eric_johnson_ada_ti_workshop_feb_2020_v4_0.pptx

ADA diabeytes managemnet

1. Phoenix, AZ February 24, 2020 Overcoming Therapeutic Inertia: Clinical Workshop

2. Eric L. Johnson, MD Associate Professor University of North Dakota School of Medicine and Health Sciences Assistant Medical Director Altru Diabetes Center Grand Forks, ND Primary Care Advisory Group, Chair American Diabetes Association Optimizing Diabetes Care to Avoid Therapeutic Inertia

3. Its not about working harder Its about working Better

4. Take the time to develop a system to tackle inertia in your practice. If you don ’ t deal with inertia, it will deal with you.

5. Economic Costs of Diabetes in the US in 2017 327 billion were spent in 2017 on diagnosed diabetes . - $237 billion in direct medical costs and $90 billion in reduced productivity Direct medical costs represent a 26% increase (adj for inflation) since 2012 ( increased prevalence and the increased cost per person affected) More than 300 million work days are lost to the economy due to diabetes Diabetes resulted in 277,000 premature deaths. American Diabetes Association. Diabetes Care. 2018 May;41(5):917-928.

6. Economic Costs of Diabetes in the US in 2017 Medications directly used to treat diabetes = $31 billion, $15 billion of which is for insulin. - Increased by 45% over 5 years after adjusting for inflation 1 in every 4 health care dollars spent (24 percent) was for the care of people with diabetes American Diabetes Association. Diabetes Care. 2018 May;41(5):917-928.

7. GLP-1R agonist 1920 1990 2000 2010 1970 Insulin SFU Pramlintide DPP-4 inhibitor Bromocriptine 1960 1980 ADA Standards of Care 1989 TZD Metformin Rapid-acting insulin Meglitinide Basal insulin 2014 α Glucosidase inhibitor SGLT-2 Inhibitor Therapeutic Advances Over Past 20 Years

8. Carls G . Huynh J . Tuttle et al . Achievement of Glycated Hemoglobin Goals in the US Remains Unchanged Through 2014. Diabetes Ther 2017;8:863–873 Achievement of individualized targets declined from 69.8% to 63.8% Despite increasing number of new diabetes medications and technologies …

9. Carls G . Huynh J . Tuttle et al . Achievement of Glycated Hemoglobin Goals in the US Remains Unchanged Through 2014. Diabetes Ther 2017;8:863–873 The percentage with HbA1c >9.0% increased from 12.6% to 15.5% Despite increasing number of new diabetes medications and technologies …

10. Disruption is Needed to Improve Care Quality in Diabetes Type 2 Diabetes Trends in the U.S. 2006-2013 Proportion of patients with Type 2 Diabetes Adapted from: Lipska KJ, Yao X, Herrin J, et al.  Trends in drug utilization, glycemic control, and rates of severe hypoglycemia, 2006–2013  [published online September 22, 2016].  Diabetes Care . doi:10.2337/dc16-0985 . DPP-4 and GLP-1 Rx approved Increased adoption of EHRs, HITECH Act, iPhone and apps introduced Affordable Care Act becomes law, proliferation of “personal tech” SGLT-2 inhibitor Rx approved Meaningful Use Implementation, PCMH, ACO formations *Subset of 1.66M patients with an A1c available N=424,348* Advances in health technology, drug therapies and policy have NOT translated to improvements in diabetes care quality

11. What’s wrong with this picture? Decline in % of patients at HbA1c <7% At best, only about 50% of patients at Goal Increase in % of patients with very poor control Unacceptable level of morbidity and mortality Diabetes-related costs to society are tremendous ALL THIS DESPITE MORE THAN 40 NEW T2D TREATMENT OPTIONS APPROVED SINCE 2005 2005 2019

12. 12 The root of the problem ... Therapeutic Inertia

13. 13 Therapeutic Inertia: Rational and Clinical Relevance The failure to establish appropriate targets and escalate treatment to achieve treatment goals Responsible for substantial, preventable complications of diabetes with the associated excess in direct and indirect health care costs

14. Khunti K, et al. Diabetes Care 2013;36:3411–7 Substantial inertia exists at each sequential intensification step 6.9-7.2 years 1 1.6-2.9 years 1 6-7.1 years 1 3.7 years 2 Pa t i en t on 1 OAD A dd i n g 2nd OAD* A dd i n g 3rd OAD* Adding i nsu li n * Adding GLP-1 RA, premixed and bolus insulin † Clinical Inertia Plays an Important Role in Delaying Intensification of Diabetes Therapy *From time when A1c was ≥7.0%, ≥7.5%, or ≥8.0%; † From time when A1c was ≥7.5%. GLP-1 RA: glucagon-like peptide-1 receptor agonist; OAD: oral antidiabetic drug. Slide courtesy of Steve Edelman, MD. 1 . Khunti K, et al. Diabetes Care. 2013;36:3411-3417. 2 . Khunti K, et al. Diabetes Obes Metab. 2016;18:401-409.

