getting comfortable with insulin: new approaches to ... · with, and adherence to, insulin therapy....

Final Live Activities Outcomes Report

January 16, 2019

Prepared for Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.ME201822712

Getting Comfortable With Insulin:New Approaches to Getting Patients Safely to Target

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Impact

Pre to Post Test Results By Learning Objectivev 13% Improvement: Identify the barriers between clinicians and patients to

discussing and initiating earlier insulin therapy for diabetes management.

v 84% Improvement: Discuss currently available basal and ultrabasal insulins and their pharmacokinetic/ pharmacodynamic profiles.

v 61% Improvement: Describe how best to initiate, utilize and intensify insulin therapy in patients with diabetes while incorporating treatment guidelines and unique patient needs.

v 47% Improvement: Integrate strategies to improve the patient experience with, and adherence to, insulin therapy.

v 2,570 attendees were reached via both online and live formats, with significant gains observed across cohorts and modalities from Pre-Test to Post-Test.

v The highest Post-Test scores were measured on the identification of barriers and concerns surrounding the initiation of insulin therapy. The greatest gains were made in learner awareness of the properties of currently available basal and ultrabasal insulins. A learning gap persisted on the modification of insulin therapy for patients with hypoglycemia requiring treatment intensification.

v Learners demonstrated significant net increases on all scored items in the 4-week Post Curriculum Assessment (PCA); however, low PCA scores reinforce the need for continued education in this area.

Executive Summary2,570*Total Attendees

7 Cities

1,308*On Site

1,262*Simulcast / Virtual Symposium

0%20%40%60%80%

100%

LO 1 LO 2 LO 3 LO 4

Pre-Test Post-Test+84.33%*+12.84%* +61.23%*

(N = 1059–1217)

v This curriculum focused on the management of type 2 diabetes, particularly with basal insulins, with discussions on selection of treatment, barriers to treatment, and ongoing patient compliance.

v The most substantial improvements were measured in learners’ knowledge of specific insulins and the implementation of insulin therapy based on treatment guidelines and patient needs.

*These numbers represent the total number of attendees, irrespective of assessment participation

+46.76%*


Curriculum Patient Impact

28,270–33,410 patients on a weekly basis

The findings reveal that this education has the potential to impact

1,603,680patients on an annual basis.

28,270–33,410

In the evaluation, learners (N = 2,570) were asked to report how many patients with type 2 diabetes they see in any clinical setting per week by selecting a range. The resulting distribution of learner responses was then extrapolated to reflect the total number of learners who have attended the onsite and online meetings.


Course Director

Activity Planning Committee

Gregg Sherman, MD

Michelle Frisch, MPH, CCMEP

Sandy Bihlmeyer M.Ed

Alan Goodstat, LCSW

Sheila Lucas, CWEP

Faculty

Robert S. Busch, MD, FACEDirector of Clinical ResearchAlbany Medical Faculty: Community Endocrine GroupAlbany, NY

Davida F. Kruger, MSN, APN-BC, BC-ADMCertified Nurse PractitionerHenry Ford Health SystemDivision of Endocrinology, Diabetes, Bone and Mineral DiseaseDetroit, MI

Rodolfo J. Galindo, MDAssistant Professor of MedicineEmory University School of MedicinePrincipal Investigator, Center for Diabetes and Metabolism ResearchDivision of Endocrinology, Diabetes and MetabolismEmory University Hospital Midtown Medical Chair, Hospital Diabetes TaskforceEmory Healthcare System Atlanta, GA

Javier Morales, MD, FACP, FACEClinical Associate Professor of MedicineDonald and Barbara Zucker School of Medicine At Hofstra/Northwell UniversityVice PresidentAdvanced Internal Medicine Group, P.C.East Hills, NY

Jeff Unger, MD, FAAFP, FACEAssistant Clinical Professor of Family MedicineUC Riverside School of MedicineDirector Unger Concierge Primary Care Medical GroupRancho Cucamonga, CA

Mark Stolar, MD Associate Professor of Clinical MedicineFeinberg School of Medicine Northwestern UniversityChicago, IL

Mark Stolar, MD Associate Professor of Clinical MedicineFeinberg School of Medicine Northwestern UniversityChicago, IL


