Your Chart Review Data. Lara Zisblatt, MA Assistant Director Continuing Medical Education Boston University School of Medicine

Transcription

1 Your Chart Review Data Lara Zisblatt, MA Assistant Director Continuing Medical Education Boston University School of Medicine

2 Participation 243 registered for the program 98 have completed the Practice Assessment 17 have completed their baseline chart review 13 have implemented their action plans and are awaiting reassessment 1 is completing follow-up chart review

3 PI Data: Gaps in Performance 49.57% (n=57) of patients had A1C values >7% at the last visit 47.37% (n=27) of patients with A1C >7% did not have their therapy intensified at the last visit

4 PI Data: Gaps in Performance (cont d) 41.74% (n=48) of patients did not have self-monitoring fasting glucose levels collected at the last visit 65.22% of patients did not have postprandial glucose levels collected at the last visit

5 PI Data: Gaps in Performance (cont d) 31.25% (n=5) of patients with A1C >9% are not currently taking more than 2 oral medications

6 Thank You! Please complete chart reviews as soon as possible If you are having trouble completing the chart reviews, please let us know. We can help! If you have any questions, please e us at mentorqi@bu.edu or call us at

7 The Ins and Outs of Insulin In Patients With Type 2 Diabetes John R. White, PA-C, PharmD Professor of Pharmacotherapy Washington State University College of Pharmacy Spokane, WA

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10 Case Study 58 y.o. Native American female Type 2 DM for 15 years Medications: Metformin 1000 mg bid (X 5 years) Glimepiride 8 mg q AM (X 15 years) Combination HCTZ 12.5 mg/losartan 100 mg q AM Atorvastatin 20 mg daily

11 Case Study (cont d) BP 138/88 mm Hg Height 5 3 Weight 203 lb BMI 36 Currently not working cares for parents who are home-bound Not involved in any physical activity; poor diet Gained 8 lb in 6 months Self-monitoring blood glucose values have risen from 130s mg/dl fasting to always >170 mg/dl over the past year No PP BG data A1C value today is 9.2%

12 ADA Standards of Care Glycemia: : A1C <7.0%, FPG mg/dl, PP BG <180 mg/dl Blood pressure: <130/80 mm Hg Lipids: LDL <100 mg/dl; TG <150 mg/dl Yearly: Dilated eye exam; urinary protein; foot exam; flu shot Other: Aspirin usage; pneumococcal vaccine AACE goals A1C 6.5%, FPG 110 mg/dl, PP 140 mg/dl NCEP - LDL 70 mg/dl

13 Lowering A1C Reduces Risk of Complications United Kingdom Prospective Diabetes Study (UKPDS) Reduction in risk (%)* P= P= P= P= P= Any diabetes-related endpoint Microvascular endpoint MI Retinopathy Albuminuria at 12 years -50 *Percent risk reduction per 0.9% decrease in A1C UKPDS. Lancet. 1998;352:

14 Cost of A1C lowering Intervention SU (glimepiride 4 mg/day) Metformin (1000 mg bid) Insulin (glargine 50 U/day) Glinide (nateglinide 120 mg tid) TZD (pio 45 mg/day) Incretin (exenatide 10 mcg bid) Gliptins (sitagliptin 100 mg/day) Cost per month ($)* A1C lowering cost, $/mean-lowering* * Adapted from White J, Campbell RK, eds, ADA/PDR Medications for the Treatment of Diabetes, 2 nd ed., In press. * Cost of supplies not included

15 Reasons for Inadequate Diabetes Care Many diabetes drugs generally lower A1C 1%-1.5% Treatment inertia Insulin Resistance Patient resistance Cost, complexity, side effects I I don t t want insulin Progressive nature of disease

16 Clinical Inertia: Failure to Advance Therapy When Required Percentage of subjects advancing when A1C >8% % of Subjects % At insulin initiation, the average patient had: 5 years with A1C >8% 10 years with A1C >7% 35.3% 44.6% 18.6% 0 Diet Sulfonylurea Metformin Combination Brown JB, Nichols GA, Perry A. Diabetes Care. 2004;27:

17 Advancing Therapy- Considerations A1C delta needed? Patient acceptance Complexity of regimen Cost Side effects and secondary effects

18 The Stages of Type 2 Diabetes Glucose Relative Insulin Function Post-Meal Glucose Fasting Glucose Insulin Resistance Insulin Level α-cell failure Years of Diabetes Adapted from RM. Bergenstal, International Diabetes Center

