviews:  January 2022 – June 2022
18-month CDS intervention period:  August 2022 – January 2024 (anticipated)
12-month CDS follow-up period:  February 2024 – January 2025
Survey clinicians and rooming:  October 2023 – December 2023
Participant Duration:
Pilot interviews of clinicians and staff – April 2022 – June 2022 
Data collection for study-eligible adolescent patients – August 1, 2022 – July 31, 2025
Surveys of clinicians and staff – October 2023 – December 2023

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1.2
SCHEMA 
Cluster Randomized Trial Implementation Process and Design*
 
 
* Clinic, staff, provider and patient enrollment numbers are estimated.
Organizational Engagement &
 6-month pilot intervention at 2 Essentia Health (EH) clinics
Adapt/revise tool based on input from EH leaders, providers and rooming staff
Assessment of provider experience and satisfaction 
with the CDS
15 Clinics
120 Rooming Staff
72 Providers
15,000 Eligible Patients
Usual Care
(Control Group)
Randomize 1:1:1
Patient-level assessment of clinical and utilization outcomes
45 Enrolled Primary Care Clinics
Low-Intensity 
Intervention Group
High-Intensity 
Intervention Group
15 Clinics
120 Rooming Staff
72 Providers
15,000 Eligible Patients
15 Clinics
120 Rooming Staff
72 Providers
15,000 Eligible Patients
2 Clinics
20 Rooming Staff
25 Providers
750 Eligible Patients

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1.3
SCHEDULE OF ACTIVITIES 
IRB Submission-Related Activities
Phase 1
Study Aspect
Estimated 
Start Date
Completion 
Date
Recruitment / 
Authorization
Consent / Assent
IRB Submission for Approval
Development, quality 
assurance and testing of the 
CDS
July 2021
End of 
Study
Full waiver of HIPAA 
authorization
Requesting waiver of 
consent and assent
Submitted initial submission 
10/12/20 and amendment 
04/28/21
Pilot clinics - PedsBP CDS 
implementation, operation, 
quality assurance and 
testing (see section 9.1.4)
Jan 2022
End of 
Study
Full waiver of HIPAA 
authorization
Requesting waiver of 
consent and assent
Submitted amendment 
01/07/22
Interview pilot clinicians 
and rooming staff
Jan 2022
June 2022
Contact by mail, email 
or in-person
Informed consent
Submitted amendment 
03/16/22
Phase 2
Study Aspect
Estimated 
Start
Completion 
Date
Recruitment / 
Authorization
Consent / Assent
IRB Submission for Approval
Intervention - CDS 
implementation, operation, 
testing and data collection 
in up to 45 study clinics
Aug 2022
Jan 2025
Full waiver of HIPAA 
authorization
Requesting waiver of 
consent and assent
Submitted amendment 
08/16/22
Post-Implementation 
rooming staff and PCP 
surveys
Oct 2023
Dec 2023
Contact by mail/email
Requesting waiver of 
informed consent 
documentation
Submitted amendment 
10/09/23

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2
INTRODUCTION
2.1
STUDY RATIONALE 
Hypertension (HTN) in youth tracks into adulthood, contributing to adult cardiovascular morbidity and mortality. 
National guidelines for the diagnosis and treatment of HTN in children and adolescents were last updated in 2017, with 
definitions for HTN that vary by age. To date, most children and adolescents with elevated blood pressure (BP) or HTN 
are not diagnosed or inadequately treated. Factors that contribute to these deficits in care include: the need to 
translate pediatric BP measures into BP percentiles, lack of clinician familiarity with pediatric HTN guidelines, and 
competing demands at clinical encounters.  
Electronic health record (EHR)-linked clinical decision support (CDS) can be used to address these barriers and improve 
the identification and management of elevated BP and HTN in children and adolescents. With funding from NHLBI, our 
team developed, implemented, and evaluated a sophisticated web-based, EHR-linked CDS to provide patient-specific 
clinical care recommendations in real time and in accordance with national guidelines for BP management in youth. In a 
2-year cluster randomized trial in 20 urban and suburban primary care clinics in an integrated health system in 
Minnesota, we demonstrated that our CDS increased repeat measurement of elevated BP during a visit and more than 
doubled clinician recognition of HTN, while promoting dietitian referrals and additional next steps in care consistent 
with national guidelines. The CDS system was well accepted by providers and as such, is now standard of care in 55 
primary care and 17 subspecialty clinics serving children across the HealthPartners health system. Implementation of 
this CDS, now referred to as PedsBP, in a new health system will help describe the optimal strategies for adaptation and 
implementation of CDS in clinics serving rural populations.
If the interventions significantly improve identification or management of BP in adolescent study subjects, risks of 
certain clinical events related to elevated BP (stroke, renal failure, myocardial infarction) may be reduced later in life. If 
the interventions fail to significantly improve identification or management of BP in adolescent study subjects, that 
knowledge will also be important because it will direct the attention of investigators to other, potentially more fruitful, 
lines of investigation. In addition, data comparing low-intensity and high-intensity approaches to CDS implementation 
will be of interest to health services researches, medical groups and health systems. Thus, regardless of specific 
findings, the results of this trial will provide important new knowledge that will ultimately contribute to improved care 
for adolescents with elevated BP.
2.2
BACKGROUND 
National guidelines for diagnosing and treating HTN in children and adolescents were published in 2004 as the Fourth 
Report36 and were updated in 2017, as the Clinical Practice Guideline for Screening and Management of High Blood 
Pressure in Children and Adolescents (2017 Guideline).9 The 2017 Guideline defines HTN in children 12 and younger, as 
blood pressure (BP) at 3 separate visits at or above the 95th percentile, and for adolescents 13 to 17 years, BP at 3 
separate visits at or above 130/80 mmHg. Stage 2 HTN is defined as 3 or more BP measurements at or above 95th 
percentile + 12 mmHg or 140/90 mmHg. Elevated BP, previously known as pre-hypertension, includes patients with one 
or more BP measurements at or above the 90th percentile or 120/80 mmHg, but not meeting criteria for HTN.
The prevalence of HTN can be estimated from clinical or population-based samples. Using definitions from the 2004 
Fourth Report, of 14,187 children and adolescents with at least three preventive health visits to a single Midwestern 
health system from 1999 to 2006, 3.4% met criteria for elevated BP and 3.6% met criteria for HTN.37 In contrast, a 
school-based screening of nearly 7,000 adolescents, conducted from 2003 to 2005, reported elevated BP in 15.7% and 

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HTN in 3.2% (2.6% stage 1 and 0.6% stage 2).13 A large retrospective cohort study using data from 196 ambulatory 
clinics within a large practice-based research network found that of children and adolescents with visits from 1999-
2014, 10.1% had elevated BP and 3.3% met criteria for HTN.12 Using the 2017 Guideline definitions, the prevalence of 
HTN in children and adolescents has ranged from 3 to 5%.14,15,38
Elevated BP and HTN during adolescence, although generally asymptomatic, is associated with immediate and long-
term adverse health effects, including left ventricular hypertrophy (LVH) and carotid intima-media thickness.39 The 
effects of BP on target organs are graded, with the risk for developing LVH increasing progressively with increases in 
BP.39-41 Studies have shown that over 20% of adolescents with HTN have concurrent evidence of LVH.40,42,43 Obesity is 
associated with elevated BP13,44-46 and is an independent risk for cardiovascular disease.47 Elevated BP during childhood 
and adolescence is associated with adult HTN and predicts long-term cardiovascular morbidity and mortality.48-51 In a 
study of Swedish males, elevated diastolic BP (DBP) during late adolescence was associated with a 10% to 15% increase 
in all-cause mortality over a median of 24 years of follow up.4  
For biological, behavioral, and pragmatic reasons, late childhood through adolescence is an ideal period for identifying 
and treating HTN. First, compared to younger children, BPs in older children and adolescents are more highly correlated 
with adult BPs.50,52,53 In addition, incident HTN in this age group is usually essential, and does not require extensive 
testing for secondary causes.9 Third, unlike younger children, older children and adolescents have increased autonomy 
and may be better able to make healthy choices regarding diet and exercise. Identifying school-aged children and 
adolescents with HTN and providing targeted education and recommendations for exercise and nutrition could have 
lifelong benefits. Finally, older children and adolescents are likely to have health insurance54,55 and consistent contact 
with medical providers. In a study from our health system, insured adolescents averaged 1.5 visits to a primary care 
provider each year.56 This contrasts with young adults, who despite insurance expansions, still experience high rates of 
being uninsured and face reduced primary care access.55,57-60  
The 2017 Guidelines recommend that for otherwise healthy children, BP should be measured annually while youth with 
obesity or other HTN risk factors should have BP measured at every clinical encounter.9 Although the cost-effectiveness 
of BP screening in adolescents has been questioned,61 there is strong evidence that providers are measuring BP during 
pediatric and adolescent preventive care visits.62,63 Early identification of HTN may help children and families adopt 
lifestyle changes needed to reduce their risk for long-term cardiovascular sequelae. The 2017 Guidelines provide 
detailed recommendations for the management of elevated BP and HTN in youth. Timing of repeat BP measurements 
and indications for treatment (lifestyle intervention, antihypertensive medication, or both) are based on the level of BP 
elevation, whether the elevation is incident or persistent, and whether the adolescent is overweight. For children and 
adolescents 6 years and older with new onset HTN who are overweight or obese, have a family history of HTN and do 
not have signs of a secondary cause for HTN, the 2017 Guidelines indicate that an extensive work-up is not needed.9
Despite potential benefits of early identification, HTN in children and adolescents is often not recognized.12,20,37 In an 
electronic database review of more than 500 youth who met clinical criteria for HTN, only 26% had a HTN or elevated 
BP diagnosis.37 Similarly, in a manual chart review of more than 700 pediatric primary care visits in which an elevated 
BP was recorded (≥90% or ≥120/80 mm Hg), only 13% were clinically recognized, defined as repeating the BP, 
diagnosing elevated BP or HTN, planning to recheck the BP, or initiating a workup for HTN.20 A retrospective cohort 
study of 196 ambulatory clinics within a large practice-based research network found that only 23% of youth who met 
criteria for HTN were diagnosed.12 The need for practical and sustainable approaches to implementing the 2017 
Guidelines has been identified as a pediatric HTN research gap.64 

