The Health eHeart Study - UCSF CMEucsfcme.com/minimedicalschool/syllabus/winter2014/feb26-Mini...
Transcript of The Health eHeart Study - UCSF CMEucsfcme.com/minimedicalschool/syllabus/winter2014/feb26-Mini...
2/24/2014
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sfghSan FranciscoGeneral Hospital
San FranciscoVA Medical Center
Medical CenterHeart & Vascular Center
UCSF
Cardiovascular Research Institute
Gladstone Instituteof Cardiovascular Disease
The Health eHeart StudyUsing big data to reduce heart disease
How You and Just About Everyone You Know Can Help Solve the Mysteries Underlying America’s Number 1 Killer
Health eHeart Study
Health eHeart Study
Where’s the Mystery?
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• Heart disease remains the leading cause of death
• More deaths due to heart disease than every cancer combined
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• More than a third of adults are obese
• An American has a coronary event once every 34 seconds
• Cardiovascular disease accounts for 1 in every 3 deaths in the US
Health eHeart Study
Conventional Research Studies
HEART DISEASE
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Conventional Research Factors
“If you live to be 100, you’ve got it made. Very few people die past that age” - George Burns
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Conventional Research Studies
Atrial FibrillationAGE
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My clinic
• 50 yo healthy man with atrial fibrillation
• 39 year old healthy woman with atrial fibrillation
• 34 year old…atrial fibrillation
• etc….
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Detective Work Through Massive Numbers
> 13 million people
Health eHeart Study
Detective Work Through Massive Numbers
> 13 million people
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Detective Work Using Dense Data
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Cost of Clinical Research
Co
st
Time
Paper-based research
Electronic data capture
Electronic health record
Smartphone-based researchTechnology Trajectory
IOM “Transforming Clinical Research” 2012 Health eHeart Study
• Framingham Heart Study Budget Cut 40%
• Others affected “even more severely” per NHLBI
• “Offering a possible model for lower-cost, large cohort research, the University of California, San Francisco (UCSF), has launched a new study called the Health eHeart…”
Total US Population
Total online population
Consumer computers
Regular mobileInternet use
2016201520142013201220112010
350
300
250
200
150
100
50
0
(mill
ion
s)
Smartphone users Tablet users
Source: Forrester Research
U.S. Technology Use
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Smartphone Use
91% of smartphone owners keep their smartphones within
3 feet, 24 hours a day.—Morgan Stanley
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External Sensors
Health eHeart Study
The Team: Principal Investigators
Greg Marcus Mark Pletcher Jeff Olgin
Health eHeart Study
What do we hope to accomplish?
• New paradigm for conducting clinical research
– More efficient & larger number of participants
– Nimble and Rapid deployment
• Develop more robust prediction algorithms
– Collect dense data
– Personalized pattern-based prediction
• Leverage & develop technology– New sensors & mHealth technologies
– Validation & translation into improved health
• Develop new paradigms for healthcare delivery– Testing ground for disease management strategies
Health eHeart Study
Clinical Research Paradigm Shift• Internet enrollment
– Engagement strategy
– Electronic consents
– Social media and virality
• eVisits
– No need for proximity to a study center
• “Real-life” and “real-time” data collection
– Blood pressures
– Weights
– Activity
– Alerts and reminders
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Clinical Research Paradigm Shift
• New methods of outcome ascertainment
– Mobile apps
• “Geofencing”
– Facebook integration
– BlueButton+ and EMR integration
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Website: Engaging & Responsive Design
Health eHeart Study
Website: Landing Page InteractionClick Heatmap
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Website: Landing Page Interaction
Scroll Heatmap
100%
50%
0%
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Modular Consenting
✔ Overall HeH Consent
✔ Biospecimen/DNA Collection
✔ In Clinic MeasuresVitals
Anthropometry
✔ In Clinic TestsECGETTEchoV02m6MWT
✔ HIPAA Authorization
Measurement App Suite
✔ Link with theirdataFitbit
iHealthWithings
EMR Link
PatientPortal Link
Health eHeart Study
REDCap: Skin & Responsive Design
• Help prompts• Sound files• Images
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REDCap: Help Functionality
Health eHeart Study
REDCap: Sound Files
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REDCap: Pictures
