Guia para Integrar Dados
Guia para Integrar Dados
Guia para Integrar Dados
Prepared by:
Dave Boston, MD 1
Deborah Cohen, PhD 2
Julie Stone, MPA 1
Erica Edwards, MS 1
Angelea Brown, MPH 1
Martha Snow, MPH 3
LeAnn Michaels 3
Lourdes González, MPH, CPH 1
Disclaimer: This practical guide was funded under contract number 75Q80120D00019 from the
Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human
Services. The authors are solely responsible for this document’s findings and conclusions, which
do not necessarily represent the views of AHRQ. Readers should not interpret any statement
in this product as an official position of AHRQ or of the U.S. Department of Health and Human
Services. None of the authors have any affiliation or financial involvement that conflicts with the
material presented in this practical guide.
Public Availability Notice: This document is made publicly available by AHRQ and may be used
and reprinted without permission in the United States for noncommercial purposes, unless
materials are clearly noted as copyrighted in the document. No one may reproduce copyrighted
material without the permission of the copyright holders. Users outside the United States must
get permission from AHRQ to reprint or translate this product. Anyone wanting to reproduce
this product for sale must contact AHRQ for permission.
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: ii
A Practical Guide
Acknowledgments
We would like to give gratitude to the Technical Expert Panel who has
given us permission to share their knowledge and experience in this
practical guide:
• Victoria Tiase, PhD, RN-BC, New York-Presbyterian Hospital
• James McCormack, PhD, Oregon Health & Science University
• James Pantelas, Patient Partner, Michigan
• Richelle Koopman, MD, MS, University of Missouri
• Matthew Roman, DPT, Duke Health
• Steven Kassakian, MD, MS, FACP, Humana Health
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: iii
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Table of Contents
FOLIO 1: Introduction: What is Patient-Generated Health Data
and Why is it Important?........................................................................................ 1
Key Learning Concepts.................................................................................... 2
What is PGHD?................................................................................................ 4
PGHD Referred to in This Guide...................................................................... 5
What Does It Mean to Integrate PGHD into the EHR?.................................... 7
Benefits of PGHD Integration ......................................................................... 7
PGHD Increases Patient Engagement and Satisfaction................................... 8
PGHD Integration into the EHR Provides a Fuller Picture of Patient Health... 8
Better Care Quicker: PGHD for More Timely, Personalized Interventions...... 9
Trends in Support of PGHD Integration and Use.......................................... 10
Health Equity and Integrating PGHD............................................................. 11
FOLIO 2: Assessing Readiness for PGHD Program Implementation..................... 13
Key Learning Concepts.................................................................................. 14
Preparing to Launch a PGHD Program in Your Practice................................ 15
Where to Start?............................................................................................ 15
Assess Staff Readiness.................................................................................. 15
Assess Patient Readiness.............................................................................. 17
Determine What Support Your Patients Need to Collect PGHD................... 17
ACTIVITY 2.1: Organizational Readiness.............................................. 20
ACTIVITY 2.2: Gauge Motivation and Concerns from
Patients and Colleagues........................................................................ 23
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
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ACTIVITY 2.3: Roadmap to PGHD Implementation:
Key Considerations Relevant to Patient Participation........................... 25
FOLIO 3: Assembling a Team to Manage Change................................................ 28
Key Learning Concepts.................................................................................. 29
Build the Team: Identify Stakeholders and Find Your Champions................ 30
Who Are Your Stakeholders?........................................................................ 30
The Role of the Champion in Change Management..................................... 30
Where to Find Champions: Who is Already Using PGHD in Clinical Care?.... 31
Designate a PGHD Coordinator to Support Patients and Staff...................... 31
Include Community Partner Organizations and Agencies............................. 32
ACTIVITY 3.1: Assemble Your Team of Champions............................... 34
ACTIVITY 3.2: Assemble a PGHD Workgroup....................................... 42
FOLIO 4: Making the Right PGHD and Information Technology
Decisions for Your Practice................................................................................... 43
Key Learning Concepts.................................................................................. 44
Choose Information Technology that Meets Your Needs............................. 45
Selecting Devices for Your PGHD Program.................................................... 46
Pathways to PGHD Integration into the EHR................................................. 46
Consider Your Approach to Patients Choosing Their Own Devices............... 48
Legal, Compliance, and Security Frameworks.............................................. 48
Data Governance.......................................................................................... 50
Privacy and Security...................................................................................... 51
ACTIVITY 4.1: Roadmap to PGHD Implementation:
Key Health IT, Legal, Compliance, and Security Considerations............ 54
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
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FOLIO 5: Evaluating the Costs of PGHD Implementation..................................... 61
Key Learning Concepts.................................................................................. 62
Big Picture Factors that Influence Your Program’s Financial Health............. 63
Billing and Reimbursement........................................................................... 63
Explore Other Sources of Funding................................................................ 64
Return on Investment................................................................................... 65
Incentive and Quality Reporting Programs................................................... 66
Develop a Budget to Implement, Grow, and Sustain Your Implementation. 67
Considerations for Your Cost Spreadsheet................................................... 67
ACTIVITY 5.1: Roadmap to PGHD Implementation:
Key Financial, Reimbursement, and Reporting Considerations............ 71
FOLIO 6: Steps to Successfully Implement a PGHD Program.............................. 73
Key Learning Concepts.................................................................................. 74
Developing Your PGHD Implementation....................................................... 75
Set Realistic and Measurable Goals for Your PGHD Implementation........... 75
Effectively Engage Your Target Group of Patients......................................... 77
Develop Diagrams and Detailed Workflows................................................. 78
Learn from Your Experience Before Scaling Your PGHD Implementation..... 80
Rapid-Cycle Testing and End-User Feedback................................................ 82
Support Staff Awareness Through Training and Messaging. ........................ 87
Scale with a Strong Internal and External Communication Plan................... 87
Share Success Stories.................................................................................... 89
Monitoring Environmental Factors............................................................... 89
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
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Resources for Implementation, Scaling, and Environmental Monitoring Your
PGHD Program ............................................................................................. 89
ACTIVITY 6.1: Bringing It All Together: Your PGHD Implementation.... 91
ACTIVITY 6.2: Craft Your First SMART Goal.......................................... 95
ACTIVITY 6.3: Develop Workflows....................................................... 96
ACTIVITY 6.4: Evaluate and Refine....................................................... 98
ACTIVITY 6.5: Scale Up and Monitor.................................................. 100
References.......................................................................................................... 102
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings:
A Practical Guide
Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide
IN THIS FOLIO
Key Learning Concepts
• Definition of patient-generated health data (PGHD).
• Integration of PGHD into the electronic health record (EHR).
provides clinical decision making support.
• Benefits of PGHD include increased patient engagement, fuller pictures of
health, and more timely interventions.
• The uptick in virtual care adoption provides support for PGHD.
• Efforts to attain health equity should be baked into program planning.
• How to Use This Practical Guide.
Integrating Patient-Generated Health Data into Electronic Health Records in Ambulatory Care Settings: 2
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FOLIO 1
Introduction: What is Patient-Generated Health Data and Why is it Important?
This guide is intended to support ambulatory care settings of all types—including offices of
physicians and other health professionals, outpatient departments, community health centers,
ambulatory surgical centers, and urgent care clinics and specialty clinics—in the design and
implementation of successful PGHD programs that can improve patient outcomes.
