Enhancing the Healthcare Mission with MobilityInfectious 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.

IDCRP: A Global Network

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.

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 IDCRPA robust, intuitive electronic data capture system in use at deployed military clinical sites providing fast, reliable, and accurate data for analysis.

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

Study #1:HIV Risk Behavior SurveyA 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 IDCRP’s 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

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

IDCRP’s ePRO Risk Behavior Survey

Survey Pause Feature

Self-Guided Survey Training

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

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.

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

Subforms Clinical Exam Page Physical Exam

Subform

Blinded Rescue Therapy

Data Feedback and Diagnoses

Standard Diarrheal Diagnosi

s

Temperature

Stool Sample

Hemoccult Status

The Benefits ofMobile Medical ResearchIncreasing 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

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

Questions?Thank you from the Infectious Disease Clinical Research Program (IDCRP) and the Henry M.

Jackson Foundation.