PHQ-9PHQ-9
HADSHADS
Labs & MeasuresLabs & Measures
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Epidemiology&Biostatistics
Recruitment
• UCSF Cardiology Clinic
• UCSF Medicine Clinic
• Other institutions
• Partnerships
– Advocacy groups
– Insurance carriers
– Established cohorts
• Social Media
• Advertising
• News & traditional media
Built-in Validation Group
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Recruitment: Media
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+
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Health eHeart AlliancePatient Powered Research Network
Progress to date
5500
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eVisits• Series of surveys & activities
– Spread out over ~1 month
– Can be done in small increments of ~1-5 minutes
– Mobile, tablet or desktop
– Email reminders
– Reward/engagement system
• Ability to update data between visits
– Frequent self-report
– Connected devices and apps
– EMR connections
• New eVisit every 6 months
• Additional activities/substudies
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Connected Devices
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Connected Devices: Partners
Pulse Oximetry BP Wt/Body Comp
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Apps: HR/Rhythm/HRV & Sleep
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Apps: Diet Capture—Food Diary
DIETPhoto Diary
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Apps: Facebook
• Integration with Facebook
• Collection of data from Facebook about social interactions
• May be important tool in determining “inter-relatedness”
• May be important tool for engagement and recruitment
• Interesting intervention trials
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Apps: Passive Data Collection
– Mobility & Activity
– Screen interaction, call/text interaction
– Behavior modeling
• Background continuous data collection from smartphone sensors
• Reminders/Messaging
• Contextual alerts
Health eHeart Study Health eHeart Study
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Outcomes Ascertainment• Electronic Medical Record Integration
– Apex (UCSF)
– Other Epic
– PracticeFusion
• Personal Health Record
• National Death Index search
• Insurance claims
• Intermediate outcomes
– Data from apps and sensors
– Validated surveys
• Building novel technology for adjudication
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Outcome Ascertainment: Geofencing
• Determine hospitalizations
• Confirm with an alert (when they leave the hospital)
• Follow-up with detail survey
Have you been hospitalized?
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Validation Studies
• Built-in validation through UCSF patients
• Validation of all measurement apps & devices
• Validation of outcomes ascertainment
• Validation of self-report data from EMR
• Validation of novel methods
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Data Security & Privacy
• Committee on Human Research (IRB) Approval
• HIPAA-compliant Docusign
– HIPAA Authorization
• Secure/encrypted website
• Data stored on HIPAA-compliant system
• Participant has username and password
• Data not sold or shared
• NIH Certificate of Confidentiality
• Transparency about Security and Privacy policy
Health eHeart Study
Engagement
• Engagement team
• Engaging, easy to use interface
• Automatic triggered messaging (email, SMS, push notifications)
• Gaming mechanics
– Device give-aways
– Status system
• Personalized approach
• Study updates
• Newsletters
• Social media
Health eHeart Study Health eHeart Study
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Enrollment: Age & Gender
0%
5%
10%
15%
20%
25%
30%
Age
F40%M
60%
Gender
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Enrollment: Race/Ethnicity
Asian
Black
Native American
Other
Pac Islander
Unknown
White
Hispanic
Non‐hispanic
Unknown
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Enrollment: CV Diseases
0
5
10
15
20
25
30
35
40
45
50
Per
cen
t (%
)
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How can it be used?
• Study questions within the cohort
• Data collection for clinical research
– Easy development of both coordinator-entered instruments or self-report
– Eg. Adult Congenital genetic study
• Intervention trials for a specific disease
• Development and testing of mobile health technology or sensor
• Secondary data analysis
Health eHeart Study
How can you contribute?
• Enrollment criteria: ≥ 18 years old and internet connection
• www.health-eheartstudy.org
– Ideally Chrome, Firefox, Safari
• Geographically agnostic
• Can contribute while waiting on line somewhere
• Be an ambassador
• Contribute data (download apps, connect devices, report hospitalizations, fill out surveys)
• Spread the word
Health eHeart Study
Why do people participate?
