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Diabetes Update - Integrating Clinical Trials with EMR Practicalities

Diabetes Update - Integrating Clinical Trials with EMR Practicalities. Michael Shannon, MD PMG Endocrinology, Olympia WA. Outline of Talk. Newly released and upcoming medications: the incretins, DPP-IV inhibitors, and what’s coming

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Diabetes Update - Integrating Clinical Trials with EMR Practicalities

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  1. Diabetes Update - Integrating Clinical Trials with EMR Practicalities Michael Shannon, MD PMG Endocrinology, Olympia WA

  2. Outline of Talk • Newly released and upcoming medications: the incretins, DPP-IV inhibitors, and what’s coming • Revised ADA/EASD and AACE guidelines: focus on potency, safety, cost • Introduction of EPIC project at Providence • Role of a Clinical Advancement Team in promoting best clinical practices

  3. The Diabetes Toolbox 2010

  4. What’s New and What’s Coming Incretins: GLP-1 agonists and analogs Incretins: DPP-IV inhibitors Sodium-Glucose Transport Proteins-2 (SGLT-2) inhibitors: Dapagliflozin

  5. Glucagon-Like Peptide-1 • Glucagon-like peptide-1 is an incretin, a gut hormone that increases the release of insulin • Many effects of GLP-1: • Increases insulin sensitivity • Inhibits glucagon release • Inhibits gastric emptying • Increases satiety and decreases food intake • Native GLP-1 improves glucose control but the short half-life limits its use (needs pump)

  6. Intestinal GLP-1 Release Mixed Meal Active GLP-1 DPP4 t1/2 = 1-2 min Rapid Inactivation Inactive GLP-1 GLP-1 Agonists and DPP-IV Inhibitors

  7. GLP-1 Agonists and Analogs • Exenatide: GLP-1 receptor agonist (BID) • Liraglutide: GLP-1 analog (QD) • Under development: • Once-weekly exenatide long-acting release (LAR) • Taspoglutide • Lixisenatide • Others in various stages

  8. GLP-1 Inhibitors: Exenatide Modification of GLP-1 to prevent degrading Modest benefit in HbA1c 0.7-1.1% Significant nausea (52% vs 8% for insulin) and emesis; RJ Heine et al, Ann Int Med 2005 Some weight loss as well Significant heterogeneity in response in clinical experience (some all-stars, some fail) Safety warnings about pancreatitis, kidneys

  9. Liraglutide • Approved January 2010; once-daily injection • Associated with similar modest decrease in HbA1c of 0.7% - 1.1% with slightly more reduction in one trial (LEAD-6) • Less renal limitations than exenatide • Possible association with pancreatitis and there is suggestion of rare thyroid tumors in rats so special warnings for medullary thyroid cancer

  10. DPP-IV Inhibitors • Sitagliptin (Januvia) and saxagliptin (Onglyza) and linagliptin (Tradjenta) • Associated with modest decrease in HbA1c of 0.5% - 0.8%; can be dosed with ESRD • Minimal side effects (possible more minor infections) • All are pregnancy Category B – unclear why • Minimal long-term safety data – possible off-target interactions with diverse DPP-IV targets

  11. SGLT-2 Inhibitors • Sodium-glucose cotransporter-2 is a protein that aids in glucose reabsorption from the kidney • Natural mutation: familial renal glycosuria • Inhibition of this protein leads to increased glucosuria – in early studies appears to reduce A1c and body weight, with possible side effect of increased UTIs and yeast infections • Several in development (dapagliflozin filed with FDA, remogliflozin, sergliflozin)

  12. Final Word on New Therapies • None of these have been in wide use for long • Lessons of rosiglitazone: hemoglobin A1c is a surrogate endpoint, not the true goal of care • None of these have any microvascular or macrovascular endpoints (trials underway) • Most of these drugs cost upwards of $6/day

  13. Interesting products – but what is their impact? Is lowering A1c the goal of care? Diagnosis is a fairly soft endpoint, but death is unequivocal. Edwin AM Gale, Lancet 2003

  14. ADA/EASD DM2 Algorithm • Updated in 2009 based on clinical trials and collective clinical judgment and experience of authors • Evaluates glucose reductions, non-glycemic effects that could reduce diabetic complications, safety, tolerability, ease of use, and cost of each intervention • Provides treatment algorithm with intervention tiers DM Nathan et al, Diabetes Care 2009