The guide is organized into folios that help your ambulatory practice—in partnership with your
patients—navigate the many steps from design, to launch, to maintenance of a successful,
sustainable PGHD integration program. Folios include planning considerations and practical
activities to support your effort to deploy a new and complex care delivery modality into
your practice.
Because your success will be highly linked to the capacity and interests of your practice staff
and the unique needs and preferences of your patients, PGHD programs are likely to differ
greatly across settings. The content of this guide is designed to support your unique journey—
pick and choose content in this guide that is useful to you. You may choose to read these folios
from beginning to end or to skip around to review content that has the greatest relevance to
your current needs. Additionally, the guide is completely searchable by keyword. Simply type
CONTROL + F (COMMAND + F for Mac users) to open the search bar.
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To make learning more meaningful, consider applying data from your own practice to inform
decisions and develop practical solutions to real challenges. Use real-life examples and patient
stories to inform your decisions around the design and implementation of your program.
Look for special icons that callout quick tips and ideas for easy scanning.
Tip Idea
Learning exercises and checklists invite active participation to tailor solutions
to your needs.
Activity
What is PGHD?
The Office of the National Coordinator for Health Information Technology (ONC)
defines PGHD as “health-related data created, recorded, or gathered by or from
patients (or family members or other caregivers) to help address a health concern.” 2
This includes patient-reported data gathered from surveys, and data generated from
remote monitoring devices, such as mobile health apps and wearable devices.
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PGHD Referred to in This Guide
For the purposes of this practical guide, we will consider the following categories and
domains of PGHD:
PGHD regarding the patient’s health-related quality of life, functional status, health
behaviors, symptoms, and symptom burden are collected via self-report. These are often
called patient-reported outcomes (PROs).
PROs are defined as “information providing the status of a patient’s health outcomes
that comes directly from the patient, without interpretation of that patient’s response
by a clinician or anyone else.” 6
There are a wide range of validated instruments to collect PROs. For example, PROMIS®
(Patient-reported Outcomes Measurement Information System) is an inventory of
validated, person-centered measures for adults and children that includes physical,
mental, and social health measures in English and Spanish, and may be administered on
paper, computer applications or software, or tablet apps.
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Patients may be asked to complete these instruments in the office, via the patient
portal, or through an app. PROs play a vital role in patient care, yet may not be routinely
captured in the EHR. 7
Biometric Data
Patient-generated biometric data include vital sign measurements and other indicators
of health such as blood pressure, blood glucose, and weight. These data can be captured
through patient-facing technology in between visits to better inform care, provide
trends, and monitor chronic conditions. Depending on the device and vendor, biometric
data may be integrated as discrete data into the EHR.
NOTE: We will not address implantable devices such as pacemakers in our discussion.
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What Does It Mean to Integrate PGHD into the EHR?
In keeping with the Clinical Decision Support (CDS) Five Rights, 8 PGHD need to be actionable
at the time of clinical decision making to make the greatest impact on patient care. PGHD
may indicate the need for further screening, medical intervention, behavioral counsel, or
medication adjustments.
When PGHD are integrated into the EHR, they are added to a patient’s health record and can be
used for clinical decision-making. These data can provide a more complete picture that informs
longitudinal, continuous care.
PGHD can be input manually into the EHR by patients, clinicians, or staff, or transmitted directly
from the patient to the EHR via a third-party vendor. Data will be entered either into a discrete
data field or as free text. This depends on the type of PGHD and the capabilities of the EHR
and third-party vendor device. PGHD collection and integration functionality may include an
additional cost from your vendor. If PGHD are entered into discrete fields, your EHR may
contain native applications that enable clinicians and patients to view PGHD data in
dashboards that assist with visualizing trends. 9
The rate and frequency by which PGHD may be transmitted and ingested into the EHR vary by
device. Some PGHD, particularly biometric data related to chronic diseases such as diabetes
or hypertension, may generate a high volume of data. To condense large volumes of data
points, batch transfers and binning algorithms can bucket data into units that can be more
easily managed by your EHR. High volumes of data, such as readings from a continuous glucose
monitor, are generally translated into data visualizations.
PGHD can facilitate patient and clinician management of conditions such as diabetes, high blood
pressure, chronic obstructive pulmonary disease, congestive heart failure, and pregnancy.
PGHD can help improve the care of homebound patients, those with mobility limitations, and
patients with transportation barriers.
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PGHD Increase Patient Engagement and Satisfaction
Using PGHD to inform medical care decisions offers patients the opportunity to become more
engaged, empowered, and connected to their health. 10 Increased patient engagement and
empowerment can contribute to better health outcomes and increased patient satisfaction with
their care. 11, 12, 13, 14 Further, PGHD provide patients reassurance in their self-management. 1, 15
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Better Care Quicker:
PGHD for More Timely, Personalized Interventions
When your PGHD integration is supported by EHR-based data visualization tools, clinicians and
patients can visualize trends and spot irregularities earlier, creating opportunities to make care
plan adjustments. Dr. Richelle Koopman explains, “People receive care during a visit, and then
they go too long between visits before we make another intervention. This goes for treatment
of everything from depression to hypertension. There are ways that PGHD—patient feedback
about what’s going on—can help us get to better care and improvement quicker.” 19
Figure 1. Example of an Idealized Data Visualization for Blood Pressure in the EHR 21
Key
180 Home Reading - Confirmed
PCP Clinic
160 Systolic BP
140 Diastolic BP
Note
Blood Pressure
Systolic
120
Range
Goal
100 Notes
01/15/2019 - R. Doctor, MD
Diastolic
80
Range
Goal
HCTZ 25
lisinopril 10
For more detailed information on the health benefits associated with the incorporation of
PGHD, please see the environmental scan.
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Trends in Support of PGHD Integration and Use
Figure 2. Drivers of PGHD Integration into the EHR in Ambulatory Care Practices
MRN: XXXX9999
PGHD Integration
Emerging healthcare technologies, Federal and State policies, evolving payment models,
and an increasingly competitive virtual healthcare marketplace, taken together with the
Nation’s collective pivot to virtual care during the COVID-19 pandemic, are among the factors
accelerating the shift to and support for PGHD integration.
This is not new territory for clinicians, who have relied on PGHD to inform treatment decisions
for decades. For example, home blood pressure measurement is not new, and it can effectively
identify white coat effect and masked hypertension. 16, 17
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Health Equity and Integrating PGHD
Through increased communication, fuller data, earlier intervention, improved self-
management, and higher engagement, the use of PGHD in ambulatory clinics may
have the potential to improve care for patients who are disproportionately impacted
by chronic disease—those with higher social risk factors such as low income, food
insecurity, and housing instability. 22, 23, 24
Yet, disparities in access and ability to use patient portals, devices, and other technologies
persist. These tools are not equitably distributed or available to those who may benefit from
PGHD most—a truth which has become more exposed throughout the COVID-19 pandemic. 25,
26, 27
Factors that potentially exacerbate the digital divide include broadband and device access,
digital health literacy, and lack of inclusive design. 1
Include health equity in your planning to help your practice identify barriers to PGHD adoption
within your patient population. This could be internet access, cost of devices, language, or
technical proficiency barriers.