19 Approach to Combination Therapy Intensifying Therapy metformin or glitazone + sulfonylurea/glinide or glucosidase inh sulfonylurea/glinide + metformin or glitazone FPG <130 mg/dl A1C < 7% FPG >130 mg/dl A1C >7% Continue AGI, DPP-IV inhib, Exenatide, Pramlintide, Insulin

20 Failing Sulfonylurea and Metformin,, Add Troglitazone 16 clinics in Canada, 200 patients A1C Baseline A1C A1C reduction from baseline >8.5% 9.7% -1.3% Reached target A1C <8% 43% Reached target A1C <7% 14% Yale JF, et al. Ann Intern Med. 2001;134:

21 Over time, most patients will need insulin to control glucose

22 Insulin Therapy in Type 2 Diabetes More than half of patients with type 2 diabetes require insulin to reach A1C goal <7% Insulin doses are usually higher in patients with type 2 diabetes (~1.2 U/kg) than in type 1 patients Increasing use of insulin earlier in course of therapy for type 2 patients Individualize insulin therapy for each patient: Oral medications(s) + qd insulin or Intensive insulin +/- other anti-hyperglycemic medications

23 Key Decision Points for Insulin Therapy in Type 2 Diabetes When to start insulin vs adding more oral agents Exenatide and sitagliptin What insulin program to start with: Once-daily NPH, glargine, or detemir Twice-daily pre-mixed How to start insulin and optimize dosing Continue or discontinue oral agents when insulin is started? When to proceed to mealtime insulin

24 Advantages of Insulin + Oral Agent vs Switching to Insulin Alone Combination therapy reduces dose of insulin required SU: 21%-38% decrease Metformin: 19%-32% decrease Metformin + SU: 62% reduction Glucose control will not deteriorate during the transition to insulin Patient learns practical skills needed before switching to insulin-only regimen Simple insulin regimens improve patient compliance Yki-Jarvinen H. Diabetes Metab Res Rev. 2002;18:S77-S81. Marre M. Int J Obesity. 2002;26:S25-S30.

25 The Basal/Bolus Insulin Concept Basal insulin Suppresses glucose production between meals and overnight 40% to 50% of daily needs Bolus insulin (mealtime) Limits hyperglycemia after meals Immediate rise and sharp peak at 1 hour 10% to 20% of total daily insulin requirement at each meal

26 Physiologic Serum Insulin Secretion Profile Plasma insulin ( (µu/ U/mL ml) Breakfast Lunch Dinner 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Time 8:00

27 Profiles: Human Insulin and Analogues Plasma insulin levels Aspart, Lispro, Glulisine Regular NPH Detemir Glargine Hours

28 Tactics for Type 2 Diabetes: Starting Basal Insulin Add single, evening insulin dose NPH or detemir (bedtime) 70/30 (evening meal) Glargine (bedtime or anytime?) Dose: 10 units or 10% patient weight in lb (200 lb=20 units) or 0.15 units per kg Adjust dose by FBG Increase insulin dose weekly as needed Increase by 2 units or 10%-20% if FBG >140 mg/dl Treat to target (usually <120 mg/dl)

29 Advancing Basal/Bolus Insulin Indicated when FBG is acceptable but A1C >7% or >6.5% and/or SMBG before dinner >140 mg/dl Insulin options To glargine, detemir, or NPH, add mealtime aspart/lispro To suppertime 70/30, add morning 70/30 Oral agent options Usually d/c SU or glinides if bolus insulin is added Continue TZD or metformin?

30 Treat-to to-target Trial Combination Oral Agents + Glargine or NPH at bedtime Type 2 DM: 756 patients aged 55, BMI 32, A1C 8.6% Continue OAD + glargine at hs A1C: : 7.5%-10% OAD failures Target FPG: <100 mg/dl Continue OAD + NPH at hs 24 wk of treatment forced titration Riddle MC, et al. Diabetes Care. 2003;26:

31 Protocol Start 10 units glargine or NPH at bedtime Forced titration schedule done by weekly phone calls with study coordinators Daily FBS - adjust weekly to <100 mg/dl >180 mg/dl - 8 units >160 mg/dl - 6 units >140 mg/dl - 4 units >120 mg/dl units FBS = fasting blood sugar Riddle MC, et al. Diabetes Care. 2003;26:

