Disclosures. NICHD Coulter Foundation UW School of Medicine Harborview Medical Center Seattle Children s Hospital

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1 Disclosures T1 Conflicts Funding The Pediatric Guideline Adherence & Outcomes Project Monica S. Vavilala, MD UW Professor of Anesthesiology & Pediatrics Director, Harborview Injury Prevention & Research Center T2 Potential Application NINDS Translating Evidence to Clinical Practice: Bricks & Mortar Silos & Blocks 98.5% NIH $ Basic science discovery NICHD Coulter Foundation UW School of Medicine Harborview Medical Center Seattle Children s Hospital Basic Phase I, II trials Observational Types of Research 09/19/16 T3 Efficacy Potential clinical application T4 Effectiveness Evidence based guidelines Theoretical 1.5% NIH $ Efficacy Phase III trials Systematic reviews Health services Observational T5 Population Health Clinical care or intervention Population health Applied Phase IV trials Implementation Communication Dissemination Diffusion Systematic reviews Public health Studies in community Outcome studies Cost-benefit Policy Beyond clinical care Social determinants Adapted from Woolf, JAMA. 2008;299: The PEGASUS Project Severe Pediatric TBI guidelines Leverages implementation science frameworks Improves Guideline adherence Translates evidence to clinical practice Clinical innovation at the fringes Pediatric TBI Evidence based recommendations 2015 deaths (0-14y) N= (18 chapters) standards (level) 4 guidelines (level II) 14 options (level III) Medical Cost Work Loss Cost Combined Cost Average $10,379 $1,190,704 $1,201,083 Total $49,137,000 $5,637,305,000 $5,686,442,000 Total TBI cost = $31B 2012 (13 topics retained) Public health burden: High Knowledge gaps: Large Modifiable: Clinically relevant: Very 5 topics dropped 2 topics added Level retained in 8 Level changed in 5 Adherence unknown Impact unknown Class 1 evidence How to use unknown Sponsored by Brain Trauma Foundation and many societies Unwanted hyperventilation pre & 5 years post 2003 guidelines Facility characteristics and 30 day in-hospital mortality Typically a 17 year lag to translate 14% of research! Minutes to first PaCO 2 sample WA State DOH, CDC, 2011 Pre BTF n=375 Post BTF n=89 p 0:55 (0:01, 9:16) 0:39 (0:01, 4:12) 0.05 ICP monitoring less frequent in infants & pediatric trauma centers VanCleve et Van Cleve, J Neurosurg 2014 Curry et al. PCCM.2008 al. J Neurosurg Data adjusted for patient level covariates 9 Mills, B. et al Submitted J. Neurotrauma Mills et al, J Neuortraum a

2 Lancet Neurology, 2013 Conceptual framework for Pediatric Guideline Adherence & Outcomes (PEGASUS) Study Task # 1: Protocols Test Guideline effectiveness To examine the association between TBI Guideline adherence & outcomes Hypotheses: 1.Guideline adherence improves outcomes 2.Barriers to Guideline adherence can be reduced Lancet Neurology Evidence based pathway can be implemented to increase Guideline adherence Inclusion criteria & definitions Age < 18 years Pediatric trauma center Severe TBI Post resuscitation GCS < 9 Head AIS > 3 TBI ICD 9 codes Included extracranial injuries Tracheal intubation > 48 hours in PICU Coding adherence indicators Took 6 months Adapted (conditionality and time) Indicators Definition and coding PH (n=5) Direct transfer to pediatric trauma center Hypoxia treated in 30 minutes Condition: hypoxia Supplemental oxygen administered Systemic hypotension treated in 30 min Condition: hypotension 0 = t direct transfer 1 = Direct transfer X 0 = Hypoxic and not treated with O2 0 = Hypoxic and treated >30 minutes 1 =Hypoxic but treated with O2 30 minutes 2 = hypoxia(all SaO2 -normal) ED (n=5) OR (n=10) ICU (n=14) X X X X 0 = 1 = X X X X 0 = Hypotensive and not treated 0 = Hypotensive and treated >30 minutes after hypotension onset 1 = Hypotensive but treated in 30 minutes 2 = hypotension X X X X Adherence rates by center and treatment location Allowed us to benchmark Adherence Total C 1 C 2 C 3 C 4 C 5 Rate (%) (n=236) (n=50) (n=42) (n=40) (n=56) (n=48) % % % % % % Total PH (5) ED (5) OR (10) PICU (14) Across all sites, 68-78% Across treatment locations at HMC, 64-79% Guideline adherence & outcomes It matters Adherence to guidelines & discharge outcomes: (n=236) Is there a dose or threshold effect? Location specific protective indicators We now have something simpler to recommend In-patient death: ahr 0.94 ( ) Every 1% increase in adherence rate is associated with a 6 % decrease in inpatient mortality Discharge GOS: arr 0.99 ( ) Every 1% increase in adherence rate is associated with a 1 % decrease in poor discharge GOS Overall Adherence Rate Quintile (Percentile) ahr (95% CI) Mortality arr (95% CI) Discharge GOS < 20 th 1.00 (Ref) 1.00 (Ref) 20 th to <40 th 0.20 (0.05, 0.80) 0.93 (0.67,1.29) 40 th to <60 th 0.27 (0.12, 0.61) 0.75 (0.54,1.04) 60 th to <80 th 0.06 (0.02, 0.17) 0.61(0.36,1.05) Main Drivers PH hypoxia OR hyperosmolar Rx OR and ICU CPP >40mmHg ICU nutrition in 72h ICU normoventilation Effect size ahr 0.20 ( ) arr 0.62 (0.42, 0.93) arr 0.74 ( ) ahr 0.06 ( ) ahr 0.22 ( ) 80 th to 99 th 0.04 (0.003, 0.57) 0.66 (0.43,1.01) Vavilala et al, Crit Care Med *adjusted for age, injury severity Vavilala et al, Crit Care Med 2014 Vavilala et al, Crit Care Med

3 Estimated adjusted per-patient costs by guideline adherence cost:charge ratios Estimated costs, US $ Hospital costs Mean (95% CI) ICU costs Mean (95% CI) Overall 101,978 (86, ,366) 75,294 (68,225-82,363) Adherence quintile 50% 92,507 (75, ,004) 74,001 (60,883-87,120) Guideline adherence is cost effective! 75% 102,854 (89, ,094) 75,409 (67,412-83,404) 90% 109,610 (91, ,705) 76,266 (64,106-88,425) 100% 114,358 (87, ,860) 76,842 (59,856-93,829) Graves et al. Ped Crit Care Med Task # 2: Perspectives and Processes 1. Examine TBI guideline adherence & outcomes 2. Barriers to TBI guideline adherence Perspectives Methods Structured surveys & focus groups 19 focus groups at 6 sites 105 nurses PICU and EM 56 attendings PICU, neurosurgery, emergency medicine, general surgery, anesthesiology 20 English and 20 LEP families Analyses Meaningful unit and content analyses Sample size = saturation Factors affecting adherence 161 provider perspectives Family centered care 40 family perspectives (20 LEP) VSM Columbus (Part II) Patient monitoring 75% 25% 80% Need consul -tant? Any order 20% Neurosurgery consult. call to arrival AVG: 22.6min SD: 16.36min Surgery consult. call to arrival AVG: 6.67min SD: 10.23min Continue until Head CT result is known Measure blood pressure Take E C G Further process flow independent on time of pediatrics arrival TBI Case, Data collection stopped Perform pulse oximetry probe IV line placed Airway examination AVG: 0.72min SD: 0.45min X -Rays (chest, pelvis) AVG: 8.5min Ultrasound AVG: 5.1min Head CT AVG: 36.7min 5% 95% Blood TBI draw start Case? AVG: 10.0min Tracheal intubation AVG: 3.6min SD: 5.35min SD: 0 min SD: 17.5min SD: 7.72min SD: 3.04min Brolliar, et al. J Neurotrauma, Moore et al. Ped Crit Care Med, min (4.02min) 8.5min (12.52 min) 5.1 min (17.62 min) 36.7min (54.32 min) 10.0 min (64.32min) 3.6min (67.92 min) VSM Harborview (Part II) VSM VSM Harborview (Part III) 10-50% ED