Commercial SupportThe Emerging Challenges in Primary Care: 2018 series of CME activities were supported through educational grants or donations from the following companies:

vER/LA Opioid Analgesic REMS Program

Companies

vLilly USA, LLC

vNovo Nordisk, Inc.

vSanofi Genzyme and Regeneron

Pharmaceuticals

vSanofi US

vActelion Pharmaceuticals US, Inc.

vAmgen, Inc.

vAstraZeneca Pharmaceuticals LP

vBoehringer Ingelheim

Pharmaceuticals, Inc.

vBoehringer Ingelheim

Pharmaceuticals, Inc. and Lilly USA,

LLC


Overview


Curriculum Overview7 Accredited Live Regional SymposiaAug 25, 2018 – Oct 27, 201827

1 Accredited Live Virtual Symposium: Sep 22, 2018

Online Interactive Enduring CME Activity :vLaunch Date: Dec. 20, 2018

vEnd Date: Dec. 19, 2019https://naceonline.realcme.com/learner/course/2143

Clinical Highlights eMonograph

eMonograph containing key

teaching points from the CME

Activity was distributed 1 week

after the meeting to all attendees.

https://naceonline.realcme.com/learner/course/2143


Learning Objectives

v Identify the barriers between clinicians and patients to discussing and initiating earlier insulin therapy for diabetes management.

v Discuss currently available basal and ultrabasal insulins and their pharmacokinetic/ pharmacodynamic profiles.

v Describe how best to initiate, utilize and intensify insulin therapy in patients with diabetes while incorporating treatment guidelines and unique patient needs.

v Integrate strategies to improve the patient experience with, and adherence to, insulin therapy.


Learning outcomes were measured using matched Pre-Test and Post-Test scores for Knowledge, Competence, Confidence, and practice strategy and across all of the curriculum’s Learning Objectives.

Outcomes Metric Definition Application

Percentage change This is how the score changes resulting from the education are measured. The change is analyzed as a relative percentage difference by taking into account the magnitude of the Pre-Test average.

Differences between Pre-Test, Post-Test, and PCA score averages

P value (p) This is the measure of the statistical significance of a difference in scores. It is calculated using dependent or independent samples t-tests to assess the difference between scores, taking into account sample size and score dispersion. Differences are considered significant for when p ≤ .05.

Significance of differences between Pre-Test, Post-Test, and PCA scores and among cohorts; significance of drivers in predictive modeling

Effect size (d) This is a measure of the strength/magnitude of the change in scores (irrespective of sample size). It is calculated using Cohen's d formula, with the most common ranges of d from 0-1: d < .2 is a small effect, d=.2-.8 is a medium effect, and d > .8 is a large effect.


Power This is the probability (from 0 to 1) that the “null hypothesis” (no change) will be appropriately rejected. It is the probability of detecting a difference (not seeing a false negative) when there is an effect that is dependent on the significance (p), effect size (d), and sample size (N).


Percentage non-overlap This is the percentage of data points at the end of an intervention that surpass the highest scores prior to the intervention. In this report, it will reflect the percentage of learners at Post-Test who exceed the highest Pre-Test scores.


Outcomes Methodology


Participation

2018 Meeting/Simulcast Date Attendees

Troy, MI 8/25/18 220

Troy, MI Simulcast 8/25/18 306

Ft. Lauderdale, FL 9/8/18 308

Nashville, TN 9/15/18 162

Virtual Symposium 9/22/18 601

Uniondale, NY 10/6/18 286

Uniondale, NY Simulcast 10/6/18 355

San Mateo, CA 10/13/18 94

Denver, CO 10/20/18 128

San Diego, CA 10/27/18 110

Total 2,570


Level 1 Participation

Demographics Patient Reach

2,570*Total Attendees

7 Cities

1,308*On Site

1,262*Simulcast / Virtual Symposium

Participation

*These numbers represent the total number of attendees, irrespective of assessment participation