The following are some considerations for building health equity into your PGHD program:
• Keep barriers in mind when selecting PGHD types and devices. If specific devices or
methods are not optional, lessen their impact with baked-in resources.
• Community partners can help fill other gaps. This could be a local library who can host
device technical support classes, or a peer support group that can share tips and tricks.
• When recruiting patients to participate in a PGHD program, offer the same opportunities
to all patients. Don’t assume lack of interest based on factors such as income, living
situation, or education. These patients may be eager and ideal candidates.
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This guide offers tips and ideas for ambulatory care practices of diverse sizes and resource
capacities, and provides suggestions for serving patients with limitations in digital literacy,
internet access, and English-language proficiency.
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Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide
IN THIS FOLIO
Key Learning Concepts
• PGHD integration may mark a significant change in your practice.
• Incorporate perspectives of staff into PGHD implementation planning.
• Incorporate patient perspectives on PGHD to achieve greater equity
and satisfaction.
• Assess your practice and patients for readiness.
Active Learning Exercises
• ACTIVITY 2.1: Organizational Readiness
• ACTIVITY 2.2: Gauge Motivation from Patients and Colleagues
• ACTIVITY 2.3: Roadmap to PGHD Implementation:
Key Considerations Relevant to Patient Participation
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Reaching this point in PGHD implementation requires numerous operational changes in your
practice that will impact your EHR, clinical teamwork, workflows, care delivery, and patient
engagement in care.
Where to Start?
It should not be difficult to find areas in your practice that would likely benefit from the
integration of PGHD into your EHR. Often, the more difficult task is prioritizing the best
opportunities for starting your program and addressing potential barriers to successful
implementation.
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
• Concerns that staff time needed to review PGHD will increase clinical staff workload.
• Lack of knowledge about how to select the right devices for patient use.
The concerns you may surface about PGHD integration are important to understand, as these
can pose substantial challenges to obtaining buy-in and successful PGHD implementation.
These experiences need to be carefully considered and addressed as you begin PGHD program
implementation.
Explore your organization’s readiness in more depth with Activity 2.1: Organizational Readiness
beginning on page 20.
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Start by assessing your patient’s motivation and challenges to collecting PGHD with Activity 2.2:
Gauging Motivation from Patients and Colleagues.
There are several factors that can limit patient’s use of PGHD.
• Digital health literacy (e-health literacy)
• Health literacy
• Language proficiency
• Technical proficiency
• Access to broadband or Wi-Fi
• Access to devices (i.e., smartphone, tablet, remote monitoring device)
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
You may find that some patients who could benefit from PGHD will need extra support. Learn
from your patients what kind of additional support would be helpful. Your practice may be
able to provide appropriate patient education, instructions, and technical support in multiple
media formats and languages that can enable a broader range of patients access to the benefits
of PGHD. 28 29
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Barriers
Patient education
and instructions
Technical support
Multiple media
Multiple languages
Community
partnerships
Wi-Fi hotspots
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
• What are examples of routine care in which patients bring PGHD to their appointments?
• What are examples of PGHD providers routinely request from patients to inform
clinical care?
• What are examples of screenings, surveys, or questionnaires routinely collected as part of
clinical care?
• What forms of remote patient monitoring are in use?
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Describe your organization’s level of enthusiasm for PGHD integration into the EHR.
What resources will executive leadership commit to providing (budget, staffing, dedicated time,
etc.) to execute this project?
Do you have a patient and family advisory committee or other venues to recruit patient
stakeholders or elicit input?
Who can be identified as a PGHD Coordinator from your practice who can champion this work?
Which processes will be used to execute new programs and quality improvement?
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Do you have a process for developing policy, protocol, training, and other needs for a new
health IT implementation?
What are staff attitudes about PGHD integration into the EHR to improve patient care?
Do staff have capacity to learn new workflows, protocols, and messaging for PGHD integration
into the EHR?
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
MOTIVATION TO PARTICIPATE
Gather information from patients and colleagues about their motivations to participate. 30
What conditions are patients most likely to manage and improve by collecting PGHD? (e.g.,
hypertension, depression, diabetes)
Does PGHD integration fill a patient care gap or unmet patient care need?
Are patients seeking new ways to communicate and share data about their conditions?
CHALLENGES
Conversely, it is important to get an idea of what your patient’s hesitations may be.
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Do your patients have physical barriers such as low dexterity, visual or hearing impairment, or
age-related barriers?
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
Your responses from previous activities in this folio will help guide you through these
considerations. This will begin forming your customized roadmap to implementation and assist
your work in Folio 6, Activity 6.1: Bringing It All Together: Your PGHD Implementation.
Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.
• Does this offering fill a patient care gap or meet an unmet patient care need?
• How do you identify patients or patient populations that are good/poor candidates?
• What are the motivations of patients to use PGHD? (e.g., improve BP control, monitor
symptoms of depression or anxiety, IVF/fertility medicine, lose weight)
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
• Do patients have sufficient resources to benefit from PGHD? (e.g., digital literacy, health
literacy, English proficiency, access to broadband or Wi-Fi, means to purchase devices)
• Are supports available to fill gaps (e.g., subsidized smartphones and data plans, lending
library of wireless devices, interpreter services, caregiver assistance)
• Have you considered how you might address inequities in access and care among
your patients?
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FOLIO 2
Assessing Readiness for PGHD Program Implementation
• Are there community partners (conventional and nonconventional) that might potentially
serve as sites for patient education and technical assistance?
• Have you considered how you might leverage resources external to your clinic in order
best engage your patients?
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A Practical Guide
Integrating
Patient-Generated Health Data
into Electronic Health Records
in Ambulatory Care Settings:
A Practical Guide
IN THIS FOLIO
Key Learning Concepts
• Build the team: Identify stakeholders and find your champions.
• A PGHD Coordinator could be crucial to success.
• External partners are powerful allies.
Active Learning Exercises
• ACTIVITY 3.1: Identify Your Team of Champions
• ACTIVITY 3.2: Assemble a Core PGHD Workgroup
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FOLIO 3
Assembling a Team to Manage Change
In Folio 2, you explored the readiness and enthusiasm of your practice to undertake PGHD
implementation, identified if you are already receiving any type of PGHD, and spoke with
patients and staff about what matters most to them. All of this was done to help you prioritize
and make informed decisions.
Folio 3 focuses on a next key step in the change management process: how to identify and
assemble your team that will lead the change.
Who will influence the success or failure of your implementation? These are the stakeholders
in your PGHD program implementation. Activity 3.1: Assembling Your Team of Champions has
a comprehensive, customizable list of possible stakeholders and champions. Depending on the
size of your operation, one person may fill multiple roles or one role might be filled by multiple
people. Activity 3.2 offers a table where you can name and organize your PGHD design and
implementation core team.
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FOLIO 3
Assembling a Team to Manage Change
As a way of building support and consensus early on, you might even consider influential staff
who have resisted change or virtual care ideas in the past.
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FOLIO 3
Assembling a Team to Manage Change
See Activity 3.1: Assemble Your Team of Champions for a more detailed list
of responsibilities and tasks for the PGHD Coordinator and other roles.