  15. ADA/EASD DM2 Algorithm Tier 1: Well validated core therapies Lifestyle + Metformin + Basal insulin Lifestyle + Metformin + Intensive insulin At diagnosis: Lifestyle + Metformin Lifestyle + Metformin + Sulfonylurea STEP 1 STEP 2 STEP 3 Tier 2: Less well validated therapies Lifestyle + Metformin + Pioglitazone + Sulfonylurea Lifestyle + Metformin + Pioglitazone Lifestyle + Metformin + GLP-1 agonist Lifestyle + Metformin + Basal insulin DM Nathan et al, Diabetes Care 2009

  16. Diabetes interventions by tiers • Tier 1 Interventions (‘well-validated core’) Lifestyle changes with diet and exercise (1.0-2.0)* Metformin (1.0-2.0) Insulin (1.5-3.5) Sulfonylureas (1.0-2.0) • Tier 2 Interventions (‘less well-validated’ core) Thiazolidinediones (pioglitazone) (0.5-1.4) GLP-1 agonists (exenatide) (0.5-1.0) • Others (less A1c lowering, less evidence, or costlier):α-Glucosidase inhibitors (0.5-0.8), Glinides (0.5-1.5) Pramlintide (0.5-1.0), DPP-IV inhibitors (0.5-0.8) DM Nathan et al, Diabetes Care 2009

  17. Comments on treatment choices • Tier 2 optionsmay be considered when weight loss is major goal (exenatide) or when hypoglycemia is major concern (pioglitazone and exenatide, not rosi) • α-Glucosidase inhibitors, glinides, pramlintide, and DPP-4 inhibitors appropriate for selected patients • Starting or intensifying insulin preferred to third oral • Algorithm is cautious in use of newer treatments DM Nathan et al, Diabetes Care 2009

  18. AACE Algorithm • Released by American Association of Clinical Endocrinologists in October 2009 • Stated by AACE to include a variety of choices based on first-line, second-line, and third-line therapies as well as secondary factors (weight, risk of hypoglycemia) • Emphasizes wider choices • Ends up somewhat overwhelming algorithm HW Rodbard et al, Endocrine Practice 2009

  19. Diabetes Toolbox: A Critical Look Drugstore.com

  20. Indications for Insulin Therapy • Severe hyperglycemia at diagnosis or at a later point despite aggressive treatment • To meet glycemic goals - hyperglycaemia despite maximum doses of oral agents • Decompensation of other organ systems that limits use of other oral agents • Early cost-effective potent treatment

  21. A Broader Toolbox Doesn’t Always Improve Clinical Outcomes • Diabetes is a progressive disease • More choices can decrease ability to intensify care (SS Iyengar, 2000) • Use algorithms as a guideline (joint ADA-EASD consensus statement or AACE/ACE) • Individual patients may have specific issues that require tailoring algorithms to their needs • Guidelines need to be available and accessible!

  22. From Trials and Guidelines to Implementing Best Practices • Providence Health & Services has 27 hospitals, major health plan, ~2000 doctors • Despite this, limited ways to disseminate best practices and learn from other regions • Two reasons for Clinical Advancement Teams: • Collect local successes and share the team practices and order sets that allow these successes • And… the entire system is going onto EPIC, for a new EMR

  23. Washington • Pneumonia Mortality: Prov Centralia • Sepsis Mortality, NOT Present on Admission, Prov Centralia • Mortality on Ventilator (use on Day 1),Prov Everett • Central Line Blood Stream Infections, Prov Everett • Mortality on Ventilator (Use after Day 1), Prov Sacred Heart, Spokane • Heart Failure Readmissions, Prov Holy Family, Spokane • Sepsis Mortality, Present on Admission, Prov Holy Family, Spokane

