5/15/2017
Institution
• Oklahoma City VA Health Care System
• 192-bed facility serving 225,000 veterans
Impact of a PharmacistManaged Diabetes Clinic
on Patients with Poorly
Controlled Diabetes
– 48 counties in Oklahoma and 2 counties in North
Texas
• Numerous Community Based Outpatient
Clinics (CBOCs)
– Ada, Altus, Ardmore, Blackwell, Enid, Lawton,
Oklahoma City, Stillwater, and Wichita Falls
• Tertiary care teaching hospital (1a) within VA
Network 19
Kate Lutek, Pharm.D.
PGY1 Pharmacy Resident
Oklahoma City VA Health Care System
Oklahoma City, Oklahoma
Abstract #8
IRB Approved
4
Disclosure Statement
Self-Assessment Questions
Kate Lutek
Potential conflicts of interest: none
Sponsorship: none
Proprietary information or results of ongoing
research may be subject to different
interpretations
• Speaker’s presentation is educational in
nature and indicates agreement to abide by
the non-commercialism guidelines provided
1. In 2012, what percentage of the American population
was estimated to have diabetes?
a. 2.4%
b. 4.6%
c. 9.3%
d. 13.7%
•
•
•
•
2
Objectives
5
Self-Assessment Questions
2. A lower HbA1C was found to correlate to a relative
risk reduction in which three complications?
a. Retinopathy, arthropathy, neuropathy
b. Neuropathy, nephropathy, cardiopathy
c. Retinopathy, neuropathy, nephropathy
d. Nephropathy, lymphadenopathy, retinopathy
• Identify the relationship between
hemoglobin A1C (HbA1C) and the
development of diabetes complications
• Evaluate barriers to control of diabetes
• Assess the role of clinical pharmacists in
diabetes management
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Epidemiology
Hemoglobin A1C: The DCCT Trial
• Prevalence
– 9.3% of the American population
– 25.9% of Americans ≥65 years
• Incidence
– 1.4 million new cases/year
• Mortality
– 7th leading cause of death (US)
http://www.diabetes.org/diabetes-basics/statistics/. 7
DCCT Research Group. Diabetes 1995;44:968-983. 10
The Role of Clinical Pharmacy
Hemoglobin A1C: The DCCT Trial
• Diabetes Control & Complications Trial (DCCT)
– Prospective, randomized control trial (n=1441) in T1DM
– Conventional versus intensive treatment (6.5 years)
• Clinical well-being
• Normal blood glucose (goal HbA1c: ≤6.05%)
– Relative risk reduction of microvascular complications
• ↓ retinopathy, nephropathy, and neuropathy
– Assessment of complications was twofold:
• Delay of onset  primary prevention cohort
• Slowing of progression  secondary prevention cohort
“To close the gaps between best practice and usual
care…will require the collective expertise of a vast
array of doctors, nurses, pharmacists, allied
health professionals, social workers, and vested
laypersons.”
- Institute of Medicine (IOM)
DCCT Research Group. N Engl J Med 1993;329:977-86. 8
Adams K, et al. Washington, DC: Nat Academies Press; 2003.
11
The Role of Clinical Pharmacy
Hemoglobin A1C: The DCCT trial
• Primary outcome: risk reduction of
Primary prevention
Secondary prevention
retinopathy
Report of a multi-institutional pharmacy system
with both inpatient & ambulatory care (1987)
ASHP survey of noted a broad ambulatory care
presence in Federal Settings (1994)
Asheville Project shows benefit of pharmacists
in diabetes management (1996)
Long-term investigation of VA ambulatory care
shows clinical & economic impact (1998)
DCCT Research Group. N Engl J Med 1993;329:977-86.
9
Helling DK, et al. ASHP 2014. 12
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5/15/2017
•
The Role of Clinical Pharmacy
The Role of Clinical Pharmacy
US Pharmacists’ Effect as Team Members of Patient Care
– Systematic Review & Meta-Analysis
– Most common interventions:
• Medication- or disease-understanding education, medication
adherence education, drug utilization review, chronic disease state
management
Design & Methods
Outcome
Endpoints
# Studies
% Showing Benefit
Therapeutic
HbA1C, LDL, SBP & DBP
224
51.4 – 100%
Safety
Various
73
60 – 81.8%
Humanistic
Adherence, patient
satisfaction, knowledge, or
QoL (general, physical, or
mental health-related)
120
12.9 – 51.1%
Clinical Pharmacist Intervention in Veterans with T2DM
Retrospective chart review (n=86) at a
Community-Based Outpatient Clinic (CBOC) in
rural Jackson, TN between January 2012 and
January 2014
Demographics
• Male (94%), white (67%), average age 62
• Average study period: 262 days/5.7 visits
Inclusion criteria
T2DM patients (A1C ≥8%) >18 years of age
referred to the pharmacotherapy diabetes clinic
Primary outcome
Change in A1C (10.5% to 7.7%, or ARR 2.8%)
Secondary outcomes
Significant ↓ in diastolic blood pressure, total
cholesterol & triglycerides
Sullivan J, et al. Ann Pharmacother 2016;50(12):1023-1027.
