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3/30/2015
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Discharge and Transitional Care of Patients with COPD: Improving Practice to Reduce Readmissions
Practitioner’s Edge is a registered service mark of Integrity Continuing Education, Inc.© 2015 Integrity Continuing Education, Inc.
Sponsored by Integrity Continuing Education, Inc.
Supported by an educational grant from Sunovion Pharmaceuticals, Inc.
Faculty Panel
Sidney Braman, MD
Professor of MedicinePulmonary, Critical Care, and Sleep MedicineIcahn School of MedicineNew York, New York
Joshua LaBrin, MD, FACP, SFHM
Assistant Professor of MedicineUniversity of Utah School of MedicineSalt Lake City, Utah
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Sidney Braman, MD– Royalties: AP Press, Guilford Press
Joshua LaBrin, MD, FACP, SFHM– No real or apparent conflicts of interest to disclose
Faculty Disclosures
3
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
Learning Objectives
4
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COPD in the hospital setting
Assessment and treatment of COPD exacerbations
Assessing COPD severity & future risk
Considerations for maintenance therapyin the hospital setting
Device selection
Discharge & transitional care planning
Additional strategies to prevent hospital readmissions
Overview of Topics Covered
5
COPD in the Hospital Setting
6
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Vestbo J, et al. MMWR Morb Mortal Wkly Rep. 2012;61(46):938-943.
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
Underdiagnosed COPD Is Commonin the Hospital Setting
7
Perera PN, et al. J COPD. 2012;9:131-141.Ford ES, et al. Chest. 2013;144(1):284-305.
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
In-hospital Burden of COPD
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Rates of Repeat ED Visits and Readmissions
10.3 10.6
13.9
17.8
10.8 10.7
12.6
15.3
10.5 10.7
12.4
15.7
0
4
8
12
16
20
2005 2006 2007 2008
ED visitsSimple inpatient admissionsComplex inpatient admissions
A substantial proportion of patients discharged for COPDare readmitted or have repeat ED visits within 30 days.
Dalal AA, et al. Respir Med. 2011;105(3):454-460.
Per
cen
t (%
)
Patients ≥40 years of age
Medicare accounted for 66.4% of all encounters.
9
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
Quality of Care and Unstable Comorbidities Contribute to Readmissions
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. 10
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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
Policies on Hospitalizations/ Readmissions for COPD
11
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-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html.
Goals for In-hospital Managementof COPD
12
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 long-
acting maintenance therapies and
follow-up
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Assessment and Treatmentof COPD Exacerbations
13
Exacerbation of COPD
14
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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Qureshi H, et al. Ther Adv Chronic Dis. 2014;5(5):212-227.
Impact of Frequent COPD Exacerbations
15
Patients with frequent exacerbations
Lower qualityof life
Increased inflammation
Faster disease progression
Increasedmorality rate
Increased riskof recurrent
exacerbations
Increased likelihood of hospitalization
70% to 80% of COPD exacerbations are triggered by viral or bacterial respiratory infections
20% to 30% are associated with exposureto environmental pollution or have anunknown etiology
Most Frequent Causes of an Exacerbation
16Sethi 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
17
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
Case Study #1: Background and Presentation
18LAMA, long-acting anticholinergic; SABA, short-acting beta2-agonist; prn, as needed.
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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 forbacterial pneumonia
Poor response to first dose of SABA
Case Study #1: Exam and Test Results
19HR, heart rate; BP, blood pressure; SpO2, oxygen saturation.
Hospital Care Pathway for COPD:Initial Presentation in the ED
20
Point of EntryED
(self-admitted or clinician referral)
Assess Severity of
Exacerbation
Implement/Modify Therapy to Treat Acute Symptoms
Diagnostic Options
Arterial blood gases, pulse
oximetry
Chest X ray, ECG
OtherModify
bronchodilatortherapy
Systemic steroids
Antibiotic therapy?
Consider NIV Other
Therapeutic Options
Consider admission
criteria
Slide courtesy of: Stanley B. Fiel, MD.
ECG, electrocardiogram; NIV, noninvasive ventilation.
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Confirm the Diagnosis of COPD Exacerbation
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History Physical Exam Diagnostic Testing
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
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.
Perera PN, et al. J COPD. 2012;9:131-141.
Risk Factors for In-hospital Mortality
22
Characteristics indicative of exacerbation severity (eg,
abnormal blood gas values)
Case severity (complications, organ system dysfunction,
severe COPD)
Older ageComorbid conditions
(number and type)
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Corticosteroids Given in the Hospital
23Niewoehner DE, et al. N Engl J Med. 1999;340:1941-1947.
TF: Death from any cause or the need for intubation and mechanical ventilation, readmission because of COPD, or intensification of pharmacologic therapy
Readmissions for COPD were similaracross all groups at 30 days.
TF, treatment failure.
30 days
Rat
e o
f T
reat
men
t F
ailu
re (
%)
0 1 2 3 4 5 6
Month
60
50
40
30
20
10
0
Glucocorticoids, 8 wkGlucocorticoids, 2 wkPlacebo
5-day Course of Corticosteroids Preferred for COPD Exacerbations
GOLD Stage 3-4
FEV1 ~31% predicted
Randomized to 5 or 14 days of prednisone(40 mg)
5-day regimen non inferior to 14-day regimen
Hospital stays averaged1 day shorter with 5-day regimen
24Leuppi JD, et al. JAMA. 2013;309(21):2223-2231.
