Your Chart Your Chart Review Data Review Data Lara Zisblatt, MA - - PowerPoint PPT Presentation
Your Chart Your Chart Review Data Review Data Lara Zisblatt, MA Lara Zisblatt, MA Assistant Director Assistant Director Continuing Medical Education Continuing Medical Education Boston University School of Medicine Boston University
Lara Zisblatt, MA Lara Zisblatt, MA
Assistant Director Assistant Director Continuing Medical Education Continuing Medical Education Boston University School of Medicine Boston University School of Medicine
John R. White, PA John R. White, PA-
C, PharmD PharmD
Professor of Pharmacotherapy Professor of Pharmacotherapy Washington State University Washington State University College of Pharmacy College of Pharmacy Spokane, WA Spokane, WA
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
(cont’ ’d) 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%
Glycemia: A1C <7.0%, : A1C <7.0%, FPG 90 FPG 90-
130 mg/dL, PP BG <180 mg/dL PP BG <180 mg/dL
Blood pressure: <130/80 mm Hg <130/80 mm Hg
Lipids: LDL <100 mg/dL; TG <150 mg/dL TG <150 mg/dL
Yearly:
– – Dilated eye exam; urinary Dilated eye exam; urinary protein; foot exam; flu shot protein; foot exam; flu shot
Other:
– – Aspirin usage; pneumococcal Aspirin usage; pneumococcal vaccine vaccine
AACE goals – A1C 6.5%, FPG 110 mg/dL, PP 140 mg/dL AACE goals AACE goals – – A1C A1C 6.5%, FPG 110 mg/dL, 6.5%, FPG 110 mg/dL, PP 140 mg/dL PP 140 mg/dL NCEP - LDL ≤70 mg/dL NCEP NCEP -
LDL ≤ ≤70 mg/dL 70 mg/dL
*Percent risk reduction per 0.9% decrease in A1C
Reduction in risk (%)*
P=.029 P=.0099 P=.052 P=.015 P=.000054
Any diabetes-related endpoint Microvascular endpoint MI Retinopathy Albuminuria at 12 years
United Kingdom Prospective United Kingdom Prospective Diabetes Study (UKPDS) Diabetes Study (UKPDS)
241.33 241.33 181.00 181.00 Gliptins Gliptins ( (sitagliptin sitagliptin 100 mg/day) 100 mg/day) 202.66 202.66 152.00 152.00 Incretin Incretin (exenatide 10 mcg bid) (exenatide 10 mcg bid) 196.00 196.00 196.00 196.00 TZD TZD ( (pio pio 45 mg/day) 45 mg/day) 105.60 105.60 132.00 132.00 Glinide Glinide ( (nateglinide nateglinide 120 mg 120 mg tid tid) ) 69.00* 69.00* 138.00 138.00 Insulin Insulin ( (glargine glargine 50 U/day) 50 U/day) 21.33 21.33 32.00 32.00 Metformin Metformin (1000 mg bid) (1000 mg bid)
9.00 9.00
14.00 14.00 SU SU ( (glimepiride glimepiride 4 mg/day) 4 mg/day)
A1C lowering cost, A1C lowering cost, $/mean $/mean-
lowering* Cost per Cost per month ($)* month ($)* Intervention Intervention
Adapted from White J, Campbell RK, eds, ADA/PDR Medications for the Treatment of Diabetes, 2nd ed., In press. * Cost of supplies not included
Many diabetes drugs—generally lower A1C
Treatment inertia – “Insulin Resistance” Patient resistance – – Cost, complexity, side effects Cost, complexity, side effects – – “ “I don I don’ ’t want insulin t want insulin” ”
% of Subjects % of Subjects
Percentage of subjects advancing when A1C >8% Percentage of subjects advancing when A1C >8%
Brown JB, Nichols GA, Perry A. Diabetes Care. 2004;27:1535-1540.