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Low rates of recognition and low adherence to pediatric BP guidelines are likely due to barriers in knowledge, attitudes, 
and behaviors.21 Providers may not be familiar with clinical criteria for HTN in youth. Competing demands at primary 
care visits are common and may crowd out time to address BP. In addition, despite recent updates, the classification of 
HTN is complex and time consuming.20 The systolic BP (SBP) and DBP cutoffs for the 95th percentile, needed for children 
12 and younger, vary by sex, age, and height percentile; without clinical decision support (CDS), patient BP data over 
time must be interpreted using a series of tables. For example, a table illustrating height-based SBP cutoffs for a 12-
year-old girl is shown in Table 1.  
In summary, lack of familiarity with HTN 
definitions, low clinician buy-in for HTN 
guidelines, time pressures in providing 
comprehensive care for children and 
adolescents,65,66 complexities of the current BP 
tables, and the need to review several previous 
BP measurements to diagnose HTN all 
contribute to under recognition. CDS, 
integrated within an existing EHR platform and 
delivered at the point of care, is ideally suited to address barriers to HTN recognition and management.67 Automated 
calculations of BP percentiles for current and prior visits can reduce the time needed to identify an incident or 
persistently elevated BP. Computer prompts regarding BP classification, recommended evaluations, and timing for 
follow-up can assist providers unfamiliar with pediatric BP guidelines. 
CDS systems have been available for more than five decades, with designs adapted to accommodate changes to clinical 
practice. Despite this long history, CDS is still an underutilized tool across clinical settings.68 In a meta-regression of 162 
computerized CDS systems, improvements in either patient outcomes or care processes (e.g., provider actions) were 
seen in just 58% of trials.69 CDS systems had higher odds of improving patient outcomes if targeting both patients and 
providers and when the CDS was developed by the respective study authors.69 A more recent systematic review found 
that providing CDS automatically, versus on demand, and displaying CDS on a computer screen, versus on paper, both 
led to moderate improvements in CDS effectiveness.70 While a unified framework for developing CDS does not yet 
exist,68 the GUIDES checklist may prove to be useful for implementing guideline-based CDS such as PedsBP.71 The 
GUIDES checklist71, developed based on opinions from international CDS experts, patients, and other healthcare 
consumers, encompasses four domains: context related to potential CDS success, CDS content, the CDS system, and 
implementation of the CDS into practice.71  The CDS tool that we developed, implemented, and evaluated at 
HealthPartners (HP) provided patient-centered CDS at the point of care improved the quality of BP measurement and 
dramatically increased provider recognition of HTN. Development and implementation of the CDS at HP was consistent 
with best practices and informed by local input from nursing and clinical leadership.22 The PedsBP CDS was well 
accepted by providers and is now live in 55 primary care clinics and 17 subspecialty clinics within HP, a large integrated 
health system.
Compared to urban youth, children living in rural regions have higher rates of obesity72 and thus are at increased risk 
for HTN and future cardiovascular disease. Yet, youth in rural regions also experience reduced access to pediatricians 
and pediatric subspecialists.29,30,73 Thus, expanding PedsBP CDS for use in a large, primarily rural health system such as 
Essentia Health (EH) may fill an important gap in care and ultimately lead to improvements in population health. 
Although the prevalence of HTN in youth is 2-5%10-12, a review of data from patients 6-17 years with a visit to an EH 
Table 1. Height-based systolic blood pressure cut-offs for a
12 year-old girl, from the 2017 Guidelines9
Height percentile
BP category
5th
10th
25th
50th
75th
90th
95th
Stage 1 HTN (95th%)
118
119
120
122
124
125
126
Stage 2 HT
(95th%+12 mmHG)
130
131
132
134
136
137
138

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primary care clinic and at least one BP measured over an 18-month period found that less than 0.3% had ever been 
diagnosed with HTN.
Even when an EHR-linked CDS is effective in the setting where it was initially developed, implementation in a new 
environment, such as a new health system, is prone to challenges.27 Adoption and effectiveness in the new setting may 
be impacted by differences in: workflow, EHR configuration, clinic culture, and patient preferences. Implementation 
strategies can vary in intensity from online webinars or email updates regarding changes to the EHR, to comprehensive 
in-person training with audit-feedback of use rates. While high-intensity implementation approaches including on-site 
training may increase adoption, these may also be challenging to implement in rural health systems such as EH, where 
clinics span a geographic region of over 400 miles. Optimal approaches to implementation of CDS in a new health 
system, and particularly in a rural health system, have not been well described.28 Building upon the extensive track 
record of the HP- and EH-based research teams,1,2 the proposed research represents a unique opportunity to improve 
health in an at-risk, rural population.
2.3
RISK/BENEFIT ASSESSMENT 
2.3.1
KNOWN POTENTIAL RISKS 
All study aspects are considered minimal risk as our intervention promotes care that is consistent with national 
guidelines and interview and survey information collected is not considered sensitive. CDS recommendations provided 
as part of the PedsBP CDS intervention are designed to support clinicians’ decision-making, not to override clinical 
judgment.
Risks to provider and rooming staff study subjects are considered minimal and principally involve consideration of the 
risk of violation of confidentiality of study data. If confidentiality were breached and quality of care were seriously out 
of range for one or more providers, EH leadership could conceivably use this information to release one or more 
providers from employment with EH. Therefore, no identifying information on individual provider performance with 
respect to the clinical domains addressed in this study or any other aspect of care gathered as part of this research 
project will be made available to EH leaders who make employment, compensation, or disciplinary decisions. 
Potential risks to study subjects who are patients include the possibility that the intervention may provide CDS advice 
to providers on the basis of the 2017 Guidelines, national standards of care for BP in children and adolescents that may 
be inappropriate for a given individual patient and, if applied without further checking the clinical status of a given 
patient, could lead to erroneous therapy, adverse events, disability, or death. However, the clinical recommendations 
are primarily related to proper measurement of height and BP, lifestyle advice, and visit intervals. Therefore, the risk of 
untoward consequences of such clinical actions is considered minimal. Moreover, this potential risk is routinely present 
in every clinical encounter within the health care system.  We have described below the methods used to minimize this 
risk.
Additional risks to patients are also minimal and include principally the risk of violation of confidentiality. To protect 
patient confidentiality, we will create an analytic dataset that includes only encrypted study identifiers. The analytic 
dataset will be created from various databases that include patient identifiers (names (temporary) and dates). We will 
use an encryption algorithm to create the encrypted study identifiers. The table that maps encrypted study identifiers 
to patient identifiers will be stored at EH. We will also adhere to all requirements imposed by the governing 
Institutional Review Board (IRB) and legal requirements such as HIPAA.

