1. No category

3/30/2015
Discharge and Transitional Care
of Patients with COPD: Improving
Practice to Reduce Readmissions
Sponsored by Integrity Continuing Education, Inc.
Supported by an educational grant from Sunovion Pharmaceuticals, Inc.
Practitioner’s Edge is a registered service mark of Integrity Continuing Education, Inc.
© 2015 Integrity Continuing Education, Inc.
Faculty Panel
Sidney Braman, MD
Professor of Medicine
Pulmonary, Critical Care, and Sleep Medicine
Icahn School of Medicine
New York, New York
Joshua LaBrin, MD, FACP, SFHM
Assistant Professor of Medicine
University of Utah School of Medicine
Salt Lake City, Utah
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Faculty Disclosures
 Sidney Braman, MD
– Royalties: AP Press, Guilford Press
 Joshua LaBrin, MD, FACP, SFHM
– No real or apparent conflicts of interest to disclose
3
Learning Objectives
 Assess future risk for worsening disease and
exacerbations in patients with chronic
obstructive pulmonary disease (COPD) to
prevent hospital readmission
 Provide individualized discharge and transitional
care plans for patients at high risk who were
recently hospitalized for COPD
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Overview of Topics Covered
 COPD in the hospital setting
 Assessment and treatment of COPD
exacerbations
 Assessing COPD severity & future risk
 Considerations for maintenance therapy
in the hospital setting
 Device selection
 Discharge & transitional care planning
 Additional strategies to prevent hospital
readmissions
5
COPD in the Hospital Setting
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Underdiagnosed COPD Is Common
in the Hospital Setting
 Estimated 15 million people in the US diagnosed
with COPD
 However, lung function tests show that up to
twice as many people may have COPD, but are
undiagnosed
 Many patients who present with an exacerbation
for the first time and are treated in the hospital
were previously undiagnosed
Vestbo J, et al. MMWR Morb Mortal Wkly Rep. 2012;61(46):938-943.
7
In-hospital Burden of COPD
 1.5 million emergency department (ED) visits
 699,000 hospital discharges
 Over $13 billion in hospital care costs
 In-hospital mortality 2.5% for all hospital
admissions from acute exacerbations of COPD,
and up to 28% for patients requiring mechanical
ventilation
Perera PN, et al. J COPD. 2012;9:131-141.
Ford ES, et al. Chest. 2013;144(1):284-305.
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Rates of Repeat ED Visits and
Readmissions
A substantial proportion of patients discharged for COPD
are readmitted or have repeat ED visits within 30 days.
20
Percent (%)
16
12
ED visits
Simple inpatient admissions
Complex inpatient admissions
17.8
15.3 15.7
13.9
12.6 12.4
10.3 10.8 10.5
10.6 10.7 10.7
2005
2006
8
4
0
2007
2008
Patients ≥40 years of age
Medicare accounted for 66.4% of all encounters.
Dalal AA, et al. Respir Med. 2011;105(3):454-460.
9
Quality of Care and Unstable
Comorbidities Contribute to Readmissions
 Patients hospitalized for COPD exacerbations
received only about 50% of the care
recommended by guidelines1
 Specific gaps related to instruction on respiratory
inhalers and scheduling a follow-up
appointment2
 Majority of readmissions within first 30 days are
related to comorbidities including cardiac, renal,
gastrointestinal, and infectious conditions3
1. Mularski RA, et al. Chest. 2006;130:1844-1850.
2. Mularski RA, et al. J Comp Eff Res. 2012;1:71-82.
3. Elixhauser A. Statistical Brief #121. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs.
Rockville, MD: Agency for Health Care Policy and Research; 2006.
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Policies on Hospitalizations/
Readmissions for COPD
 Goals of the Healthy People 2020 Program (US DHHS)
– Increase diagnosis of COPD
– Improve activity level in patients with COPD
– Reduce ED visits, hospitalizations, and deaths
 Updates to CMS Readmissions Reduction Program
– CMS will reduce payments to hospitals for COPD readmissions
within 30 days
– Maximum penalty at 3% of a hospital's Medicare reimbursement
DHHS, Department of Health and Human Services; CMS, Centers for Medicaid & Medicare Services.
Available at: www.healthypeople.gov/2020; Available at :http://www.cms.gov/Medicare/ Medicare-Fee-for-ServicePayment/AcuteInpatientPPS/Readmissions-Reduction-Program.html.