At insulin initiation, the average patient had: At insulin initiation, the average patient had:
5 years with A1C >8%
10 years with A1C >7%
20 20 40 40 60 60 80 80 100 100
Diet Diet 66.6% 66.6% Sulfonylurea Sulfonylurea Metformin Metformin 35.3% 35.3% 44.6% 44.6% Combination Combination 18.6% 18.6%
50 100 150 200 250
5 10 15 20 25 30 50 100 150 200 250 300 350
Years of Diabetes
Insulin Resistance Insulin Level Fasting Glucose
α-cell failure
Post-Meal Glucose
Adapted from RM. Bergenstal, International Diabetes Center
Glucose Relative Insulin Function
metformin or glitazone + sulfonylurea/glinide
sulfonylurea/glinide + metformin or glitazone Continue
FPG <130 mg/dL A1C < 7% FPG >130 mg/dL A1C >7%
AGI, DPP-IV inhib, Exenatide, Pramlintide, Insulin
14% Reached target A1C <7% 43% Reached target A1C <8%
A1C reduction from baseline 9.7% Baseline A1C >8.5% 16 clinics in Canada, 200 patients A1C
Yale JF, et al. Ann Intern Med. 2001;134:737-745.
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
When to start insulin vs adding more
– 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
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.
Basal insulin – Suppresses glucose production between meals and
– 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
4:00 4:00 25 25 50 50 75 75 8:00 8:00 12:00 12:00 16:00 16:00 20:00 20:00 24:00 24:00 4:00 4:00
Breakfast Breakfast Lunch Lunch Dinner Dinner Plasma insulin ( Plasma insulin (µU/ U/mL mL) ) Time Time
8:00 8:00
Plasma insulin levels Hours NPH Glargine Regular Aspart, Lispro, Glulisine Detemir
2 4 6 8 10 12 16 18 20 22 24 14
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)
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?
Combination Oral Agents + Glargine or NPH at bedtime Combination Oral Agents + Glargine or NPH at bedtime
Target FPG: Target FPG: < <100 mg/dL 100 mg/dL Type 2 DM: 756 patients aged 55, BMI 32, A1C Type 2 DM: 756 patients aged 55, BMI 32, A1C 8.6% 8.6% 24 wk of treatment 24 wk of treatment forced titration forced titration Continue OAD + NPH at Continue OAD + NPH at hs hs Continue OAD + glargine at Continue OAD + glargine at hs hs OAD failures OAD failures A1C A1C: 7.5% : 7.5%-
10%
Riddle MC, et al. Diabetes Care. 2003;26:3080-3086.
FBS = fasting blood sugar
Start 10 units glargine or NPH at bedtime Forced titration schedule done by weekly
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 - ↑ 0-2 units
Riddle MC, et al. Diabetes Care. 2003;26:3080-3086.
Riddle MC, et al. Diabetes Care. 2003;26:3080-3086.
100 150 200 4 8 12 16 20 24
Weeks of Treatment FBG (mg/dL)
Glargine NPH
6 6.5 7 7.5 8 8.5 9 4 8 12 16 20 24
Weeks of Treatment A1C (%)
Glargine NPH
Symptomatic Symptomatic Hypoglycemia Hypoglycemia by Time of Day by Time of Day
Hypoglycemia Hypoglycemia Episodes (no.) Episodes (no.) (PG (PG ≤ ≤72 mg/dL) 72 mg/dL)
Insulin glargine Insulin glargine NPH insulin NPH insulin 50 50 100 100 150 150 200 200 250 250 300 300 350 350 20 20 22 22 24 24 2 2 4 4 6 6 8 8 10 10 12 12 14 14 16 16 18 18
Time of Day (h) Time of Day (h)
B L D B L D
Basal Basal insulin insulin
20 20
Riddle MC, et al. Diabetes Care. 2003;26:3080-3086.
* *All reported events, including symptoms only.
All reported events, including symptoms only.
Hermansen K, et al. Diabetes Care. 2006;29:1269-1274.