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2.3.2
KNOWN POTENTIAL BENEFITS 
No claim is made in communications with provider or rooming staff study subjects that any personal benefit will accrue 
from participating in this project.  
Providers will have no defined benefits from participating in this project. However, the CDS is designed to optimize 
identification and management of BP in children and adolescents and may familiarize some providers with new and 
potentially useful information that can be used to improve their clinical care. Providers will not receive monetary 
compensation for time devoted to the study, other than a small payment for completion of the surveys.
Patient study subjects and their parents or legal guardians will have no defined personal benefit from participating in 
this project and will receive no compensation. No communication between research team members and study subject 
patients is planned as part of the study protocol. Although some patients may receive earlier identification or 
management of BP as a result of this intervention, no claim of clinical benefit to an individual patient can or will be 
made.
2.3.3
PROTECTION AGAINST RISK 
The following measures will be taken to protect providers and patients from the risk of breach of confidentiality: A 
unique study ID code unrelated to the medical record number or other study subject-specific information will be 
assigned to each patient and provider study subject and used to link data from various sources and needed for analysis. 
A crosswalk table linking this code number to a provider, patient name or medical record number will be destroyed 
within 12 months after completion of the linked databases needed to test study hypotheses. The rooming staff and PCP 
interviews and survey consent procedures will be reviewed in advance, approved, and monitored on an ongoing basis 
by the IRB.
The following measures will be taken to minimize the risk that a provider will act wrongly on the basis of information 
provided through CDS developed for this study: Each project-related communication to providers will include a written 
explanation indicating that the CDS is a suggestion, not a mandate, and that the action should only be taken if judged to 
be clinically appropriate by the treating provider on the basis of the patient’s health, previous health care, current 
treatment, and other factors.
2.3.4
VULNERABLE SUBJECTS
The study will include children and adolescents 6 to 17 years old at study entry (index visit). Aims of the study are to 
improve BP care and HTN recognition in children and adolescents, as they are a population at risk for having their HTN 
not clinically recognized. As such, it is necessary that this study involves children as research subjects. This study is 
minimal risk as our intervention promotes care that is consistent with national guidelines. It is important to 
systematically address elevated BP and HTN in this age-group, as children and adolescents have been excluded or 
underrepresented in previous research studies. To ensure that CDS recommendations for identification and 
management of elevated BP are appropriate for these patients, we will exclude pregnant or postpartum adolescents. 
Patients with a known HTN diagnosis or those taking antihypertensive medication will still qualify for CDS-triggered 
alerts but, because their HTN is not new-onset, they will be excluded from analyses. 
The study is specifically designed to include study subjects age 6-17 years old at entry, with up to 12 months of 
subsequent follow-up.  Thus, all patient study subjects are classified as children when they enter the study.  There are a 
number of clear and compelling reasons why those under age 18 years are included in this study:

Peds & TeenBP Main Study Protocol v. 1.8
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1.
Elevated BP in children and adolescents is associated with elevated BP in adulthood and with subsequent 
increased risk of untoward clinical events related to elevated BP (strokes, renal failure, myocardial infarction) 
later in life.
2.
Identification and clinical care for elevated BP and HTN in children and adolescents is far from what is currently 
recommended by the 2017 Guidelines. Thus, research to guide care improvement is justified and necessary. To 
identify those with elevated BP, providers must interpret measured BP values in the context of age, gender, 
and height percentile.  EHR technology provides a powerful tool ideally suited to translate raw BP data into BP 
percentile data, and to assess patterns of data over multiple visits to correctly classify those with elevated BP or 
HTN.  The same technology can then be used to provide patient-specific point-of-care clinical decision support 
based on correct BP classification and the 2017 Guidelines.  
3.
Because both the definition of elevated BP and BP-related care recommendations are substantively different 
for children, adolescents and adults, it is important to conduct research specifically with children and 
adolescents.  
Therefore, it is very appropriate to conduct this research project with children and adolescents and their care providers 
to address distinct problems related to elevated BP and HTN in adolescents.
Dr. Kharbanda, study Co-PI is a Board-certified pediatrician and subspecialty Boarded in Adolescent Medicine. She has 
over 15 years prior experience conducting research in children and adolescents, including 2 large NIH-funded cluster 
randomized trials using CDS tools to improve pediatric care.
Dr. Benziger, study Co-PI is a Board-certified cardiologist and medical director of heart and vascular research at a large 
rural healthcare system. She has a Master of Public Health in epidemiology and is an expert in cardiovascular disease 
prevention and clinical trials, including site PI of multiple pragmatic randomized clinical trials through Patient-Centered 
Outcome Research Institute (PCORI) aimed at reducing cardiovascular disease burden.
3
OBJECTIVES AND ENDPOINTS 
Overall goals are to evaluate the effectiveness of the PedsBP CDS and to compare low- and high-intensity approaches 
to CDS implementation. We will adapt the PedsBP CDS for use at Essentia Health and to measure the implementation 
processes and outcomes.  
We may use the GUIDES checklist to assist us in improving use of the CDS, and will frame our implementation based on 
the following four domains: 1) CDS context, 2) CDS content, 3) CDS system, and 4) CDS implementation.71
There are two primary outcomes. One is repeat BP measurement during the same clinic visit, of an initial BP that is 
≥95th percentile for children 6-12 years or ≥130/80 mmHg for adolescents 13-17 years. Repeat BPs can be measured by 
providers or rooming staff but will only contribute to this outcome if recorded in the vitals section of the EHR. The 
other primary outcome is clinical recognition of HTN within 6 months of meeting criteria for HTN. Post-implementation 
comparisons of high- plus low-intensity implementation versus usual care and high- versus low-intensity 
implementation interventions will be conducted for the primary endpoints of BP remeasurement at the index visit (for 
patients with an elevated first BP), and BP recognition within 6 months of the index visit (for patients newly meeting 
HTN criteria). 
In secondary analyses we will evaluate the impact of the adapted PedsBP CDS on management of HTN including diet 
and exercise counseling, provision of antihypertensive medications, subspecialty referrals, and diagnostic testing. In 

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addition, among youth newly meeting criteria for HTN, we will explore differences in BP control at 12 months. This 
research builds on prior research in pediatric and adolescent HTN10,16,23,31,32, cardiovascular disease,33,34 and CDS 
development and implementation.22,24,35 Our multidisciplinary team seeks to improve the quality of BP measurement, 
increase HTN recognition, and promote guideline adherent management of HTN in rural youth  — all  necessary first 
steps towards improving cardiovascular health in this population.
4
STUDY DESIGN
4.1
APPROACH TO ADAPTATION AND IMPLEMENTATION
4.1.1
PHASE 1 – ORGANIZATIONAL ENGAGEMENT AND PILOT TESTING
Organizational Engagement
We will engage EH clinic leadership and managers, informatics personnel, providers, and rooming staff, through 
meetings to review standard clinical workflow (e.g., timing of: BP measurement, height measurement, entry of height 
and BP data into the EHR, and clinician review of EHR data) along with variance in these processes across clinical sites. 
As in our prior studies, we will work with leadership to identify potential barriers and facilitators that would influence 
adoption of the CDS.96 All PedsBP algorithms and interfaces will be extensively reviewed by EH stakeholders prior to 
implementation. EH has 18 volunteer patient advisory councils that engage patients and families as advisors, mentors, 
and educators. The main goal of this program is to improve the patient and family experience and quality of healthcare. 
With guidance from our consultant, Dr. Joseph Konstan, from the University of Minnesota, the EH research team will 
recruit representative members to review and critique PedsBP CDS interfaces and associated educational material. 
Pilot Testing
With approval from clinical leaders to proceed, we will then recruit one rural and one urban EH clinic not in the full 
intervention study and pilot the PedsBP CDS for up to six months. The purpose of the pilot is to verify that 1) we are 
capturing all data elements needed for intervention analysis, 2) test all components of the CDS algorithms, to make 
sure they are working as designed/intended, 3) refine algorithms ahead of full intervention. Additional quality 
assurance will be done on a random sample of patients identified as eligible for receiving the CDS via chart reviews to 
ensure data accuracy (see Section 9.1.4 for more on quality assurance and testing).  During the pilot we will also 
conduct in-depth interviews with providers and rooming staff at pilot clinics, asking probing questions (e.g., ‘How does 
the CDS fit in your workflow?’, ‘Was the CDS useful’?, ‘Was the CDS disruptive?’, ‘Did the CDS help you in making a 
decision about your patient’s blood pressure management?’, ‘How can the study team facilitate use of the CDS’?) about 
the PedsBP CDS, aiming to identify facilitators and barriers to use (separate interview-specific protocol will be 
submitted). Up to six months is allotted for the pilot, allowing for an iterative process of piloting, feedback from 
providers and rooming staff, modifications to the CDS display, wording of recommendations or criteria for triggering 
BPAs, as needed, with subsequent piloting of the modified tool. In addition, the long pilot period may be needed to 
ensure that providers and rooming staff have sufficient exposure to the CDS, including for patients newly meeting 
criteria for HTN (expected background rate 2-3%). Upon reaching a stable CDS platform with general acceptance from 
providers and clinic staff, the project will move to Phase 2, the full intervention. 
4.1.2
PHASE 2 – FULL INTERVENTION

