enhancing the healthcare mission with mobility infectious disease clinical research program (idcrp)...
TRANSCRIPT
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Enhancing the Healthcare Mission with MobilityInfectious Disease Clinical Research Program (IDCRP)
Liz Woolley and Josh Kumpf
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Disclaimer The IDCRP was formed in 2005 through an
Interagency Agreement between the National Institute of Allergy and Infectious Diseases (NIAID) and the Uniformed Services University (USU) and is supported by the Henry M. Jackson Foundation pursuant to a cooperative agreement.
The information or content and conclusions do not necessarily represent the official position or policy of, nor should any official endorsement be inferred on the part of, BUMED, the Department of Defense, or the United States Government.
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IDCRP: A Global Network
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IDCRP’s Healthcare Mission
Investigate infectious diseases of concern to the US military.
Conduct safe, effective research around the world.
Provide clean, accurate data in a time sensitive manner.
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Medical Research Challenges Reliable, accurate, and
efficient capture of clinical data
Multiple remote military clinical sites
Limited internet connectivity
Capture participant data in variety of formats
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Mi-Forms Mobility at IDCRPA robust, intuitive electronic data capture system in use at deployed military clinical sites providing fast, reliable, and accurate data for analysis.
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IDCRP’s Mobile EDC System
50 tablets deployed at 6 US domestic sites and 3 overseas US/UK bases
Handwriting recognition based system that mimics paper CRFs or surveys
Three studies currently using Mi-Forms; two more added by end of FY14
Flexibility to be used for ePRO surveys, CRFs, or EMRs
Awarded 2013 Microsoft Life Science Innovation Award (with Mi-Co) for development and deployment of mobile EDC solution
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Study #1:HIV Risk Behavior SurveyA mobile, confidential, electronic patient reported outcomes questionnaire to gain insight into the risk behaviors of HIV+ patients
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A Confidential ePRO Survey
Survey to capture patient-reported HIV risk behaviors
New component of IDCRP’s longest running study
Participants complete surveys yearly
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Mobile ePRO Challenges Must maintain
confidentiality of subject responses
Participants have limited time available for survey
Add mobility without adding complexity
Limited internet connectivity
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IDCRP’s ePRO Risk Behavior Survey 35 Microsoft Surface Pro 1-2
tablets
Subject PIN encryption and limited ability to view completed surveys for confidentiality
Pause feature
Self-guided participant training
Easy-to-use format for both CRCs and participants
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IDCRP’s ePRO Risk Behavior Survey
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Survey Pause Feature
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Self-Guided Survey Training
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Maintaining Confidentiality
Capture
• Survey completed by participant• Responses hidden from CRC while on tablet
Local
Storage
• Completed survey only accessible for CRC to change basic subject information
• Responses hidden and locked
Session Finis
h
• PIN encrypted• Session sent to database with masked PIN• Unencrypted during analysis
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Study #2:Clinical Trial Data Captureat Remote SitesAn international multisite randomized controlled trial evaluating single-dose treatments to cure acute watery diarrhea or dysentery, which will lead to revised DoD practice guidance.
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A Multisite Clinical Drug Trial
Joint US-UK clinical drug trial to evaluate treatment of travelers diarrhea
Enrolling active duty US and UK military members from four bases in Afghanistan, Djibouti, Honduras, and Kenya
Subjects participate in 5 study visits over a one-month period
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TrEAT TD Challenges High investigator turnover –
most users only available for 1-2 months
Unreliable internet connectivity
Limited physical storage space
Provide blinded rescue therapy codes with or without internet connection
Ensure diagnoses of illnesses are done according to same rigorous standards for each participant
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Clinical Trial Mobile EDC Blinded Rescue Therapy
lookup
Offline remote sessions
EDC system provides diagnosis based on 5-point analysis of clinician input
Visit Navigators or “Table of Contents”
Intuitive EDC system setup
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Visit Navigators
• eCRFs organized into forms by Visit
• Specialized eCRFs available in Unscheduled Visit form and Rescue Therapy form
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Subforms Clinical Exam Page Physical Exam
Subform
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Blinded Rescue Therapy
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Data Feedback and Diagnoses
Standard Diarrheal Diagnosi
s
Temperature
Stool Sample
Hemoccult Status
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The Benefits ofMobile Medical ResearchIncreasing the quality and quantity of data, and putting it to use faster, with Mi-Forms.
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Efficient Data Capture Data is captured in real-time on
electronic forms
No need for transcription, double-data entry, and reconciliation
Most valuable assets (CRCs, providers) spend more time enrolling and caring for patients
No longer spend resources tracking and managing 1000s of individual CRFs
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Expanding Range with Mobility
Mobile EDC can go where the patients are
No more “tail wagging the dog” of static EDC
Doctors are mobile, why not EDC?
EDC system can be easily moved among clinical sites and within sites
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Accurate Data Validation Real-time checks at point of
data capture
Reduction of query load and missing data by 90%
Prevent bad data from getting into DB in first place
Simple logic check programming when compared to other SAS-based EDC systems
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Mi-Forms Query Module Integrates Query
creation, resolution, and management into Mi-Forms EDC
Can be used in Mi-Forms Client or as web app
System tracks and logs lifecycle of each query
Queries can enter the system from manually from web app or client, or via CSV import
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Intuitive EDC Solution Mi-Forms electronic forms
and stylus input with immediate handwriting recognition mimics data collection format users are comfortable with
Easy-to-use, easy-to-learn
Everything users need can be placed on tablet and is always available
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Coordinated IT Infrastructure Multiple sites means
multiple IT/IA contacts, different rules, and different hardware
Mobile EDC allows IDCRP to “own” and mange our IT needs Hardware Software Connectivity Document management
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Lessons Learned Involve users early and often
Don’t expect one size fits all solution
Review current system and future needs regularly
Understand what makes your project unique
Don’t underestimate hardware issues
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Questions?Thank you from the Infectious Disease Clinical Research Program (IDCRP) and the Henry M.
Jackson Foundation.