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Health Outcomes, Quality, and Cost: Opportunities for Pediatric Endocrinology

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My talk for the Paul Kaplowitz Endowed Lectureship for contributions to quality and cost-effective care in Pediatric Endocrinology at the Pediatric Endocrine Society Meeting 2016. Thank you so much Dr. Kaplowitz! And a hat tip to Lawson Wilkins, who developed learning health systems ages ago.

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Health Outcomes, Quality, and Cost: Opportunities for Pediatric Endocrinology

  1. 1. Joyce Lee, MD, MPH
 Associate Professor
 Pediatric Endocrinology
 Child Health Evaluation and Research Unit
 University of Michigan
 Twitter: @joyclee Health Outcomes, Quality, and Cost: Opportunities for Pediatric Endocrinology Paul Kaplowitz Endowed Lectureship for contributions to quality and cost-effective care in Pediatric Endocrinology
  2. 2. Dr. Paul Kaplowitz
  3. 3. Disclosures
 
 JAMA Pediatrics
 Verily
 Business Innovation Factory
  4. 4. Disclosures
 
 I work in the laboratory of healthcare delivery
 
 Pediatric Clinical/Translational Researcher

  5. 5. Clinical Effectiveness Knowledge Clinical Efficacy Knowledge Improved Quality, Value, & Population Health Basic Biomedical Science T1 T2 T3 Dougherty JAMA 2008 Translational Research Clinical Efficacy Research
  6. 6. Clinical Effectiveness Knowledge Clinical Efficacy Knowledge Improved Quality, Value, & Population Health Basic Biomedical Science T1 T2 T3 Dougherty JAMA 2008 Translational Research Health Services Research •  Access/Quality •  Health Utilization •  Health Outcomes •  Costs/Cost-effectiveness
  7. 7. Clinical Effectiveness Knowledge Clinical Efficacy Knowledge Improved Quality, Value, & Population Health Basic Biomedical Science T1 T2 T3 Dougherty JAMA 2008 Translational Research Health Services Delivery •  Systems Design •  Quality Improvement Science •  Human-centered Design/Participatory Design
  8. 8. Clinical Effectiveness Knowledge Clinical Efficacy Knowledge Improved Quality, Value, & Population Health Basic Biomedical Science T1 T2 T3 Dougherty JAMA 2008 Translational Research “If I publish it, it will be done”
  9. 9. 1982 B-blockers post-MI improved mortality Translating knowledge and therapies takes too long
  10. 10. 2007
 25 years later T Lee NEJM 2007 % of Pts Receiving B-Blockers Post-MI
  11. 11. “Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM” 1983-1993 Diabetes Control and Complications Trial
  12. 12. 23% 26% 21% 0% 20% 40% 60% 80% 100% <6 6-<13 13-<20 Age A1c Goals of <7.5% for <18 yrs, <7% for 18+ % Individuals meeting HbA1c targets (T1D Exchange) 
 2013 20 years later
  13. 13. “If I publish it, it will be done” There is a translational gap in Pediatric Endocrinology, which is why we need the Science of Health Services Research and the Science of Health Services Delivery to achieve the goal of providing the best possible medical care for our patients
  14. 14. Disclaimer: Measuring costs and cost- effectiveness are just one aspect of the science of health services research and health services delivery Focus of this talk: 
 
