Presentation on theme: "Enhancing the Healthcare Mission with Mobility Infectious Disease Clinical Research Program (IDCRP) Liz Woolley and Josh Kumpf."— Presentation transcript:
Enhancing the Healthcare Mission with Mobility Infectious Disease Clinical Research Program (IDCRP) Liz Woolley and Josh Kumpf
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.
IDCRPs 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.
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
Mi-Forms Mobility at IDCRP A robust, intuitive electronic data capture system in use at deployed military clinical sites providing fast, reliable, and accurate data for analysis.
IDCRPs 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
Study #1: HIV Risk Behavior Survey A mobile, confidential, electronic patient reported outcomes questionnaire to gain insight into the risk behaviors of HIV+ patients
A Confidential ePRO Survey Survey to capture patient-reported HIV risk behaviors New component of IDCRPs longest running study Participants complete surveys yearly
Mobile ePRO Challenges Must maintain confidentiality of subject responses Participants have limited time available for survey Add mobility without adding complexity Limited internet connectivity
IDCRPs 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
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 Finish PIN encrypted Session sent to database with masked PIN Unencrypted during analysis
Study #2: Clinical Trial Data Capture at Remote Sites An international multisite randomized controlled trial evaluating single-dose treatments to cure acute watery diarrhea or dysentery, which will lead to revised DoD practice guidance.
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
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
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
Visit Navigators eCRFs organized into forms by Visit Specialized eCRFs available in Unscheduled Visit form and Rescue Therapy form
Data Feedback and Diagnoses Standard Diarrheal Diagnosis Temperature Stool Sample Hemoccult Status
The Benefits of Mobile Medical Research Increasing the quality and quantity of data, and putting it to use faster, with Mi-Forms.
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
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
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
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
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
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
Lessons Learned Involve users early and often Dont expect one size fits all solution Review current system and future needs regularly Understand what makes your project unique Dont underestimate hardware issues
Questions? Thank you from the Infectious Disease Clinical Research Program (IDCRP) and the Henry M. Jackson Foundation.