32 Treat-to to-target Trial: Efficacy Results Glargine NPH Glargine NPH FBG (mg/dl) 150 A1C (%) Weeks of Treatment Weeks of Treatment Riddle MC, et al. Diabetes Care. 2003;26:

33 Treat-to to-target Trial: Timing and Frequency of Nocturnal Hypoglycemia Symptomatic Hypoglycemia by Time of Day Hypoglycemia Episodes (no.) (PG 72 mg/dl) Basal insulin * * * * Insulin glargine NPH insulin * * B L D 20 Riddle MC, et al. Diabetes Care. 2003;26: Time of Day (h)

34 Detemir vs NPH Insulin in T2DM (n=476) A1C (%) Detemir NPH Study Week Hypoglycemic Events* Detemir NPH Study Week *All All reported events, including symptoms only. Hermansen K, et al. Diabetes Care. 2006;29:

35 Return to Case: 58-Year Year-Old Native American Female Currently treated with metformin/glimepiride A1C 9.2% FBG >170 mg/dl BMI 36 Physically inactive

36 Case: 58-Year Year-Old Native American Female 10 units glargine added to her OHA; instructed to adjust daily by 2 units every 3 days until FBG <120 mg/dl Comes back six weeks later taking 32 units Reports that her FBG is mg/dl

37 Stepped Insulin Therapy Basal Plus Concept OHA mono- or combination therapy Diet and exercise Basal insulin once daily (optimized) Basal Plus 1 prandial for largest glucose excursion Basal Plus 2 prandial for largest glucose excursions Basal Bolus Bolus Basal + 3x prandial A1C uncontrolled A1C uncontrolled, FBG on target PPBG >8.8 mmol/l (>160 mg/dl) Time Raccah D, et al. Diabet Metab Res Rev. 2007;23:

38 Be aggressive: Follow standards of care Summary Making frequent adjustments in therapy is the norm this is a progressive disease Use insulin in patients who need it Start basal insulin (once daily) along with the patient s OHAs Use enough insulin FPG < mg/dl Be enthusiastic and positive when discussing with patient Add mealtime analogue insulin if A1C is not at goal Start with largest meal try starting with 4 units

39 Practice-Based Improvements Working Toward Glycemic Control Elaine Fleck, MD Associate Clinical Professor of Medicine Department of Internal Medicine New York Presbyterian Hospital- Columbia University Medical Center New York, NY

40 Improving Care What gaps do you see between care as it is and care as it could and should be for patients? Identify goals that you would like to accomplish over the next 2 weeks to 3 months Understand and implement techniques that can change the nature of care delivery in your practice How can you plan, do, study, and act? Institute for Healthcare Improvement. Available at: Accessed September 29, 2008.

41 Fundamental Questions for Improvement What are we trying to accomplish? How will we know that a change is an improvement? What changes can we make that will result in improvement? Institute for Healthcare Improvement. Available at: Accessed September 29, 2008.

42 The PDSA Cycle for Learning and Improvement Act What changes are to be made? Next cycle? Study Complete the analysis of the data Compare data to predictions Summarize what was learned Plan Objective Questions and predictions (why) Plan to carry out the cycle (who, what, where, when) Plan for data collection Do Carry out the plan Document problems and unexpected observations Begin analysis of the data

43 A PDSA Cycle Objective: Test the use of encounter forms to facilitate visit Revise form. Try new form with 3 patients tomorrow; MA will put form on chart. Will encounter forms facilitate severity classification? Dr. X will try form with severity class Qs with 3 patients on Thurs Dr. X found the form helpful for prompting; thought items on form should be in a different order. Need better process for getting form to provider. Dr. X tried with two patients. Couldn t find a form for third patient.

44 Practice Improvements Using Evidence-Based Medicine

45 Treat-to to-target Trial Randomize addition of glargine or human NPH insulin to oral therapy of type 2 patients with diabetes Titration using simple algorithm to target fasting plasma glucose Forced weekly titration schedule for target FPG 100 Results showed: 60% of patients reached A1C 7 independent of insulin type Less nocturnal hypoglycemia with glargine Riddle MC, et al. Diabetes Care. 2003;26:

46 GOAL A1C Trial Examined the influence of active titration of insulin glargine using a simple algorithm Use of office-based POC A1C testing vs laboratory A1C testing on glycemic control Secondary goal: could this be implemented in a primary-care setting? Kennedy L, et al. Diabetes Care. 2006;29:1-8.