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Goals for In-hospital Management
of COPD
Assess & treat
exacerbation to
stabilize patient
Implement
individualized
inpatient
treatment plan
Assess risk for
future
exacerbations
• Evaluate COPD
severity
• Evaluate patient
comorbidities
Evaluate current
medical
management and
home care
environment
Implement
individualized
discharge and
transitional care
plans to prevent
readmission to
include longacting
maintenance
therapies and
follow-up
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Assessment and Treatment
of COPD Exacerbations
13
Exacerbation of COPD
An exacerbation of COPD is an acute
event characterized by a worsening of
the patient’s respiratory symptoms that
is beyond normal day-to-day variations
and leads to a change in medication.
Vestbo J, et al. GOLD 2015 update.
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Impact of Frequent COPD Exacerbations
Patients with frequent exacerbations
Lower quality
of life
Increased
morality rate
Increased risk
of recurrent
exacerbations
Increased
inflammation
Faster disease
progression
Increased likelihood
of hospitalization
Qureshi H, et al. Ther Adv Chronic Dis. 2014;5(5):212-227.
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Most Frequent Causes of an
Exacerbation
 70% to 80% of COPD exacerbations are
triggered by viral or bacterial respiratory
infections
 20% to 30% are associated with exposure
to environmental pollution or have an
unknown etiology
Sethi S, Murphy TF. N Engl J Med. 2008;359(22):2355-2365.
Sapey E, Stockley RA. Thorax. 2006;61(3):250-258.
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Case Study #1: 62-year-old Female
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Case Study #1: Background and
Presentation
 62-year-old female
 History
– Current smoker with 35 pack-year history
– Current diagnosis of COPD by primary care physician
 Current medications
– LAMA maintenance therapy and SABA prn
– Forgets to take her second inhaler sometimes
 Presentation
– Cough and dyspnea while walking over the last several
hours
– Used rescue inhaler 4 times in last 2 hours
LAMA, long-acting anticholinergic; SABA, short-acting beta2-agonist; prn, as needed.
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Case Study #1: Exam and Test Results
 Persistent productive cough with clear, white sputum
 Physical exam
–
–
–
–
Wheezing and decreased breath sounds on lung exam
Temperature: 99.7
HR: 82
BP: 143/91
 SpO2: 79% on room air
 Imaging and laboratory testing negative for
bacterial pneumonia
 Poor response to first dose of SABA
HR, heart rate; BP, blood pressure; SpO2, oxygen saturation.
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Hospital Care Pathway for COPD:
Initial Presentation in the ED
Point of Entry
ED
(self-admitted or
clinician referral)
Assess
Severity of
Exacerbation
Diagnostic Options
Arterial blood
gases, pulse
oximetry
Chest X
ray, ECG
Other
Implement/Modify
Therapy to Treat
Acute Symptoms
Consider
admission
criteria
Therapeutic Options
Modify
bronchodilator
therapy
Consider NIV
Systemic
steroids
Antibiotic
therapy?
Other
ECG, electrocardiogram; NIV, noninvasive ventilation.
Slide courtesy of: Stanley B. Fiel, MD.
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Confirm the Diagnosis of COPD
Exacerbation
History
Physical Exam
 Diagnosis of COPD
 Cigarette smoking
 Dyspnea on ordinary
exertion, shortness of
breath at rest
 Cough, phlegm
 Wheezing on lung
exam
 Decreased breath
sounds
 Use of accessory
muscles
 Pursed-lip breathing
 Hyperinflation
Diagnostic Testing
 SpO2 <88% on
room air
 Abnormal chest X ray
 Hyperinflation on
chest imaging
Courtesy of Dr. Robert Wise, MD, Johns Hopkins Medicine, Johns Hopkins Bayview Medical Center.
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Risk Factors for In-hospital Mortality
Characteristics
indicative of
exacerbation
severity (eg,
abnormal blood gas
values)
Older age
Perera PN, et al. J COPD. 2012;9:131-141.
Case severity
(complications,
organ system
dysfunction,
severe COPD)
Comorbid
conditions
(number and type)
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Corticosteroids Given in the Hospital
Rate of Treatment Failure (%)
60
30 days
50
40
30
TF: Death from any cause or the need for
intubation and mechanical ventilation,
readmission because of COPD, or
intensification of pharmacologic therapy
20
Readmissions for COPD were similar
across all groups at 30 days.
Glucocorticoids, 8 wk
Glucocorticoids, 2 wk
Placebo
10
0
0
1
2
3
Month
4
5
6
TF, treatment failure.
Niewoehner DE, et al. N Engl J Med. 1999;340:1941-1947.
23
5-day Course of Corticosteroids
Preferred for COPD Exacerbations
 FEV1 ~31% predicted
 Randomized to 5 or
14 days of prednisone
(40 mg)
 5-day regimen non inferior
to 14-day regimen
 Hospital stays averaged
1 day shorter with 5-day
regimen
Patients Without Exacerbation (%)
 GOLD Stage 3-4
100
5 days
Short-term group
75
Conventional group
14 days
50
25
0
0
50
100
150
Time From Inclusion, d
200
GOLD, Global Initiative for Chronic Obstructive Lung Disease; FEV1. forced expiratory volume in 1 second.