• Altruism
• Altruism
• Altruism
• Interesting
• Cutting edge
– Medicine
– Gadgets
• Meaningful
• Family member with heart disease
• Have suffered from heart disease
• FunHealth eHeart Study
Thank You
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Social Networks and Health
James Fowler, PhDProfessor of Medical Genetics and Social ScienceUC San Diego
Intersection between natural and social sciences. Focuses on social networks, behavioral science, genetics, health and big data
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Intervention Trials
• Ability to rapidly identify CV disease populations and sub-populations
– Example: NYHA Class III-IV Heart Failure patients
• Ability to rapidly invite to participate
• Ability to rapidly electronically consent and randomize
• Ability to provide behavioral or monitoring interventions electronically
• Ability to provide drug interventions rapidly
• Ability to monitor measures and outcomes
Health eHeart Study
Engagement: Their Data
Health eHeart Study
Apps: Diet Capture—Food Diary
TADAtechnology assisteddietary assessment
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Biospecimen Collection
DNA/Serum/WBC’sIn Person
DNA-Spit KitRemote
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Biospecimen Collection (future)
• Salivette
• Blood testing devices
• “Chain” labs
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Individualized Prediction Algorithms
Time
TimeHealth eHeart Study
0
500
1000
1500
2000
2500
Timeline: Enrollment
3/8/13 3/15/13 3/22/13 3/29/13 4/5/13
WSJ
SF Chronicle
4/12
FUNDING HIRED TEAM
DESIGN& DEVELOPMENT
ENROLLMENT BEGAN
Oct 2012 Nov 2012 March 2013
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Disease Management Trials• Identify those at most need for followup or
intervention
– Remote monitoring
– Electronic visits
– EMR computerized abstraction
– “Air traffic control” panel to highlight those in need of attention
• Intervention directed at specific problem
– Medication adjustment
– Medication compliance
– Diet compliance
– Lifestyle compliance
– Co-morbiditiesHealth eHeart Study
Rigorous mHealth testing ground
• Many companies and startups have taken a consumer electronics approach
• Low bar for FDA approval
– Often 510K approval
• Misperception that doctors want and need “more data”
• Few have clinical trials showing impact on clinical outcomes or cost
• Reimbursement models rarely considered
Health eHeart Study
Remote Measures
• BP
• HR
• HR variability
• Weight
• Edema
• Vascular reactivity
• ECG
• O2 Sat
• Glucose/Ha1c
• Biomarkers
• Metabolism
• 6MWT
• Sleep
• Diet
• Activity
• Behavior
• New sensors
• New measures
Health eHeart Study
Rigorous mHealth testing ground
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Apps: Diet Capture—FFQ
FFQ
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Disease Management Trials
• Manage a team of non-medical and medical personnel
• Early Disease Management Projects
– Hypertension
– Heart Failure
– CAD
– Atrial Fibrillation
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eVisits
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Healthcare Costs
UC Atlas of Global Inequality, UCSC Health eHeart Study
Health eHeart: Data Collection
• Survey data
– Self-report
• Measurements
– Self-report
– Connected devices
– Apps
– EMR
– In-person visits
• Outcomes
Health eHeart Study
Funding
• Initial grant from SalesForce
– Startup
– Infrastructure
• Anticipating additional projects funded by NIH and other sources
Health eHeart Study
Engagement: Reinforcement
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Engagement: Reinforcement
Health eHeart Study
Engagement: Personal Touch
• Personalized emails
Hi Jeff,Welcome, and thank you for signing up for the Health eHeart Study! I'm excited to have you join us in the fight against heart disease. Every minute someone dies of a heart attack in the U.S., but it's people like you who will help change that shocking statistic for the better.
First of all, let me introduce myself. My name is Kourtney and I'll be your coordinator for the Health eHeart Study. That means that if you have any questions, need more information, or want to comment on how we're doing, I'm your go-to person. Feel free to get in touch any time at [email protected] or (415) 504-2941.
Looking forward to making a difference together!Kourtney ImburgiaClinical Research Coordinator
Health eHeart Study
Engagement: Personal Touch
Health eHeart Study
Healthcare Costs
UC Atlas of Global Inequality, UCSC
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Smartphone Use
0%
10%
20%
30%
40%
50%
60%
2009 2011 2013
Smartphone Use Age 55+
Source: Nielson 2013 Health eHeart Study
UCSF Cardiology Clinic
Health eHeart Study
Vision• Develop, understand, and define the next
generation of cardiovascular assessment/care
• Integrate new technology into cardiac research to help drive change in:
– Cardiac assessment
– Chronic care management
– Patient engagement
– Public Health
• Develop a solution collect and analyze “big data” in a mega cardiovascular cohort study
• Provide a test-bed for emerging tools and techniques in cardiovascular digital health
Goals
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Participant Recruitment
Cardiology Ambulatory PracticeCV Prevention PracticeGeneral Medicine Practice
100,000 to 1 Million participants
Health eHeart Study
Data Collection: Geofencing
• Determine hospitalizations and doctor visits
• Contextual reminders/surveys
• Drive timely patient engagement
Have you been hospitalized?