47 GOAL A1C Trial: Results Percentage of patients with A1C >7.0% at week 24 in each treatment arm, stratified by baseline A1C Kennedy L, et al. Diabetes Care. 2006;29:1-8.

48 Goal A1C Trial: Lessons Learned With minimal instruction, patients were able to follow insulin dose titration algorithm and achieve significant A1C reductions, regardless of intensity of titration monitoring POC A1C testing results in greater proportion of patients at goal A1C (<7) Use of less aggressive insulin algorithm still results in better glycemic control Primary-care clinical practices can adopt algorithmic care when instituting insulin

49 Change Ideas vs Specific PDSA Changes Vague, strategic, creative Improve glycemic control in patients with diabetes A P SD Adopt basal insulin algorithm for primary-care practice Educate team members in use of algorithm Specific, actionable, results Provider to identify 3 patients with A1C >7.5 for > 3 months to initiate insulin using algorithm Revise and expand to use algorithm with 3 other providers

50 Adopting a Basal Insulin Algorithm: Why? Extremely helpful for sites with multiple providers and house staff Concrete guidelines decrease clinical inertia Using evidence-based guidelines increases buy-in Stealing ideas makes this easier to create Sensitive to patients health literacy needs Other team members incorporated into care

51 Initiation and Adjustment of Basal Insulin Regimens Start with bedtime long-acting insulin at 10 U or 0.15 U/kg Glargine or Detemir or NPH When switching from daily or BID NPH to glargine and detemir, consider 20% reduction in initial insulin dose If patient is on oral medications, consider the following: Consider decreasing sulfonylurea by 25% Metformin dose does not need to be adjusted when starting insulin Reduce thiazolidinedione dose when starting basal insulin due to risk for weight gain and fluid retention

52 Initiation and Adjustment of Basal Insulin Regimens (cont (cont d) Check fasting AM blood glucose daily for 1 week Goal: at least 3 times/week without symptoms of hypoglycemia If 3 readings are: <70: Call provider : Increase by 2 U 70-80: Decrease by 4 U : Increase by 4 U : No change 200: Increase by 6 U Continue to check fasting glucose daily and adjust weekly to meet goal Check A1C at 3 months if not at goal Riddle MC, et al. Diabetes Care. 2003;26:

53 Change Ideas vs Specific PDSA Changes Vague, strategic, creative Improve glycemic control in patients with diabetes Adopt basal insulin algorithm for primary-care practice AP SD Educate team members in use of algorithm Specific, actionable, results Provider to identify 3 patients with A1C >7.5 for > 3 months to initiate insulin using algorithm Revise and expand to use algorithm with 3 other providers

54 Change Ideas vs Specific PDSA Changes Vague, strategic, creative Improve glycemic control in patients with diabetes Adopt basal insulin algorithm for primary-care practice Educate team members in use of algorithm Specific, actionable, results AP SD Provider to identify 3 patients with A1C >7.5 for >3 months to initiate insulin using algorithm Revise and expand to use algorithm with 3 other providers

55 Repeated Use of the PDSA Cycle Model for Improvement What are we trying to accomplish? How will we know that a change is an improvement? What change can we make that will result in improvement? Hunches, Theories, Ideas A S P D Very Small Scale Test Improve glycemic control Reduced A1C Adopt algorithm A P S D DATA Follow-up Tests D S P A A P S D Wide-Scale Tests of Change Changes That Result in Improvement Implementation of Change

56 Multiple Cycles to Test and Implement Components Use of algorithm by all providers/team D S Can we institute algorithm for insulin in primary-care practice? A P S D Learning A P S D D S P A A P S D P A Cycle 2: Additional team member to explain how to start insulin with plan to call patient in one week Cycle 1: One provider to identify 3 patients with A1C > 7.5 for >3 months and initiate insulin using algorithm. Cycle 5: Review data and peer feedback Cycle 4: Trial by all providers and team Cycle 3: Revise and try using two providers and expand team

57 Tips for Success Improvement occurs in small steps Repeated attempts needed to implement new ideas Assess regularly, measure results to improve plan Failed changes = learning opportunities Plan communication Engage leadership support

58 Negative results on the fish Let s try rubbing two sticks together.

59 Additional Resources for Practice Improvement Group classes Conversation mapping Nurse case management in underinsured Philis-Tsimikas A, et al. Diabetes Care. 2004;27: POC testing Self-management education Sone H, et al. Diabetes Care ;25: Nurse-directed diabetes care Davidson MB. Diabetes Care. 2003;26:

60 Q&A