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We will randomize clinics to one of three arms and will utilize the ‘Educate’ intervention strategy, varying by intensity, 
as described by Powell et al.97 The low-intensity intervention clinics may receive education and training following 
standard practice for delivering any updates to primary care at EH. Within two weeks of our go-live date, providers and 
rooming staff would receive an email with links to a short instructional video demonstrating provider and rooming staff 
roles in the PedsBP CDS. The clinics randomized to the 
high-intensity implementation may be offered the same e-
learning, with reminders to view the online training 
video using EH’s internal learning assignments. In 
addition, at high-intensity clinics study personnel may 
conduct in-person or video conference training for 
available providers and rooming staff. These in-person 
trainings may occur within eight weeks of our go-live.  
Following implementation, high-intensity clinic staff may 
receive monthly email reports showing PedsBP use rates. 
An example, adapted from an ongoing CDS project at EH, 
is shown in Figure 1. 
In addition, the project manager may meet either in-person or remotely with each high-intensity clinic's nurse manager 
monthly throughout the intervention period to assess continued use of PedsBP and to gather feedback ensuring real-
time observation of implementation fidelity. Support from EH leaders and clinic providers, along with monitoring and 
feedback, will help maximize adoption of PedsBP, as demonstrated by CDS use at 75%-80% of targeted visits in previous 
projects. 
To further encourage use of the tool, high-intensity clinics may be offered a best practice ‘lunch and learn’ for CDS 
usage at goal. If a clinic achieves four non-consecutive months at or above 75% usage rate, the PedsBP team will 
provide a catered project-related meeting. The team will provide a meeting agenda for the clinic manager and/or nurse 
supervisor with the expectation that notes from the meeting will be returned to the team. This ‘lunch and learn’ may 
also be offered at 10 non-consecutive months at or above 75% CDS usage. 
4.1.3
PHASE 3 – ANALYSES
This period encompasses analyses, reporting of key study results, and implementation of the intervention in the non-
intervention clinics, if requested by EH. Throughout the study, there will be ongoing analysis of data as they become 
available, and preliminary results will be presented at meetings and/or reported in peer-reviewed articles.
5
STUDY POPULATION
In this study, we aim to evaluate the PedsBP CDS in up to 45 primary care clinics with an estimated total of 216 primary 
care providers and 360 rooming staff. The majority of sites are staffed by family practice physicians (n=31). 
Pediatricians (n=2), both family practice and pediatricians (n=4) or advanced practice providers alone (n=8) cover the 
remaining sites. 
Based on prep data, we estimate that over the 18-month study period there will be 44,061 unique patients 6-17 years 
with BP, height and weight recorded, with an average of 2.02 visits per patient over the study period. Similar to 
demographics of the region, the population is 90% white, non-Hispanic. Fifteen percent of youth receiving care at these 
sites are obese, with BMI ≥95th percentile. Elevated BP is common (10-20% of patients with at least 1 BP meeting 
Figure 1. Example of Peds & TeenBP Use Report

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criteria for elevated BP), yet diagnoses for hypertension were only found in 120 (<0.3%).
5.1
INCLUSION CRITERIA
Patients will be eligible for the PedsBP CDS tool if:
a)
6-17 years of age
b)
BP measured and entered in the vital sign section during an ambulatory primary care visit in a randomized 
primary care clinic
c)
not pregnant or postpartum
Patients must meet these eligibility criteria to be included into study analyses: 
a)
have at least one index visit to a randomized primary care clinic in the intervention period
b)
meet eligibility for PedsBP CDS at index visit
c)
no previous HTN diagnosis prior to index visit 
d)
not taking antihypertensive medication prior to index visit
e)
not opted out of use of their data for research via general consent prior to performing analyses
Primary care providers must meet these eligibility criteria to participate in this study: 
a)
practice at a randomized primary care clinic
b)
be a pediatric or family medicine care provider (pediatrician, family physician, nurse practitioner or physician 
assistant), and 
c)
provide ongoing clinical care for children and adolescents
Provider and rooming staff inclusion criteria for interviews and surveys are provided in separate protocols.
5.2
EXCLUSION CRITERIA
Patients will be excluded from analyses if the following criteria are met: 
a)
outside of the inclusion age range (<6 years and ≥18 years) at index visit 
b)
pregnant or postpartum adolescents during study period
c)
known HTN diagnosis or taking antihypertensive medication at index visit
d)
opted out of use of their data for research via general consent prior to performing analyses
Provider and rooming staff exclusion criteria for interviews and surveys are provided in separate protocols.

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6
STUDY INTERVENTION(S)
6.1 STUDY INTERVENTION(S) 
6.1.1
DESCRIPTION OF CDS INTERVENTION
The PedsBP CDS will be integrated within the EHR (EPICare, Verona, WI) with data transfer to and from a web service, 
based at HP, for data processing. PedsBP CDS will be activated when a patient 6-17 years has a BP measured and 
entered in the vital sign section of the EHR during an ambulatory primary care visit in a randomized study clinic. Eligible 
patients will be allocated to the study arm assigned to their clinic at their index visit.  Figure 2 illustrates how data 
would flow from the EHR to and from the HP-based web-service for the proposed study. 
The PedsBP CDS tool includes seven key 
features: 
(i)
a best practice advisory (BPA) 
regarding the need for height data 
to classify the BP by percentile 
(ii) a BPA to repeat any BP that is 
≥95th percentile or ≥130/80 mm 
Hg 
(iii) classification of current and prior 
BPs in the prior two years and 
identification of BPs in stage 1 
HTN and stage 2 HTN range 
(iv) review of previous HTN diagnoses 
and BPs in order to classify an 
elevated BP at the current or 
index visit as a first or second 
elevated BP, or as meeting criteria 
for HTN 
(v) review of medications and 
diagnoses that may affect BP 
(vi) tailored CDS based on HTN category and previous diagnoses 
(vii)graphical representation of current and prior BP data by age and BP percentile. 
Each of these features is described below in Figure 3.
Figure 2. Peds & TeenBP CDS Data Capture

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The first component of the CDS is a BPA to ensure a current height measurement for children 12 and under (needed to 
compute BP percentiles): (a) If a height is entered at the visit, it will be used; (b) If no height is entered when entering a 
BP, the closest antecedent 
height recorded within 1 year 
is used to calculate a BP 
percentile, assuming a 
constant height percentile. If 
there is no height available for 
the current visit or the prior 
12 months, a BPA displays 
requesting a height be 
measured and recorded in the 
EHR. As height measurement 
is standard in pediatric care, 
this BPA is currently firing in 
less than 1% of visits.
The second component of the 
CDS, a BPA to repeat an 
elevated BP, is triggered for 
BPs ≥95th percentile in 
children 6-12 years or ≥130/80 
mmHg in youth 13-17 years 
when the BP is entered into 
the vital signs section of the 
EHR, and the vital signs box is 
closed. 
In the third component, the CDS will use the lowest SBP for that visit to assign BP percentiles and classify BPs as 
normotensive, elevated BP, stage 1 HTN, or stage 2 HTN. If the initial elevated BP is not repeated, the BP percentile will 
be calculated for the available measurements. BP percentiles are calculated as in Appendix B of the Fourth Report36 and 
include the new reference population, as described in the 2017 Guidelines.9 
In the fourth component of the CDS, for patients with BP 95th percentile (6-12 years of age) or ≥130/80 mmHg (13-17 
years of age), the CDS reviews data pulled from the EHR including prior HTN diagnoses, prior BPs and heights. The index 
and previous BPs and diagnosis data are used to categorize elevated BPs as incident or persistent, and to determine 
whether a patient meets clinical criteria for new onset stage 1 or stage 2 HTN, or pre-existing HTN.  
In the fifth component of the CDS, current medications (e.g., oral steroids or stimulants that increase BP or diuretics 
that lower BP) and prior diagnoses that may affect BP are displayed. In addition, current body mass index (BMI) and 
BMI percentile are calculated. For patients meeting criteria for obesity, BMI ≥95th percentile with new onset HTN, 
obesity is noted in the CDS as a potential cause for the HTN.  
In the sixth component of the CDS, providers receive tailored CDS for BPs ≥95th percentile or ≥130/80 mmHg. The CDS 
recommendations are specific, based on the magnitude of BP elevation (stage 1 or stage 2 HTN) and whether the BP is 
Figure 3. Example of Peds & TeenBP CDS for 6-year old meeting criteria for Stage 1 HTN

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incident or persistent. If the patient has a prior diagnosis of HTN, the CDS provides tailored feedback regarding whether 
the BP is at goal (<95th percentile) or elevated and possibly requires initiation or a change in medication. 
In the seventh component of the CDS, current and previous SBPs and DBPs, within the last 2 years are graphed and 
displayed, with elevated BP, stage 1, and stage 2 HTN BP cutoffs specified. This feature allows providers to visualize 
patient-level variability and trends in BP over time. In addition, the CDS can be printed for families, to assist with shared 
decision making. An example, including the display of BPs over time, is shown in Figure 3. 
6.2
RANDOMIZATION STRATEGY
Covariate-based constrained randomization98 may be used to enhance study arm balance on key factors during 
randomization of the clinics in this cluster-randomized trial. This method permits the use of multiple balance factors 
and can yield improved study arm balance and increased statistical power beyond simple randomization when balance 
factors are included in both the design and analysis phase99 of the study. Clinic-level attributes of clinics and patient mix 
to be used as balance factors will be obtained via EHR data and ascertained for care in clinics in the 18 months prior to 
randomization. Proposed clinic-level balance factors include baseline levels of BP re-measurement and HTN 
recognition, number of visits with patients age 6-17 (ranging from 145 to 6556 patients per clinic over 18 months in 
preparatory data), location (metropolitan/micropolitan (20 clinics) versus small town/rural (25 clinics)), and proportion 
of public pay patients (ranging from 13% to 73%). Randomization will be carried out with the CCR macro for use within 
SAS100, and conducted one month prior to implementation of the low- and high-intensity strategies in clinics. 
7
TRAINING REQUIREMENTS
7.1
OVERALL TRAINING APPROACH
Training for clinics in low- and high-intensity arms will be developed to incorporate general training, study-specific 
training, and mechanisms for competency assessment. The study team is responsible for the development of a 
comprehensive Training Plan, instructional material, and delivery of the training (e.g., via self-study, webinar, or 
teleconference). Within primary care clinics randomized to receive the PedsBP CDS, rooming teams will be trained on 
how to recognize the PedsBP alerts and may receive basic education on BP measurement and HTN; PCPs will be trained 
on how to use the PedsBP CDS. Training instructions will include how to let the study team know of any issues or 
questions. Traditionally, we have completed such trainings at in-person lunch meetings with clinic personnel, but will 
also consider other training modalities, such as web-based trainings or teleconferences, depending on the standard 
training practices and clinic leadership preference.
8
STATISTICAL CONSIDERATIONS 
8.1
STATISTICAL HYPOTHESES
Specific Aim 1: Among youth 6-17 years with an elevated BP measurement (≥95th percentile or ≥130/80 mmHg), to 
evaluate the effectiveness of the adapted PedsBP for repeat BP measurement:
Hypothesis 1: Youth with elevated BP measured at a PedsBP intervention clinic will be more likely to have a repeat BP 

