5/21/2018. Type 2 Diabetes. Clinical inertia in type 2 diabetes patients based on recent real-world data

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1 Clinical inertia in type 2 diabetes patients based on recent real-world data Andrea DeSantis, DO Department of Family Practice Rohan Mahabaleshwarkar, PhD Center for Outcomes Research and Evaluation Type 2 Diabetes In 2015, 30.3 million people or 9.4% of the population has Diabetes Another 84.1 million or 33.9% have Prediabetes, a condition if not treated often leads to Type 2 diabetes within 5 years Diabetes was the 7th leading cause of death in 2015 Estimated costs in 2017 were $327 billion. Average annual expenditure is $16,750 per person Adjusted for age and sex, the average cost was 2.3 times higher than those without diabetes Centers for Disease Control, US Dept of Health and Human Services American Diabetes Association. Economic Costs of Diabetes in the U.S. in Diabetes Care. March American Diabetes Association Classification Non Diabetic <5.7 Pre Diabetes Diabetes >6.4 1

2 2016 ADA HbA1c Guidelines Less Stringent <8.0 Older patients with comorbidities More Stringent <7.0 younger healthier patients Background Nearly half of patients with Type 2 Diabetes (T2D) do not achieve recommended glycosylated hemoglobin (HbA1c) goal of < 7%. 1,2 and 40% do not reach an HbA1c of < 8% 3 Clinical inertia or the delay of treatment intensification is a major cause of inadequate glycemic control. 4 Though adherence factors play a large roll in clinical inertia, often providers do not escalate therapy for various reasons. 1.Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting HbA1c, blood pressure, and LDL goals among people with diabetes, Diabetes Care. 2013; 36(8): Phillips LS, Branch WT, Cook CB, et al. Clinical inertia. Ann Intern Med. 2001; 135(9): Centers for Disease Control and Prevention. A1c distribution among adults with Diagnosed Diabetes, Accessed February 12, Schmittdiel, PhD, Heisler, Mishele, MD, MPA et al. Why Don t patients Achieve Recommended Risk Factor Targets? Poor Adherence vs Lack of Treatment Intensification. Journal of General Internal Medicine. Jan 28, (5) Our Study Objectives To determine the proportion of Type 2 Diabetes Mellitus (T2DM) patients experiencing Clinical Inertia (i.e., lack of treatment intensification after Metformin Monotherapy[MM] failure). Determine the impact of patient and provider factors on Clinical Inertia in T2DM patients. Evaluate the impact of timely treatment intensification on glycemic goal attainment (A1c < 8% [<7% in the secondary analysis]) among T2DM patients failing MM Explore challenges of dealing with Clinical Inertia and tips for overcoming it. 2

3 Methods Data Source The Carolinas Healthcare System s electronic medical records data Inclusion Criteria: Had the diagnosis of Type 2 Diabetes Mellitus years old MM started during January 2009 to September 2013 Had an uncontrolled A1c ( 8%/7%) after at least 3 months of MM Exclusion criteria: Patients on any other anti-hyperglycemic drugs prior to the date of the first A1c value 8%/7% after at least 90 days of MM Those with type 1 or gestational diabetes Time line: April 2009 to December 2014 Metformin monotherapy 90 days or more Uncontrolled HbA1c 180 days or more Clinical Inertia Failure to escalate therapy Patient Variables Age Gender Ethnicity Insurance BMI HbA1c at index date Blood Pressure Cardiovascular disease Cerebrovascular disease Renal disease Liver disease Lipids 5/21/

4 Provider Variables Provider age Ethnicity Gender Provider Specialty Primary care (FP, IM, GP) Sub specialist (Endocrinology) Diabetic Case load 5/21/ Statistical Analysis To quantify the impact of patient and provider factors on clinical inertia Generalized estimating equations to find significant factors Impact of treatment intensification on glycemic control Time to event analysis to determine if timely treatment intensifications is associated with earlier glycemic control Study patient population 4