Leuppi JD, et al. JAMA. 2013;309(21):2223-2231.
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Antibiotic Therapy Recommended for
Patients with Infectious Exacerbation
 Retrospective study of patients >40 years old
hospitalized for a COPD exacerbation and
treated with systemic corticosteroids (N=53,900)
 Addition of antibiotics was associated with:
– 40% reduction in in-hospital mortality
– 13% reduction in 30-day readmission for COPD
Stefan MS, et al. Chest. 2013;143(1):82-90.
Vestbo J, et al. GOLD 2015 update.
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Summary of Exacerbation Management
 Assess severity of symptoms, chest radiograph, blood gases,
and/or O2 saturation to guide management
 Provide O2 as indicated
 Consider NIV/IMV and criteria for admission if necessary
 Provide bronchodilator therapy
– Increase doses/frequency of SABA therapy
– Combine SABAs with anticholinergics
– Use spacers or air-driven nebulizers
 5-day course of oral corticosteroids preferred
 Consider antibiotics for infectious exacerbations
 Consider adjunctive therapies as necessary
IMV, invasive mechanical ventilation.
Vestbo J, et al. GOLD 2015 update.
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Assessing COPD Severity & Future Risk
27
Estimation of COPD Severity Not Always
Aligned with Objective Measures
 COPD severity is underestimated in ~50% of
patients when measured clinically compared
with severity derived by spirometry
 Spirometry resulted in a change in treatment
in ~33% of patients
Mapel DW, et al. Am J Med. 2015. [Epub ahead of print]
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Severity of COPD Symptoms:
Classification Using Spirometry
Category
Severity
Spirometry (% predicted)
FEV1 ≥80%
FEV1/FVC <0.70
GOLD 1
Mild
GOLD 2
Moderate
50%≤ FEV1 <80%
FEV1/FVC <0.70
GOLD 3
Severe
30%≤ FEV1 <50%
FEV1/FVC <0.70
GOLD 4
Very severe
FEV1 <30%
FEV1/FVC <0.70
FVC, forced vital capacity.
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
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Association of Disease Severity with
Frequency of COPD Exacerbations
ECLIPSE STUDY
Hospitalized for exacerbation in year 1
Frequent exacerbations
50
47
Patients (%)
40
33
33
30
22
20
10
0
18
7
GOLD 2
(N=945)
GOLD 3
(N=900)
GOLD 4
(N=293)
ECLIPSE, Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints.
Hurst JR, et al. N Engl J Med. 2010;363(12):1128-1138.
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Risk Evaluation in COPD: Potential for
Serious Events by Disease Severity
Exacerbations
Per Year
Hospitalizations
Per Year
3-year
Mortality
GOLD 1
?
?
?
GOLD 2
0.7 - 0.9
0.11 - 0.2
11%
GOLD 3
1.1 - 1.3
0.25 - 0.3
15%
GOLD 4
1.2 - 2.0
0.4 - 0.54
24%
Category
Vestbo J, et al. GOLD 2015 update.
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Assessment of COPD Severity and Risk:
Exacerbation History and Symptoms
 Exacerbation history
 Modified Medical Research Council Dyspnea Scale
– Assesses severity of patient breathlessness
– 5 grades: 0 no breathlessness to 4 very severe
 COPD Assessment Test (CAT)
– 8-question assessment that assigns a score of 1 to 5 to each
question
– Measures frequency of symptoms
– Higher scores denote a more severe impact of COPD on a
patient’s life
mMRC and CAT have been validated and relate well to other
measures of health status and predict future mortality risk.
Bestal SC, et al. Thorax. 1999;54(7):581-586.
COPD Assessment Test is a trademark of the GlaxoSmithKline group of companies.
© 2009 GlaxoSmithKline group of companies. All rights reserved. Last updated: February 24, 2012.
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Risk Assessment of COPD: Updated
GOLD Guidelines
4
<30%
Risk
3
(C)
(D)
≥2
30%-50%
GOLD
Classification
of Airflow
Limitation
Risk
Exacerbation
History
2
50%-80%
1
(A)
(B)
1
0
≥80%
mMRC 0-1
CAT < 10
mMRC ≥ 2
CAT ≥ 10
Symptoms
(mMRC or CAT score)
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
33
Best Predictor of Future Exacerbation:
Exacerbations in Past Year
ECLIPSE STUDY
Exacerbations
during the past year
Odds Ratio
(≥2 vs 0)
P value
Odds Ratio
(1 vs 0)
P value
5.72
<.001
2.24
<.001
Hurst JR, et al. N Engl J Med. 2010;363(12):1128-1138.