57.94%

25.29%

9.55%3.35% 2.45% 1.42%

NP MD PA RN DO Other

Profession Years in Practice

Patient Care Focus: 92%

29.58%

17.37% 18.32%

34.73%

< 5 5–10 11–20 > 20

Level 1: Demographics and Patient Reach

73.82%

12.63%4.08% 3.16% 2.63%

Primary Care Other Hospitalist Cardiology EmergencyMedicine/Critical

Care

Specialists:Endocrinology 1.45%Gastroenterology 1.05%Psychiatry/Neurology 0.92%Rheumatology 0.26%

Patients with type 2 diabetes seen each week, in any clinical setting:

0% 10% 20% 30% 40%

> 25

21–25

16–20

11–15

6–10

1–5

None

Specialty

Average number of patients with type 2 diabetes seen each week per clinician: 12


Level 2-5:Outcomes Metrics


80.93%(39.29%)

37.69%(40.04%)

40.59%(37.36%)

44.18%(43.31%)

91.31%(28.17%)

69.47%(38.34%)

65.45%(37.57%)

64.84%(41.00%)

Identify the barriers between cliniciansand patients to discussing and initiating

earlier insulin therapy for diabetesmanagement.

Discuss currently available basal andultrabasal insulins and their

pharmacokinetic/ pharmacodynamicprofiles.

Describe how best to initiate, utilize andintensify insulin therapy in patients withdiabetes while incorporating treatmentguidelines and unique patient needs.

Integrate strategies to improve the patientexperience with, and adherence to,

insulin therapy.

Learning Objectives Analysis

Learning Objective 1 Learning Objective 2 Learning Objective 3 Learning Objective 4

v Significant gains (ranging from 13% to 84%) were achieved on all Learning Objectives.

v Post-Test averages remained low (<70%) on the three Learning Objectives related to available basal and ultrabasal insulins, insulin treatment selection guidelines, and patient adherence to insulin therapy. Only Learning Objective 1 on the barriers to insulin treatment showed a high Post-Test score (91%).

• Although learners demonstrated low Post-Test scores (65%-69%) on these three Learning Objectives, scores were still greatly improved compared to the much lower Pre-Test scores, which ranged from 38% to 44%.

(N = 1059–1217)

Pre-Test Post-Test

+12.84%* +84.33%* +61.23%* +46.76%*

*significant at the p ≤ 0.05 level


Learning Domain Analysis (N = 987–1263)

Pre-Test Post-Test

v Significant gains (29%–58%) were achieved in all learning domains.

v The most substantial gains (51% and 58%) were measured in the scored Knowledge and Competence domains.

• Despite the gain, the Competence score remained low (60%) at Post-Test.

v The substantial 29% increase in the Confidence rating was due to an increase in reported Confidence to address barriers to the effective integration of insulin therapy. The Post-Test rating, however, remained low (3.5).

v The 31% increase in practice strategy reflects the increased reported intent to consider continuous glucose monitoring for patients with type 2 diabetes not meeting glycemic targets. Again, the Post-Test rating remained low (3.9).

2.69(1.00)

3.47(0.92)

Confidence

54.76%(33.13%)

35.62%(40.30%)

82.50%(27.65%)

60.03%(43.05%)

Knowledge Competence

2.94 (1.35)

3.85 (0.94)

Practice

+29.07%* +31.16%*

*significant at the p ≤ 0.05 level, matched data

+50.65%* +57.56%*


Curriculum/Activity Intervention Effect

Learning Domain Effect Size* % Non-OverlapKnowledge 0.909 59.35%

Competence 0.585 42.36%

Effect Size Definition: This is a standardized measure of the strength/magnitude of the change in scores, irrespective of sample size. This metric quantifies the association between outcome and exposure to education, in a way which makes meta-analysis possible. There exist many types of effect size measures, each appropriate in different situations. We select Cohen’s d for this analysis, which is a standardized difference in mean. Most commonly, d ranges from 0–1: d < 0.2 is a small effect, d = 0.2–0.8 is a medium effect, and d > 0.8 is a large effect.


Learning Domain by Professional Cohort

v Nurse practitioners (NPs) and physicians demonstrated statistically significant gains in all learning domains.

v In Knowledge and Competence, NPs demonstrated higher Pre-Test and Post-Test averages compared to physicians.