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measurement during their visit as compared to those attending usual care clinics. 
Hypothesis 2: Youth with elevated BP measured at a high-intensity PedsBP clinic will be more likely to have a repeat BP 
measurement during their visit, as compared to those attending low-intensity PedsBP clinics.   
Specific Aim 2. Among youth 6-17 years meeting criteria for HTN, to evaluate the effectiveness of the adapted PedsBP 
for improving HTN recognition:
Hypothesis 3: Youth meeting criteria for HTN at a PedsBP intervention clinic will be more likely to be clinically 
recognized within 6 months of their index visit, as compared to those attending usual care clinics.
Hypothesis 4: Youth meeting criteria for HTN at a high-intensity PedsBP clinic will be more likely to be clinically 
recognized within 6 months of their index visit, as compared to those attending low-intensity PedsBP clinics.
Table 2. Study Contrasts and Outcomes by Hypothesis
Hypothesis
Contrast
Denominator
Outcome(s)
Data source(s)
H1
CDS (low- or high-
intensity) versus
Usual care
H2
CDS low-intensity
versus
CDS high-intensity
First BP at visit ≥95th 
percentile (ages 6-12) or 
≥130/80 mmHg (ages 13-17)
Repeat BP measured and 
recorded at same visit
Automated BP 
data from EHR or 
CDS
H3
CDS (low- or high- 
intensity) versus
Usual care
H4
CDS low-intensity
versus
CDS high-intensity
BP at visit and at least 2 of 4 
prior BPs, within last 2 years, 
≥95th (ages 6-12) or ≥130/80 
mmHG (ages 13-17)
HTN recognition within 6 
months of meeting criteria for 
HTN
Automated data 
from EHR or 
CDS
Secondary / 
Exploratory
CDS (low or high intensity) 
versus
Usual care
BP at visit and at least 2 of 4 
prior BPs, within last 2 years, 
≥95th (ages 6-12) or ≥130/80 
mmHG (ages 13-17)
Management within 6 months 
of meeting criteria for HTN 
including:
Lifestyle counseling, Referrals, 
Medications for HTN, 
Diagnostic imaging /
BP at 12 months
Provider satisfaction
Automated data 
from EHR or CDS, 
limited chart 
review and 
provider survey
8.2
SAMPLE SIZE DETERMINATION
Aim 1. Preliminary data from EH indicate there were 44,061 unique patients age 6-17 with visits to the 45 largest EH 
primary care clinics in an 18-month period. This data also indicates that 16% (n=7,258) of patients age 6-17 years had 
an elevated BP at initial measurement and BP re-measurement occurred at 30% (n=2210) of encounters with an 
elevated BP. The initial PedsBP trial had a clinic-level ICC for BP re-measurement of 0.03 and BP re-measurement of 
28% in UC and 47% in the PedsBP arm.23 With an expected 7,258 patients (161 per clinic), this study has 99% power for 
the H1 comparison of low- plus high-intensity clinics (30 clinics) with 15 UC clinics (alpha=.05, two-sided test, ICC=0.03) 
to detect a raw BP re-measurement difference of 15% between the usual care arm (30%) vs. low- plus high-intensity 
arms (45%). The minimum detectable difference with 80% power is 8% (30% UC vs. 38% low- plus high-intensity arms). 
With an expected 4,840 patients (161 per clinic), this study has 80% power for the H2 comparison of low-intensity (15 
clinics, 2420 patients) vs. high-intensity clinics (15 clinics, 2420 patients), with alpha=.05, two-sided tests, ICC=0.03, to 

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detect a minimum detectable difference in BP re-measurement of 10% between the low-intensity arm (40%) vs. the 
high-intensity arm (50%).
Aim 2. Based on the prior Peds & TeenBP trial24, along with observational studies of pediatric HTN10-12 we anticipate 2% 
of patients age 6-12 and 3% of patients age 13-17 will newly meet HTN criteria at a visit over 18 months, yielding a 
sample size of 1060 patients (24/clinic). The PedsBP study found that 21% of patients newly meeting HTN criteria were 
recognized over 6 months in UC and 55% in the PedsBP arm24, and the clinic-level ICC for HTN recognition was 0.035. 
With 1060 patients (24/clinic) and 45 clinics, this study has 99% power (alpha=.05, two-sided test, ICC=0.035) for H3 to 
detect a difference in HTN recognition of 17% between UC (20%) and the low- plus high- intensity arms (37%), and a 
minimum detectable difference of 11% (20% UC vs. 31% low- plus high-intensity arms) at 80% power. For H4 the 
minimum detectable difference at 80% power for HTN recognition among 706 patients (24/clinic) is 14% between low-
intensity (30%) and high-intensity (44%) arms. Power computations account for the design effect due to clinic 
randomization and unequal counts of clinics in some comparisons and were conducted with PASS 2019.  
8.3
POPULATIONS FOR ANALYSES
We will continue to engage with EH leadership to ensure the active participation of EH clinics. EH leadership support for 
this project, as evidenced in the letters of support, ensures the participation of primary care clinics.
Patients 6 to 17 years of age with a BP recorded at a participating EH primary care clinic will be eligible and 
automatically enrolled on the basis of data recorded in the EHR and captured by the PedsBP CDS. Given that one of the 
primary purposes of the study is to test the effectiveness of the different intervention approaches, including a high-
intensity intervention with additional outreach and engagement of clinicians and rooming staff, we do not plan to 
conduct additional recruitment or retention activities. 
Aim 1 outcomes will be assessed in the context of care provided at the index visit with an isolated hypertensive BP 
recorded.  Aim 2 outcomes will be assessed over a period of 6 months following when a patient meets criteria for HTN. 
Clinical recognition of HTN, dietitian or other lifestyle referral and lifestyle counseling will be assessed based on care 
received. There will be no additional efforts to recall patients for additional study visits. For subjects with no follow-up 
visits, Aim 2 outcomes will be assessed based on clinical actions at the index visit.
Providers and rooming staff will be invited to participate in surveys and in-depth interviews through email or in-person 
recruitment by EH study staff. Surveys and interviews will be conducted at the time of recruitment as well as through a 
follow-up survey at the end of the intervention period. We will work with clinic administrative staff as necessary to help 
coordinate interviews and surveys with clinicians and rooming staff in a way that is not disruptive to regular clinic 
operations. 
Data sources
Data required for PedsBP CDS-enhanced care will be sent to HPI for PedsBP operations. CDS data is retained in the 
transactional data store with minimal access until needed for analysis. With respect to the transactional data store, the 
following measures will be taken to protect PCPs and patients from the risk of breach of confidentiality: A unique study 
ID code unrelated to the medical record number or other study subject-specific information will be assigned to each 
patient at the index visit (first visit in the intervention period). The study ID is used to link data from patient encounters 
over time and various data sources that are needed for analysis. All index and subsequent encounter data for eligible 
patients, including vitals, medications and diagnoses, are securely stored behind a firewall within a limited de-identified 
dataset. 

