Transcript Enhancing the Healthcare Mission with Mobility

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.
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
IDCRP
A 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 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
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
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
Subforms
 Clinical
Exam Page
 Physical
Exam Subform
Blinded Rescue Therapy
Data Feedback and Diagnoses
Stool Sample
Hemoccult
Status
Temperature
Standard
Diarrheal
Diagnosis
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 MiForms 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,
 Everything
easy-to-learn
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.