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Risk Factors for COPD Exacerbations
 Continued exposure to:
– Cigarette smoke
– Industrial particulates
– Indoor/outdoor pollution
Worsening symptoms (dyspnea, cough, and secretions)
Declining lung function
Viral upper respiratory infections
Increase in rescue medication use
Maintenance medication nonadherence
Poor device technique and inadequate medication
administration
 Previous exacerbation/hospitalization






Vestbo J, et al. GOLD 2015 update.
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COPD-associated Risk for Comorbidity
High cholesterol 0.84 (0.75-0.93)
Obesity 0.87 (0.79-0.97)
Hay fever 1.14 (1.02-1.28)
Stomach ulcers 1.26 (1.06-1.51)
Sleep apnea 1.35 (1.17-1.56)
Hypertension 1.32 (1.20-1.47)
CHD 1.34 (1.14-1.57)
GERD 1.41 (1.25-1.58)
PVD 1.45 (1.02-2.06)
Stroke 1.54 (1.20-1.97)
Osteoporosis 1.66 (1.43-1.94)
CHF 3.26 (2.37-4.49)
0
1
2
3
4
Risk for Comorbidity (Adjusted Odds Ratio)
CHD, congenital heart disease; GERD, gastroesophageal reflux disease;
PVD, peripheral vascular disease; CHF, congestive heart failure.
Putcha N et al. Chronic Obstr Pulm Dis. 2014;1(1):105-114.
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Impact of Comorbidities on Disease
Progression and Future Exacerbations
 The majority of patients with COPD exhibit
≥3 comorbidities
 A subset of these have been associated
with ↑ likelihood of disease progression
and readmission for exacerbation
–
–
–
–
–
–
CHF
Lung cancer
Anxiety
Depression
Skeletal muscle weakness
Osteoporosis
37
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
Mortality Risk Within the First 30 Days
Following Initial Discharge for COPD
7
Odds Ratios
6
6.1
Comorbid Condition
All P<.0001
5
4.3
4
3.8
3
2.3
1.8
2
1.7
1.6
1.4
1.2
1
0
Septicemia Aspiration
Acute
Acute Renal Myocardial Pneumonia C. difficile
Pneumonia Respiratory
Failure
Infarction
Failure
Duffy S, et al. J COPD F. 2015;2(1): 17-22.
Pulmonary Congestive
Heart
Heart
Disease
Failure
38
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Considerations for Maintenance Therapy
in the Hospital Setting
39
Delays in Maintenance Therapy
Are Costly
 In post discharge setting, patients with delayed
maintenance therapy had a 43% (P<.001) higher risk
of future hospitalization/ED visit1
– Every 30-day delay associated with 9% increase
in risk (P=.002)
 Patients with COPD with higher adherence to prescribed
maintenance regimens experienced fewer hospitalizations
and lower Medicare costs2
 Should we consider advancing the initiation of
maintenance therapies to the hospital setting?
1. Dalal AA, et al. Am J Manag Care. 2012;18(9):e338-e345.
2. Simoni-Wastila L, et al. Am J Geriatr Pharmacother. 2012;10(3):201-210.
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Hospital Stays for Exacerbations
of COPD Following Initiation of LAMA
14
Hospital Stay (± SD d)

P<.05
12
10
*
8
6
Early addition of
maintenance LAMA
(tiotropium) to a
respiratory-therapistdirected bronchodilator
protocol for patients
hospitalized for COPD
exacerbation reduced:
4
– Hospital stays
2
– Hospital costs
0

2004 2006
January
2004 2006
February
2004 2006
March
No safety concerns
2004 2006
Jan-Mar
Combined
SD, standard deviation.
Drescher GS, et al. Respir Care. 2008;53(12):1678-1684.
41
Odds of Readmission 31% Lower When
Nebulized LABA Initiated in Hospital
Readmission Rate (%)
Overall, significantly lower (8.7% vs 11.9%)
30-day readmissions with arformoterol
20
15
10
P=.028
Neb-SABA
Arformoterol
17.5
P=.031
P=.867
P=.696
5.8
7.3
12.6
8.9 9.3
8.1
9.9
5
0
Minor
Moderate
Major
Extreme
Severity of Illness
LABA, long-acting beta-agonists.
Bollu V, et al. Int J Chron Obstruct Pulmon Dis. 2013;8:631-639.