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A crosswalk table linking this code number to a medical record number or patient name will be created by EH 
programmers in order to 1) check against opt out lists, and 2) link to study outcomes. EIRH Informatics Analysts 
assigned to this research project will exclude patients who have opted out via general consent; data for these patients 
will not be stored in analytic data files. The data for patients who have opted out of external research will be deleted 
from analyses files. The crosswalk will be destroyed within 12 months after completion of the linked databases needed 
to test study hypotheses. This project will be governed by a Business Associates Agreement, DUA, and appropriate 
services agreements. 
8.4
STATISTICAL ANALYSES
Aim 1. Preliminary data from EH indicate there were 44,061 unique patients age 6-17 with visits to the 45 largest EH 
primary care clinics in an 18-month period. This data also indicates that 16% (n=7,258) of patients age 6-17 years had 
an elevated BP at initial measurement and BP re-measurement occurred at 30% (n=2210) of encounters with an 
elevated BP. The initial Peds & TeenBP trial at HealthPartners had a clinic-level ICC for BP re-measurement of 0.03 and 
BP re-measurement of 28% in UC and 47% in the Peds & TeenBP arm.23 With an expected 7,258 patients (161 per 
clinic), this study has 99% power for the H1 comparison of low- plus high-intensity clinics (30 clinics) with 15 UC clinics 
(alpha=.05, two-sided test, ICC=0.03) to detect a raw BP re-measurement difference of 15% between the usual care 
arm (30%) vs. low- plus high-intensity arms (45%). The minimum detectable difference with 80% power is 8% (30% UC 
vs. 38% low- plus high-intensity arms). With an expected 4,840 patients (161 per clinic), this study has 80% power for 
the H2 comparison of low-intensity (15 clinics, 2420 patients) vs. high-intensity clinics (15 clinics, 2420 patients), with 
alpha=.05, two-sided tests, ICC=0.03, to detect a minimum detectable difference in BP re-measurement of 10% 
between the low-intensity arm (40%) vs. the high-intensity arm (50%).
Aim 2. Based on the prior Peds & TeenBP trial24, along with observational studies of pediatric HTN10-12 we anticipate 2% 
of patients age 6-12 and 3% of patients age 13-17 will newly meet HTN criteria at a visit over 18 months, yielding a 
sample size of 1060 patients (24/clinic). The Peds & TeenBP study found that 21% of patients newly meeting HTN 
criteria were recognized over 6 months in UC and 55% in the Peds & TeenBP arm24, and the clinic-level ICC for HTN 
recognition was 0.035. With 1060 patients (24/clinic) and 45 clinics, this study has 99% power (alpha=.05, two-sided 
test, ICC=0.035) for H3 to detect a difference in HTN recognition of 17% between UC (20%) and the low- plus high- 
intensity arms (37%), and a minimum detectable difference of 11% (20% UC vs. 31% low- plus high-intensity arms) at 
80% power. For H4 the minimum detectable difference at 80% power for HTN recognition among 706 patients 
(24/clinic) is 14% between low-intensity (30%) and high-intensity (44%) arms. Power computations account for the 
design effect due to clinic randomization and unequal counts of clinics in some comparisons and were conducted with 
PASS 2019.  
Hypotheses 1 and 2 for Aim 1 posit that patients with an elevated BP seen at clinics with low- or high-intensity PedsBP 
CDS will be more likely to have their BP re-measured as compared to patients seen at usual care clinics, and that repeat 
measurement will be more likely for patients seen at high-intensity rather than low-intensity clinics. Because clinics are 
randomized and the outcome varies at the patient level, generalized linear mixed-model regression with a logit link and 
binomial error distribution will be used to test the effect of the interventions using the model specified below.
    Aim 1, H1:      BP_Remeasureji = γ00 + γ10TeenBPj + γ20StratFactorsj + γ01PatientCovarsi + [uj0 + eji]
    Aim 1, H2:      BP_Remeasureji = γ00 + γ10HighVsLowj + γ20StratFactorsj + γ01PatientCovarsi + [uj0 + eji]

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The dependent variable for Aim 1 (BP_Remeasure) is a binary indicator of post-implementation re-measurement of BP 
at the index visit at which the elevated BP occurred. For H1 this endpoint will be predicted by a fixed effect study arm 
term (TeenBPj) contrasting low- plus high-intensity PedsBP clinics with usual care clinics, stratification factors used in 
the clinic randomization (StratFactorsj), and patient-level covariates of age, sex, and SBP percentile of the elevated BP. 
A random intercept for clinics is included (uj0) to account for the clinic-level randomization. The analysis for H2 will 
contrast high- and low-intensity clinics (HighVsLowj)) and exclude usual care clinics from the analysis, but otherwise be 
similar to H1. Statistically significant study arm contrasts (alpha=.05) and parameters in the expected direction will 
support the H1 and H2 predictions stated for Aim 1.
Hypotheses 3 and 4 for Aim 2 posit that patients who newly meet HTN criteria at clinics with low- or high-intensity 
PedsBP CDS will be more likely to have their HTN recognized within 6 months as compared to patients seen at usual 
care clinics, and that recognition of HTN will be more likely for patients seen at high-intensity rather than low-intensity 
clinics. Generalized linear mixed-model regression with a logit link and binomial error distribution may be used to test 
the effect of the interventions following the same analytic strategy and equations for H1 and H3 above, with the 
substitution of HTN recognition as an endpoint in place of BP re-measurement, and the use of patient-level covariates 
of the lowest SBP percentile at the index visit, and BMI percentile at the index visit. Study arm contrasts will test 
differences in BP recognition for CDS (low-intensity or high-intensity) vs. Usual care and high-intensity vs. low-intensity. 
Statistically significant study arm contrasts (alpha=.05) and parameters in the expected direction will support the H3 
and H4 predictions stated for Aim 2.
8.4.1
ANALYSIS OF THE SECONDARY ENDPOINT(S)
Management of HTN within 6 months of meeting criteria will be described, including lifestyle counseling, dietitian 
referrals, subspecialty referrals, initiation of antihypertensive medications, and diagnostic imaging as individual 
endpoints in separate analyses and following the analytic approach described above for H3. Heterogeneity of the 
effects of the two implementation strategies will be examined in pre-specified subgroups defined by age (6-12, 13-17), 
BMI (>30 vs. <30), sex, and race/ethnicity, as feasible. Models described earlier will incorporate interaction terms of 
patient factors and study arm fixed effects and utilize study arm contrasts to estimate parameter estimates and 
standard errors for differences in implementation strategies within these subgroups of patients. We anticipate at least 
60% response rate among 214 providers in completing the provider survey. We predict that one or more follow-up BPs 
within 12 months of meeting criteria for HTN will be available for 70% of patients meeting criteria for HTN at 
intervention clinics and 50% of patients meeting criteria for HTN at usual care clinics.
9
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
9.1
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS
9.1.1
INFORMED CONSENT PROCESS
We are requesting a waiver of informed consent of providers and rooming staff, and a waiver of parental permission and 
child assent of patients, to implement and operate the PedsBP CDS in primary care clinics for the following reasons: (a) 
All treatment options included in the CDS algorithms are based on current national guidelines, and no other care 

Peds & TeenBP Main Study Protocol v. 1.8
Page 23 of 36
recommendations are provided. Thus, the care recommendations provided conform to current standards of care and 
ought not to represent any risk to patients beyond the routine risk that all patients assume whenever they have contact 
with the medical care system. (b) At intervention clinic training sessions and on CDS displays in the EHR, we emphasize 
that the material provided is meant only as a suggestion, not as a mandate, and that it is inappropriate for a provider to 
follow suggested treatment options without further checking the clinical status of a given patient. (c) It would be 
impractical to consent or assent patients (due to large numbers) and impossible to answer the primary research questions 
(due to selection effects related to consent) if informed consent of patients were required.
Because use of PedsBP CDS tool itself is considered usual care and all necessary data to determine eligibility, implement 
and operate the PedsBP CDS intervention, test the study hypotheses and assess the impact of the intervention are derived 
from electronic health records (EHRs), waivers of HIPAA authorization, informed consent, parental permission and child 
assent are being requested to identify and enroll patients who are to be included in the study.
All rooming staff and PCPs will be consented to participate in any interviews or surveys. DETAILS OF INTERVIEWS AND 
SURVEYS ARE PROVIDED IN SEPARATE PROTOCOLS.
9.1.1.1
SURVEY AND INTERVIEW CONSENT PROCEDURES AND DOCUMENTATION
DETAILS OF INTERVIEWS AND SURVEYS ARE PROVIDED IN SEPARATE PROTOCOLS.
The informed consent process is a means of providing study information to each prospective participant and allows for 
an informed decision about participation in the study. The informed consent forms will include all the required elements 
of informed consent. Prior to informed consent, research staff will provide a detailed description of the study and 
interview or survey to the potential participant and provide a copy of the consent to read. If the participant is interested 
in participating in the interview or survey, he or she will have the opportunity to ask any questions related to 
participation. 
The informed consent forms will be updated or revised whenever important new safety information is available or 
whenever the protocol is amended in a way that may affect participants’ participation in the study. Participants will be 
informed that their participation is voluntary and they may withdraw from the study at any time, for any reason, without 
penalty. Individuals who refuse to participate in interviews or surveys or who withdraw will be treated without prejudice.
9.1.2
KEY ROLES AND STUDY GOVERNANCE
For the proposed study, the EH Institutional Review Board (IRB) will serve as the single IRB (sIRB) of record. Prior to 
implementing the proposed study, EH and HP will sign an authorization agreement specifying roles and responsibilities. 
If any new organizations are added after the AHRQ award, they too will recognize EH as the sIRB of record for the study 
and complete an authorization agreement. The EH PI will directly communicate with the EH IRB. EH will maintain all 
authorization agreements and the IRB communication plan between the participating sites.