15. The Diabetes Appointment Know your ABC’s A 1c Individualized Goal, if not there change something B lood Pressure less than 140/90 C holesterol Tackling barriers Tell me what you think we should be doing today? “These aren’t just numbers we are chasing; they are numbers with meaning, and medications are tied to numbers”

16. Promotors of Therapeutic Inertia Often Cited… 16 Adapted from: G Reach, V Pechtner, et al.; Clinical inertia and its impact on treatment intensification in people with type 2 diabetes mellitus ; Diabetes & Metabolism Vol 43, Issue 6, Dec. 2017, 501-511 Clinician-Related Insufficient time Failure to set clear goals Failure to initiate treatment Failure to titrate treatment to achieve goals Failure to identify and manage comorbidities (e.g. depression) Patient ‘highjacks’ the clinical encounter Reactive rather than proactive care Underestimation of patient's need Patient-Related Denial of having the disease Denial that the disease is serious Low health literacy High cost of medication Too many medications Medication side-effects Poor communication between physician and patient Lack of trust in physician SDOH, Depression or substance abuse Lifestyle factors Absence of symptoms Healthcare System/Practice –related No clinical guidelines No disease registry No visit planning No active outreach to patients No decision support No team approach to care Poor communication between physician and staff

17. Our view ... 17 Although therapeutic inertia impacts all populations, targeting individuals with type 2 diabetes is our first priority The causes of clinical inertia are multifactorial, with contributory elements from five stakeholder groups: People with diabetes Clinicians and other healthcare providers Healthcare systems Payors Industry

18. What else is important to know about therapeutic inertia? 18 Early tight control leads to longer term maintenance of glycemic control. 1 – A legacy effect. Therapeutic inertia leads to a reduced likelihood of achieving target levels later in the disease trajectory. 2 Early intensification of treatment, in appropriate patients, is associated with a shorter time to subsequent glycemic control. 3 Therapeutic inertia has been associated with a reduced quality of life for the patient, along with increased risks of morbidity and mortality. 1. M Abdul-Ghani, C Puckett , et al . Initial combination therapy with metformin, pioglitazone and exenatide is more effective than sequential add-on therapy in subjects with new-onset diabetes. Results from the efficacy and durability of initial combination therapy for type 2 diabetes (EDICT): a randomized trial. Diabetes Obes Metab 2015; 17: 268–275. 2. D Mauricio, L Meneghini, et al . Change in insulin dose and HbA1c by geographical region—results from the diabetes unmet need with basal insulin evaluation (DUNE) Study. Diabetes 2018; 67(Suppl. 1). DOI: 10.2337/db18- 1037-P. 3. U Desai, NY Kirson et al . Time to treatment intensification after monotherapy failure and its association with subsequent glycemic control among 93,515 patients with type 2 diabetes. Diabetes Care 2018; 41: 2096–2104.

19. Glycemic Therapeutic Inertia Know the ADA algorithm 19

20. Standards of Medical Care in Diabetes—2020

21. The Standards. Intended to provide clinicians, patients, researchers, payers, and other interested individuals with the components of diabetes care, general treatment goals, and tools to evaluate the quality of care.

22. Search of scientific diabetes literature over past year Recommendations revised per new evidence Professional Practice Committee Reviewed by ADA’s Board of Directors Living Standards Funded out of ADA’s general revenues Does not use industry support EVIDENCE PROCESS FUNDING

23. 23 Pharmacologic Approaches to Glycemic Treatment New 2020 Figure 9.1 has been revised to include the latest trial findings on GLP-1 receptor agonists and SGLT2 inhibitors. It now suggests that these drugs should be considered for patients when atherosclerotic cardiovascular disease (ASCVD), heart failure, or chronic kidney disease predominates independent of A1C Figure 9.2 has been simplified to more easily guide providers through intensification to injectable therapies

24. Pharmacologic Approaches to Glycemic Treatment Glucose-lowering Medication in Type 2 Diabetes: Overall Approach Pharmacologic Approaches to Glycemic Management: Standards of Medical Care in Diabetes - 2020 . Diabetes Care 2020;43(Suppl. 1):S98-S110

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27. 27 Intensifying to injectable therapies. DSMES, diabetes self-management education and support; FPG, fasting plasma glucose; FRC, fixed-ratio combination; GLP-1 RA, glucagon-like peptide 1 receptor agonist; max, maximum; PPG, postprandial glucose. Adapted from Davies et al. (33)

28. Getting the Medications 28

29. “I always get these medications declined” If I get a decline, I ask the pharmacist what is likely to be covered in the same class (i.e., if dapagliflozin is covered and canagliflozin isn’t), “prescribe to the formulary” Many medications have discount vouchers online that are easy to get Doing these 2 things- I hardly ever have to do a preauthorization Medicare D- patient can often work with pharmacist to choose a plan that is a good match for their medications 29

30. Prior Authorizations Anticipate them and dictate into encounter note Document a patient-centered narrative and the patient needs Note previous treatment “Failures” Cite Standards of Care ADA Treatment Algorithm FDA Indications Secondary Benefits Desired Cardiovascular or Renal Benefit Stand Firm in you Professional opinion Liability for denied therapies is not transferred to the provider Coverage for therapeutic options it is dictated by the payor...call it out if it goes against your medical judgment