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Initiating LABA Therapy in Outpatient Setting
Lowers Risk of All-cause Hospitalization
Proportion of Patients
1.0
0.8
0.6
0.4
 26% reduction in hospitalizations
with LABA vs SABA in 6-month
follow-up period
0.2
Long Acting Beta Agonist
Short Acting Beta Agonist
0.0
0
20
40
60
80 100 120
Time (days)
140
160
180
43
Bollu V, et al. J Med Econ. 2013;16(8):1082-1088.
Combined Assessment of COPD:
Updated GOLD Guidelines
4
<30%
Risk
3
(C)
(D)
≥2
30%-50%
GOLD
Classification
of Airflow
Limitation
Risk
Exacerbation
History
2
50%-80%
1
(A)
(B)
1
0
≥80%
mMRC 0-1
CAT < 10
mMRC ≥ 2
CAT ≥ 10
Symptoms
(mMRC or CAT score)
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
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GOLD Recommendations for Initial
Pharmacotherapy
Patient
Group
Recommended
First Choice
A
SAMA prn or SABA prn
B
LAMA or LABA
C
ICS + LABA or LAMA
Alternative
Choice
Other Possible
Treatments
LABA or LAMA or
Theophylline
SABA + SAMA
SABA and/or SAMA
LAMA + LABA
Theophylline
LAMA + LABA or
SABA and/or SAMA
LAMA + PDE4 or
Theophylline
LABA + PDE4
ICS + LABA + LAMA or
D
ICS + LABA and/or LAMA
ICS + LABA + PDE4 or
LABA + LAMA or
Carbocysteine
SABA and/or SAMA
Theophylline
LAMA + PDE4
SAMA, short-acting muscarinic antagonist; ICS, inhaled corticosteroid; PDE4, phosphodiesterase type 4 inhibitor.
Vestbo J, et al. GOLD 2015 update.
45
Available Long-acting Bronchodilator
Monotherapies
Agent
Delivery
Manufacturer
Nebulizer
Sunovion
Nebulizer
Mylan
DPI
Merck
Indacaterol
DPI
Novartis
Olodaterol
SMI
Boehringer Ingelheim
Salmeterol
DPI
GlaxoSmithKline
Aclidinium
DPI
Forest
Ipratropium
IA
Boehringer Ingelheim
Tiotropium
DPI, IS
Pfizer/Boehringer Ingelheim
Umeclidinium
DPI
GlaxoSmithKline
Arformoterol
Formoterol
LABA
LAMA
DPI, dry powder inhaler; SMI, soft mist inhaler; IS, inhalation spray; IA inhalation aerosol.
Vestbo J, et al. GOLD 2015 update.
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Probability of Exacerbation (%)
Reduction in Exacerbations with LAMA
Therapy (UPLIFT Study)
80
Placebo
Tiotropium
60
14% reduction in exacerbations
and significant delay in the time to
the first exacerbation (16.7 months
vs 12.5 months)
40
Hazard ratio, 0.86
(95% CI, 0.81-0.91)
P<0.001
20
0
0
6
12
18
24
30
Month
36
42
48
CI, cardiac output; SAE, serious adverse event.
Tashkin DP, et al. N Engl J Med. 2008;359:1543-1554.
47
Pooled Long-term Safety Data for
Tiotropium for COPD
 Pooled safety data from 35 placebo-controlled
trials of tiotropium for COPD
 24,555 patients and 14,909 patient-years of
exposure to tiotropium
 Regardless of device, tiotropium does not
increase the overall risks of AEs, SAEs, FAEs, or
CV events
AE, adverse event; SAE, serious adverse event; FAE, fatal adverse event; CV, cardiovascular.
Halpin DMG, et al. Int J Chron Obstruct Pulmon Dis. 2015;10 239-259.
48
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Nebulized LABA Results in Greater Lung
Function vs Placebo (12 Weeks)
400
Drug administered
Change in FEV1 (mL)
(Week 12)
350
300
x
250
Arformoterol 15 µg bid
Arformoterol 25 µg bid
Arformoterol 50 µg qd
Salmeterol 42 µg bid
Placebo
200
150
100
50
0
x
-50
-100
bid, twice daily; qd, once daily.
x
x
0
xx
x
x
x
x
x
x
x
2
4
6
8
x
10
x
x
12
22
24
Time After Study Drug Administration (hr)
Baumgartner RA, et al. Clinical Therapeutics. 2007;29:261-278.