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Principal Investigator
Principal Investigator
Medical Monitor or Independent Safety 
Monitor
Catherine Benziger, MD
Cardiologist
Elyse Kharbanda, MD
Senior Investigator, Pediatrician
Carolyn Bramante, MD
Internist, Pediatrician
Essentia Health 
HealthPartners
University of Minnesota
218-786-3443
952-967-5038
TBD
Catherine.Benziger@essentiahealth.org 
Elyse.O.Kharbanda@Healthpartners.com 
bramante@umn.edu 
9.1.3
SAFETY OVERSIGHT
The PIs, Drs. Kharbanda and Benziger will be responsible for the safety of the trial and adherence with the study 
protocol. In addition, we have invited a single medical monitor, independent of the study, Dr. Carolyn Bramante, to 
lead the Data Safety Monitoring Plan. As in prior work by our group, we will select an independent medical monitor 
with relevant clinical and research expertise. The intervention provides point-of-care clinical decision support (CDS) to 
primary care providers designed to identify children and adolescents with elevated BP and HTN and suggests care 
options that may be appropriate in specific clinical scenarios. Suggestions provided to PCPs are based on national 
recommendations and will be further vetted by clinical leaders at Essentia Health (EH) prior to implementation. Alerts 
are designed to support clinicians’ decision making, not to override clinical judgment.  
The study team will convene within 3 months of the beginning of the intervention at a face-to-face or phone meeting 
with the independent safety monitor and will meet up to twice annually through the study. The independent safety 
monitor will provide guidance on the study evaluation and intervention protocols, including quality assurance and 
safety issues related to the intervention protocols, implementation strategies, and data-handling activities. The 
independent safety monitor will also provide periodic input and feedback on the progress of study accrual of patients, 
eligibility determination issues, data completion rates, and adverse events. Consistent with NIH, AHRQ, EH and 
HealthPartners (HP) policy, the medical monitor is not be affiliated with HP or with EH.  
As a minimal risk, pragmatic trial, we do not propose interim analyses or stopping rules.  A special focus of interest will 
be the safety of patients exposed to the study intervention. We will collect data from the electronic health record (EHR) 
or the CDS to identify potential rare adverse events related to untreated or undertreated HTN, such as malignant HTN 
or stroke. In addition, using automated methods we will monitor for hospitalizations within 6 months following 
exposure to the CDS, with additional clinical review regarding any potential for the CDS to have impacted subsequent 
events. The PIs will be responsible for responding to unsolicited complaints, for reviewing potential serious adverse 
events, and for additional communications with the IRB and with AHRQ.
9.1.4
CDS QUALITY ASSURANCE AND TESTING
Additional quality assurance (QA) and testing will be conducted to ensure appropriate functioning of the algorithms, 
which determine clinical recommendations made by the CDS to the provider and patient. Study personnel at EH will be 
responsible for manual chart review of select patients’ electronic medical records. No information will be will collected, 
used, or disclosed for study analyses.  
A full waiver of HIPAA Authorization is requested to access medical record for QA and testing purposes. 
9.1.5
DATA HANDLING AND RECORD KEEPING 

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9.1.5.1
DATA COLLECTION AND MANAGEMENT 
Data from the PedsBP CDS will be stored throughout the study, to be linked through a unique study ID with the minimum 
EHR and administrative data to evaluate study outcomes. Data transfer is secured using certificate-based authentication 
and IP whitelisting. In addition, data access is secured using FHIR based OAuth protocols.
In compliance with HIPAA regulations140, no personally identifiable health information (PHI) will be shared outside of 
the affiliated covered entities (ACE).  
The study team has extensive experience in health services research and clinical research with human subjects, with 
procedures to safeguard privacy and personal information. All study records are protected by:

Locked storing all paper records in a secure location

Use of untraceable study ID numbers instead of names wherever possible

Password protection as well as firewalls

Strong user login authentication on all electronic devices

Physical security for all electronic devices containing personal information
We will establish common study variable definitions drawn from national standards and from definitions used in HP’s 
previous studies.101 We will construct variable definitions and data-extraction procedures for demographics, enrollment 
characteristics, vital signs, pharmacy, and outpatient encounters and diagnoses. We will develop conceptual and 
operational definitions and technical specifications for data elements without established definitions. Data from all 
sources will be restructured into a common format and data elements combined into uniform files. All person-level 
information will be linked by a unique identifier so data can be compiled to the person level. Data integrity will be 
assessed to ensure that observations are valid, reliable, and consistent. Each variable will be tested for completeness 
and out-of-range values. The accuracy of HTN identification,102 selected laboratory results, BP data, and pharmacy 
data103 has been established in previous work in adult cohorts and found to be excellent. Definitions will be adapted 
from HP’s prior Peds & TeenBP clinical trial.22-24 
9.1.5.2
STUDY RECORDS RETENTION
Data will be retained in secure storage following the completion of the study in accordance with Minnesota and federal 
law. We guard against the potential for breach of subject confidentiality through a multi-layered system of data 
protection policies, processes, staff training, software safeguards and physical security measures for both paper and 
electronic data involved in research.
The following measures will be taken to protect subjects from the risk of breach of confidentiality: 
•
All data collected in the study will be identified by using a previously assigned arbitrary and unique subject 
identification number to each participant. 
•
A file containing a link between the study ID and individually identifying information will be maintained by a EH 
programmer who is member of the study team through the conclusion of the study. 
•
A crosswalk table linking the study ID to a patient identity will be destroyed within 12 months after the linked 
databases needed to test study hypotheses are completed. 
•
All electronic study data will be maintained in a computerized database residing on a username- and password-
protected file server to which only the researchers involved in the study will have access. 

Peds & TeenBP Main Study Protocol v. 1.8
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•
All study-related paper documents containing individually identifiable information will be maintained in locked 
file cabinets.
9.1.6
PUBLICATION AND DATA SHARING PLAN
In addition to presenting results at national meetings and in peer-reviewed journals, the investigators are available for 
any other dissemination activities that AHRQ staff deem appropriate. We plan to register this study on ClinicalTrials.gov 
and post results of the study on ClinicalTrials.gov when available, consistent with HP and EH research policies. As study 
findings become available, we will share with EH clinical leaders and EH Patient Advisory Councils. The importance of 
translating evidence-based care recommendations into primary care practice has long been known as a very high 
priority but few projects have addressed this need in children and adolescents living in rural regions, at risk of long-
term adverse cardiovascular outcomes by virtue of elevated BP and related cardiovascular risk factors and with limited 
access to pediatric subspecialty care. A key deliverable of this project is identification of optimal implementation 
strategies for clinical decision support or other care improvement interventions in rural clinics. These findings can then 
be extended to improve care for other pediatric risk factors and clinical conditions, especially in rural areas. The 
proposed study aims to translate the billions of dollars of private and public-sector investment in EHR technology into 
tangible improvements in the quality of care that children and adolescents receive in primary care practices.  
Sharing of study procedures and outcomes is an essential element of this research.  We are determined to ensure that 
data sharing occurs on a local, regional and national level.  
Our plan includes the following:     
Local:  We will work closely with clinical and administrative leaders at Essentia Health (EH) to ensure our CDS tool will 
be well accepted and locally relevant. During the intervention and analysis phases of the project we will continue to 
meet with these leaders to update them on our findings. If desired, once the intervention period is complete, we will 
activate the CDS at all EH pediatric and family practice clinical sites.  Findings of our research will be presented to local 
clinical and administrative leaders. 
Regional:  To assure regional dissemination of results and findings of this research will be presented at regional 
conferences, such as the Minnesota Academy of Family Physicians Innovation and Research Forum, and others. Results 
will also be communicated to other regional and state-wide medical groups including the Minnesota Department of 
Health and the Institute for Clinical Systems Improvement, a regional shared learning quality improvement 
organization.  
National:  Our main study findings will be presented at national meetings and will be published in peer-reviewed 
journals. If the funding agency so desires, and if permitted under then-current law, at the conclusion of the funding 
period we may provide a de-identified data set to AHRQ at their written request for the use of other qualified 
researchers in the future.  