 Cost & Cost-effectiveness (CE)
  15. 15. Takeaways Costs/CE affects access to therapies for our patients Understanding Costs/CE helps us optimize our use of health care resources by identifying which clinical strategies may lead to greater value for cost Understanding Costs can help us think about opportunities for developing new models of care
  16. 16. Takeaways Costs/CE affects access to therapies for our patients Understanding Costs/CE helps us optimize our use of health care resources by identifying which clinical strategies may lead to greater value for cost Understanding Costs can help us think about opportunities for developing new models of care
  17. 17. We built a model based on efficacy results from the pivotal trial used for the ISS FDA approval & studies from the literature Hypothetical cohort of 10 year old boys treated w/ GH compared with an untreated control cohort 5 year duration of tx GH dosing 0.37 mg/kg/week 5th% weight 30% discontinuation rate in 1st year of tx Yearly visits with Endo, bone age, TFTs, IGF-1
  18. 18. Main Outcome Measures Incremental cost per child Incremental growth per child Incremental cost per inch
  19. 19. Results Incremental Cost per Child, $ Incremental Growth per Child (inches) Cost per Inch, $ 99,959 1.9 $52,634
  20. 20. Incremental Cost per Child, $ Incremental Growth per Child, in Cost per Inch, $ Lower Efficacy (1.8 in) Higher Efficacy (3.9 in) 99,959 99,959 1.2 2.6 81,875 38,783 Age at initiation ages 8-13y Age at initiation ages 12-16y 81,268 126,123 1.9 1.9 42,792 66,411 Discontinuation rate, 0% Discontinuation rate, 40% 137,779 87,352 2.6 1.7 53,531 52,174 Treatment Duration, 7y (Ages 8-15y) Treatment Duration, 10y (Ages 5-15) 122,513 145,550 2.5 3.2 49,396 45,156 Dosing Regimens Low-dosage GH (0.24 mg/kg per wk) Standard-dosage GH (0.37 mg/kg per wk x 2y followed by high-dosage GH at puberty (0.7 mg/kg per wk) x 3y Standard-dosage GH (0.37 mg/kg per wk) x 1y followed by high-dosage GH at puberty (0.7 mg/kg per wk) x 4y 65,092 155,440 170,866 1.4 3.1 3.4 45,700 49,821 50,384 Sensitivity Analyses
  21. 21. Conclusions Estimate of $52,000 was substantially higher than a previous cited cost estimate of $35,000 No alternative GH treatment strategies change the cost-effectiveness of the therapy The cost of the drug drives CE
  22. 22. Takeaways Cost and CE affects access to therapies for our patients Understanding Costs/CE helps us optimize our use of health care resources by identifying which clinical strategies may lead to greater value for cost Understanding Costs/CE can help us think about opportunities for developing new models of care
  23. 23. 2010 ADA guidelines Prediabetes HbA1c ≥ 5.7% & <6.5% Diabetes HbA1c ≥ 6.5% 2010 ADA Guidelines The guideline was based exclusively on data from adults. No pediatric data about test efficacy/effectiveness or cost- effectiveness.
  24. 24. Study Design: Cross-sectional cohort of 254 children 10-17 years with a BMI ≥ 85th% 2-hour OGTT (Gold standard) Nonfasting HbA1c Nonfasting 50 gm 1 hour glucose challenge test Nonfasting Random glucose Outcome was Dysglycemia (2-hr Glu≥140) as defined 2- hour OGTT (Prediabetes n=99, Diabetes n=3) Receiver Operator Characteristic Curves and Compared Area Under the Curve
  25. 25. 0% 25% 50% 75% 100% 0% 25% 50% 75% 100% Sensitivity(Truepositive) 1-Specificity (False ) Sensitivity(Truepositive) 1-Specificity (False Positive) *p=0.02 1-hr 50 gm Glucose Challenge Test (GCT) Random Glucose HbA1c Test performance of nonfasting glucose tests of glycemia was better than HbA1c 5.7% 110 100 110 120 6.0% AUC Random Glucose 0.68 (0.61-0.76)* 1 hour GCT 0.70 (0.62-0.78)* HbA1c 0.55 (0.47-0.64)
  26. 26. Strategy Cutoff Sensitivity (%) Specificity (%) 2 hr OGTT - 100% 100% Hemoglobin A1c 5.7% (ADA) 45% 57% 6.0% (IDF) 32% 74% 6.5% 7% 98% 1-hr Glucose Challenge Test (mg/dL) 110 63% 63% 120 44% 81% Random Glucose (mg/ dL) 100 55% 67% 110 30% 88% Test Performance for Detecting Prediabetes
  27. 27. Test Performance for Detecting Diabetes Strategy Cutoff Sensitivity (%) Specificity (%) Hemoglobin A1c 5.7% (ADA) 33% 56% 6.0% (IDF) 33% 71% 6.5% 33% 96%
  28. 28. Model of a hypothetical cohort of the 2.5 million overweight or obese adolescents 10-19 years of age eligible for screening Modeled a one-time screening program for diabetes and dysglycemia from the societal perspective
