CER 2016 Srivastava

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  • UCSF Symposium on Comparative Effectiveness Research
     
    Sponsored by the UCSF Clinical and Translational Sciences Institute
     
    Tuesday, February 2, 8:00 AM – 12:15 PM
    Laurel Heights Auditorium
    3333 California Street, San Francisco
  • UPDATED – 7/22/2011
  • *Nearly 700 hospitalists representing 83 sites across the US and Canada
    *Focus on new membership survey in REDCap; will be user-friendlier, simpler
    *Will be sent out on listserv on July 30; they will have until Sept 30
    *Needs to be completed by current and new member sites
  • Good morning. Today I’m going to talk to you about a CER study comparing intravenous vs. oral antibiotics for the post-discharge treatment of children with acute osteomyelitis, but it’s really a story of the difficulties of knowledge discovery and knowledge translation. To begin the story, I’d like you to imagine the following, very real scenario.
  • Your child, or grandchild or niece or nephew, is admitted to your local hospital and diagnosed with osteomyelitis of the right knee, the tibia to be exact. The child receives IV antibiotics and responds nicely with a reduction in his fever, pain, and swelling and return to normal function, at which point the doctors inform you that in order to effectively treat the infection, the child will need another 4 weeks of antibiotics, and that they plan to insert a PICC line to ensure delivery of high doses of the antibiotic. At this point you call your friend or relative who is a pediatrician at a hospital in a different state, and they say, “really, at our hospital we treat kids for 4 weeks, but we transition them to oral antibiotics for the duration of their post-discharge therapy”. And so your natural reaction is, “What’s going on? Why is there such a big difference in approach? And which approach works better?”
  • Theo and I, disturbed by this high rate of complications, say, we have to answer this question of whether Peltola’s approach to oral antibiotic therapy is as effective as the IV route, and whether others are having this terrible experience with CVC complications.
  • The first thing we find, is that there is this wild variation in use of the oral route, from only 10% at some hospitals, to over 95% of osteo cases in other hospitals.

    Propensity score adjusted differences in treatment failure (rehosp within 6 months)
    Treatment failure rate was 5% (54 of 1021) in the prolonged intravenous therapy group and 4% (38 of 948) in the oral therapy group.
    No significant association between treatment failure and the mode of antimicrobial therapy.
    35 (3.4%) children in prolonged intravenous therapy group readmitted for a catheter-associated complication.
  • We think, OK, we’ve proven to everyone that we don’t need CVCs to treat osteo. We convince everyone at CHOP to stop using PICC lines. End of story, on to the next research question.
    It’s about 2012, and I decide to take a look at PHIS data from 2009-2011, and what I see was quite upsetting. We have increased the use of oral therapy to some extent, but at many hospitals, more than half of the kids were still receiving PICC lines.
  • Why?
    For starters, we had no D&I plan
    But we also heard from skeptics that there were some limiations to our study.
  • Ultimatley published in JAMA Pediatrics
  • So at this point, we decided to apply to PCORI to do a more definitive study.
  • M: This slide can serve to tee up for them why PRIS is doing PHIS+, Handoff, and Boston CHIPRA. At least 2/3 projects fit nicely into this process. There needs to be a construct that provides motivation for why you are selecting projects to work on.

    PHIS+ is necessary for doing CE to create evidence.
    CHIPRA will likely lead to measures that identify clinical variation in care where evidence is available.
    Handoffs is a good example of collaborations to reduce variation?
  • M: This slide can serve to tee up for them why PRIS is doing PHIS+, Handoff, and Boston CHIPRA. At least 2/3 projects fit nicely into this process. There needs to be a construct that provides motivation for why you are selecting projects to work on.

    PHIS+ is necessary for doing CE to create evidence.
    CHIPRA will likely lead to measures that identify clinical variation in care where evidence is available.
    Handoffs is a good example of collaborations to reduce variation?
  • M: This slide can serve to tee up for them why PRIS is doing PHIS+, Handoff, and Boston CHIPRA. At least 2/3 projects fit nicely into this process. There needs to be a construct that provides motivation for why you are selecting projects to work on.

    PHIS+ is necessary for doing CE to create evidence.
    CHIPRA will likely lead to measures that identify clinical variation in care where evidence is available.
    Handoffs is a good example of collaborations to reduce variation?
  • M: This slide can serve to tee up for them why PRIS is doing PHIS+, Handoff, and Boston CHIPRA. At least 2/3 projects fit nicely into this process. There needs to be a construct that provides motivation for why you are selecting projects to work on.