time = NVAT Patient perspective Categories of NVAT =, doctors, gaps Any order Measure blood pressure Perform pulse oximetry probe IV line placed Need consul -tant? Take ECG AVG: 0.26min 0.26min (4.56min) SD: 0.3min 61% 39% Pediatrics consultant call to arrival AVG: 2.0min SD: 3.98min X-Rays (chest, abdomen, pelvis) AVG: 15.4min SD: 7.4min 15.4min (19.96min) Ultrasound AVG: 3.0min SD: 1.0min Patient monitoring Further process flow independent on time of pediatrics arrival 3.0min (22.96min) Head CT AVG: 42.7min SD: 24.2min 42.7min (65.6min) TBI Case, Data collection stopped 78% TBI Case? 22% Continue until Head CT result is known Connected to ventilator 0.3min (65.9min) Blood work drawn until AVG: 21.7min SD: 17.7min 21.75min (87.71min) Central venous catheter placement AVG: 40.3min SD: 0.0min 25% Central venous cathete r placed? 75%? 75% Surgery consultant AVG: 1.49min SD: 3.32min 25% 34% Patient monitoring 66% Airway examination Consultant needed Neurosurgery consult AVG: 18.9min SD: 15.3min Decision made to transfer 7.5min (95.21min) Need Patient passed away 51.7% Patien t alive? 0% Surger y? 48.3% 100% ED gives report to ICU Patient survives ED gives report to OR OR ICU TOTAL NVAT Columbus PATIENT CAT.1. CAT.2. CAT % 46.43% 11.04% Category 1 Category 2 Category Harborview TOTAL NVAT CAT1 PATIENT CAT2 CAT % % 5.78% Category 1 Category 2 Category 3 3

4 Simulation Does NVAT matter? NVAT may be associated with a higher likelihood of poor GOS IRR P> z 95% CI n-value added time Age (y) Examine TBI guideline adherence & outcomes 2. Barriers & facilitators to TBI guideline adherence 3. Best practice program to increase TBI guideline adherence Can make better decisions Eliminate non-value added processes Decrease NVAT Improve system performance Adjusted for age, ISS DC Children s collaboration validate findings from HMC and Columbus 100 pediatric trauma cases Ajdari et al, J Health Care Quality, in-press 28 Ajdari, et al, in-progress PEGASUS program elements Domains Tasks # 3: Plan models what if scenarios Elements Protocols Key performance indicators Perspectives & processes Education, barriers, NVAT, rewards, iterative Timeline, metrics, PDCA Plan 29 Next Steps: Pilot PICU pathway adoption Started 05/27/ Examine TBI guideline adherence & outcomes 2. Barriers & facilitators to TBI guideline adherence 3. Best practice program to increase TBI guideline adherence 60 Patients Eligible for Pathway Main Measures: 56 Patients Initiated on Pathway 4 missed pathway 3 within first 2 months of pathway roll-out 1 extubated <24 hours v% Pathway adoption among potentially eligible in 24 hours v% Guideline adherence achieved in first 72 h 15 died within 72 hours 20 extubated within 48 hours 7 not TBI 14 Patients met original PEGASUS criteria for analysis Across Treatment Locations (PH, ED, OR, PICU) PICU pathway from PICU to 8E or SCH Real-time intraoperative decision support for pediatric TBI PICU Inclusion criteria 1.HMC Age < 18y 4.PICU admission GCS < 9 5.Head AIS 3 6.Polytrauma included 7.Alive & ICU tracheal intubation 48 h 11/2014 PICU KPIs 1. Nutrition start in 72h 2. All CPP > 40mmHg 3. prophylactic PaCO2 < 30mmHg Delayed diagnoses Ashley Coletti, MD, Taniga Kiatchai, MD, Bala Nair, PhD Inclusion All craniotomies with TBI terms Age < 18 years Tasks Real time OR scheduling capture Real time algorithm Option for manual activation What are the Guidelines? What are the rules What is the alert frequency? What are the messages? Harmonize with OCCAM Challenges Data latency Data sampling Training Explain non-adherence or attempts 4