  29. 29. Screening Strategies Evaluated 2-hour oral glucose tolerance test Hemoglobin A1c (HbA1c) Random Glucose 1-hr 50gm Glucose Challenge Test If positive, 2-hr OGTT
  30. 30. Base Case Assumptions 16% prevalence of dysglycemia (n=400,000) 0.02% prevalence of diabetes (n=500) 100% adherence 2-hr OGTT has 100% sensitivity and specificity Liese et al, Pediatrics, 2006 Li et al, Diabetes Care, 2009
  31. 31. Cost Assumptions Screening Strategy Cost per Screen ($ 2010)* Patient time for Testing** 2-hr OGTT $18.44 135 min HbA1c $13.90 15 min 1-hr GCT $6.80 75 min Random Glucose $5.62 15 min ½ Mean Hourly Wage (All Occupations) $10.68/hour Physician Time 1/5th visit=$20 Direct and Indirect Costs *Medicare reimbursement rates **Wage data (Bureau of Labor Statistics)
  32. 32. Study Outcomes Proportion of cases (diabetes/dysglycemia) identified Total costs (direct & indirect) Cost per case identified (direct & indirect)
  33. 33. Sensitivity Analyses Alternative estimates of HbA1c test performance Higher or lower prevalence (±25%) Differing levels of adherence (75% for nonfasting and 50% for 2-hr OGTT) Doubled provider time Halved HbA1c costs
  34. 34. $831,166 (33%) 2 hr OGTT $312,224 (100%) HbA1c 5.7% HbA1c 5.5% $731,822 (33%) HbA1c 6.5% $571,344 (33%) Cost per Diabetes Case Identified ($) %ofCasesIdentified Base Case (100% adherence) High Effectiveness Low Cost per case Low Effectiveness High Cost Per Case
  35. 35. $831,166 (33%) 2 hr OGTT $312,224 (100%) HbA1c 5.7% HbA1c 5.5% $731,822 (33%) HbA1c 6.5% $571,344 (33%) Cost per Diabetes Case Identified ($) %ofCasesIdentified Base Case (100% adherence)
  36. 36. $831,166 (33%) 2 hr OGTT $312,224 (100%) HbA1c 5.7% HbA1c 5.5% $731,822 (33%) HbA1c 6.5% $571,344 (33%) HbA1c 6.5% $577,843 (32%) Cost per Diabetes Case Identified ($) %ofCasesIdentified Alternative HbA1c Thresholds HbA1c 5.7% $329,249 (71%)
  37. 37. Costs per Dysglycemia Case Identified ($) %ofCasesIdentified Alternative HbA1c Thresholds HbA1c 6.5% $3370 (7%) $938 (32%) HbA1c 5.7% $763 (45%) HbA1c 5.5% $721 (30%) RPG 110 $709 (44%) 1-hr GCT 120 $571 (63%) 1-hr GCT 110 $498 (55%) RPG 100 2 hr OGTT $390 (100%) HbA1c 6.5% $5754 (4%) HbA1c 5.7% $826 (34%)
  38. 38. Sensitivity Analyses did not change the Overall Rankings Alternative estimates of HbA1c test performance Higher or lower prevalence (±25%) Differing levels of adherence (75% for nonfasting and 50% for 2-hr OGTT) Doubled provider time Halved HbA1c costs
  39. 39. Conclusions/Implications HbA1c had lower effectiveness and higher costs Why would we prioritize a screening test that performs worse and costs more? A1c is still useful at diagnosis of diabetes, but random or 1-hour GCT may be more promising screening tests Should the ADA change its policy on HbA1c for children? What should the AAP recommend?
  40. 40. Takeaways Cost and CE affects access to therapies for our patients Understanding Costs/CE helps us optimize our use of health care resources by identifying which clinical strategies may lead to greater value for cost Understanding Costs/CE can help us think about opportunities for developing new models of care
  41. 41. Most studies of cost in adults, non-US populations, privately insured kids, so we studied kids covered under California Children’s Services Outcomes: We measured health utilization and costs for 652 children with presumed T1D enrolled for the period July 1, 2009, to June 30, 2012. Aged 0-21 years Continuously enrolled for at least 365 days Had an outpt visit for T1D in the year Were taking insulin
  42. 42. $5603 $58 $144 $2930 $1579 0 2000 4000 6000 8000 10000 12000 Overall Population ED (0.4%) (60%) Hospitalizations (1.3%) Outpatient Clinic (13%) Monitoring Supplies Overall Median Annualized Expenditure Rates (23%) Insulin
  43. 43. S/P DKA Episode #3 Flat affect Lives 2 ½ hours away 3 hour clinic visit Does not bring meter HbA1c = 14%
  44. 44. Clinical Effectiveness Knowledge Improved Quality, Value, & Population Health Basic Biomedical Science T1 T2 T3 Dougherty JAMA 2008 Translational Research Health Services Delivery •  Systems Design •  Quality Improvement Science •  Human-centered Design/ Participatory Design Health Services Research •  Health Utilization •  Health Outcomes •  Costs/Cost-effectiveness •  Access/Quality Clinical Efficacy Knowledge
  45. 45. Design of a Learning Health System for Type 1 Diabetes
  46. 46. Healthcare delivery system as scientific laboratory
 