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FOLIO 3
Assembling a Team to Manage Change
Partnering with local organizations and stakeholders has demonstrated long-lasting health
benefits to diverse groups of patients. For example, one study partnered with local barbershops
to support blood-pressure reduction among Black male barbershop patrons. This collaboration
resulted in significant blood-pressure reduction when coupled with medication management
by specialty-trained pharmacists. 33 This is one creative partnership your organization could
consider to strengthen your PGHD implementation and patient engagement.
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FOLIO 3
Assembling a Team to Manage Change
Modify responsibilities to fit your practice needs, structure, and resources and choose
champions from this list to form your core PGHD workgroup.
Instructions: Type names directly into the field or print to handwrite. Click the checkbox to
indicate if this person(s) is a member of the core PGHD workgroup.
PGHD COORDINATOR
Name:
Core workgroup member
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FOLIO 3
Assembling a Team to Manage Change
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FOLIO 3
Assembling a Team to Manage Change
CLINICAL CHAMPION(S)
NOTE: Include clinicians and clinical support staff involved in PGHD implementation in your
practice. (e.g., physicians, physician assistants, nurse practitioners, nurses, care managers,
clinical pharmacists, medical assistants)
Name:
Core workgroup member
PATIENT(S)
NOTE: Include patients from your patient and family advisory council, if applicable.
Name:
Core workgroup member
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FOLIO 3
Assembling a Team to Manage Change
Name:
Core workgroup member
• Ensure your practice meets PGHD implementation reporting requirements for regulatory
programs, certifications, alternative payment programs (e.g., patient-centered medical
home recognition, uniform data system reporting, accountable care organizations).
• Monitor for opportunities to participate in PGHD implementation incentive programs.
• Partner with EHR vendors to automate PGHD-related data capture for reporting purposes.
Name:
Core workgroup member
• Assess bandwidth and equipment needs in various settings (e.g., exam room, remote
office, patient home).
• Consult on technology solutions and equipment vendors.
• Install, configure, test, and maintain PGHD implementation hardware and software.
• Support patients with initial setup/validation/calibration for prescribed remote monitoring
devices, fitness trackers/wearables.
• Assist with staff and patient PGHD implementation training and troubleshooting.
• Coordinate with MTT assisting patients in their homes.
• Work with EHR vendor to ensure interoperability for seamless, bidirectional
PGHD exchange.
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FOLIO 3
Assembling a Team to Manage Change
INFORMATICS CHAMPION(S)
Name:
Core workgroup member
• Partner with clinicians and the EHR vendor to automate clinical criteria for PGHD triage.
• Design effective dashboards or data visualization tools to present the right PGHD at the
right time to inform clinical decision making.
• Work with clinician champion to Identify segments of the patient population that are good
candidates for PGHD.
• Participate in developing solutions to streamline interoperability between PGHD devices
or apps and the EHR (e.g. SMART on FHIR APIs, SMART Markers). See the following sidebar
for more information.
• Communicate the importance of ingesting PGHD as discrete data elements rather than
free text.
• Advocate for standardized codes for PGHD-related services and procedures (e.g., CPT,
SNOMED, LOINC).
SMART Health IT
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FOLIO 3
Assembling a Team to Manage Change
BILLING/FINANCE CHAMPION
Name:
Core workgroup member
• Stay current on PGHD billing and reimbursement policies and rates (local, regional, State,
Federal, CMS, Medicaid, private payer).
• Ensure billing codes and modifiers (e.g., ICD-10, CPT, SNOMED, LOINC) are optimized for
reimbursement and data collection purposes.
• Track PGHD-related costs, fees, penalties, incentives, revenue and variable
financial dynamics.
• Monitor for PGHD implementation incentive opportunities with private payers or
major employers.
• Project PGHD implementation return on investment (both revenue and cost savings).
LEGAL CONSULTANT
Name:
Core workgroup member
• Ensure legal and regulatory compliance with Federal, State, and payer guidelines.
• Vet vendors and providers; negotiate and manages external contracts.
• Oversee Business Associate Agreements and Data Use Agreements with contracted device
and app vendors.
• Review liability and cybersecurity issues related to PGHD implementation.
• Advise on top-of-license clinical support staff functions related to PGHD implementation.
• Consult on legal aspects of PGHD implementation policies, protocols, and workflows.
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Assembling a Team to Manage Change
Name:
Core workgroup member
Name:
Core workgroup member
• Partners with clinicians, informaticists, and IT specialists to pair existing and native EHR
features to support clinical use cases for PGHD implementation.
• May offer a menu of proven interoperable PGHD apps and devices
(e.g., SMART on FHIR gallery).
• May offer “plug and play” PGHD kits with one or more devices tailored to specific
clinical applications.
• May offer solutions to ingest or translate PGHD in languages other than English.
• May offer staff technical training and support.
• May offer patient education and technical support.
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FOLIO 3
Assembling a Team to Manage Change
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FOLIO 3
Assembling a Team to Manage Change
Your core workgroup may include a mix of champions and other representatives who
will support your PGHD implementation.
Executive Sponsor:
PGHD Coordinator:
Patient Representative(s):
Practice Manager/Operations:
Quality Reporting:
Health IT:
Billing/Finance:
Other:
Other:
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IN THIS FOLIO
Key Learning Concepts
• Identify information technology best suited to your PGHD implementation.
• Legal, compliance, and security factors must be considered ahead
of implementation.
Active Learning Exercises
• ACTIVITY 4.1: Roadmap to PGHD Implementation: Key Health IT, Legal,
Compliance, and Security Considerations
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Making the Right PGHD and Information Technology Decisions for Your Practice
Cost
Whether you would like customization or not, be sure to talk with your EHR vendor about
cost, as functions related to integrating PGHD into your EHR are likely to have a cost. See
Folio 5: Evaluating the Costs of PGHD Implementation for more information.
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Making the Right PGHD and Information Technology Decisions for Your Practice
Tip: The good news is that you do not have to do all this research and
testing yourself. Some EHR vendors furnish PGHD device kits tailored to
specific clinical conditions. There are also third-party vendors who offer
PGHD packages and/or facilitate EHR integration. Identifying these available
options will significantly lighten your workload.
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Making the Right PGHD and Information Technology Decisions for Your Practice
Patient
PGHD Source Device
(& Device
App)
API
Mobile
Third-party Data
Health API
Vendor Aggregator
App(s)
API API
Clinic Patient
EHR
Portal
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Be mindful of scenarios that call for multiple devices. This will increase the complexity for both
your practice and your patients. For example, while kits of devices can be helpful for patients
to track COVID-19 symptoms (digital thermometer, blood pressure cuff, and pulse oximeter)
or diabetes (wireless glucometer, blood pressure cuff, and weight scale), they also require
sophisticated patient tracking of data from each device and a more complex and timely process
for uploading data via the portal for each device.
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Consent
Finally, work with your legal and compliance team to ensure that proper consent is collected
from adults and minors with respect to PGHD. For example, the Children’s Online Privacy
Protection Act requires parent or guardian consent before collecting personal identifiable
information from patients under 13 years of age. 36
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Making the Right PGHD and Information Technology Decisions for Your Practice
Data Governance
Establishing a data governance plan will help you build an organization-wide framework of
policies and standards to manage and protect your health information data assets. 37 A data
governance plan can also help you inform policies and protocols to establish your practice’s
response time to address abnormal PGHD values. It will also help your practice set patient
expectations about such things as terms of use for PGHD in clinical care, turnaround time for
communications, and instructions for urgent or emergent symptoms related to PGHD.
