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. Johndrow 1 , Chris Wachtstetter 1 , Nicholas M. Martilik 1 , Mark P. Della Valle 1 , Matthew D. Curry 1 , Polly P. Armsby 1 , Carley L. Prynn 1 , Katherine Sisco 1 , Richard K. Kwok 2 , Lawrence S. Engel 2,3 , Dale P. Sandler 2 1 Social & Scientific Systems, Inc. 2 National Institute of Environmental Health Sciences 3 University of North Carolina, Chapel Hill y p

P Presentation Overview i O i Presentation Goals:  GuLF STUDY Introduction GuLF STUDY Introduction  Clinic Exams Components and Challenges  Build or Buy B ild B  System Features/Demonstration 2

St d Obj Study Objective ti Assess health effects associated with oil spill clean-up 3

S Study Timeline d Ti li 4/20/10 Clinical Exam Deep Water (Aug 14 – Jan 16) Horizon Oil Spill Follow-Up (May 13 – Apr 15) Home Visit Exams (May 11 – May 13) Cohort Enrolled Cohort Enrolled (Mar 11 – Mar 13) 90% of clean-up ended Clean-Up Work Apr Apr Jul Jul Oct Oct Jan Jan Apr Apr Jul Jul Oct Oct Jan Jan Apr Apr Jul Jul Oct Oct Jan Jan Apr Apr Jul Jul Oct Oct Jan Jan Apr Apr Jul Jul Oct Oct Jan Jan Apr Apr Jul Jul Oct Oct Jan Jan 2010 2011 2012 2013 2014 2015 4

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 5 5

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 3 rd Party 3 rd Party Computerized neurobehavioral assessments Pulmonary function testing Mental health referral follow-up 6 6

Clinical Exam Procedures 7 7

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

S System Requirements R i  Standardize data collection across sites  Manage overall clinic workflow  Support scheduling  Allow for computer-assisted interviews  Provide a means for real-time capture of clinical findings P id f l ti t f li i l fi di  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 9

Addi i Additional Nuances l N  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 10

B ild Build or Buy? B ? Clinical Data Systems • Useful for clinical research / trials • Not suitable for survey administration • Limited case/project management tools, management tools Survey Tools Survey Tools Other needs Other needs control of paradata • Good for CAI • Clinical scheduling administration • Specimen workflow • Limited case/ project Limited case/ project management and linkage management and linkage management tools to specimen inventory • Integration with 3 rd party • Requires programming for validation checks systems (neuro, lung tests etc ) tests, etc.) • Limitations for repeating • Limitations for repeating question groups or • Generate and track Integrated section navigation mailings data system • Telephony integration Decided to build – no software currently available meets all requirements 11

D Data System Modules S M d l Launcher Data Collection and Reporting  Questionnaire and clinical data  Grant and control user access  Produce report of findings Mailing Applications  Control checkout activities  Prepare lists for three letter types Upload Utility p y  Send securely to fulfillment center  Transfer exam test files from site laptops to Scheduler SSS servers  Check file names and contents Check file names and contents   Control call center and site tasks Control call center and site tasks  User at site resolves problems  Scheduling, reminder calls, exam check-in, reminder and follow-up calls Lab Tracker Barcode Generator Barcode Generator  Receipt and control   Prepare customized form, sample and box Sample batching, processing, shipping storage labels 12

Launcher  Provides access  Provides access to all other applications  Displays subsystems currently in use  Admin features control user access and privileges 13

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 14

Scheduling – Clinic Calendar View Scheduling – Clinic Calendar View  Calendars show available (green) and booked (red) slots  Administrators can adjust clinician availability clinician availability 15

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 participant and data entry 16

Clinical Exam Application Clinical Exam Application Question Participant number, name information Navigation pane p Notes  Auto-calculated fields (averages, features height in inches, weight in lbs, BMI)  Pop up messages for out-of range answers, other validation checks 17

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  Auto-calculates elapsed lap, total time 18

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  Leaves room to ensure privacy 19

Clinical Exam Application – Substance Abuse Module  Module is launched  Participant completes questions about recreational P ti i t l t ti b t ti l drug use in privacy  Module cannot be closed or minimized without hotkey 20

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 Uncollected samples cannot be received,  unreceived samples cannot be processed, etc. 21

Lab Tracker – Processing Samples  Validations ensure adherence to standards like adequate clotting, centrifugation times, etc.  Explanations required for exceptions to standards 22

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 future analyses 23

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.) 24

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 Lung function results f ti lt Referrals for affordable healthcare offered, as needed ff d d d 25