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9.2
ABBREVIATIONS AND SPECIAL TERMS
AAP
American Academy of Pediatrics
BP
Blood pressure
BMI
Body mass index
BPA
Best practice advisory
CDS
Clinical decision support
DBP
Diastolic blood pressure
EH
Essentia Health
EHR
Electronic Health Record
HP 
HealthPartners
HTN
Hypertension
IRB
Institutional Review Board
LVH
Left ventricular hypertrophy
PI
Principal Investigator
QA
Quality Assurance
SAE
Serious Adverse Event
SBP
Systolic blood pressure
sIRB
Single Institutional Review Board
USPSTF
United States Preventive Services Task Force
9.3
PROTOCOL AMENDMENT HISTORY
IRB Ref. 
Number
IRB 
Submission 
Date
Approval 
Date
Description of Change
AMND-1.1
04.28.2021
06.09.2021
Request for single IRB and waiver of assent
AMND-2.0
01.07.2022
01.13.2022
Updated details for the pilot and training plan
AMND-6.0
03.16.2022
03.21.2022
Updated for full intervention (Phase 2)
AMND-7.0
01.19.2023
01.25.2023
Added data dictionary for safety and reporting
AMND-8.0
10.09.2023
10.10.2023
Updated to reflect Initial review of clinician and staff surveys
AMND-10.0
12.14.2023
12.18.2023
Added Appendix 1 describing assessment of cardiovascular risk factors 
and health related social needs
AMND-13.0
03.06.2025
TBD
Updated data collection dates

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description of a practical approach and early findings. Health Res Policy Syst. 2017;15(1):15.
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providers reduces cardiovascular risk: a randomized trial. J Am Med Inform Assoc. 2018;25(9):1137-1146.
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11
APPENDIX 1 – ASSESSMENT OF RISK FACTORS
Assessment of Cardiometabolic Disease Risk Factors and Health-Related Social Needs in Pediatric Patients 
with and without IDD 
Background and Rationale:
Cardiometabolic risk in childhood and adolescence is associated with future disease and cardiovascular mortality1,2,3. 
Although precise definitions and cut-offs may vary, cardiometabolic and cardiovascular disease (CVD) risk in childhood 
and adolescence can be measured across five domains (blood pressure (BP), lipids, glucose/Hgb A1c, smoking, body 
mass index (BMI)). Of these, BP and BMI are routinely assessed at all pediatric primary care visits, smoking status may 
be assessed during adolescent well visits, and lipids and glucose/Hgb A1c may only be assessed in patients with obesity 
or other risk factors4,5,6. 
People with Intellectual and Developmental Disabilities (IDD) have higher rates of cardiometabolic risk factors and 
cardiovascular disease compared to similar patients without IDD7,8. There is evidence that this risk begins to accumulate 
in childhood, but there is a lack of data describing the prevalence of CVD risk factors in pediatric patient populations 
with IDD. In order to learn how to better serve pediatric patients with IDD and their families and prolong length and 
quality of life for individuals with IDD, better data on risk factors and areas for potential risk modification are needed. 
Essentia Health started routinely collecting data on patients’ health-related social needs (HRSN) in 2020 in all primary 
care visits. This includes personal and medical transportation, food scarcity and food insecurity, and financial strain 
aimed to identify those report any adverse social conditions that can contribute to poor health9,10,11. Prior studies have 
noted an association between CVD risk and HRSN12.
The PedsBP clinical decision support (CDS) tool has potential to improve BP measurement, remeasurement and control, 
as well as raise awareness of CVD risk factors and work up for secondary causes13. Assessment of HRSN routinely occurs 
in primary care clinics and association of HRSN and CVD risk factors is important to describe.
This cross-sectional analysis utilizes the baseline data from patients’ PedsBP CDS index visit obtained from web service 
call data that is gathered at the index visit, as well as historical data prior to the index visit that will be gathered from 
the EHR.
Aims: 
1.
In youth 6-17 years of age, describe the assessment of CVD risk factor and HRSN data in the EHR by: 
a.
rural vs urban dwelling
b.
male vs female sex
c.
IDD vs non-IDD
2.
In youth 6-17 years of age with CVD risk factor and HRSN assessment in the EHR, describe the prevalence of 
CVD risk factors and HRSN: 
a.
rural vs urban dwelling
b.
male vs female sex
3.
Describe the association of CVD risk factors and HRSN.
4.
Determine the prevalence of having one or more- cardiometabolic risk factors among a cohort of pediatric 
patients 6-17 years receiving care in a large, primarily rural health system with a diagnosis of IDD (as defined by 

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ICD-10 diagnostic codes for IDD). Compare this prevalence with that of patients of similar age in the health 
system without IDD diagnosis. 
Hypotheses:
1.
Comparing study-eligible pediatric patients on the assessment of CVD risk factor and HRSN data:
a.
Assessment of CVD risk factors and HSRN will be more complete in urban-dwelling than rural-dwelling 
pediatric patients.
b.
Assessment of CVD risk factors and HSRN will be more complete in female than male pediatric patients.
c.
Assessment of CVD risk factors and HSRN will be more complete in patients with IDD than patients 
without IDD.
2.
Comparing study-eligible pediatric patients on the prevalence of CVD risk factors and HRSN:
a.
Rural pediatric patients will have a higher prevalence of CVD risk factors and HRSN than urban pediatric 
patients. 
b.
Male pediatric patients will have a higher prevalence of CVD risk factors and HRSN than female 
pediatric patients. 
3.
Patients with a higher count of HRSN will be more likely to have any CV risk factors. 
4.
Among those with at least two documented cardiometabolic risk measures, those with IDD will have increased 
CVD risk, compared with those with no IDD diagnosis.
Population: All PedsBP study-eligible patients aged 6-17 years on the date of a potential index visit (first visit) at a 
randomized Essentia Health clinic between August 1, 2022, to July 31, 2023.  
Exclusion Criteria: Opted out of use of their data for research prior to performing analyses.
Informed Consent: See Section 9.1.1 above.  
Main Measures: A complete list of variables that will be collected can be found in the data dictionary (separate 
document located in the study file).
Variable
Description
Data Source
Patient Description
Age, sex, race, ethnicity, vitals, labs, medications, diagnoses, 
encounters
CDS, EHR Clarity
Provider Type and Specialty
Standard categories
EHR Clarity
Tobacco and Marijuana Status
Standard categories
EHR Clarity
Rural-urban commuting area (RUCA) 
Ruca, zip code(s)
EHR Clarity
Intellectual and Developmental 
Disabilities (IDD)
Autism spectrum disorder, intellectual disability, cerebral palsy, 
genetic conditions, child disintegrative disorder
fetal alcohol syndrome
EHR Clarity
Health-Related Social Needs (HRSN)
Personal transportation, medical transportation, food scarcity, 
food insecurity, and financial strain
EHR Clarity
Analysis Plan:
Aim 1: Describe the assessment of CVD risk factor and HRSN data in the EHR by urban vs. rural patient dwelling, patient 
sex, IDD vs. non-IDD status. 

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The count and percentage of patients having assessment in the EHR will be computed for: a) assessment of 
information needed to document each individual CVD risk factor in the EHR (e.g., BP measured at the index visit, 
lipids measured ever, glucose or A1c measured ever, smoking assessed in the past 2 years, BMI recorded in the past 
2 years, problem list diagnosis of any CVD risk factor), b) documentation of any HRSN in the EHR. These summaries 
will be computed for all patients and stratified individually and multiply by patient dwelling (rural, urban), patient 
sex, patient age group. Differences in assessment of information (0/1) for each assessment will be assessed with 
logistic regression analysis predicting assessment of information from patient factors used as stratification 
variables.  
The same analysis strategy will be used to describe and test assessment of CVD risk factor information and HRSN 
for patients with IDD vs. non-IDD.
Aim 2. Describe the prevalence of CVD risk factors and HRSN by urban vs. rural patient dwelling, patient sex.
The prevalence of CVD risk factors will be computed as: a) the prevalence of any risk factor among the five of 
interest, and b) the prevalence of each individual risk factor. HRSN prevalence will be computed as the presence of 
any HRSN present. These summaries will be computed for all patients having CVD risk factor assessment (and HRSN 
assessment) from Aim 1 and stratified individually and multiply by patient dwelling (rural, urban), patient sex, 
patient age group. Differences in prevalence as defined above will be assessed with logistic regression analysis 
predicting prevalence from patient factors used as stratification variables. In addition, multiple linear regression 
will be used to assess the association of count of CVD risk factors with patient factors. Models will include the 
stratification factors listed above.
Aim 3. Describe the association of CVD risk factors and HRSN.
The association of any CVD risk factor (0/1) with presence of HRSN (0/1) overall and stratified individually and 
multiply by patient dwelling, patient sex, patient age group will be assessed in contingency table analysis and 
tested via Pearson and Cochran-Mantel-Haenszel chi-square tests. The association of each CVD risk factor with 
presence of HRSN (0/1) will be addressed with the same approach. 
Multiple linear regression will be used to assess the association of count of CVD risk factors with presence of HRSN 
(0/1). Models will include the stratification factors listed above. One set of models will exclude any interactions and 
a second set will include interactions in order to formally test for differences in the association of count of CVD risk 
factor and HRSN by subgroups (e.g., patient age group). 
Aim 4. Describe the prevalence of having one or more CVD risk factors in patients with a diagnosis of IDD vs. no 
diagnosis. 
The prevalence of CVD risk factors will be computed as: a) the prevalence of any risk factor among the five of 
interest, and b) the prevalence of each individual risk factor. HRSN prevalence will be computed as the presence of 
any HRSN present. These summaries will be computed for all patients having CVD risk factor assessment (and HRSN 
assessment) from Aim 1, and multiply stratified by IDD vs. non-IDD and patient age group. Differences in 
prevalence as defined above will be assessed with logistic regression analysis predicting prevalence from IDD vs. 
non-IDD and patient factors used as stratification variables. In addition, multiple linear regression will be used to 
assess the association of count of CVD risk factors with IDD vs. non-IDD and patient factors. 
References
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