• In both of these domains, physicians demonstrated modestly greater gains.v On the Confidence ratings, physicians demonstrated higher Pre-Test and Post-Test averages;

NPs, however, demonstrated the greater increase.v On the practice strategy rating, physicians demonstrated a lower Pre-Test average rating;

however, their greater increases minimized any score difference by Post-Test.


Learning DomainNurse Practitioner Physician

N Pre-Test Post-Test % Change N Pre-Test Post-Test % Change

Knowledge 228 58.19%(31.00%)

87.28%(24.01%) +50.00%* 126 53.44%

(31.31%)81.75%

(28.21%) +52.97%*

Competence 209 39.95%(42.01%)

66.51%(41.53%) +66.47%* 108 36.11%

(38.39%)63.89%

(42.40%) +76.92%*

Confidence 187 2.63(0.92)

3.41(0.87) +29.47%* 113 2.88

(1.02)3.53

(1.00) +22.39%*

Practice 199 2.88(1.33)

3.77(0.94) +30.66%* 118 2.65

(1.21)3.79

(0.94) +42.81%*



At follow-up:

v Statistically significant net gains were measured from Pre-Test to the Post Curriculum Assessment (PCA) in all areas except for practice strategy, in which a non-significant net increase was measured.

v Significant net gains were measured in Knowledge and Competence; however, the score slippage that was observed in these domains resulted in low PCA scores, reinforcing the need for continued education on the use of insulins for managing type 2 diabetes.

v The greatest net increase (29%) were observed in practice strategy, due to a minimal score decrease between Post-Test and PCA. The lack of significance was due to the elevated scatter in learner scores.

4-Week Retention Analysis

54.76%(33.13%) 35.62%

(40.30%)

82.50%(27.65%)

60.03%(43.05%)

65.44%(47.56%)

40.70%(49.13%)

0%20%40%60%80%

100%

Knowledge CompetencePre-Test Post-Test PCA

+14.26%*

2.69(1.00)

2.94(1.35)

3.47(0.92)

3.85(0.94)

3.24(0.91)

3.80(1.02)

1.00

2.00

3.00

4.00

Confidence PracticePre-Test Post-Test PCA

+19.50%* +20.45%* +29.25%

(N = 570)


Disease state awareness Diagnostic evaluation Patient education

Screening protocols Pharmacotherapy

Please select the specific areas of skills, or practice behaviors, you have improved regarding the treatment of patients with type 2 diabetes since this CME activity. (Select all that apply.)N=570

(4-week Post Assessment)

82% 74% 88%

75% 90%


Insurance/financial issues Medication costs Formulary restrictions

Time constraints Patient adherence

What specific barriers have you encountered that may have prevented you from successfully implementing strategies for patients with type 2 diabetes since this CME activity? (Select all that apply) N=570

(4-week Post Assessment)

86%

88%74%

84%81%


Identified Learning Gap: Modification of insulin therapy in T2D patients with hypoglycemiaOn two Competence questions which asked learners to identify appropriate treatment modifications inT2D patients with hypoglycemia, Post-Test scores remained low (48% and 66%):

A 57-year-old man with a 15-year history of T2D reports occasional hypoglycemia at night, documented by CGM. He sometimes skips his basal insulin because he’s worried about hypoglycemia. Current medications include metformin 1000 mg bid and insulin glargine U100 48 units qhs. A1C: 7.7%; SMBG: fasting glucose 64-138 mg/dL, postprandial glucose 160-220 mg/dL. Any of the following might be appropriate, EXCEPT:• At Post-Test, only 48% of learners correctly answered: “switch from glargine U100 to human regular insulin U500.”

A 49-year-old woman with a 12-year history of T2D reports occasional hypoglycemia (~once/week). Her A1C is 7.8% and SMBG log shows average nighttime glucose 170 mg/dL and morning glucose 90 mg/dL. Current medications include metformin 1000 mg bid and insulin glargine U100 64 units qhs. Which of the following might be appropriate?• At Post-Test, only 66% of learners correctly answered: “Identify BeAM factor 80 mg/dL and recommend prandial insulin,

GLP-1RA or SGLT2-I.”


Overall Educational Impactv Significant improvements (ranging from 29% – 58%) were seen across all learning domains.