    PHIS+ is necessary for doing CE to create evidence.
    CHIPRA will likely lead to measures that identify clinical variation in care where evidence is available.
    Handoffs is a good example of collaborations to reduce variation?
  • TALK ABOUT HVHC

    M: This slide can serve to tee up for them why PRIS is doing PHIS+, Handoff, and Boston CHIPRA. At least 2/3 projects fit nicely into this process. There needs to be a construct that provides motivation for why you are selecting projects to work on.

    PHIS+ is necessary for doing CE to create evidence.
    CHIPRA will likely lead to measures that identify clinical variation in care where evidence is available.
    Handoffs is a good example of collaborations to reduce variation?
  • CER 2016 Srivastava

    1. 1. Specialty and Generalist Collaboration: Multidisciplinary Teams Raj Srivastava, MD, FRCP(C), MPH Assistant Vice President for Research, Intermountain Healthcare Professor of Pediatrics, University of Utah School of Medicine Chair, Executive Council, Pediatric Research in Inpatient Settings (PRIS) Network UCSF Symposium on Comparative Effectiveness Research San Francisco, CA February 2, 2016
    2. 2. Perform comparative effectiveness research aimed at defining best practices Implement best practices and measure patient/cost outcomes Disseminate results to healthcare institutions Core Principles Pediatric Research in Inpatient Settings (PRIS) • PRIS is an independent hospitalist research network founded through a collaborative effort of three organizations: the Academic Pediatric Association (APA), the American Academy of Pediatrics (AAP), and the Society for Hospital Medicine (SHM) • >800 hospitalists from 100 centers
    3. 3. PRIS Mission Improve the health of and healthcare delivery to hospitalized children and their families
    4. 4. Organizational Structure Advisory Board Intermountain Healthcare – Brent James IHI – Don Berwick NICHQ – Charlie Homer Other Research/Network/Pediatric Leaders Ex-Officio Organizations CHA – Matt Hall APA – Mark Schuster AAP – John Klein SHM – Andrew Auerbach Network Coordinator Betsy Holm PRIS Members PRIS Executive Council Rajendu Srivastava, MD, MPH, Chair Chistopher P. Landrigan, MC, MPH, Past Chair Patrick Conway, MD, MSc Ron Keren, MD, MPH Sanjay Mahant, MD, MSc Samir S. Shah, MD, MSCE Jay Berry, MD MPH Karen Wilson, MD, MPH Theokils Zaoutis, MD, MSCE
    5. 5. PRIS Membership
    6. 6. 2009 2010 2011 2012 2013 2014 First annual meeting Executive Council Salt Lake City • APA, AAP and SHM Prioritization Project funded by CEOs • CHA $1.4 million over 3 years PI: R Srivastava, involves 7 PRIS sites PHIS+ study funded with ARRA (almost) • PHIS+ R01 - $9 million over 3 years PI: R Keren, involves 6 PRIS sites I-PASS study funded with ARRA • I-PASS R01 - $3 million over 3 years, PI: C Landrigan, involves 10 PRIS sites February 2009 November 2014PRIS Activities
    7. 7. What’s Collected on Each Patient Encounter in PHIS Patient Abstract Diagnoses (ICD-9) Procedures (ICD-9) Patient Abstract and ICD-9 Coding Billed Transaction/ Utilization Data (all items/services billed to the pt) Pharmacy Imaging/ Radiology Lab Clinical Supplies Other * Room/Nursing * Surgical Svcs * Other misc Patient Encounter Hospital ID Disposition Patient ID APR-DRG Dates/LOS MS-DRG Age, Bw, Gest Age Key Physicians Principal Diagnosis Payer Principal Procedure
    8. 8. • 39 CEOs received their hospital-specific utilization reports • Goal was to align clinical leadership with hospital administration
    9. 9. Standardizing Unit Costs • Median cost for CBC = $32 • 2 CBC’s: cost = 2 x $32
    10. 10. 2009 2010 2011 2012 PIVVOT study funded by PCORI • $2 million over 3 years PI: R Keren, involves 40 PRIS sites GAPPS study funded by CHIPRA grant • U01 over 5 years PI: M Shuster, involves 15 PRIS sites2013 2014 February 2009 November 2014PRIS Activities
    11. 11. The Pediatric IntraVenous Vs. Oral antibiotic Therapy (PIVVOT) Study Ron Keren, MD, MPH Professor of Pediatrics and Epidemiology Perelman School of Medicine at the University of Pennsylvania Vice President of Quality The Children’s Hospital of Philadelphia
    12. 12. Imagine
    13. 13. Background • Some serious bacterial infections (e.g. complicated pneumonia, perforated appendicitis, osteomyelitis) require prolonged home antibiotic therapy • After inpatient improvement with IV antibiotics, choice is between outpatient parenteral therapy via PICC line or oral antibiotics • Scarce evidence showing which treatment option is more effective
    14. 14. 2007 Pediatrics 2009;123:636–642
    15. 15. PHIS data from 2000-2005
    16. 16. 2012 PHIS data from 2009-2011