5 Patient Characteristics Goal HbA1C <8 (N = 996) Characteristic Descriptives Age, Mean (SD) 53.6 (11.9) Gender, N(%) Female 420 (42.2) Male 576 (57.8) Race/ethnicity, N(%) American Indian or Alaska native 2 (0.2) Asian 17 (1.7) Black 325 (32.6) Hispanic 14 (1.4) Other (includes multiracial and unknown) 53 (5.3) White 585 (58.7) Insurance, N(%) Commercial 431 (43.3) Medicaid 40 (4.0) Medicare 127 (12.8) Other (includes self pay, charity, and unknown) 398 (39.9) Clinical Inertia proportion for Goal HbA1C < Clinical Inertia Treatment Intensification. Patient and Provider Factors for Clinical Inertia for Goal HbA1c <8 Results from the Generalized Estimating Equations model OR = Odds ratio; LCL = lower 95% confidence limit; UCL = upper 95% confidence limit *Generalized estimating equations 5

6 Patient and Provider Factors for Clinical Inertia for Goal HbA1c <8 Higher HbA1c at Index Date - Providers could be reluctant in intensifying treatments in patients who are closer to glycemic control targets Renal Disease and Liver Disease - Providers may be more willing to reduce risk of further adverse complications due to elevated HbA1c in these patients Age of the provider - More recently trained providers may be more up to date with new practice guidelines and therefore more likely to adhere to these guidelines* - Seasoning of the Provider (maturing practice, wait and see approach to new guidelines) *Francke AL, Smit MC, deveer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak. 2008;8:38; Choudhry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of healthcare. Ann Intern Med. 2005;142: Kaplan-Meier Curve for Timely Treatment Intensification for goal HbA1c <8 Probability of not achieving glycemic control Results from the Cox Proportional Hazards Models for goal HbA1C < 8* *Adjusted for patient demographics, comorbidities, and labs HR = Hazards ratio; LCL = lower 95% confidence limit; UCL = upper 95% confidence limit *Adjusted for patient age, gender, race/ethnicity, insurance, HbA1c at index date, BMI, blood pressure, lipids, and diabetes related comorbid conditions 6

7 Patient Characteristics Goal HbA1C <7 (N = 3,209) Characteristic Descriptives Age, Mean (SD) 56.4 (11.7) Gender, N(%) Female 1,562 (48.7) Male 1,647 (51.3) Race/ethnicity, N(%) American Indian or Alaska native 3 (0.1) Asian 49 (1.5) Black 866 (27.0) Hispanic 60 (1.9) Other (includes multiracial and unknown) 190 (5.9) White 2,041 (63.6) Insurance, N(%) Commercial 1,401 (43.7) Medicaid 110 (3.4) Medicare 530 (16.5) Other (includes self pay, charity, and unknown) 1,168 (36.4) Clinical Inertia proportion for Goal HbA1c < 7 [VALUE] 67.9 Clinitial Inertia Treatment Intensification Patient and Provider Factors for Clinical Inertia for HbA1c >7 Results from the Generalized Estimating Equations model OR = Odds ratio; LCL = lower 95% confidence limit; UCL = upper 95% confidence limit; AI = American Indian; AN = Alaska Native; ID = index date; PCP = primary care physician 7

8 Patient and Provider Factors for Clinical Inertia for Goal HbA1c < 7 Increased patient age - A1c targets are increased in older adults based on long disease history, limited life expectancy, and extensive comorbid conditions - Fear of "Polypharmacy" and medication side effects Primary Care vs Subspecialty - Specialists may be more likely to be up to date with latest diabetes management recommendations - Staffing and appointment time for specialists are more likely to be focused heavily on diabetes management Kaplan-Meier curve for Goal HbA1c <7 Probability of not achieving glycemic control Results from the Cox Proportional Hazards Models for Goal HbA1C < 7% *Adjusted for patient demographics, comorbidities, and labs HR = Hazards ratio; LCL = lower 95% confidence limit; UCL = upper 95% confidence limit *Adjusted for patient age, gender, race/ethnicity, insurance, HbA1c at index date, BMI, blood pressure, lipids, and diabetes related comorbid conditions 8