49
1-year Safety of Nebulized LABA Therapy
(Arformoterol) vs Placebo
 Patients were ≥ 40 years of age
 Baseline
– FEV1 ≤ 65% predicted, FEV1 > 0.50 L, FEV1/FVC ≤ 70%,
and ≥ 15 pack-year smoking history
 COPD exacerbation-related hospitalizations were
9.0% (arformoterol) vs 14.3% (placebo)
 Risk for first respiratory SAE was
50% lower with arformoterol with placebo (P=.003)
 Overall, arformoterol had an approximately 40% lower risk
of respiratory death or COPD exacerbation-related
hospitalization over 1 year vs placebo
Donohue JF, et al. Chest. 2014;146(6):1531-1542.
50
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Available Long-acting Bronchodilator
LABA/LAMA Combination Therapies
AGENT
DELIVERY
MANUFACTURER
Vilanterol + umeclidinium
DPI
GlaxoSmithKline/Theravance
Olodaterol + tiotropium
SMI
Boehringer Ingelheim
Vestbo J, et al. GOLD 2015 update.
51
LABA/LAMA Combination Associated
with Reduced Risk for Exacerbations
Placebo
UMEC 125
UMEC/VI 125/25
Percentage of Patients With
an Exacerbation
30
25
20
15
10
5
~50% reduction in exacerbations overall and
exacerbations resulting in hospitalizations
0
0
31
62
Donohue JF et al. Respir Res. 2014;15:78.
93 124 155 186 217 248 279 310 341 372
Time to Event (days)
52
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3/30/2015
Available Long-acting Bronchodilator
Therapies in Combination with ICS
Agent
Delivery
Manufacturer
Formoterol + budesonide
MDI
AstraZeneca
Salmeterol + fluticasone
DPI
GlaxoSmithKline
Vilanterol + fluticasone
DPI
GlaxoSmithKline
Formoterol + mometasone*
MDI
Merck
*Off-label use. Not indicated for the treatment of patients with COPD.
MDI, Metered dose inhaler
Vestbo J, et al. GOLD 2015 update.
53
Lung Function with ICS/LABA
Combination Therapy (TORCH Study)
Primary endpoint of mortality
not reached in this study.
Adjusted Mean Change
in FEV1 (mL)
100
↓ annual rate of exacerbations
from 1.13 to 0.85 (P<.001)
50
0
Combination
therapy
–50
Fluticasone
Salmeterol
–100
Placebo
–150
0
24
48
Calverley P, et al. N Engl J Med. 2007;356:775-789.
72
96
Weeks
120
156
54
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PDE4 Inhibition
 May inhibit fibroblast-mediated contraction and
formation of fibrotic tissues, which can disrupt
lung function
 Roflumilast
– Oral, selective, long-acting inhibitor of an enzyme
called PDE4
– Indicated for treatment to reduce the risk of
exacerbations in patients with severe COPD
associated with chronic bronchitis and a history of
exacerbations
Fabbri LM, et al. Lancet. 2009;374(9691):695-703; Calverley PM, et al. Lancet. 2009;374(9691):685-694;
Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management
and prevention of chronic obstructive pulmonary disease. 2010 update. Available at: www.goldcopd.com.
55
Therapies on the Horizon
Type
LAMA
LABA /
LAMA
Agent
Delivery
Manufacturer
Nebulizer
Sunovion
DPI
Vectura, Sosei/Novartis
MDI
Pearl
Indacaterol +
glycopyrronium
bromide
DPI
Vextura, Sosei/Novartis
Aclidinium +
formoterol
DPI
Almirall/Forest
Glycopyrronium
bromide
56
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Device Selection
57
Misuse of Handheld Devices in
Hospitalized COPD Patients is Common
Misuse Rate for Hospitalized
Patients with COPD (N=40)
85%
85%
81%
80%
 COPD patient population
is diverse with various
levels of functioning
 Handheld devices
assume patient is able
to use correctly
75%
70%
65%
60%
55%
50%
MDI
MDI
FP/SAL
DPI
Adapted from: Press VG, et al. J Gen Intern Med. 2011;26(6):635-642.
Fromer L, et al. Postgrad Med. 2010;122(2):83-93.
58
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Inspiratory Flow Rates in Patients
with COPD
 ~1 of 5 patients with advanced COPD and ≥ 60 years
of age exhibited a suboptimal peak inspiratory flow rate
(PIFR) against DPI resistance (<60 L/min)1
– 80% were female, had shorter height, and lower FVC and
inspiratory capacity (IC)
 A study of DPI vs nebulized LABA in patients with
suboptimal PIFR (53 ± 5 L/min) found that improvements
in FEV1, FVC, and IC were significantly higher with
arformoterol than with salmeterol at 15 minutes2
 Patients with suboptimal PIFR may have difficulty
actuating a DPI, which may reduce medication delivery
1. Mahler DA, et al. J Aerosol Med Pulm Drug Deliv. 2013;26(3):174-179.
2. Mahler DA, et al. J Aerosol Med Pulm Drug Deliv. 2014;27(2):103-109.
59
Patient/Caregiver Experiences
with Nebulized Therapy
 Patients were “Highly satisfied with their current
nebulized treatment” (89%) and had “Easier
breathing” (68%)
 Patients agreed that nebulization provided “Better control
of symptoms” (85%) and “Greater confidence that the
right amount of medication was being delivered” (84%)
 Caregivers stated that nebulization “Made it easier
to care for their friend/family member” (86%)
Sharafkhaneh A, et al. J COPD. 2013;10(4):482-492.