Consider building a data governance framework that can help your practice with the
following topics:
Patient Consents
It may be necessary to obtain signed privacy and security consent forms from your patient
population. For example, rules for collecting and sharing PGHD may differ for pediatric
patients with type 1 diabetes using continuous glucose monitors compared to adult
hypertension patients uploading information into their patient portal.
EHR Ingestion
Your practice may find it useful to set parameters around how often certain types of PGHD
should be ingested into the EHR. PGHD may be collected and transmitted daily, weekly,
or monthly. Devices such as heart monitors can transmit data every few seconds. In such
instances, data governance may help determine the binning algorithms to manage large
volumes of data. Ensure that data do not become too abundant and indigestible to the
clinical care teams.
Data Quality
In the context of PGHD integration into the EHR, data governance can help ensure that
PGHD are reliable, validated, timely, and clinically actionable. It may determine how often
your practice sends PGHD requests, PRO surveys, or other prompts for patients to provide
PGHD. Your data governance plan can include specifications for the length of survey
instruments and free text data elements.
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Federal and State regulatory oversight may become more standardized as broader adoption
grows, particularly pertaining to consumer health devices. In the meantime, it can be difficult to
assure patients, clinicians, and practices that PGHD are private and protected. This is what we
know so far.
HIPAA
The Health Insurance Portability and Accountability Act of 1996’s (HIPAA) Privacy and
Security Rules apply to PGHD when data become part of your practice’s health record.
PGHD should be de-identified in transit, which flow from the patient’s device, often via
multiple intervening connections into the practice’s EHR. Because the practice cannot
control each step of this process, it is crucial to seek HIPAA-compliant vendors and platforms
that perform privacy and security measures such as encryption. As noted by the Office of
the National Coordinator for Health Information Technology (ONC), prior to reaching the
EHR, PGHD are open to higher security risk because they are not necessarily protected
by the same HIPAA regulations, potentially increasing their vulnerability to cyber threats
and breaches. 38
To comply with HIPAA regulation, it is prudent to work with your practice’s security and IT
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staff to ensure safe transit of PGHD into the EHR through appropriate physical, technical,
and administrative safeguards.
Tip: When using third-party vendors that will handle protected health
information, use a Business Associate Agreement to stipulate that security
and privacy practices of the vendor uphold HIPAA regulations.
Because the legal and policy environment around PGHD continues to evolve, practices with the
capacity may consider assigning a staff role to monitor new developments in this area that may
affect your programs and patients.
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Tip: Leverage your stakeholder group for guidance and assistance. Convene
representatives from the clinical team, patients, support staff, and legal and
compliance to review your protocols and practices and look for gaps.
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Making the Right PGHD and Information Technology Decisions for Your Practice
These considerations will help form your customized roadmap to implementation and assist
your work in Folio 6, Activity 6.1: Bringing It All Together: Your PGHD Implementation.
Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.
Device Considerations
• Will you standardize a formulary of validated devices, screening instruments, and apps?
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• Does your EHR permit multiple device inputs for one patient?
Device Selection
• How will devices be integrated with the smartphone, computer, apps, and the EHR?
• Which devices work equally well on both iPhone and Android phones?
• Have devices been validated for accuracy? Can you locate evidence from the device
vendor or elsewhere that demonstrates that the data collected are accurate?
• Do your payers have specific requirement for device use linked to reimbursement? For
example, as of 2021, Medicare requires that medical devices supplied to patients for
remote physiologic monitoring services are valid, reliable, and meet FDA criteria.
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ADDITIONAL CONSIDERATIONS
• What types of data can be ingested via your health information exchange?
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• What kinds of digital visualization tools or dashboards might you use to interpret and
monitor PGHD values? Might these data visualization tools have applications for
patient education?
Legal Considerations
• Does monitoring the PGHD to be collected during the PGHD implementation require
additional medical liability coverage?
• What are the Federal, State, regional, and local regulations and policies governing the
PGHD to be collected in the implementation?
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• Have you developed criteria to ensure data are clinically relevant, valid, accurate,
and timely?
• Can you automate methods to flag clinically significant data; parse signal from noise?
• Can you trace provenance of data (i.e., what is the data’s origin and what steps took place
for it to reach its destination)?
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• What legal, regulatory, clinical, technological, patient safety, and communications policies
and protocols need to be in place?
• What are the expectations and obligations for clinicians to respond to passive/continuous
PGHD with abnormal values?
• How will patients reporting PGHD with abnormal values during off hours be managed?
• What is the course of action if a patient sending abnormal results does not respond
to outreach?
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• How might PGHD integration into the EHR increase vulnerabilities to cyberattacks?
• How will you educate your patients about their protections under HIPAA?
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IN THIS FOLIO
Key Learning Concepts
• Identify factors that will influence your program’s financial sustainability.
• Develop a budget to implement, grow, and sustain your program.
• Estimating initial and ongoing costs.
• Identify sources of funding and cost savings.
Active Learning Exercise
• ACTIVITY 5.1: Roadmap to PGHD Implementation:
Key Financial, Reimbursement, and Reporting Considerations
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Evaluating the Costs of PGHD Implementation
This folio will help you consider the financial costs and potential gains of your PGHD program.
Beginning with broader factors such as billing, reimbursement, return on investment (ROI), and
funding sources that will impact your program, the remainder of the folio offers guidance on
how to estimate the initial costs associated with PGHD implementation, as well as resources
needed to maintain your PGHD program in the future.
As you read through this folio, keep in mind that PGHD program implementation is an
organizational change that will involve all aspects and people in your practice. Work with your
team to identify all of the different resources and staff support that you will need to get PGHD
implementation off the ground.
Medicare
Since 2018, the Medicare Chronic Care Management (CCM) program has reimbursed providers
and care managers for collecting and interpreting PGHD in the management of hypertension,
diabetes, asthma, and several other chronic diseases. 40
The Medicare physician fee schedule for calendar year 2021 41 finalized reimbursement policies
for remote physiological monitoring (RPM) services performed by both physicians and non-
physician providers (NPP). These services may be medically necessary for acute care as well as
managing chronic conditions.
Devices patients use for RPM services must meet the FDA’s definition of a medical device. The
patient must collect and transmit their PGHD electronically. These rules go into effect after the
COVID-19 Public Health Emergency ends.
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Medicaid
According to a 2021 survey conducted by the Center for Connected Health Policy (CCHP),
Medicaid programs in 26 States reimburse for remote patient monitoring. 42 Policies and rates of
reimbursement for PGHD services vary widely from State to State. The CCHP updates its online
State Telehealth Laws and Reimbursement Policies report twice per year. 43
Private Insurance
A growing number of private insurers offer subsidized fitness trackers and digital medical
devices to incentivize participation in individual or employer-sponsored fitness and
wellness programs. Many are also beginning to cover the use of RPMs to support chronic
care management.