    17. 17. Why not much change? • No dissemination and implementation plan • Study limitations – Administrative data only – Questions about ascertainment of osteo diagnosis, exposure, outcome – Residual confounding – Rise of CA-MRSA
    18. 18. JAMA Pediatrics 2015 Feb;169(2):120-8.
    19. 19. Partnership • Pediatric Research in Inpatient Settings (PRIS) Network • Children’s Hospital Association (CHA) and its member hospitals
    20. 20. Personnel • PI: Ron Keren (Children’s Hospital of Philadelphia, PRIS EC) • Site PIs: – Raj Srivastava (University of Utah, PRIS EC Chair) – Shawn Rangel (Children’s Hospital Boston) – Samir Shah (Cincinnati Children’s Hospital Medical Center, PRIS EC) – Matt Hall (Children’s Hospital Association) • Biostatisticians – Russell Localio (Children’s Hospital of Philadelphia) – Xianqun Luan (Children’s Hospital of Philadelphia) • Other personnel: – Study coordinators: Rachel deBerardinis and Allison Parker (Children’s Hospital of Philadelphia) – Family advocates: Kathryn Conaboy and Darlene Barkman (Children’s Hospital of Philadelphia) – PRIS Network Manager: Jaime Blank (University of Utah)
    21. 21. Study Aim • Specific Aim #1: To compare the effectiveness of oral antibiotics vs. intravenous antibiotics delivered via a PICC line in children who require prolonged home antibiotic therapy after hospitalization for complicated pneumonia, perforated appendicitis, or osteomyelitis • Specific Aim #2: To compare patient and caregiver reported quality of life and adherence to therapy for oral antibiotics vs. IV antibiotics delivered via a PICC in children who require prolonged home antibiotic therapy after hospitalization for a serious bacterial infection.
    22. 22. Methods • Retrospective cohort study • Children hospitalized from January 1, 2009, through December 31, 2012, at 36 participating children’s hospitals
    23. 23. PCORI CER Proposal • Chart review to confirm diagnosis, exposure, outcomes • Within and across hospital propensity score-based full matching • Stakeholder engagement
    24. 24. Treatment Failure Defined as revisit to the ED or a rehospitalization for: – change in the antibiotic prescribed or its dosage – prolongation of antibiotic therapy – conversion from the oral to the PICC route – bone abscess drainage – debridement of necrotic bone – bone biopsy – drainage of an abscess of the skin or muscle – arthrocentesis – diagnosis of a pathologic fracture
    25. 25. Site involvement • Approximately 5 minutes per chart • Average of 200 charts per site (range: 50-600) • Average of 17 hours (range: 4-50) • Can be completed by: – Yourself – Research assistant – Nurse – Other trained staff member • Site compensation: – Grant money allocated for chart review – Payment according to number of charts/hours worked – Paid through a purchase-service agreement
    26. 26. Purchase Service Agreement • Simplest arrangement– fee for service • No indirects (F&A) costs • Site submits an invoice • CHOP approves it and mails a check
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    28. 28. IRB • Sites will have the option of having CHOP serve as the IRB of record or submitting an IRB at their own institution • In order for CHOP to serve as the IRB of record: – Sites will need to fill out a one-page form signed by an IRB official at their institution and send it to CHOP • Some site’s IRBs may require their own IRB submission– we can provide you a complete protocol.
    29. 29. Institutional Review Board, Committees for the Protection of Human Subjects IRB AUTHORIZATION AGREEMENT CHOP IRB Authorization Agreement page 1 November 29, 2011 This agreement allows The Children’s Hospital of Philadelphia IRB (CHOP IRB) to act as the IRB of record for another FWA Institution. Name of Designated Institution Providing IRB Review Committees for the Protection of Human Subjects (CHOP IRB) The Children’s Hospital of Philadelphia Assurance (FWA): FWA00000459 Name of Institution Relying on the Designated IRB Name of Relying Institution: Assurance (FWA): The Officials signing below agree that may designate and rely on the CHOP IRB for review and continuing oversight of its human subjects research described below. This agreement is limited to the following specific protocol(s): IRB Number: 13-010086 Title of Study: Pediatric IntraVenous Versus Oral antibiotic Therapy Principal Investigator: Ron Keren Sponsor or Funding Agency: Patient-Centered Outcomes Research Institute (PCORI) By signing this agreement, both institutions have agreed that the CHOP IRB will serve as the IRB of record and are agreeing to uphold their individual responsibilities as listed on page 2 of this document. The IRB at CHOP will follow written procedures for reporting its findings and actions to appropriate officials at the relying institution. Relevant minutes of IRB meetings will be made available upon request. The relying institution remains responsible for ensuring compliance with the CHOP IRB’s determinations and with the Terms of its OHRP- approved FWA. This document must be kept on file by both parties and provided to OHRP upon request. Signature of Signatory Official at CHOP: Signature Date Print Full Name Institutional Title Signature of Signatory Official at the Relying Institution: Signature Date Print Full Name Institutional Title
