Development of an Integrated Data System for the Gulf Long-Term - - PowerPoint PPT Presentation

Development of an Integrated Data System for the Gulf Long-Term Follow-up STUDY (GuLF STUDY) Gulf Long Term Follow up STUDY (GuLF STUDY)

David Johndrow Social & Scientific Systems, Inc. August 3, 2015

David A. Johndrow1, Chris Wachtstetter1, Nicholas M. Martilik1, Mark P. Della Valle1, Matthew D. Curry1, Polly P. Armsby1, Carley L. Prynn1, Katherine Sisco1, Richard K. Kwok2, Lawrence S. Engel2,3, Dale P. Sandler2

1 Social & Scientific Systems, Inc. 2 National Institute of Environmental Health Sciences 3 University of North Carolina, Chapel Hill y p

P i O i Presentation Overview

Presentation Goals:

GuLF STUDY Introduction

• GuLF STUDY Introduction
• Clinic Exams Components and Challenges

B ild B

• Build or Buy
• System Features/Demonstration

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St d Obj ti Study Objective

Assess health effects associated with oil spill clean-up

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S d Ti li Study Timeline

Clinical Exam (Aug 14 – Jan 16) Deep Water Horizon Oil 4/20/10 Follow-Up (May 13 – Apr 15) Spill Home Visit Exams (May 11 – May 13) Cohort Enrolled Cohort Enrolled (Mar 11 – Mar 13) 90% of clean-up ended

Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan

Clean-Up Work

Apr Jul Oct Jan

2011 2012 2014 2013 2010

Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan Apr Jul Oct Jan

2015

Apr Jul Oct Jan

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Clinical Exam Overview Clinical Exam Overview

6 200 eligible participants ~6,200 eligible participants 4 - hour exam Two clinical sites

• University of South Alabama
• Louisiana State University

Coordinating Center & Central Lab

• SSS, Durham, NC

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Clinical Exam Procedures Clinical Exam Procedures

Health Questionnaires

• Physical health, mental health, substance abuse

Clinical and anthropometric measurements

• Height, weight, hip / waist circumference, blood pressure, heart

rate

Biological sample collections

• Hair, toenails, saliva, urine, blood,

Peripheral nervous system testing 3rd Party Computerized neurobehavioral assessments Pulmonary function testing 3rd Party

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Mental health referral follow-up

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Clinical Exam Procedures

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A i i i C ll d i D S Activities Controlled in Data System

8 days after visit, if sample not returned ~7 days before visit Release for Scheduling 30 days after receiving MH referral 3-4 days after visit Send mail 2-3 days before visit 3-5 days after receiving 2 weeks before visit ~ Weekly shipments Ship ils/Saliva Site ment for urning aliva tion Letter ule Appt. rmation etter ic Visit rmation Call minder to rn Saliva inder to rn Saliva about al health ferral Reminder Call eturn imens to tral Lab S Toena to Paym Ret Sa Invitat Sched Confi Le Clin Confi C Rem Retur Rem Retur SSS SSS SSS Site Site Case SSS Qx menta ref SSS First R C SSS SSS SSS Re Speci Cent Site SSS SSS SSS Site Site Case SSS SSS SSS SSS SSS Site

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S R i System Requirements

• Standardize data collection across sites
• Manage overall clinic workflow
• Support scheduling
• Allow for computer-assisted interviews

P id f l ti t f li i l fi di

• Provide a means for real-time capture of clinical findings
• Print bar codes for samples and storage containers
• Generate report of clinical findings

Generate report of clinical findings

• Link to external medical referral sources
• Track lab sample collection, processing, storage
• Upload data from medical devices
• Provide real-timed data QC checks

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Addi i l N Additional Nuances

• Some procedures are done at one sight but not the other
• Data in one module can drive workflow in another (e g
• Data in one module can drive workflow in another (e.g.

exam outcomes can influence scheduling, reminders and follow-up calls) p )

• Software had to be developed in the absence of a pilot

study to fully assess workflow and user interactions with y y the system

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B ild B ? Build or Buy?

Clinical Data Systems

• Useful for clinical

research / trials

Survey Tools

• Not suitable for survey

administration

• Limited case/project

management tools

Other needs Survey Tools

• Good for CAI

administration

• Limited case/ project

management tools, control of paradata

Other needs

• Clinical scheduling
• Specimen workflow

management and linkage Limited case/ project management tools

• Requires programming

for validation checks

• Limitations for repeating

management and linkage to specimen inventory

• Integration with 3rd party

systems (neuro, lung tests etc )

Integrated data system

• Limitations for repeating

question groups or section navigation tests, etc.)