Your team’s billing and reimbursement champion might investigate the opportunities to bill for
services related to PGHD implementation. It will be crucial to determine the reimbursement
rates for those services and restrictions tied to reimbursement. For example, reimbursement
might be contingent on whether the service is rendered by a physician or NPP. It may depend
on the particular device or app the patient uses to collect and share their PGHD. Your practice’s
payer mix will help guide where to focus research.
• Federal, State, and local government agencies that may offer grant opportunities to
support PGHD implementation.
• Funding from private foundations, including companies that manufacture PGHD devices
and apps.
• Discount programs or price breaks may be available. For example, inquire with your EHR
and medical device vendors about PGHD on large volume purchases of equipment or
software licenses.
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• Risk-sharing models or other value-based payment ideas with local payers and healthcare
organizations. Such funding arrangements may provide incentives to integrate PGHD to
improve care outcomes.
Return on Investment
ROI is a common analysis to gauge value. There are multiple ways to look at the financial ROI for
PGHD programs in your practice. The billing and reimbursement champion on your team will be
able to provide information about the payer rates of reimbursement for various PGHD related
services. These figures can be used to develop projections for future PGHD-revenue streams
based on anticipated billing volume.
At present, rates of reimbursement are relatively low and will likely not offset all costs related
to your PGHD program. As this changes, consider the indirect cost savings generated by a
PGHD program.
In addition, systemic cost savings related to PGHD integration may be possible. 46 Work with
your payers to determine if there are shared benefits for your practice.
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Examples include:
• Health Resources and Services Administration (HRSA) Uniform Data System (UDS)
reporting program
• Centers for Medicare and Medicaid Services (CMS) Clinical Quality Measures
(CQMs) program
Regional accountable care organizations as well as certain Medicare services, such as the
Initial Preventive Physical Exam, Annual Wellness Visit, and CCM program, also require
reporting on electronic PGHD integration into the EHR.
As of 2020, the HRSA UDS Controlling High Blood Pressure measure will
only accept blood pressure readings collected by a clinician or a remote
monitoring device. This UDS measure aligns with CMS clinical quality
measure CMS165.
Under the Medicare Access and CHIP Reauthorization Act of 2015, CMS
established a pair of payment structures to support RPMs. xv Eligible
clinicians may participate in Medicare fee-for-service activities that reward
use of PGHD through the Merit-Based Incentive Payment System (MIPS).
47
Providers exempt from participating in MIPS may choose the Advanced
Alternative Payment Models structure that provides financial incentives for
using PGHD to offer more flexible and timely care that improves outcomes
and reduces costs. 48
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Use the following section as a guideline of considerations as you build the budget for your
PGHD program.
NOTE: This list is not comprehensive and will need to be customized to meet the unique needs
of your practice.
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Initial Costs
3. Staffing
Consider if you have the capacity and expertise on staff to lead the PGHD implementation in-
house, or whether your will contract with a consultant. If the latter, you will need to estimate
consultant time and costs.
Staffing costs may include:
• Dedicated planning, testing, and implementation time.
• New roles added to staff model (i.e., PGHD Program Manager).
• Development and delivery of staff training.
• External contracts.
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4. Communications
Consider the costs associated with building your communications plan regarding PGHD
implementation and use. Communications will likely be targeted to practice staff and patients.
Examples of communications activity costs include:
• Patient-facing campaign to tout benefits and boost uptake of PGHD.
• Patient instruction materials in a variety of media and languages.
• Writing and publicizing success stories to gain PGHD implementation support.
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Idea: Plan ahead for ongoing costs and reducing clinician burden
Consider including lines in your budget for ongoing staff training on evolving
PGHD implementation best practices or scaling up your program. Your
financial champion may also want to consider the financial implications of
strategies to relieve clinician burden such as:
• Using clinical support staff working at the top of their licenses.
• Using triage pools to monitor and flag PGHD coming into the EHR.
• Developing algorithms and data visualization tools to efficiently use
PGHD for clinical decision making.
Your practice may benefit from coordinating with other like practices engaged in PGHD
integration, including possibly sharing PGHD coordinators across practices to help you build on
and implement learnings from your peers. You may also consider engaging medical societies
who can connect you to resources and other practices doing similar work. Finally, you may even
be able to engage students from local colleges and universities to aid your practice in the design
and/or evaluation of your new program.
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These considerations will help form your customized roadmap to implementation and assist
your work in Folio 6, Activity 6.1: Bringing It All Together: Your PGHD Implementation.
Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.
BILLING CONSIDERATIONS
• For billing purposes, does it matter which clinical role performs various aspects of
the work?
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FINANCIAL CONSIDERATIONS
• Will your practice create a loaner library to assist patients unable to afford
validated devices?
REPORTING CONSIDERATIONS
• Which PGHD might be useful to capture for quality reporting or incentive programs?
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IN THIS FOLIO
Key Learning Concepts
• Set realistic and measurable goals.
• Effectively engage your target group of patients.
• Develop a workflow to support staff engagement and program design.
• Learn before scaling your PGHD program.
• Conduct rapid-cycle tests of change and applying end-user feedback.
Active Learning Exercises
• Activity 6.1: Bringing It All Together: Your PGHD Implementation
• Activity 6.2: Set SMART Goals
• Activity 6.3: Develop Workflows
• Activity 6.4: Evaluate and Refine
• Activity 6.5: Scale Up and Monitor
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Steps to Successfully Implement a PGHD Program
Throughout this folio, an example of a PGHD implementation for patients with uncontrolled
hypertension helps illustrate concepts such as developing SMART goals and using Plan-Do-
Study-Act (PDSA) cycles.
Specific
What are you trying to accomplish?
Who is responsible?
How will you accomplish it?
Measurable
What quantifiable benchmarks does your project have?
How many or how much?
Attainable/Achievable
Is this goal actually doable within the timeframe?
Do you have the resources needed to reach this goal?
Reasonable/Relevant
What is the benefit of reaching this goal?
Why are you embarking on this project?
Time-Bound
What is your deadline to meet this goal?
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Engage the core PGHD workgroup to set your small-scale PGHD implementation goals and
ensure they are realistic. Collectively determine what success will look like for your practice and
how to quantify it.
The following is an example of a clinical use case being transformed into an implementation
plan using the SMART framework.
The clinic has just been awarded a grant for the purchase of home blood pressure
(BP) devices.
During our first stakeholder meeting, we decided to focus on a select set of hypertensive
patients for our PGHD implementation. We chose hypertension because we have
a large volume of our uncontrolled hypertension patients. We thought we would
try incorporating PGHD in a small subset to see if we could move the needle before
extending this intervention to a larger patient population. We also have a clinician who
is very interested in championing this topic and has energized her team of medical
assistants and the nurse pool about this endeavor.
Our goal is to provide 25 patients with Bluetooth-enabled cuffs to collect blood pressure
readings that will integrate into the EHR within 3 months and then measure our target
population’s pre and BP measurements and their device usage data. We decided to also
conduct post-intervention surveys to assess both the patient’s and staff’s satisfaction
with our implementation. Our stakeholder team will then reconvene to review the
implementation data and discuss next steps. The following example displays this use
case using a SMART framework to support our implementation design and intervention.
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R – Reasonable: It is certainly a worthy goal to improve BP in this population and reduce risk
of cardiovascular events. This will also provide valuable insight into the use of PGHD in future
population health initiatives.
