Session #28: Clinical Standards Work To Improve Evidence-Based Care Delivery: A How-To Workshop

1. Pre-Session Poll Question • On a scale of 1 to 5, how effective is your organization’s ability to deliver coordinated care for clinical conditions? • Not at all effective • Somewhat effective • Moderately effective • Very effective • Extremely effective • Unsure or not applicable Session #28:Clinical Standards Work To Improve Evidence-Based Care Delivery: A How-To Workshop Charles G. Macias MD, MPH Chief Clinical Systems Integration Officer, Texas Children’s Terri Brown MSN, RN Assistant Director Clinical Outcomes & Data Support Evidence Based Outcomes Center Texas Children’s

2. Texas Children’s Hospital West Campus/Woodlands, Health Plan, pediatric practices, Pavilion for Women, physician services organization

3. Emergency department: his triage evaluation demonstrated heart rate and other findings consistent with early signs of shock Delivery of critical resuscitation fluids was slow and undertreated Antibiotics arrived hours after they were ordered Lung inpatient unit: a “Rapid Response Team” was called 3 ½ hours after the evaluation of concerning signs and symptoms Pediatric Intensive Care Unit Blood pressure was not obtainable Put on a ventilator Aggressive drug therapies Procedural interventions to artificially oxygenate his blood Johnny Jones 8 year old boy with a history of lung transplant Johnny died 18 hours after he first arrived

4. Diagnostic and therapeutic errors identified in the ED and the inpatient ward by multiple provider types A gap in meaningful communication between providers created confusion in management plans Neither management guidelines nor the EMR were providing clinical standards or clinical decision support for practitioners Systems were not well integrated Root cause analysis

5. …and in New York 12 year old boy with a laceration from a fall 2 days prior arrived at an Emergency Department He received intravenous fluids and drugs to prevent vomiting after laboratory analyses were obtained, but not reviewed Discharged and returned the next day with fulminant signs and symptoms of septic shock Rory Staunton died 2 days later

6. New York State Department of Health • The Rory Staunton Act • Hospitals shall have in place evidence-based protocols for the early recognition and treatment of patients with severe sepsis/septic shock… • Analytics: all severe sepsis/septic shock patients to be entered in the NYS database for annual risk adjusted mortality rates Public Health Law, State of New York, Sections 405.2 and 405.4 of Title 10

7. The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge Defining quality KN Lohr, N Engl J Med, 1990

8. Poll Question #2 How many medical articles are published each year? 1,000,000 800,000 600,000 400,000

9. Explaining variation: it is impossible for the mind to evaluate and translate all of the existing evidence to formulate medical decisions IOM 2013

10. Correlation between quality and cost • Describing variation in care in three pediatric diseases: gastroenteritis, asthma, simple febrile seizure • Pediatric Health Information System database (for data from 21 member hospitals) • Two quality-of-care metrics measured for each disease process • Wide variations in practice • Increased costs were NOT associated with lower admission rates or 3-day ED revisit rates Kharbanda AB, Hall M, Shah SS, Freedman SB, Mistry RD, Macias CG, Bonsu B, Dayan PS, Alessandrini EA, Neuman MI. Variation in resource utilization across a national sample of pediatric emergency departments. J Pediatr. 2013

11. Poll Question #3 What percentage of healthcare expenditures are attributed to waste? 8% 14% 22% 36%

12. The US healthcare system is inefficient 36% $210 Billion Overuse for tests and therapies beyond established evidence Procedural/surgical intervention vs appropriate watchful wait Discretionary use of services or devices Unnecessary choice of higher-cost services • $765B of healthcare expenditures is waste (2009) • Unnecessary services • Inefficiently delivered services • Excess administrative costs • Prices that are too high • Missed prevention opportunities • Fraud • IOM, The Healthcare Imperative 2010; Berwick JAMA 2012

13. Reforming healthcare Institute of Medicine Best Care at Lower Cost 2013

14. Systematically developed statements or recommendations to assist the practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. Institute of Medicine (1992). Guidelines for clinical practice: from development to use Ubiquitous nature Existence Textbooks: “Treatment” Drug of choice in hospital formulary Hospital policy Informal process for development: variable performance Clinical practice guidelines