  24. Oregon Pneumonia Readmissions, Prov Hood River AMI Readmissions, Prov Milwaukie Neonatal Morbidity/Mortality, Prov St Vincent, Portland (infants 501-1500 grams) Heart Failure Readmissions, Prov Milwaukie TIE! Out Patient Data Percent of patients over 65 with documented pneumococcal vaccination: Winner: PMG South Eagle Point @ 91% [near Medford OR] (Range: 26% - 91%; P H & S average: 51%) Percent of ambulatory diabetics who have not had an LDL test drawn in the past year:     Winner:PMG West Linn (in West Linn, OR--South of Portland) 29% (range: 29% -  70%, P H & S average: 56%) Present of ambulatory adult diabetics with most recent HgAic > 9% who have not had a HgA1c drawn the past year: Winner: tie between PMG North Plaza [by Providence Portland medical Center  Hospital in Portland] AND PMG Teaching Clinic, Milwaukie (near Providence Milwaukie) @ 12% (range: 70- 12, P H & S average: 19)

  25. Clinical Guidance for EHR Build • Clinical Advancement Teams • “Think Tanks” in 32 disciplines • Mainly virtual every 2 weeks; one in-person orientation • 6 to 8 Collaborative Build Sessions • Travel to Seattle • April-August • As Needed Decisions • Quick decisions, e.g. correcting an omission or typographical error Non-physician Clinicians Physicians

  26. Clinical Advisory Council Coordinates and oversees “Clinical Guidance” to support the Quality Strategic Framework. Core subgroups Safe Medication Formulary Workgroup 32 specialty Clinical Advancement Teams Interdisciplinary Content Review Physician Content Review Workgroup Clinical Decision Support Workgroup Other task forces / workgroups as needed Clinical ROI Workgroup Regulatory / Accreditation Workgroup

  27. Clinical Advancement Teams

  28. Who is on a Clinical Advancement Team?

  29. Endocrinology/Diabetes: 2 endos, 2 hospitalists, 3 PharmD, 3 PCPs, 3 nurse specialists, 4 CDEs, and one laboratory specialist

  30. Inclusive “Mountain” of Subject Matter Experts Clinical Champions SME representatives hundreds of Subject Matter Experts CAT Phone, email Print outs Quick conversations Section meetings Translate clinical input into the EHR

  31. CAT Team: “People Skills” for EPIC Clinical Champions SME representatives Translate clinical input into the EHR

  32. CAT Goals to Achieve • Order sets that are usable and up to date (no, they don’t still make insulin ultralente) • Workable dashboard for best clinical practices • When was my last diabetic eye exam? • How few clicks to order a urine microalbumin? • Extractable data for disease management registries and (likely) for payor demands/ACO • Find local successes and disseminate them

  33. ADA/EASD DM2 Algorithm Tier 1: Well validated core therapies Lifestyle + Metformin + Basal insulin Lifestyle + Metformin + Intensive insulin At diagnosis: Lifestyle + Metformin Lifestyle + Metformin + Sulfonylurea STEP 1 STEP 2 STEP 3 Tier 2: Less well validated therapies Lifestyle + Metformin + Pioglitazone + Sulfonylurea Lifestyle + Metformin + Pioglitazone Lifestyle + Metformin + GLP-1 agonist Lifestyle + Metformin + Basal insulin DM Nathan et al, Diabetes Care 2009

  34. Content to Review • Inpatient: • Diabetic Ketoacidosis Admission • Insulin drip order set • Subcutaneous Insulin order sets • Outpatient: • Diabetes Outpatient Visit • Thyroid disease • Special groups: pediatrics, obstetrics

  35. CAT Team: Identifying Barriers • Fear of loss of autonomy • Fear of technology changes to workflow • Generalized resistance to intrusion on “the way it’s always been” (territorial behavior)

  36. Many ways to contribute feedback • Add a comment to the online collaboration tool • Phone / email your Clinical Champion or subject matter expert representative • Discuss at a sub-section meeting or team meeting • Physician liaisons / point persons: print-outs • Quick conversations

  37. Conclusion There are interesting new therapies available and on the horizon, but all still have limited long-term safety and hard endpoint data The ADA/EASD guidelines support first-tier use of metformin, sulfonylureas, and insulin, with second-tier use of GLP-1 and pioglitazone Providence will use EPIC to take best local practices and spread success across system Clinical Advancement Teams will draw out local experts to grow best care in Providence

  38. Diabetes Quality Metrics are HerePay for Performance is EvolvingEMR and Integration are Continuingand our diabetes care can’t be “last in”

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