60
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Clinical Scenarios Where Nebulized
Therapy May Be Preferred
 Cannot generate adequate inspiratory flow required by DPIs
 Cannot use pMDIs or DPIs appropriately despite adequate education and training
 Debilitated after hospitalization and cannot coordinate breathing with device
requirements
 Inadequate symptom relief with appropriate use of pMDIs or DPIs
 Nonadherence with pMDIs or DPIs
 Preference for nebulization
 Cognitive impairment (eg, Alzheimer’s, altered consciousness)
 Impaired manual dexterity (eg, arthritis, Parkinsonism, or stroke)
 Pain or weakness from neuromuscular disease (eg, multiple sclerosis)
 Need for higher bronchodilator or corticosteroid doses to control diseases
 Cannot afford therapy with pMDIs or DPIs
pMDI, pressurized metered dose inhaler.
Dhand R et al. J COPD. 2012;9(1):58-72.
61
Quality of Life (QOL) Improvements with
Nebulized Therapy
 QOL improvements seen more with nebulized
therapy compared with DPI1
 An effective regimen for improving QOL is the
combination of nebulizer in the morning and
night, with an inhaler in the afternoon and
evening2
1. Gross NJ, et al. Respir Med. 2008;102(2):189-197.
2. Tashkin DP, et al. Am J Med. 2007;120(5):435-441.
62
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Discharge & Transitional
Care Planning
63
Case Study #2: 72-year-old Male
64
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Case Study #2: Background
 72-year-old male
 History
–
–
–
–
Former smoker with 45 pack-year history
Current diagnosis of GOLD Group C
Arthritis
Poor vision
 Current medications
– Nebulized SABA
– LAMA DPI (has trouble coordinating breathing with device)
 Presents to ED experiencing an exacerbation
for the second time in <3 weeks
65
Case Study #2: Presentation and Exam





Productive cough upon taking deep breaths
Dyspnea: trouble walking across the room
Chest tightness
No significant edema
Physical exam
–
–
–
–
Wheezing and decreased breath sounds
Temperature: 100.2
HR: 70, regular rate, no murmurs
BP: 130/72
 SpO2: 86%
66
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Case Study #2: Management
Administered oxygen
Administered SABA/SAMA combination
Admitted to the hospital following reassessment
Prescribed oral corticosteroids and antibiotics
Initiated on a nebulized LABA therapy to be
continued in home setting
 No family present





SAMA, short-acting anticholinergic.
67
Follow up and Other Key Items to
Consider at Discharge
Items
 Schedule follow-up visit within 1 week (preferably within 72 hours)
 Maintenance treatment and importance of adherence
 Technique instruction
 Assess home care
 Assess need for oxygen and/or home nebulizer
 Smoking cessation
 Vaccinations
 Pulmonary rehabilitation
 Provide plan for comorbidities
Vestbo J, et al. GOLD 2015 update.
68
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Reported Patient Outcomes Associated
with Scheduled Follow up
 An outpatient visit during the month after
admission for an exacerbation resulted in fewer
ED visits (14%) and 30-day readmissions (9%)1
 30-day readmission was 10 times more likely for
patients not attending a primary care follow-up
within 4 weeks of discharge2
1. Sharma G, et al. Arch Intern Med. 2010;170(18):1664-1670.
2. Misky GJ, et al. J Hosp Med. 2010;5(7):392-397.
69
Recommendations at Discharge Not
Carried Through Despite Guidelines
 At discharge:
– 55% of patients not prescribed maintenance
bronchodilators
– 23% of patients not prescribed an inhaled therapy
Yip NH, et al. COPD. 2010;7(2):85-92.