15. Poll Question #4 What % of a patient population is a reasonable target for guidelines? 20% 50% 80% 95%

16. Evidence-based guidelines help control complexity Summarize available evidence and translate to guidance for care Address treatment uncertainties and reduce variation in care delivery where evidence lacks Help maximize use of healthcare resources: system efficiency Improve patient outcomes: diagnostic accuracy and therapeutic effectiveness Enhance shared decision making between patients and physicians Provide a framework for analytics Pareto principle 80/20 rule 20% of the problems cause 80% of the trouble Freeing the clinician to focus on the “art” of medicine Empowering the “art” of medicine Adapted from Penney and Foy. Best Practice and Research, 2007

17. Understanding epistemology in order to create a clinical standards system Scientific judgment Preference Judgment EVIDENCE ANALYZE EVIDENCE BENEFITS, HARMS, AND COST DECISIONS Outcomes Adapted from D Eddy MD, PhD

18. Decision making and quality Transparency: values and preferences Evidence & Recommendation Evaluation EVIDENCE SHARED BASELINE HIGH QUALITY CARE DATA TRANSFORMATION Performance measures Adapted from D Eddy MD, PhD

19. An institutional home: Evidence-Based Outcomes Center at TCH Andrea Jackson, MBA, RN Research Specialist Christine Procido, MPH Research Specialist Jennifer Nichols, MPH Research Specialist KaGibbs, MSN/MPH, RN Research Specialist Magliaro, MS, RN, CS, CPHA Clinical Specialist, PFW Tom Burke Research Assistantnt Sherin Raju Research Assistant Ashley Breland MSN, RN Clinical Decision Support Specialist Terri Brown MSN, RN Assistant Director of EBOC Charles Macias, MD, MPH Medical Director of EBOC, CCE MD Lead, Clinical Programs Ellis Arjmand, MD, MMM, PhD Director of Practice Standards, Dept of Surgery Associate Director of EBOC

20. Identifying quality gaps High prevalence Resource intensive care High morbidity or mortality Marked variations in care EDW, analytics, and the key process analysis 1. Evidence-Based Outcomes Center (TCH): systematic development of clinical standards

21. National Guideline Clearinghouse www.guidelines.gov Professional societies American Academy of Pediatrics (AAP): http://aappolicy.aappublications.org Academic institutions: Pediatrics: Texas Children’s Hospital, Seattle Children’s, CHOP, Cincinnati Children’s Searching for existing guidelines

22. 23 item list with six domains scope and purpose stakeholder involvement rigor of development clarity and presentation applicability editorial independence Each item rated from “strongly agree” to “strongly disagree” by reviewers An additional overall assessment AGREE II (Appraisal of Guidelines Research and Evaluation)

23. Team Community or Subject Area Practitioner Leader Champion of Guideline topic Sub-specialists in the area of focus Nurses Pharmacist Other Allied Healthcare providers (RTs, OT/PT, etc.) Family / patient Clinical Effectiveness and other support Facilitator Methodologist Librarian Data analyst and outcomes coordinator Educator 2. W. Edwards Deming and teams “Bottom-up”team building and interdisciplinary functioning as tenets of quality improvement

24. 3. Identifying the questions in PICO format P I C O Population Intervention Comparison Outcome of Interest • ”In ED patients with suspected sepsis…” “…does application of a trigger tool…” • ”when compared to routine assessment…” • “lead to shorter time to recognition”

25. 4. Conducting the search with library-trained personnel

26. Developed by a widely representative group of international developers Clear separation between quality of evidence and strength of recommendations Quality (evidence) How sure one is that the estimate of treatment effect is sufficient to support the recommendation Strength (recommendation) How sure one is that adherence to recommendation will result in improved outcome Explicit acknowledgment of values and preferences 5. Evaluating the evidence: GRADE Grading of Recommendations, Assessment, Development, and Evaluation Guyatt et al, BMJ 336;924

27. Transparency

28. Standardize regardless of gaps in evidence include pathways Revisit evidence frequently and rigorously Clinical/outcomes research to increase evidence base Standardization

29. Clinical Decision Support

30. 6. Engage stakeholders: EBOC transparency for approval • Governance • Content and analytics team • Evidence-based steering • Medical, surgical, women’s health champions, and research assistants • Enterprise-wide vetting • Legal database archiving: “standard of care”

31. Clinical Systems Integration Governance Structure Clinical System Integration Executive Leadership Council Clinical Technology Council Content and Analytics Team Clinical Implementation Team Quality Improvement and permanent care process teams EBP and the Enterprise Data Warehouse are part of this structure EMR and all clinical technologies Develops clinical standards (guidelines) and oversees clinical data/ predictive analytics Oversees development and implementation of clinical programs/ analytics and knowledge assets Prioritizes and Assess technology initiatives that integrate with the EMR or proposed as independent solutions