    30. 30. Record Status Dashboard
    31. 31. Chart Reviews • Chart reviews conducted October 1, 2013 through December 31, 2013 • Training will be provided (webinar) • Number of charts depends on your patient volume • Data coordination at CHOP • REDCap database for data entry (web-based)
    32. 32. 0 200 400 600 800 Not Reviewed Complete 1001 1003 1005 1007 1008 1010 1011 1012 1014 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2-12 2013 2015 2016 2017 2018 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2033 2036 2037 2039 3001 HOSPITAL NUMBER Feedback Loop to Engage the Clinicians
    33. 33. Results • 2060 children with osteomyelitis • 1005 oral antibiotics, 1055 PICC-administered antibiotics. • The proportion of children treated via the PICC route varied across hospitals from 0 to 100%. • Treatment failure risk difference = 0.3% [95% CI, −0.1% to 2.5%]) (across hospital matched analyses) • Among children in PICC group, 158 (15.0%) had a PICC complication that required an emergency department visit (n = 96), a rehospitalization (n = 38), or both (n = 24).
    34. 34. Comments • Likely to be strongest evidence available to answer question • RCT not feasible • Confirms results of prior study that used only administrative data • Results consistent, even with rise in MRSA prevalence (study period 2009-2012)
    35. 35. Secrets to Success • Funding institute interested in CER • Availability of data —PHIS —hosted by CHA • Pediatric Research in Inpatient Settings (PRIS)—research network to identify site leads and facilitate chart review • Engaged clinicians
    36. 36. Dissemination • PCORI-organized CME seminar • JAMA Pediatrics sponsored Twitter Journal Club • CHA sponsored webinar • Coverage in dozens of pediatric and lay media
    37. 37. Authorship/Attribution
    38. 38. Implementation • Partner with CHA to produce quarterly reports • We validated admin codes and they have high sens/spec for case, exposure, outcome ascertainment. • Audit and feedback reports back to CMOs, CQOs, CSOs. • Change package-- education, guideline, treatment recommendations
    39. 39. How will PRIS achieve its vision?
    40. 40. Demonstrate improvement in patient outcomes/ impact on cost outcomes Goal: Delivery of High Value Care Goal: Delivery of High Value Care Reduce Variation Condition 1
    41. 41. Condition 1 Condition 2 Condition 3 Condition 2 Priority Condition Step 1 Goal: Delivery of High Value Care Goal: Delivery of High Value Care Goal: Delivery of High Value Care Reduce Variation Condition 1 Demonstrate improvement in patient outcomes/ impact on cost outcomes
    42. 42. Condition 1 Condition 2 Condition 3 Condition 2 Priority Condition Necessary Data (PHIS+) Evidence/ Evidence-Based Best Practices No Evidence Step 1 Step 2 Goal: Delivery of High Value Care Goal: Delivery of High Value Care Goal: Delivery of High Value Care Reduce Variation Condition 1 Demonstrate improvement in patient outcomes/ impact on cost outcomes
    43. 43. Condition 1 Condition 2 Condition 3 Condition 2 Priority Condition Necessary Data (PHIS+) Evidence/ Evidence-Based Best Practices Collaboration of Physician/Nursing Champions Across Hospitals No Evidence Step 1 Step 2 Step 3 Goal: Delivery of High Value Care Goal: Delivery of High Value Care Goal: Delivery of High Value Care Reduce Variation Condition 1 Demonstrate improvement in patient outcomes/ impact on cost outcomes
    44. 44. Condition 1 Condition 2 Condition 3 Condition 2 Priority Condition Necessary Data (PHIS+) Evidence/ Evidence-Based Best Practices Collaboration of Physician/Nursing Champions Across Hospitals No Evidence Step 1 Step 2 Step 3 Goal: Delivery of High Value Care Goal: Delivery of High Value Care Goal: Delivery of High Value Care Reduce Variation Condition 1 Step 4 Demonstrate improvement in patient outcomes/ impact on cost outcomes Data Tracking System – to Measure and Monitor Patient/Cost Outcomes
    45. 45. raj.srivastava@hsc.utah.edu www.prisnetwork.org

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