• Generate and track

mailings

• Telephony integration

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Decided to build – no software currently available meets all requirements

D S M d l Data System Modules

Launcher

• Grant and control user access

Data Collection and Reporting

• Questionnaire and clinical data

Mailing Applications

• Prepare lists for three letter types
• Produce report of findings
• Control checkout activities

Upload Utility

• Send securely to fulfillment center

Scheduler

• Control call center and site tasks

p y

• Transfer exam test files from site laptops to

SSS servers

• Check file names and contents
• Control call center and site tasks
• Scheduling, reminder calls, exam check-in,

reminder and follow-up calls

Barcode Generator

Check file names and contents

• User at site resolves problems

Lab Tracker Barcode Generator

• Prepare customized form, sample and box

storage labels

• Receipt and control
• Sample batching, processing, shipping

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Launcher

• Provides access
• Provides access

to all other applications

• Displays

subsystems currently in use

• Admin features

control user access and privileges

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Scheduling

• Displays participant information

(name and demographics) ( g p )

• Displays contact history
• User confirms or updates contact

p information

• Set appointment or enter other

status information status information

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Scheduling – Clinic Calendar View Scheduling – Clinic Calendar View

• Calendars show available

(green) and booked (red) slots

• Administrators can adjust

clinician availability clinician availability

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Barcode Generator

• Customized labels generated

for each participant p p

• Barcodes and human-

readable text

• Controls all exam-related

documents and samples, including parent and child aliquots

• Participant receives lanyard

and card with barcode and card with barcode

• Used at each step in exam to

ensure match between

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participant and data entry

Clinical Exam Application Clinical Exam Application

Participant information Question number, name Navigation pane p

• Auto-calculated fields (averages,

height in inches, weight in lbs, BMI)

Notes features

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• Pop up messages for out-of range

answers, other validation checks

Clinical Exam Application – Walk Test

• Participant completes 10 laps while

examiner coaches and records data

• Clicks button at each lap
• System records start time of each lap

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• Auto-calculates elapsed lap, total time

Clinical Exam Application – Substance Abuse Module

• Examiner launches module for participant
• Examiner launches module for participant
• Gives laptop to participant
• Leaves room to ensure privacy

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• Leaves room to ensure privacy

Clinical Exam Application – Substance Abuse Module

• Module is launched

P ti i t l t ti b t ti l

• Participant completes questions about recreational

drug use in privacy

• Module cannot be closed or minimized without hotkey

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Lab Tracker – Receiving Samples

• Displays participants expected today and overall
• Displays participants expected today and overall

collection status (arrived, completed, etc.)

• Samples scanned in lab and receipt status updated

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• Uncollected samples cannot be received,

unreceived samples cannot be processed, etc.

Lab Tracker – Processing Samples

• Validations ensure

adherence to standards like adequate clotting, centrifugation times, etc.

• Explanations

required for exceptions to standards

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Lab Tracker – Processing Samples

• Each tube is processed according to unique
• Each tube is processed according to unique

needs of sample type

• Individual aliquots are created, scanned and

tracked

• Sample conditions are documented to inform

future analyses

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future analyses

Lab Tracker – Boxing Specimens

• Samples are boxed and

shipped by type

• Ensures materials are placed

in appropriate containers and storage areas (fridge, -20°C g ( g freezer, -80°C freezer, etc.)

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Report of Findings

Report generated includes:

• Body measurements and body mass

y y index

• Blood pressure
• Heart rate

Heart rate

• Hemoglobin A1C
• Cholesterol and triglyceride levels

L f ti lt

• Lung function results

Referrals for affordable healthcare ff d d d

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• ffered, as needed

Summary

• No single commercial product could cover all of our

needs needs.

• Integrating disparate commercial products had major

drawbacks that would –

• Force us to compromise on some key requirements.
• Limit our ability to change in response to real world

y g p implementation challenges.

• Potentially box us in for future exams, which could

include new requirements.

• For all these reasons, we decided to build, and so far, so

d

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good.

A k l d Acknowledgements

Errol Crook, University of South Alabama D id W l h L i i St t U i it David Welsh, Louisiana State University

For questions, email David Johndrow: djohndrow@s-3.com

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