• The cohort analysis of professions showed that NPs demonstrated modestly higher Post-Test scores than physicians in Knowledge and Competence (87% and 67% for NPs vs. 82% and 64% for physicians, respectively), while physicians demonstrated a modestly higher Post-Test averages on the Confidence ratings (3.41 for NPs vs. 3.53 for physicians).

• Live onsite learners demonstrated higher Post-Test averages than online participants in all learning domains for this curriculum, driven by greater percent increases in all areas except Confidence.

• Analysis of learning retention in the PCA showed that significant net gains (14% – 29%) from Pre-Test were measured in all learning domains. The greatest increase was measured in learners’ reported intent to consider continuous glucose monitoring for a patient with T2D who is not meeting glycemic targets (2.94 at Pre-Test to 3.8 in the PCA).

v Significant improvements (ranging from 13% – 84%) were measured across all Learning Objectives.

§ A high Post-Test score was measured on the Learning Objective on barriers to treatment; however, low Post-Test scores were measured on the other three Learning Objectives related to currently available basal and ultrabasal insulins, insulin treatment guidelines, and patient adherence to insulin therapy.

§ Onsite learners achieved higher Post-Test averages and greater score increases than online learners on all Learning Objectives.

v The analysis of the Competence domain identified a persistent learning gap related to the modification of insulin therapy in T2D patients with hypoglycemia requiring treatment intensification.

• Despite score improvements of 30% and 103%, learners remained challenged (Post-Test scores of 48% and 66%) on two Competence questions that addressed the use of human regular insulin, prandial insulin, GLP-1RA, or SGLT2-I in patients with type 2 diabetes who are currently taking insulin glargine.


Appendix


Learning ObjectiveLive Onsite Learners Live Online Learners


Identify the barriers between clinicians and patients to discussing and initiating earlier insulin therapy for diabetes management.

780 80.77%(39.41%)

92.44%(26.44%) +14.44%* 279 81.36%

(38.94%)88.17%

(32.29%) +8.37%*

Discuss currently available basal and ultrabasal insulins and their pharmacokinetic/ pharmacodynamic profiles.

847 37.13%(40.07%)

71.66%(37.40%) +93.00%* 347 39.05%

(39.93%)64.12%

(40.02%) +64.21%*

Describe how best to initiate, utilize and intensify insulin therapy in patients with diabetes while incorporating treatment guidelines and unique patient needs.

856 39.27%(37.31%)

66.55%(37.01%) +69.46%* 361 43.72%

(37.29%)62.83%

(38.73%) +43.72%*

Integrate strategies to improve the patient experience with, and adherence to, insulin therapy.

813 42.25%(43.11%)

65.56%(40.61%) +55.17%* 339 48.82%

(43.43%)63.13%

(41.86%) +29.31%*

Learning Objectives Analysis – Live Onsite vs. Live Online Audience• “Live onsite learners” include only those attending in-person meetings.

• ”Live online learners” include those from both the Simulcast and Virtual Symposium.


v Both onsite and live online learners demonstrated significant score increases across all of the curriculum’s Learning Objectives.

v Onsite learners demonstrated greater score increases from modestly lower Pre-Test scores, resulting in higher Post-Test averages on all Learning Objectives.

v The high scores measured on the Learning Objective discussing barriers to treatment, and the low scores on the other three Learning Objectives showed no dependence on modality.



• “Live onsite learners” include only those attending in-person meetings.

• ”Live online learners” include those from both the Simulcast and Virtual Symposium.

Learning Domain Analysis – Live Onsite vs. Live Online Audience

v Both live and live online learners demonstrated significant and substantial score increases in all learning domains.

v Live onsite learners demonstrated higher Post-Test scores in all learning domains, and greater score increases in all areas except for Confidence.