10.0 10.0 9.0 9.0 8.0 8.0 7.0 7.0 6.0 6.0
2 0 4 4 8 8 12 12 16 16 20 20 24 24 Detemir Detemir NPH NPH A1C (%) A1C (%)
Study Week Study Week
Hypoglycemic Events* Hypoglycemic Events* 2 2 4 4 8 8 12 12 16 16 20 20 24 24
Study Week Study Week
400 400 350 350 300 300 250 250 200 200 150 150 100 100 50 50 Detemir Detemir NPH NPH
Currently treated with metformin/glimepiride A1C 9.2% FBG >170 mg/dL BMI 36 Physically inactive
10 units glargine added to her OHA;
Comes back six weeks later taking 32 units Reports that her FBG is 130-140 mg/dL
Raccah D, et al. Diabet Metab Res Rev. 2007;23:257-264.
Diet and Diet and exercise exercise OHA mono OHA mono-
combination combination therapy therapy Basal Basal insulin insulin
(optimized) (optimized) Basal Plus Basal Plus 1 1 prandial prandial for largest for largest glucose glucose excursion excursion Basal Plus Basal Plus 2 2 prandial prandial for largest for largest glucose glucose excursions excursions Basal Basal— —Bolus Bolus Basal Basal + 3x + 3x prandial prandial
A1C A1C uncontrolled uncontrolled A1C A1C uncontrolled, FBG on target uncontrolled, FBG on target PPBG >8.8 PPBG >8.8 mmol mmol/L (>160 mg/dL) /L (>160 mg/dL)
Time Time
Be aggressive:
– Follow standards of care – 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 <110-120 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
Practice Practice-
Based Improvements
Working Toward Working Toward Glycemic Glycemic Control Control Elaine Fleck, MD Elaine Fleck, MD
Associate Clinical Professor of Medicine Associate Clinical Professor of Medicine Department of Internal Medicine Department of Internal Medicine New York Presbyterian Hospital New York Presbyterian Hospital-
Columbia University Medical Center New York, NY New York, NY
What gaps do you see between care as it is and care as it as it could and should be could and should be for patients? for patients?
Identify goals that you would like to accomplish over the next 2 weeks to 3 months the next 2 weeks to 3 months
Understand and implement techniques that can change the nature of care delivery in your practice change the nature of care delivery in your practice
How can you plan, do, study, and act?
Institute for Healthcare Improvement. Available at: http://www.ihi.org/IHI/Topics/ChronicConditions/AllConditions/Changes/. Accessed September 29, 2008.
What are we trying to accomplish?
How will we know that a change is an improvement? improvement?
What changes can we make that will result in improvement? improvement?
Institute for Healthcare Improvement. Available at: http://www.ihi.org/IHI/Topics/ChronicConditions/AllConditions/Changes/. Accessed September 29, 2008.
Act
are to be made?
Plan
predictions (why)
the cycle (who, what, where, when)
Study
analysis of the data
predictions
was learned
Do
and unexpected
Will encounter forms facilitate severity classification?
severity class Qs with 3 patients on Thurs
a form for third patient.
helpful for prompting; thought items on form should be in a different order. Need better process for getting form to provider. Revise form. Try new form with 3 patients tomorrow; MA will put form on chart.
Objective: Test the use of encounter forms to facilitate visit
insulin to oral therapy of type 2 patients with diabetes
plasma glucose
– 60% of patients reached A1C ≤7 independent of insulin type – Less nocturnal hypoglycemia with glargine
Riddle MC, et al. Diabetes Care. 2003;26:3080-3086.
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.
Percentage of patients with A1C >7.0% at week 24 Percentage of patients with A1C >7.0% at week 24 in each treatment arm, stratified by baseline A1C in each treatment arm, stratified by baseline A1C
Kennedy L, et al. Diabetes Care. 2006;29:1-8.