Health eHeart Study
Data Collection: Surveys
Health eHeart Study
Data Collection: Measurement App
• Physiologic monitoring from smartphone
– Without external sensors
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Data Collection: Biospecimens
SF Based Remote
DNA Spit Kit
DATA REPOSITORYHealth eHeart Study
Data Collection: Medical Records
Data Repository
Health eHeart Study
Technical Framework
Data Collection
Data Repository
SurveysAppsSensorsBiospecimensMedical Records
Health eHeart Study
Data Repository Considerations
• Multi-modal
– Traditional survey data
– Nonsequitur passive data
– Continuous monitoring data
• Multi-site
– In-house data collection
– Multiple vendors
– Multiple devices
• Medical records
– Pulled from our EMR
– Transmitted from other MRs
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Participant Engagement
• Recognized as very important
• Hired engagement specialist (formerly at Keas)
– Risk scores
– Feedback
– Gaming
– Other engagement strategies
• UCSF CTSI participant recruitment and engagement (Nariman Nasser) services
• Developing plan for testing
Health eHeart Study
Sustainability: Infrastructure
• Infrastructure built to be nimble and not requiring large personnel team
– Easy to develop/deploy new surveys
– Study “dashboard” to manage participants and new studies
– Easy and real-time sub-cohort selection
– Communications hub for communication with participants
• Leverage existing UCSF infrastructure
– Redcap
– Salesforce
– Cloud storage
– New UCSF long-term relationships
Health eHeart Study
Sustainability: Funding• American Heart Association
– Have already had discussions with AHA and they are interested in using Health eHeart for their stats data collection
• NIH Funding
– Excellent track record amongst team
• Industry funding
– Digital health companies
• Crowd sourced funding
• Other philanthropic support
– For faculty recruitment
– Fellow support
• Monetized by-productsHealth eHeart Study
Sustainability: UCSF Commitment
UCSF Information Services(Bawa)
UCSF Center for Digital Innovation(Blum)
UCSF Cardiology(Olgin)
UCSF Office of Innovation, Technology & Alliances
(Lium/Sinha)
UCSF Data ManagementEpidemiology
(Pletcher)
UCSF CTSI(Nasser)
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The Team: Investigators
• Jeff Olgin, MD—Cardiology/Clinical Trials
• Mark Pletcher, MD, MPH—Epidemiology
• Greg Marcus, MD, MAS—Cardiology/Epidemiology
• Mike Blum, MD—Medical Informatics
• James Folwer, PhD—Social Scientist
• Ida Sim, MD—mHealth
• TBA—Machine Learning/Big Data
Health eHeart Study
The Team: Operations Staff
Operations
• Opinder Bawa, CTO School of Medicine
• Tuhin Sinha, PhD—Technical Project Director
• Carol Maguire—Research Coordinator
• Leslie Ziani—Project Management
Health eHeart Study
The Team: Technical StaffProduct Development/Management
• Ed Martin—UCSF Deputy Director SaaS
• Nina Jameson—ISU Business Analyst
• Todd Parsnick—Web App Developer
• Christa Smith—Web Front End Developer
• Laura Bettencourt—Data Management
Patient Recruitment/Engagement
• Nariman Nasser (UCSF CTSI)—Recruitment/engagement
• Tracy Strickroth—Recruitment/Engagement
• Chris York (formerly of Keas)—Web Design/Engagement psychology
• Heidi Kotansky (formerly of Keas)—Writer
Health eHeart Study
The Team: Post-doctoral fellows• Gabrielle Brooks, MD—Postdoc fellow
• Alexis Beaty, MD, MAS—Fellow
• Geoffrey Tison, MD, MPH—Fellow
• David Ouyang—PhD candidate
• TBA (MIT Media lab)—post-doc
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Partners• Ginger.io—Passive data collection smartphone
app
• Azumio—Measurement app
• AliveCor—mobile ECG
• Wireless Medical—wearable sensors
• Vital connect—wearable sensors
• MC10—wearable sensors
• Salesforce– engagement platform
• …
Health eHeart Study
Progress
• IRB Approval pending
– Submitted and pre-reviewed
• Website design nearly complete
– Website
• Mobile app development active
• Website development active
Health eHeart Study
Stewardship Plan
• Naming?
– Website
• 6 month progress report
• Ad hoc reports for major milestones
– Release dates
– Press
– Big findings/publications
• Other?
Health eHeart Study
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Rigorous mHealth testing ground
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Data Collection: External Sensors
DATA REPOSITORY
Measurement Sensors Wearable Sensors
Health eHeart Study
Credit Card Fraud Detection
• Small purchase at gas station followed by a very large purchase (often electronic store)
• Lots of internet purchases
• Training set to establish a baseline• Machine learning to adjust baseline• Detect deviations from baseline
Health eHeart Study
Nimble study implementation
Design intervention
Cohort Selection
Develop Data Collection Tools
& Database
Patient Recruitment
Consent & Randomization
Traditional Health eHeart
Months Months
Days-WeeksMonths
Month/Years Minutes
Years Days-Weeks
Days-WeeksMonth/Years
Recruitment