9 Limitations Because of the retrospective nature of the study, causality between predictors and outcomes could not be established. Results were based on what the physician prescribed, not on what the patient actually did. Medication adherence was not included in the study due to lack of that data in the retrospective analysis. Clinical reasons for the delay in treatment intensification such as potential side effects and drug interactions was not available. Information about life style factors, including diet, exercise, smoking behaviors, and alcohol intake was also not available. Findings may not be generalizable to other populations. Conclusions and Implications Clinical inertia rates observed in our study suggest that the prevalence of clinical inertia in current T2D clinical practice in Atrium Health is substantial. Timely treatment intensification was associated with earlier glycemic goal achievement in T2D patients failing MM. These findings may help provide some insight for guidelines and interventions aimed at reducing clinical inertia in practice. Barriers to treatment intensification Feedback from providers at Atrium Health Patients don t adhere to current treatment regimen Limited time of the visit Managing multiple comorbidities Cost of medications Third Party Payer issues Patients don t provide adequate information on their health behaviors Guidelines may be too stringent? Evolving recommendations. 9

10 Possible solutions Feedback from providers at Atrium Health Having dedicated diabetes primary care visits Access to clinical pharmacists Referring patients to specialists when deemed appropriate Involving care coordinators to focus on longitudinal care of patients between visits Implement tailored patient-centered interventions to motivate patients Case #1 70 year old non-english speaking Hispanic male PMHx hypertension, hyperlipidemia, chronic low back pain, newly diagnosed skin cancer BP168/98, HR 88, BMI 38 Labs: Hb-A1c 9.8, creatinine 1.3 LDL Chol 180, HDL 35, LDL 120 Triglycerides 325 Medications: Lisinopril 20 mg, Naprosyn OTC and Colchicine PRN. (Wife gestures noncompliance) Retired, married, smokes 1/2 PPD and has Medicaid/Medicare. Started Metformin 500 mg ER daily with instructions to escalate gradually to 2 grams daily. Atorvastatin 40 mg added & increased Lisinopril/HCTZ 40/25 mg Case #1- Follow up at 3 months Did not bring glucometer, medications, or glucose log. Takes 500 mg of metformin daily 5 to 6 days a week due some initial diarrhea and confusion with dose escalation. Missed the appointment with diabetes educator - problems with cell phone. He is noticing a persistent dry cough. POC glucose level is 225. HbA1c is 9.1 He continues to eat 3-4 tortillas with each meal. Still smokes, but less 4-5/day and his BP is 152/94 You have minutes.. What do you do? 10

11 Managing multiple comorbidities Case #1- What would you do? A) Encourage him to escalate the Metformin to maximum dose and re-schedule the Diabetes educator? B) Start another oral medication like a DPP4 or SGLT2 inhibitor? C) Add a GLP-1 agonist or bedtime insulin? D) Focus on hypertension, cough and tobacco cessation? E) Give him a pill box and teach him how to retrieve saved messages on cell phone? World Health Organization Adherence to the Plan of care 11

12 Case #1 Follow up at 6 months He met with the diabetes educator and brings in the glucose machine. He is now taking 2000 mg of metformin. HbA1c is 8.4% BP 136/82 BMI 36 Creatinine is 1.2 He is walking 5 days a week and has quit smoking. He is amenable to taking another medication but is worried about copay cost and side effects. What would you do? The Stages of Change Continuum Adapted from DiClemente and Prochaska, 1997 Challenges in Health Care Face time with the patient 12

13 Tips for Overcoming Clinical Inertia Take Time for Diabetes management Try to use a Patient Centered Approach to decision making Involve Family! Involve a Team Approach to care that might include Clinical Pharmacists RN, LPN, MOA Diabetes Educators, Health Coaches, Psychotherapists Care Coordinators, health navigators, MSW Practice based? Third party payer based? Communicate Treatment Goals Erlich, Slawson and Shaughnessy, Am Fam Physician 2014 Feb 15;89(4): QUESTIONS & CONCERNS 5/21/