With minimal instruction, patients were able to follow insulin dose titration algorithm and achieve insulin dose titration algorithm and achieve significant A1C reductions, regardless of intensity of significant A1C reductions, regardless of intensity of titration monitoring titration monitoring
POC A1C testing results in greater proportion of patients at goal A1C (<7) patients at goal A1C (<7)
Use of less aggressive insulin algorithm still results in better glycemic control in better glycemic control
Primary-
care clinical practices can adopt algorithmic care when instituting insulin care when instituting insulin
Vague, strategic, Vague, strategic, creative creative Specific, actionable, Specific, actionable, results results
Improve glycemic control in Improve glycemic control in patients patients with diabetes with diabetes Adopt basal insulin algorithm for Adopt basal insulin algorithm for primary primary-
care practice Educate team members in use of Educate team members in use of algorithm algorithm Provider to identify 3 patients with Provider to identify 3 patients with A1C >7.5 for > 3 months to initiate A1C >7.5 for > 3 months to initiate insulin using algorithm insulin using algorithm Revise and expand to use algorithm Revise and expand to use algorithm with 3 other providers with 3 other providers A P S D
Extremely helpful for sites with multiple providers and house staff 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 health literacy needs
Other team members incorporated into care
– Glargine or – Detemir or – NPH
consider 20% reduction in initial insulin dose
– 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
(cont’ ’d) d)
– Goal: 80-130 at least 3 times/week without symptoms of hypoglycemia – If ≥3 readings are: <70: Call provider 130-160: Increase by 2 U 70-80: Decrease by 4 U 161-199: Increase by 4 U 81-129: No change ≥200: Increase by 6 U
meet goal
Riddle MC, et al. Diabetes Care. 2003;26:3080-3086.
Vague, strategic, Vague, strategic, creative creative Specific, actionable, Specific, actionable, results results
Improve glycemic control in Improve glycemic control in patients patients with diabetes with diabetes Adopt basal insulin algorithm for Adopt basal insulin algorithm for primary primary-
care practice Educate team members in use of Educate team members in use of algorithm algorithm Provider to identify 3 patients with Provider to identify 3 patients with A1C >7.5 for > 3 months to initiate A1C >7.5 for > 3 months to initiate insulin using algorithm insulin using algorithm Revise and expand to use algorithm Revise and expand to use algorithm with 3 other providers with 3 other providers A P S D
Improve glycemic control in patients Improve glycemic control in patients with diabetes with diabetes Adopt basal insulin algorithm for Adopt basal insulin algorithm for primary primary-
care practice Educate team members in use of Educate team members in use of algorithm algorithm Provider to identify 3 patients with Provider to identify 3 patients with A1C >7.5 for >3 months to initiate A1C >7.5 for >3 months to initiate insulin using algorithm insulin using algorithm Revise and expand to use algorithm Revise and expand to use algorithm with 3 other providers with 3 other providers
Vague, strategic, Vague, strategic, creative creative Specific, actionable, Specific, actionable, results results
A P S D
Hunches, Theories, Ideas Changes That Result in Improvement
A P S D A P S D
A P S D
D S P A
DATA
Very Small Scale Test Follow-up Tests Wide-Scale Tests
Implementation
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?
Model for Improvement
Improve glycemic control Reduced A1C Adopt algorithm
Can we institute algorithm for insulin in primary-care practice?
Use of algorithm by all providers/team A P S D
A P S D A P S D D S P A
Learning
D S P A Cycle 1: One provider to identify 3 patients with One provider to identify 3 patients with A1C > 7.5 for >3 months and initiate insulin using A1C > 7.5 for >3 months and initiate insulin using algorithm algorithm
.
Cycle 2: Additional team member to explain Additional team member to explain how to start insulin with plan to call patient in how to start insulin with plan to call patient in
Cycle 3: Revise and try using two Revise and try using two providers and expand team providers and expand team Cycle 4: Trial by all providers Trial by all providers and team and team Cycle 5: Review data Review data and peer feedback and peer feedback
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
“Negative results on the fish…Let’s try rubbing two sticks together.”
Group classes
Conversation mapping
– – http:// http://www.healthyi.com/hcp/diabetes/Default.aspx www.healthyi.com/hcp/diabetes/Default.aspx
Nurse case management in underinsured
– Philis-Tsimikas A, et al. Diabetes Care. 2004;27:110-115.
POC testing
Self-
management education
– – Sone Sone H, et al. H, et al. Diabetes Care Diabetes Care. 2002;25:2115 . 2002;25:2115-
2116.
Nurse-
directed diabetes care
– – Davidson MB. Davidson MB. Diabetes Care Diabetes Care. . 2003;26:2281 2003;26:2281-
2287. .