31. Cardiovascular Inertia 31

32. 32 Cardiovascular Disease and Risk Management . This section is endorsed for the second consecutive year by the American College of Cardiology Recommendations for statin treatment (primary and secondary prevention, 10.19–10.28) have been revised to minimize ASCVD risk and to align with the “2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary published in June 2019 Discussion of REDUCE-IT was added to the section “Treatment of Other Lipoprotein Fractions or Targets,” and a new recommendation (10.31) was included on considering icosapent ethyl for reducing cardiovascular risk

33. Back to the Algorithm 33

34. Lifestyle and Behavioral Approaches 34

35. Weight Reduction Even 3-5% reduction in bodyweight has an impact Mention to patients when they don ’ t gain weight Remember it is several factors that go into this Eat during daylight hours The body defends its weight set point Intake the majority of calories prior to 3pm Carbs best at lunch (least insulin resistance) Get plenty of sleep, leverage weight reduction diabetes therapies, & stress reduction

36. Exercise Ask your patient… “what do you do to stay active?” Explore job duties Does employer have a wellness program?

37. Use Your Community Know what is in the community Diabetes Prevention Services Where I live, even small rural locations often have small commercial fitness centers (some employers pay) Simple things (i.e., three 5 minute walks per day)

38. Psychosocial Issues Facilitating Behavior Change and Well-being to Improve Health Outcomes 5.31 Psychosocial care should be integrated with a collaborative, patient-centered approach and provided to all people with diabetes, with the goals of optimizing health outcomes and health-related quality of life. ( A) 5.32 Psychosocial screening and follow-up may include, but are not limited to, attitudes about diabetes, expectations for medical management and outcomes, affect or mood, general and diabetes-related quality of life, available resources ( fi nancial, social, and emotional), and psychiatric history. ( E)

39. Psychosocial Issues (Cont’d ) Facilitating Behavior Change and Well-being to Improve Health Outcomes 5.33 Providers should consider assessment for symptoms of diabetes distress, depression, anxiety, disordered eating, and cognitive capacities using appropriate standardized and validated tools at the initial visit, at periodic intervals, and when there is a change in disease, treatment, or life circumstance. Including caregivers and family members in this assessment is recommended. ( B) 5.34 Consider screening older adults (aged ≥ 65 years) with diabetes for cognitive impairment and depression. ( B)

40. Psychosocial Issues (cont’d) How do I approach this? Usually something simple, such as “have you ever had and issues with anxiety or depression? Does your diabetes affect your mood?”

41. “I don’t like taking all of these medicines” These medications have a purpose; being active and eating well are important, but not enough for most people When I started doing diabetes care 25 years ago, people died younger; we didn’t have good choices for treatment then If we can stop a medication, or a better choice comes along, we’ll make a change Always call if you are having a medication problem 41

42. Technology Approaches 42

43. Utilizations of Technology for Individuals Use it to lessen disease burden, increase patient engagement, and improve outcomes: Continuous glucose monitoring- increasingly a good choice Insulin Delivery Devices Apps for carb counting, weight reduction Step counters or fitness pals Smart Watches Challenge patient to find one they like and show it to you You don ’ t need to know all of the options, but be familiar enough with one to have a resource

44. Electronic Health Record/Artificial Intelligence Can be as simple as “slice and dice”- for example, once or twice a year we generate a letter to all of those with A1C>9 who have been seen in the last year “Smart phrases”, templates. I see 3 or 4 typical types of diabetes patients, no need to start a chart note at “ground zero” for all of them More and more, AI will manage large data sets 44

45. Who Is On Your Team? What are they doing? If you have access to dieticians and nurse educators, use them- I sometime do an “every other” appointment approach If your clinic/system has phone nurses/medical home, use them. I don’t have time to make a lot of phone follow-up (with a few exceptions) If you use behavioral health screening, assign that to a particular member of your team (often a nurse, or someone in reception). Office nurse (or designee)- medication reconciliation 45

46. Diabetes Labs A1C 2-4 times yearly Chemistry panel, to include renal and hepatic 1-2 times yearly, prn Urine for microalbumin 1 or 2 times a year CBC annually, particularly if on aspirin and/or renal disease Lipids only for monitoring compliance Celiac screening in type 1 periodically (ever 3 years and prn) Thyroid screening usually annual in type 1 These are set up as standing orders- if I miss it, nurse orders I’m not obsessed with having these done prior to appointment If they aren’t in clinic 30 minutes before, I’d rather see them first

47. Decision cycle for patient-centered glycemic management in type 2 diabetes. American Diabetes Association Dia Care 2020;43:S37-S47 ©2020 by American Diabetes Association

48. It’s All in the Follow Up Establish the next appointment at the current visit Agree upon the action plan to be reviewed at the next appointment Advise your patients were are going to keep pace with their disease Phone follow-up (we have nurses dedicated to this role)

49. 49 Barriers and Solutions Peer Learning Exercise What is the biggest barrier to reducing TI in your practice or experience? What strategies, mentioned here or otherwise, have you found that work to address your top barrier? Or, maybe you haven’t found solutions and want advice from others?

50. 50 Questions?