32. Clinical SystemsIntegration domains Information System Centric IT determines interpretation of science Automation Centric Increased reliability but poor validity • Analytic System • Implementation • Science and Clinical Standards Organizational Centric (Clinicians stop coming to meetings if evidence and measurement are both missing) “The means to facilitate the coordination of patient care across conditions, providers, settings, and time in order to achieve care that is safe, timely, effective, efficient, equitable, and patient focused.” -The American Medical Association

33. Evidence-Based Outcome Center Acute Chest Syndrome *updated Acute Gastroenteritis Acute Heart Failure Acute Hematogenous Osteomyelitis Acute Ischemic Stroke Acute Otitis Media Apparent Life-Threatening Event (ALTE) Appendicitis *updated Arterial Thrombosis Asthma *updated Attention Deficit Hyperactivity Disorder Autism Assessment and Diagnosis Bronchiolitis *updated Cancer Center Procedural Management Cardiac Thrombosis Central Line-Associated Bloodstream Infections Closed Head Injury Community-Acquired Pneumonia *updated Cystic Fibrosis – Nutrition/GI >12 y/o *updated C-Spine Assessment Deep Vein Thrombosis Diabetes Perioperative Management Diabetic Ketoacidosis Fever and Neutropenia in Children with Cancer Fever Without Localizing Signs (FWLS) 0-60 Days *updated Fever Without Localizing Signs (FWLS) 2-36 Months*updated Hyperbilirubinemia IntraosseousLine Placement IV Lock Therapy Kawasaki Disease Migraine Treatment-Emergency Center Neonatal Thrombosis Nutrition/Feeding in the Post-Cardiac Neonate Obstetric Hemorrhage due to Uterine Atony Perioperative Management of Anterior Mediastinal Masses PICC Securement Procedural Sedation *updated Rapid Sequence Intubation Respiratory Management of Preterm Infants Septic Arthritis Septic Shock Skin and Soft Tissue Infection Status Epilepticus Suspected Child Physical Abuse Tracheostomy Management Urinary Tract Infection

34. Outcomes Quality Measurement and analytics (EDW): Patient outcomes Financial metrics Utilization metrics

35. Financial Impact-inpatient

36. Care Process Team EBG in EMR

37. Understanding epistemology in order to create a clinical standards system Scientific judgment Preference Judgment EVIDENCE ANALYZE EVIDENCE BENEFITS, HARMS, AND COST DECISIONS Outcomes based Outcomes Evidence based Adapted from D Eddy MD, PhD

38. Lessons learned • Wide variations in practice can be minimized with systematically developed clinical standards • Quantitative assessments (KPA) can help identify gaps in quality • Systematic use of tools (e.g. GRADE) will help standardize approaches to the integrity of clinical standards • Governance and a systems integration strategy are critical to effective uptake • Evaluation of outcomes through analytics allows guided implementation and transparency of outcomes

40. Poll Question #5 On a scale of 1-5, how well is your organization using data to drive provider behavioral change and performance improvement in clinical care? Poorly Not well Reasonably well Well Extremely well Unsure or not applicable

41. Choose one thing… What one thing (or more) can you do differently after hearing this presentation?

42. Analytic Insights Questions & Answers A

43. Thank You

44. Session Feedback Survey • On a scale of 1-5, how satisfied were you overall with this session? • Not at all satisfied • Somewhat satisfied • Moderately satisfied • Very satisfied • Extremely satisfied What feedback or suggestions do you have?

45. Upcoming Sessions Breakout Sessions – Wave 5 (2:20 PM – 3:05 PM) • Panel – Data Governance in Healthcare • How One ACO Is Using Analytics to Position Itself for Population Health Management and Shared SavingsJames J. Dearing, DO, FACOFP, FAAFP, Vice President, Chief Medical Officer, Honor Health • Panel – Best Practices in Achieving Physician Engagement • Panel – Precision Medicine and Embracing Variability • Improving Analytics and Processes to Ease Hospital CrowdingWes Elfman, Visualization Developer, Clinical and Business Analytics, Stanford Health CareTerrill Wolf, Manager, Data Architecture, Clinical and Business Analytics, Stanford Health Care Location Grand Salon Imperial Ballroom A Imperial Ballroom B Murano Venezia