70
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Additional Strategies to Prevent
Hospital Readmissions
71
COPD Patient Care Pathway:
Identifying Additional Strategies
Consider 72-hour
postdischarge follow-up call
Postdischarge
Setting
Reassess with spirometry if
patient shows improvement
Collaborative
Care Team:
1- to 2-week
post-discharge
follow-up
Transition Management
Patient Education/Counseling
• Cultural competency
• Health literacy
Home Care
• Update referral tracking and care information
• Communicate with specific providers
• Assess for barriers to care and refer to
community/social services/other HCPs, if needed
• Provide patient education/counseling
• Refer to pulmonary rehab, if applicable
Evaluate patient health literacy
Pharmacy
Medication reconciliation
Consider including therapy
known to reduce exacerbation
risk (long-acting inhaled
bronchodilators, with or without
inhaled steroids, and possible
PDE4 inhibitors)
Medication Management
• Assess patient tolerability
• Assess patient response to medications
• Assess for medication nonadherence
• Reconcile any new medications
HCP, healthcare provider.
Slide courtesy of: Stanley B. Fiel, MD.
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Changes in Post discharge Care Policy
(2013)
 Outpatient providers must provide 3 key services:
– Make contact with patients within 2 days of discharge
– Have a face-to-face visit with moderate-complexity or highcomplexity patients within 7-14 days of discharge
• CPT Code 99495 – Transitional care management services with
moderate medical decision complexity (face-to-face visit within 14
days of discharge)
• CPT Code 99496 – Transitional care management services with
high medical decision complexity (face-to-face visit within 7 days of
discharge)
– Provide care coordination services within 30 days of discharge
 Provides financial incentive to assess patients 1 to 2
weeks following discharge
Kangovi S, et al. Chest. 2014;145(1):149-155.
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/
Transitional-Care-Management-Services-Fact-Sheet-ICN908628.pdf
73
SHM’s Project BOOST: Goals
 Identify patients at high risk for
rehospitalization and target specific
interventions to mitigate potential
adverse events
 Reduce 30-day readmission rates
 Improve patient satisfaction scores and HCAHPS scores
related to discharge
 Improve flow of information between hospital and
outpatient physicians and providers
 Improve communication between providers and patients
 Optimize discharge processes
SHM, Society of Hospital Medicine; HCAHPS, Hospital Consumer Assessment of Healthcare Providers.
74
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Pulmonary Rehabilitation:
Program Essentials
Smoking Cessation
 Considered to be the most important therapeutic intervention
in patients with COPD
 Has been shown to reduce COPD risk and mitigate the
decline in pulmonary function
 Brief clinical interventions are clinically effective and cost
effective
 Smoking cessation aids
– Nicotine replacement
gum, patch, inhaler
– Bupropion
– Varenicline
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365;
Fiore MC, at al. Am J Prev Med. 2008;35(2):158-176.
75
Pulmonary Rehabilitation:
Program Essentials (cont’d)
 Exercise training
 Nutrition counseling
 Education
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
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Pulmonary Rehabilitation Reduces COPD
Exacerbation Frequency
5.00
*
*P<.0005
Pre-PR
Post-PR
4.50
Mean Number of
Exacerbations
4.00
*
3.50
3.00
2.50
2.00
*
1.50
1.00
0.50
0.00
Exacerbations
Hospitalizations
Exacerbations Out
of Hospital
Mean number of exacerbations (total), hospitalizations, and exacerbations out of hospital 1 year before
and 1 year after pulmonary rehabilitation (PR).
van Ranst D, et al. Int J Chron Obstruct Pulmon Dis. 2014;9:1059-1067.
77
Vaccinations to Prevent Future COPD
Exacerbations
 Influenza vaccines
– ↓ respiratory tract infections that result in hospitalization and
death in patients with COPD
 Pneumococcal vaccines
– ↓ rate of community-acquired pneumonia in COPD patients
– Pneumococcal infections result in a significant percentage of
acute exacerbations of COPD
 Vaccinations remain highly underused
– 38.4% of patients with COPD admitted to a university medical
center had a prior influenza vaccine
– Only half of eligible patients presenting with an exacerbation to a
set of urban hospitals had influenza and pneumococcal vaccines
Yip NH, et al. COPD. 2010;7(2):85-92.
Nantsupawat T, et al. Chron Respir Dis. 2012;9(2):93-98.
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Summary
 Exacerbations of COPD impose a significant health and
economic burden in the hospital setting
 Appropriate inpatient management should include
confirmation of diagnosis by objective measures and risk
assessment
 Individual patient characteristics, in particular comorbid
conditions, influence the potential for readmission and
should be addressed at the point of care
 Maintenance therapy matters and should be taken into
account as part of the inpatient treatment and discharge
plans
 Provision for individualized discharge and transitional
care plans may help prevent hospital readmissions
79
Additional Resources
 SHM Project BOOST
– www.hospitalmedicine.org/boost
 Project RED (Re-Engineered Discharge)
– www.bu.edu/fammed/projectred/
 COPD Foundation
– www.copdfoundation.org
Krishnan JA, et al. J COPD F. 2015;2(1):70-80.
80
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