Chisholm-Burns MA, et al. Med Care 2010;48(10):923-933. 13
Humanistic Outcomes
Pharmaceutical care is the “responsible
provision of drug therapy for the purpose of
achieving definite outcomes that improve a
patient’s quality of life.”
Diabetes Pharmacotherapy Clinic at
the Oklahoma City VA HCS
•
Purpose
– Retrospective chart review (July 1st 2015 – March 1st, 2017)
– Prospective patient care satisfaction survey
•
Inclusion criteria
– Adults ≥18 years old
– A1C ≥9.0% in 6 months prior to clinic enrollment
– A1C after initial appointment (must be 3–6 months after enrollment)
•
Exclusion criteria
– Diagnosis of T1DM
•
Primary Outcome:
– Percentage of patients with final A1C <9%
Hepler CD. Am J Hosp Pharm 1990;47:533-543.
Mohammed MA, et al. Ann Pharmacother 2016;50(10) 862–881. 14
The Role of Clinical Pharmacy
16
17
Diabetes Pharmacotherapy Clinic at
the Oklahoma City VA HCS
• Secondary Outcomes:
– Predictors of success of A1C lowering:
• Clinical:
–
–
–
–
–
–
–
BMI
DM medications
Chronic medications
Duration of DM
Initial and final SBP and DBP
Complications of DM
Comorbidities
• Demographic:
– Age, race, gender
– Proximity to OKC VAHCS
– Number of missed appointments
– Other endpoints:
• Percentage achieving A1C<8% and A1C<7%
• Percentage change (final to initial A1C)
Helling DK, et al. ASHP 2014. 15
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Patient Care Satisfaction Survey
•
Participant Flow
19-item phone survey
– Modeled on VA national primary care patient care satisfaction survey
Seen in OKC PHARMD
clinics with A1C<9%
(-40)
Initial visit prior to 7/1/15
(-23)
No A1C 3-6 months after
enrollment
(-8)
No diagnosis of T2DM
(-2)
Never seen
233 patients
160 patients
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Baseline Demographics
Variable (Mean)
Statistics
Gender
Male: 91.9%
Female: 8.1%
Age
61.3 years
Proximity to OKC VAHCS
30.6 miles
Missed Appointments
1.4
BMI
34.6 kg/m2
DM Medications
2.3
Chronic Medications
12.2
Duration of DM
10.8 years
Initial A1C
10.5%
Neuropathy
60%
Retinopathy
21.9%
Nephropathy
16.2%
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Primary Outcome
 Percentage of patients achieving an A1C of less than 9%
Race
A1C <9%
White
African American
Yes
No
American Indian or Alaska Native
Native Hawaiian or Pacific Islander
3% 1%
53%
23%
47%
73%
20
Baseline Demographics
Comorbidity
Frequency
Cardiac
81.9%
GI
26.9%
HIV
---
Hematological
10%
Hepatobiliary
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Secondary Outcomes
• Predictors of success for A1C <9%
Older Age
• 63.2 versus 59.1 years
• 95% CI: (1.16 to 7.04)
3.1%
Immunologic/Rheum
23.1%
Metabolic/Endocrine
79.4%
Musculoskeletal
46.9%
Neoplastic
8.1%
Neurologic
22.5%
Psychiatric
50.6%
Renal
13.8%
Fewer Missed
Appointments
21
• 0.9 versus 1.9 appointments
• 95% CI: (-0.51 to -1.46)
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Secondary Outcomes
Secondary Outcomes - Survey
• Initial A1C (10.5%) – Final A1C (8.9%) 
A1C <8%
A1C <7%
1.6% A1C
reduction
Yes No
Yes No
“In the last six months, did you/how often did…
8
Did your pharmacist spend enough time with you?
9
You and your pharmacist talk about starting or stopping a
prescription medication?
Yes (85.7%)
10 When (#9), how much did your pharmacist talk about reasons
you might want to take a medication?
A lot (88.9%)
11 When (#9), how much did your pharmacist talk about reasons
you might NOT want to take a medication?
A lot (72.2%)
12 When (#9), did your pharmacist ask you what was best for
YOU?
Yes (83.3%)
10%
32%
68%
90%
Majority
Response
13 Using a number 0-10 (0 is worst possible provider and 10 is
best possible provider), how would you rate this pharmacist?
Always (95.2%)
10 (81%)
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Secondary Outcomes
Secondary Outcomes - Survey
“In the last six months, did you/how often did…
Change in A1C
>0.5% increase
14 Your pharmacist ask you if there are things that make it hard for you
to take care of your health?