Learning DomainLive Onsite Learners Live Online Learners


Knowledge 911 53.64%(32.62%)

83.53%(26.64%) +55.73%* 352 57.67%

(34.26%)79.83%

(29.95%) +38.42%*

Competence 736 35.46%(40.45%)

61.75%(42.68%) +74.14%* 321 35.98%

(39.93%)56.07%

(43.62%) +55.84%*

Confidence 739 2.77(1.05)

3.55(0.94) +28.26%* 248 2.46

(0.82)3.25

(0.85) +31.75%*

Practice 745 2.93(1.37)

3.89(0.94) +32.92%* 258 2.97

(1.27)3.74

(0.95) +26.14%*


87.44%

3.38%

7.37%

1.80%

79.98%

4.48%

12.73%

2.80%

4. Poor patient adherence to insulin

3. Pain from insulin injections

2. Weight gain with insulin

1. Patient age

Which of the following is the leading health care provider concern about starting insulin therapy in a patient with T2D?

All of the following approaches support effective insulin initiation, EXCEPT:

15.37%

6.86%

73.76%

4.02%

37.40%

8.00%

47.46%

7.14%

4. Have patients self-titrate insulin dose whenappropriate

3. Provide writ ten customized insulin care plan

2. Use random self-monitorng of bloodglucose

1. Use insulin pens when possible

Knowledge Questions:

+9.33%

+55.40%

✓

✓

N = (1249–1330)

Note: Data is unmatchedPre-Test Post-Test


18.01%

76.99%

3.68%

1.32%

45.25%

37.08%

12.30%

5.37%

4. Degludec U100

3. Glargine U300

2. Detemir

1. Lispro

Which of the following insulin formulations has a duration of action of ~36 hours?

Knowledge Questions (continued):

+107.64%✓

N = (1343–1454)

Note: Data is unmatchedPre-Test Post-Test


19.57%

8.77%

10.89%

48.45%

12.31%

23.69%

9.14%

15.95%

37.22%

13.99%

5. Add rapid-acting insulin before ≥1 meal and reduce basal insulin dose

4. Switch from glargine U100 to fixed-ratio basalinsulin/GLP-1 RA

3. Switch from glargine U100 to ultralong-actingbasal insulin

2. Switch from glargine U100 to human regularinsulin U500

1. Add GLP-1 RA and reduce basal insulin dose

A 57-year-old man with a 15-year history of T2D reports occasional hypoglycemia at night, documented by CGM. He sometimes skips his basal insulin because he’s worried about hypoglycemia. Current medications include metformin 1000 mg bid and insulin glargine U100 48 units qhs. A1C: 7.7%; SMBG: fasting glucose 64-138 mg/dL, postprandial glucose 160-220 mg/dL. Any of the following might be appropriate, EXCEPT:

Competence Questions

+30.17%

N = (1049–1129)

Note: Data is unmatched

✓

A 49-year-old woman with a 12-year history of T2D reports occasional hypoglycemia (~once/week). Her A1C is 7.8% and SMBG log shows average nighttime glucose 170 mg/dL and morning glucose 90 mg/dL. Current medications include metformin 1000 mg bid and insulin glargine U100 64 units qhs. Which of the following might be appropriate?

10.26%

19.26%

65.98%

3.42%

16.49%

44.04%

32.51%

5.72%

4. Regardless of BeAM factor, increase basalinsulin dose to lower nighttime glucose levels and

A1C

3. Based on low BeAM factor, switch from insulinglargine U100 to ultralong-acting basal insulin

2. Ident ify BeAM factor 80 mg/dL and recommendprandial insulin, GLP-1 RA or SGLT2-I

1. Ident ify BeAM factor 220 mg/dL and initiateDPP-4 inhibitor

+102.96%✓

Pre-Test Post-Test


Confidence Question:Please rate your confidence in your ability to address barriers to effective integration of insulin therapy early in the management of patients with type 2 diabetes (T2D):

Confidence & Practice QuestionsN = (1196–1314)

Practice Question:How often do you consider continuous glucose monitoring for a patient with T2D who is not meeting glycemic targets?

Pre-Test Post-Test Note: Data is unmatched

13.19%

31.86%

40.85%

12.80%

1.30%

4.10%

14.30%

36.71%

33.44%

11.45%

5. Very confident

4. Pretty much confident

3. Moderately confident

2. Slightly confident

1. Not at all confident

23.97%

24.66%

5.71%

1.98%

15.14%

22.71%

22.38%

20.47%

19.30%

5. Always

4. Often

3. Sometimes

2. Rarely

1. Never

getting comfortable with insulin: new approaches to ... · with, and adherence to, insulin therapy....

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