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Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
Use of the Electronic Medical Record and Clinical and ...
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Use of the Electronic Medical Record and Clinical and ...

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  • Slow down introduction slightly (breathe here, mention MSTP) Presentation about how used EMR and research resources by CTSA to study biomarkers of sepsis…
  • REDCap enables Mobile CRU personnel to quickly access only one part of a research participant’s information – the informed consent documents, which they must see before collecting and processing the research samples. It also provides the researchers with more comprehensive data entry, storage, manipulation and reporting capabilities than are available in the commonly-used Microsoft Access or Excel.
  • State phlebotomist driven first was unsatisfactory and then go into pager Phlebotomist – 13/21 = 62% capture rate
  • This slide demonstrates key results of all of these study processes… Change title – look at abstract for phrasing…
  • Questions to prep for: What do with useless panel? Basic science knowledge gained about pediatric sepsis pathophys, animal model comparison Controls/normal references for this study. Baseline sample in critically ill children/neonates (data from comparable population); need for reference values in more healthy individuals
  • Transcript

    • 1. Use of the Electronic Medical Record and Clinical and Translational Science Award Resources for Research Involving Biomarkers of Sepsis in Critically Ill Neonates and Children Justin E. Juskewitch 1 Swati Prasad MBBS 2 Joseph P. Grande MD, PhD 3,4 Roshini Abraham PhD 5 W. Charles Huskins MD, MSc 2 1 Medical Scientist Training Program, Mayo Clinic, Rochester, MN 2 Department of Pediatric Infectious Disease, Mayo Clinic, Rochester, MN 3 Department of Nephrology, Mayo Clinic, Rochester, MN 4 Department of Pathology and Laboratory Medicine, Mayo Clinic, Rochester, MN 5 Department of Clinical Immunology, Mayo Clinic, Rochester, MN
    • 2. I have documented that I have no relevant financial relationships to disclose or COIs to resolve. I have documented that my presentation will not involve discussion of unapproved or off-label, experimental or investigational use.
    • 3. <ul><li>SIRS = systemic inflammatory response syndrome </li></ul><ul><li>Management different for sepsis versus other forms of SIRS </li></ul><ul><li>Identifying infection requires microbial culture </li></ul><ul><ul><li>48 hours incubation time </li></ul></ul><ul><ul><li>Volume and access issues (neonates) </li></ul></ul>Sepsis = SIRS + infection Critical Care Medicine (1992) 20: 864-874 Need: More rapid, low volume assay
    • 4. Immune Signature for Infection? <ul><li>New technologies allow for simultaneous measurement of multiple immune markers </li></ul><ul><ul><li>Cell surface molecules (flow cytometry) </li></ul></ul><ul><ul><li>Plasma cytokines (Luminex assay) </li></ul></ul><ul><li>Advantages: </li></ul><ul><ul><li>Multimarker panel vs. individual markers </li></ul></ul><ul><ul><li>Low blood volume (1 – 2 cc total) </li></ul></ul><ul><ul><li>Faster turnaround time </li></ul></ul>CD64, HLA-DR, CD163 on neutrophils and monocytes IL-1  , IL-1ra, IL-2, IL-4, IL- 5, IL-6, IL-8, IL-10, IL-12 p40, IL-12 p 70, TNF-  , and INF- 
    • 5. Study Challenges <ul><li>Sepsis episodes are acute, unpredictable events -&gt; prospective subject screening and enrollment </li></ul><ul><li>Lab tests to diagnose sepsis including blood cultures involve STAT orders (sepsis work-ups) -&gt; instantaneous notification and rapid study sample ordering </li></ul><ul><li>Biomarkers are labile -&gt; rapid collection, processing, and storage (&lt; 1 hr) </li></ul>
    • 6. Study Design Pediatric and Neonatal ICU Cohort May 1, 2009 Collect additional study samples Evaluate subject eligibility Obtain informed consent and baseline samples Clinically ordered sepsis work-up for enrolled patient Jan 31, 2011
    • 7. Methods Data Set Pediatric and Neonatal ICU Cohort July 1, 2009 Jan 31, 2011 Oct 15, 2009 May 1, 2009 369 admissions 62 eligible 23 enrolled 33 flow cytometry samples 32 plasma cytokine samples <ul><li>16 baseline samples </li></ul><ul><li>9 sepsis work-up samples </li></ul><ul><li>8 follow-up samples </li></ul>
    • 8. Subject Screening &amp; Enrollment <ul><li>Subjects screened for eligibility using EMR </li></ul><ul><li>Approached for enrollment </li></ul><ul><li>Baseline study samples are arranged with next clinical draw </li></ul><ul><li>Need: Instantly accessible research database to house enrollment information and signed consent forms </li></ul>Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 9. REDCap Developed by Vanderbilt CTSA; hosted by Mayo CTSA Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 10. REDCap Online signed parental permission and assent forms for rapid access (NIH regulations) Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 11. Sepsis Work-Up Study Samples <ul><li>Need: System to notify study staff of these orders quickly and consistently </li></ul><ul><li>Need: Rapid way to arrange study samples along with sepsis work-up </li></ul>Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage Median = 25 min (n = 9)
    • 12. Study Pager Paged when blood culture ordered in NICU and PICU 96% capture rate (107/112) Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 13. Electronic Study Sample Order Clinical order for STAT blood culture Directly into hospital order system Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage Patient Information
    • 14. Electronic Study Sample Order Electronic order form for study samples Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 15. Electronic Study Sample Order Electronic study sample order alongside STAT blood culture order Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage Patient Information
    • 16. Processing &amp; Storage of Study Samples Analytical validation -&gt; labile markers (&lt; 1 hr) Refrigeration (flow cytometry) Frozen plasma (cytokines) Need: 24/7 rapid processing and storage of all research samples Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 17. Mobile Clinical Research Unit 24/7 laboratory collection and processing services at the patient’s bedside Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage
    • 18. End Result Maximum Acceptable Processing Time Screen &amp; consent patients Notification of sepsis work-up Order study samples Sample processing &amp; storage (n = 33) (n = 32)
    • 19. Summary <ul><li>EMR and CTSA resources addressed all study challenges </li></ul><ul><ul><li>Acute, unpredictable clinical events </li></ul></ul><ul><ul><li>STAT laboratory orders </li></ul></ul><ul><ul><li>Labile biomarkers </li></ul></ul><ul><li>Firsts at Mayo Clinic : </li></ul><ul><ul><li>Use of REDCap for electronic access to signed study consent forms </li></ul></ul><ul><ul><li>Use of research study pager tied directly into EMR clinical orders </li></ul></ul><ul><ul><li>Use of an inpatient study sample order in the EMR </li></ul></ul>
    • 20. <ul><li>Funding </li></ul><ul><li>NIH UL1RR024150 </li></ul><ul><li>NIH F30DK084671 </li></ul><ul><li>CTSA Child Health Research Fellow Award </li></ul>Acknowledgements Mayo Collaborators Mayo CTSA REDCap Staff Joseph Wick Michael Lin Mayo Electronic Ordering Staff Rachelle House Mark Foley Munawwar Khan Mobile CRU Staff Nancy Hawley Diane Swanson Mayo Clinic NICU, PICU Staff Sheri Crow, MD William Carey, MD Christopher Colby, MD

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