T - Time-bound: These are clear and achievable. Six months is a tight cycle, but the program
involves only a small group of staff and patients.
Activity 6.2 will guide you through a SMART goal activity on page 96. Methods and strategies
for evaluation of goals will be discussed in the second half of this folio.
More information on selecting the initial group of patients to enroll in your program can be
found in Folio 2.
When it is time to engage with your patients for your PGHD implementation, you could collect
information using a patient focus group or through individual patient interviews to hear their
interests, concerns, and questions about the specific project. We recommend asking patients
the following questions as you develop your program.
• Do you share data currently, such as bringing in handwritten logs, inputting data into the
portal, or asking about health-related apps or devices?
• From your past experience with illness, what data would have been useful to share with
your medical team?
• What is your comfort level with technology such as apps and devices?
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• In your opinion, would receiving patient digital health data help meet unmet care needs?
• Do you worry about how much added time collecting PGHD will take?
• What else would you like the practice to know about getting digital data from patients?
Idea: Provide training and support before patients use their device.
Before sending patients home with a new device or app, offer opportunities
for training and technical support. Make educational materials available in
a variety of media and languages. Additional considerations should be given
to those with dexterity, vision, or hearing impairments. Understanding
cultural values can be very helpful as well. You might consider non-clinical
resources to engage patients and improve adoption, such as working with
community centers, faith-based organizations, even barber shops. 49
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Swimlane Diagrams
Swimlane diagrams (also known as flowcharts) can be an effective way to demonstrate
chronology and responsibility. This, combined with adequate time and training, can also
help alleviate staff resistance to change. Each step in a process is identified by which role
is responsible and at what point in the process it occurs. Icons can be used to further
communicate about particular steps in the process, such as where the process starts and
ends, if a decision needs to be made, or if another workflow needs to be referenced or used
in between steps. For more information on how to build and use swimlane diagrams, see
AHRQ’s Workflow Assessment for Health IT Toolkit section on flowcharts.
Figure 2 is an example of a swimlane diagram showing one clinic’s workflow for getting an
integrated device and instructions for use to a patient. Activity 6.3 provides a blank swimlane
diagram to practices thinking through a PGHD process.
Device Workflow
This workflow describes the process of prescribing, receiving, and registering device for a patient.
July 21, 2021
1 Devices include blood pressue machine, optimeters, glucose monitors, thermometers, etc.
2 Information includes vendor, serial number, date of distribution, date of mailing, date of patient receipt
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• Short user experience surveys or focus groups can be used to collect valuable information
about what various end-users like about the PGHD integration process as well as aspects
they would improve. Consider seeking patient input on their experience with the following
topics:
◦ Patients’ ability to easily use and understand the device, including its interface and
language settings.
◦ Ease of uploading patients’ data into the EHR via patient portal.
◦ Patient awareness about how their data are being used at the point of care.
• You may also consider soliciting feedback from all the involved staff members. Examples of
questions you might ask include:
◦ How satisfied are staff with training and onboarding into the program?
◦ How well do workflows deliver actionable data for clinical decision making?
◦ How are those criteria are being using to screen for participation?
◦ Do staff feel they have the technical skill to locate PGHD data in the EHR and
visually display them in a way that is easy to interpret?
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Idea: PGHD Coordinators can help onboard new clinicians and patients.
If you are a larger organization or plan to apply a PGHD program across
multiple use cases, it may be beneficial to assign distinct PGHD coordinators
to oversee and share responsibility. If you are a smaller organization and
need to assign this role to clinical staff, you may want to monitor how much
time this takes away from patient care. Ideally, your practice can identify
nonclinical technical specialists with the expertise and dedicated time to
focus on supporting patients and clinicians. These technical support staff
may work with clinicians and patients on site, in the clinic, or virtually via
phone or videoconference.
Tip: Ensure training and technical support resources keep pace with
program expansion. Perhaps the most critical piece of scaling up is to
ensure both staff and patients have abundant education to correctly use
PGHD devices, apps, and instruments, as well as knowledgeable and timely
technical support to help troubleshoot when things go wrong. Engaging
care coordinators, home health providers, and community organizations can
be helpful to serve as trainers or coordinators to augment clinic staff.
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• Choose a measurable change you would like to test. Remember to start small. This
can be a minor tweak to a routine process.
• Determine the units of measurement you will use.
• Plan the actions to make this happen.
• Describe why you want to perform this change and what you hope to achieve.
• Study the data with your team to interpret the impact of the change.
• Identify what you have learned.
• Decide on next steps.
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Let’s continue with the hypertension program example to demonstrate observing, learning, and
refining processes using this framework.
The plan was implemented, and we are now at the 6-month mark. Operational details
for this stage of the cycle can be found on page 76 and 77, including the use of project
management tools such as a Swimlane Workflow Diagram.
We are ready to review the operational, BP, and qualitative survey data.
Operational Data:
• 21/25 patients completed the program, returning their devices and having a post-
intervention visit with the clinician. Two devices didn’t work adequately, one was lost, and
one was broken.
• There were 56 critical alerts from 12 patients; 50 of them were appropriate and responded
to within 2 business days.
• There were 11 alerts that were triggered due to a patient neglecting to indicate on their
smartphone that their medication was taken for 5 days. Upon reaching the patients, they
all reported 100% compliance but forgot about checking off the reminders on their phone.
• The pharmacist had a 40% connection rate with phone calls, averaged 1.8 successful calls
per patient, and connected with 23/25 patients at least once.
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• Three cases of white-coat hypertension and two cases of resistant hypertension were
added to the problem list.
Survey Data:
• Patient surveys were returned by 19/25 patients. Overall satisfaction score was 4.1/5.
The main barrier identified was difficulty getting the cuff readings to sync with the portal.
Many also found the process a little tedious, especially the educational materials and daily
prompts. Facilitators included the phone calls and the IT help desk.
• Staff surveys were returned by 7/8 staff members and overall satisfaction was 3.9/5. The
main themes identified EHR usability on the plus side and inadequate time to perform
PGHD duties on the minus side.
Though clearly a truncated version of a real evaluation process, the data summary
nevertheless highlights the vital information that can be obtained from the Study
portion of a PDSA cycle.
• Eliminate the compliance alerts. This is addressed with the phone calls anyway.
• Continue with the critical value alerts, but plan on carving out 30 minutes of protected
time for responses and followup. Look further into the data to see if we can raise the
alert limit.
• Celebrate the BP response, but there are still too many patients with uncontrolled
hypertension. The clinical team will enhance the algorithm, extending the program for
those who were making progress but didn’t reach goal, while removing some of the
automated content found to be more annoying than useful.
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• Chart review of the five patients who had mixed or negative responses.
• Provide patient education and collaborate with their IT team and device vendor to get the
percentage of electronically interfaced BPs over 50%.
Incorporate the suggested modifications and repeat testing for as many cycles as necessary. This
process can be especially valuable to fine tune PGHD integration workflows.
When you are satisfied with the results within the limited group of providers and patients
participating in your implementation, consider replicating it across other groups of providers
and/or patients. This will enable you to validate that your PGHD solution performs well under a
variety of circumstances and settings with different portions of your patient population. Based
on findings from this round of testing, make further modifications as needed. Activity 6.4
provides a blank PDSA template as an option to use in your practice.