 Clinical Care, Research, and Quality Improvement are no longer separate efforts but are deliberately designed to be integrated
 
 Research informs practice and practice informs research
 
 Learning Health System
  47. 47. Technology Tools Focus on Outcomes/Quality Improvement Collaborative Network What does a Learning Health System Consist Of?
  48. 48. Patient-reported Data Data Clinician-reported Data Clinical Care Quality Improvement Research A “Data in Once System”
  49. 49. Data Capture at Clinical Encounter
 through the EMR
  50. 50. Research Grade Data is Entered & Measured Consistently Across All Centers
  51. 51. Collection of Patient Reported Outcomes
  52. 52. Technology Tools Focus on Outcomes/Quality Improvement Collaborative Network What does a Learning Health System Consist Of?
  53. 53. Multiple Outcomes are Followed Across Centers the Network in Real-time
  54. 54. Clinical Centers can Measure the Effects of Improvement Interventions
  55. 55. Clinical Centers Can Perform Population Management
  56. 56. Technology Tools Focus on Outcomes/Quality Improvement Collaborative Network What does a Learning Health System Consist Of?
  57. 57. Collaborative Network of Patients & Caregivers, Clinicians, Researchers Sharing Virtual/In Person “Stealing Shamelessly & Sharing Seamlessly” Resources, QI Interventions, Innovations One Patient è Many Patients One Provider è Many Providers
 
 One Visit è Many Visits
  58. 58. Identify her as a high risk patient & provide clinical support between visits Depression Screening (QI Intervention) Diabetes coach (self-management skills) Peer support (Group Classes) Diabetes education for millennials What can a Learning Health System do for Kayla?
  59. 59. $5603 $58 $144 $2930 $1579 0 2000 4000 6000 8000 10000 12000 Overall Population ED (0.4%) (60%) Hospitalizations (1.3%) Outpatient Clinic (13%) Monitoring Supplies (23%) Insulin “An opportunity” Overall Median Annualized Expenditure Rates
  60. 60. Alternative Payment Models (accountable care organizations (ACOs), bundled payments, and advanced primary care medical homes) Currently at 20% of Medicare Goal of 30% by 2016 Goals of 50% by 2018
  61. 61. “Wilkins demonstrated his organized approach to patient care. Impressed by the poor care of children with congenital syphilis and their lack of follow-up care, he started a dedicated clinic, organized the care, and obtained a special social worker to develop a follow-up system.”
  62. 62. Health Outcomes, Cost, Quality, 
 and Learning Health Systems of Care: Our opportunity to fulfill 
 Wilkins’ vision of care 
 for Pediatric Endocrinology!
  63. 63. Valerie Castle, MD Ram Menon, MD Gary Freed, MD, MPH Sarah Clark, MPH Matthew Davis, MD, MAPP UM Pediatric Endocrinology Twitter: @joyclee Email: joyclee@med.umich.edu
 http://www.doctorasdesigner.com/ Acknowledgements Emily Hirschfeld Ashley Garrity Nayla Kazzi En-Ling Wu Beth Tarini Esther Yoon Jim Gurney Acham Gebremariam
  64. 64. www.diabetesemoticons.com nightscoutstudy.info

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