5 ED implementation 02/09/2015 PICU (05/ /2015) Potentially pathway eligible on PICU admission: Ø60 patients, age 7±2 y, 69% M ØMechanism falls (52%), 25% inflicted TBI, 42% SDH Ø89% polytrauma PICU KPI effects 93% pathway adoption Ventilation and nutrition targets met CPP attempts made Electronic ordering Main measures (N=56): Ø56 (93%) pathway adoption in 24 hours of PICU admission Ø85% Guideline adherence Other observations: Ø12 deaths in 72 hours and 5 (14%) eligible died > 72 hours Ø8 initially considered eligible not intubated for full 48 hours Ø3 non-trauma diagnosis after pathway adoption ØDespite efforts, achieving 100% all CPP > 40mmHg was not possible in all patients. 20 Smart Anesthesia Manager (SAM) activations (N=19 patients) (11/2014 to 02/2016) 76% activation rate SAM activated N = 20 Unknown age N = 1 (Jan 16) 269 patients admitted to Pediatric ICU TBI Craniotomy eligible N = 26 SAM failed to activated N = 6 Unknown procedure N = 1 (Jan 16) 3 KPIs v CPP > 40mmHg v Hyperosmolar therapy v Unwanted hyperventilation Generic procedure name N = 3 (M ar 15, Jul 15, Dec 15) AIMS system down N =1 (Jul 15) Hypocarbia and hypercarbia events detected by SAM (N= 20 craniotomies/ 19 patients) before and after program correction Hypocarbia = EtCO2 or PaCO2 < 30 mmhg, hypercarbia = EtCO2 or PaCO2 > 40 mmhg. ED indicator adherence work in progress ED LOS < 2 hours 95% adherence Head CT time by 10 minutes Hypoxia treated in 30 minutes after onset 100% adherence at HMC Supplemental oxygen administered 100% adherence at HMC TBD Systemic hypotension treated within 30 min of admission Hypertonic saline or mannitol for high ICP Fever control T<38.5C PEGASUS impact on HMC care HMC Access to Excellence Pathway ED: 48%, OR 76%, PICU 93% Pre Post Goal Finally Guideline adherence and patient safety ü Shown Guideline adherence is efficacious (Class II) ü High levels of program adoption ü PICU Guideline adherence increased ü Ventilation, nutrition ü OR SAM-TBI accuracy ü ED & OR benchmarks identified ü High end user satisfaction ü NVAT and outcomes Adherence HMC 69% TBD 80% ED (n=23) 48% 48% 75% OR (n=19) 64% TBD 74% PICU (n=14) 64% 85% 90% ED Severe TBI pathway started 0% 48% 100% Time from ED arrival to CT scan (mins) LOS (mins) NVAT (mins) 50% TBD TBD OR Hyperosmolar Rx for high ICP TBD TBD 75% All CPP > 40mmHg 53% 64% 75% PaCO mmHg unless herniation/need 18% TBD TBD PICU All CPP >40mmHg 72% 70% 80% Nutrition start within 72 hours 90% 100% 100% PaCO mmHg unless herniation 12% 83% 90% PH / 8E Pending TBD TBD TBD 5

6 The PEGASUS program Leverages implementation science frameworks Improves Guideline adherence Translates evidence to clinical practice Clinical innovation at the fringes Acments Anesthesiology Bala Nair, PhD Ashley Colletti, MD Taniga Kiatchai, MD Pediatrics/PICU Fred Rivara, MD, MPH Beth Ebel, MD, MSc, MPH Jerry Zimmerman, MD, PhD Mike Bell, MD (Pittsburgh) Pat Kochanek, MD (Pittsburgh) Rich Mink, MD (Harbor) Lauren Rakes, MD (SCH) Surgery/Neurosurgery Richard Ellenbogen, MD Randall Chesnut, MD Jon Groner, MD (Columbus) Neurology Chris Giza, MD (UCLA) Mark Wainwright (rthwestern) Rehabilitation Ken Jaffe, MD Social Work Megan Moore, MSW PhD Radiology Kalpana Kanal, PhD Johnathan Swanson, MD Wendy Cohen, MD Epidemiology Ali Rowhani, MD, PhD Mary Kernic, PhD Vivian Lyons, PhD-C Biostatistics Jin Wang, PhD Chris Mack, MSc Nursing Pamela Mitchell, RN, PhD Rosemary Grant, RN Laura Sissions-Ross, RN Industrial Engineering Linda Boyle, PhD Ali Ajdari, PhD-C Psychiatry Doug Zatzick, MD Quality and Safety/ Nursing Carolyn Blayney, RN Mark Taylor, RN Amanda Potter NIH 6