There are many resources and guidance on how to carry out PDSA cycles.
Follow these links to learn more.
Institute for Healthcare Improvement (IHI): Science of Improvement: Tips
for Testing Changes
IHI: Why You Should Be Curious about PDSAs
LifeQI: Understanding PDSA Cycles
LifeQI: Benefits of PDSA Cycles
AHRQ: Health Literacy Universal Precautions Toolkit, 2nd Edition
AHRQ: Fillable Plan Do Study Act (PDSA) Tool for Health Care
Quality Improvement (QI)
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It begins with your statement of purpose that explains your practice’s rationale for PGHD
integration. Your team’s communications champion might think about creating standard
phrasing to use in staff education and training that focuses on the benefits of PGHD integration
from the perspectives of the staff that might gain from using it in routine care.
Consider creating scripts or talking points that staff can reference when speaking with patients
about the benefits of PGHD integration. These can help prepare staff for fruitful conversations
with patients who approach the care team about using PGHD in their care. Focus on real
benefits patients will experience, such as:
• Collecting PGHD can provide data from your daily life to help your clinician see a fuller
picture of your health.
• PGHD can support your self-management of [condition] and help you feel better.
Scripting can also offer language that supports new cultural norms. For example, a medical
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assistant might introduce the idea of using a wireless BP cuff to control hypertension by saying,
“Your doctor would like you to try this easier way that we can monitor your blood pressure
together, stay in closer touch, and more quickly make changes to your medications as needed.”
Encourage patients to participate in this new program by using various communication media.
Here are some ideas:
• Create patient messaging that uses consistent language and graphics across multiple
communications channels. These may range from printed patient education brochures and
postcards to online information accessible via the patient portal or direct email messages
• Consider recording phone loops touting PGHD that patients can listen to while waiting on
hold or video loops that can play on monitors in waiting rooms. What languages do your
patient speak? If you have significant populations of non-English speakers, offer materials
in languages that best accommodate your patients.
◦ For Patients: small gift cards, gym passes, or other item from community partners.
◦ For Clinicians and other care team members: lunch at a local restaurant, small care
package, movie night bundle, or staff outing.
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Staying current on this changing environment can help ensure that your practice’s
activities remain compliant with Federal and State rules, and that you can maximize
available reimbursement.
• Institute for Healthcare Improvement: How-to Guide for Sustainability and Spread
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• Guide for monitoring scale-up of health practices and interventions: MEASURE evaluation
Environmental Monitoring
• The Center for Connected Health Policy (CCHP) updates a report twice a year on state
telehealth laws and reimbursement policies.
• CCHP also maintains a database of federal telehealth laws and policies for Medicare and
private payers.
• The Federal Trade Commission offers an overview of the laws that may apply to mHealth
mobile apps and the various agencies that oversee compliance.
• Rock Health is a digital health venture capital firm that publishes The Rock Weekly, a
weekly newsletter about emerging developments in digital health technology.
• The UCSF Center for Vulnerable Populations publishes research findings about equitable
digital health solutions designed to bridge the digital divide.
• The Duke Mobile App Gateway for Digital Health is a project of the Duke Clinical &
Translational Science Institute (CTSI) focused on digital health and mobile health app
research and innovation.
• The Office of the National Coordinator for Health Information Technology (ONC) maintains
information about digital health technologies, policies, and regulations.
• HIMSS Health App Guidelines Work Group (formerly known as Xcertia) is a consortium of
health leaders to create mHealth app guidelines and set standards for privacy, security,
content, usability and other criteria.
• Centers for Medicare and Medicaid Services Electronic Clinical Quality Measures Resource
Center continually updates its FHIR education page to assist with implementing this
standard to accelerate data exchange. Find many open source tools to test and evaluate
FHIR APIs.
• Health Level Seven International maintains a webpage and a Twitter feed (follow @
FHIRnes using #FHIR) for updates on FHIR development.
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FOLIO 6
Steps to Successfully Implement a PGHD Program
As you begin this activity, reference your work from Folios 2, 3, 4, and 5 to build the
PGHD implementation.
• Review the list of strengths, gaps, and resources needed to begin PGHD integration.
• Convene the core PGHD workgroup to create the PGHD implementation, identify
resources needed, lead team members, and create an implementation timeline.
• The PGHD Coordinator leads brainstorming and guides action steps to build the
PGHD implementation.
Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.
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HEALTH IT DECISIONS
• Develop and distribute processes and standard operating procedures for consent,
monitoring and outreach for the PGHD you will implement.
• Describe what happens when PGHD are clinically out of range. How are the data points
identified? Who is notified? Who will follow up with the patient?
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• What conditions that could benefit from PGHD do you bill for most often?
• Are you able to sustain the program until it becomes more cost efficient?
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What
PGHD to be collected:
PGHD Device:
How
Receiving PGHD:
Measures to monitor:
Your PGHD workgroup has developed the details for your PGHD implementation. Now your
team can set a timeline to begin testing.
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Benchmark goal:
S (Specific):
M (Measurable):
A (Attainable/Achievable):
R (Reasonable/Relevant):
T (Time-bound):
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The swimlane template on the following page (page 98) is intended for practice. It can
be printed or edited directly in PDF reader software.
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Instructions: Type directly into the workflow name, description, date, and role title fields or print to handwrite. Fill in tasks according to role
and place in the process. Not all fields need to be filled in. Icons can be hand drawn or placed using some PDF reader software.
Workflow Name:
Description:
Date:
Role 1:
Role 2:
Role 3:
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Project Title:
Cycle Number:
Start Date:
End Date:
Brief description:
Objective for this cycle: Collect data Test a change Implement a change
Plan: Ask questions, predict results, determine what data need to be collected by whom.
Questions:
Predictions:
Data to be collected:
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Do: Make the change/do the activity and collect data. Document what happened both
positive and negative.
Positive +
Negative -
Study: Summarize your learnings, ask new questions, identify new issues. How does this
compare with your predictions?
Learnings:
Results:
New questions/issues:
Next cycle:
Team members:
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Use the following checklist to determine key considerations with your PGHD team. Use
Activities 6.1-6.4 as you slowly scale up and expand your PGHD capacity.
Instructions: After each consideration, use the form field to record notes. Type directly into
the field or print to handwrite.
PATIENT CONSIDERATIONS
• How do you want to scale up your implementation to a larger group of patients? Do you
want to offer PGHD to a larger subset of patients? All of your patients with a specific
chronic condition?
• How will this be communicated across patients? What health IT support will be in place
for them?
• How do you want to scale up your implementation to a larger group of clinic staff? Do you
want to expand your implementation to additional care teams, clinical groups, and/or
across your organization?
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• In what ways will your internal and external communication plan need to be modified?
HEALTH IT CONSIDERATIONS
• What additional devices or apps would be most beneficial to your patients and staff next?
• How does your EHR support these devices and additional information?
LEGAL/ENVIRONMENTAL CONSIDERATIONS
• What, if any, internal and external legal, regulatory, clinical, technical, patient safety,
communications, and protocols have been updated that may impact expanding PGHD?
FINANCIAL CONSIDERATIONS
• What funding and billing reimbursement guidelines best support expanding PGHD?
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