>0.5% decrease
15
71%
You and your pharmacist talk about things in your life that worry you
and cause you stress?
16 You and your pharmacist talk about a personal problem, family
problem, alcohol use, drug use, or mental/emotional illness?
17
11%
18%
Do you feel like your overall control of DM has improved due to your
pharmacist?
Majority
Response
Yes (90.5%)
Yes (81%)
No (61.9%)
Yes (100%)
18 Has your experience with a pharmacist improved your overall
satisfaction with primary care?
Yes (95.2%)
19 Has your experience with a pharmacist improved your overall
satisfaction with the VA?
Yes (100%)
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Secondary Outcomes - Survey
Secondary Outcomes
“In the last six months,
did you/how
often did…
Majority
• Prospective
patient
care satisfaction
Response
survey (n=21)
1 Contact your pharmacist with a medical question?
Yes (61.9%)
• Highest-rated items (>90%):
– Interactive:
2
You get an answer to your medical question that same day?
Always (92.9%)
3
Your pharmacist explain things in an easy-to-understand
way?
Always (90.5%)
4
Your pharmacist listen carefully to you?
Always (100%)
5
Your pharmacist give you easy-to-understand information
about your these questions or concerns?
Always (90.5%)
6
Your pharmacist seem to know important information about
your medical history?
Always (85.7%)
7
Your pharmacist show respect for what you had to say?
Always (100%)
27
•
•
•
•
•
Quick response time
Clear explanations
Listening and showing respect
Sufficient length of interactions
Assessing barriers to control
– Perceptions of care:
• Improvement of diabetes control
• Experience with primary care
• Experience with the OKC VAHCS
• Lowest-rated items (<80%):
– Discussion of reasons not to take a medication
– Discussion of personal problems
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Discussion
Sullivan, et al. 2016.
Self-Assessment Questions
1. In 2012, what percentage of the American population
was estimated to have diabetes?
a. 2.4%
b. 4.6%
c. 9.3%
d. 13.7%
Lutek, et al. 2017.
Duration ~8.7 months
Duration ~4.5 months
Patients seen ~5.7 times
No visit data & no minimum
A1C-lowering 2.8%
A1C-lowering 1.6%
Rural setting in a CBOC
62% pts live within 25 miles
Miss 2 consecutive visits  dx
36% of pts missed ≥2 visits
Sample size: n=86
Sample size: n=160
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Discussion
Self-Assessment Questions
• Limitations
– No time sequence of A1C values prior to enrollment
– No assessment of maintenance of lowered A1C values
– Patient care satisfaction survey not strictly implemented
– Retrospective cohort study & no designated controls
2. A lower HbA1C was found to correlate to a relative
risk reduction in which three complications?
a. Retinopathy, arthropathy, neuropathy
b. Neuropathy, nephropathy, cardiopathy
c. Retinopathy, neuropathy, nephropathy
d. Nephropathy, lymphadenopathy, retinopathy
32
35
Conclusions
References
• PACT clinical pharmacists at OKC VAHCS are impacting diabetes
care through quantitative and qualitative measures
1.
Overall Numbers, Diabetes and Prediabetes. American Diabetes Association. Available at:
http://www.diabetes.org/diabetes-basics/statistics/. Accessed September 3, 2016.
2. The DCCT Research Group. The Effect of Intensive Treatment of Diabetes on the Development
and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. N Engl J
Med 1993;329:977-86.
3. The DCCT Research Group. The relationship of glycemic exposure (HbA1c) to the risk of
development and progression of retinopathy in the diabetes control and complications trial.
Diabetes 1995;44(8):968-83.
4. Adams K, Corrigan JM, eds. Priority areas for national action. Transforming health care quality.
Washington, DC: The National Academies Press;2003.
5. Chisholm-Burns MA, Lee JK, Spivey CA, et al. US Pharmacists’ Effect as Team Members on
Patient Care: Systematic Review and Meta Analyses. Med Care 2010;48(10):923-933.
6. Helling DK, Johnson SG. Defining and Advancing Ambulatory Care Pharmacy Practice: It is Time
to Lengthen Our Stride. ASHP Ambulatory Care Conference and Summit. March 3-4, 2014.
7. Sullivan J, Jett PB, Cradick M, et al. Effect of Clinical Pharmacist Intervention on Hemoglobin
A1C Reduction in Veteran Patients with Type 2 Diabetes in a Rural Setting. Ann Pharmacother
2016;50912):1023-1027.
8. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp
Pharm. 1990;47:533-543.
9. Mohammed MA, Moles RJ, Chen TF. Impact of Pharmaceutical Care Interventions on HealthRelated Quality-of-Life Outcomes: A Systematic Review and Meta-Analysis. Ann Pharmacother
2016;50(10):862-881.
• Pharmacists can address in greater depth reasons why patients
might NOT want to take medications
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