14 days
5 days
Pat
ien
ts W
ith
ou
t E
xace
rbat
ion
(%
)
0 50 100 150 200
Time From Inclusion, d
100
75
50
25
0
Conventional group
Short-term group
GOLD, Global Initiative for Chronic Obstructive Lung Disease; FEV1. forced expiratory volume in 1 second.
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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
Antibiotic Therapy Recommended for Patients with Infectious Exacerbation
25Stefan MS, et al. Chest. 2013;143(1):82-90.Vestbo J, et al. GOLD 2015 update.
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
Vestbo J, et al. GOLD 2015 update. 26
IMV, invasive mechanical ventilation.
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Assessing COPD Severity & Future Risk
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COPD severity is underestimated in ~50% of patients when measured clinically compared with severity derived by spirometry
Spirometry resulted in a change in treatmentin ~33% of patients
Estimation of COPD Severity Not Always Aligned with Objective Measures
28Mapel DW, et al. Am J Med. 2015. [Epub ahead of print]
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Category Severity Spirometry (% predicted)
GOLD 1 MildFEV1 ≥80%
FEV1/FVC <0.70
GOLD 2 Moderate50%≤ FEV1 <80%
FEV1/FVC <0.70
GOLD 3 Severe30%≤ FEV1 <50%
FEV1/FVC <0.70
GOLD 4 Very severeFEV1 <30%
FEV1/FVC <0.70
Severity of COPD Symptoms: Classification Using Spirometry
29
FVC, forced vital capacity.
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
Association of Disease Severity with Frequency of COPD Exacerbations
30Hurst JR, et al. N Engl J Med. 2010;363(12):1128-1138.
ECLIPSE STUDY
7
18
33
22
33
47
0
10
20
30
40
50
GOLD 2(N=945)
GOLD 3(N=900)
GOLD 4(N=293)
Pat
ien
ts (
%)
Hospitalized for exacerbation in year 1 Frequent exacerbations
ECLIPSE, Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints.
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CategoryExacerbations
Per YearHospitalizations
Per Year3-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%
Risk Evaluation in COPD: Potential for Serious Events by Disease Severity
31Vestbo J, et al. GOLD 2015 update.
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
Assessment of COPD Severity and Risk: Exacerbation History and Symptoms
32
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.
mMRC and CAT have been validated and relate well to other measures of health status and predict future mortality risk.
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Risk Assessment of COPD: Updated GOLD Guidelines
Risk
GOLD Classification
of Airflow Limitation
Risk
Exacerbation History
mMRC 0-1CAT < 10
330%-50%
1≥80%
≥ 2
1
0
(C) (D)
(A) (B)
4<30%
mMRC ≥ 2CAT ≥ 10
Symptoms(mMRC or CAT score)
250%-80%
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
34Hurst JR, et al. N Engl J Med. 2010;363(12):1128-1138.
Odds Ratio(≥2 vs 0) P value
Odds Ratio(1 vs 0) P value
Exacerbations during the past year
5.72 <.001 2.24 <.001
ECLIPSE STUDY
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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
Risk Factors for COPD Exacerbations
35Vestbo J, et al. GOLD 2015 update.
0 1 2 3 4
CHF 3.26 (2.37-4.49)
Osteoporosis 1.66 (1.43-1.94)
Stroke 1.54 (1.20-1.97)
PVD 1.45 (1.02-2.06)
GERD 1.41 (1.25-1.58)
CHD 1.34 (1.14-1.57)
Hypertension 1.32 (1.20-1.47)
Sleep apnea 1.35 (1.17-1.56)
Stomach ulcers 1.26 (1.06-1.51)
Hay fever 1.14 (1.02-1.28)
Obesity 0.87 (0.79-0.97)
High cholesterol 0.84 (0.75-0.93)
Risk for Comorbidity (Adjusted Odds Ratio)
COPD-associated Risk for Comorbidity
36Putcha N et al. Chronic Obstr Pulm Dis. 2014;1(1):105-114.
CHD, congenital heart disease; GERD, gastroesophageal reflux disease; PVD, peripheral vascular disease; CHF, congestive heart failure.
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The majority of patients with COPD exhibit ≥3 comorbidities
A subset of these have been associatedwith ↑ likelihood of disease progressionand readmission for exacerbation
– CHF
– Lung cancer
– Anxiety
– Depression
– Skeletal muscle weakness– Osteoporosis
Impact of Comorbidities on Disease Progression and Future Exacerbations
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365. 37
6.1
4.3
3.8
2.3
1.8 1.7 1.61.4
1.2
0
1
2
3
4
5
6
7
Septicemia AspirationPneumonia
AcuteRespiratory
Failure
Acute RenalFailure
MyocardialInfarction
Pneumonia C. difficile PulmonaryHeart
Disease
CongestiveHeart
Failure
Mortality Risk Within the First 30 Days Following Initial Discharge for COPD
Duffy S, et al. J COPD F. 2015;2(1): 17-22.
Comorbid Condition All P<.0001
Od
ds
Rat
ios
38
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Considerations for Maintenance Therapyin the Hospital Setting
39
In post discharge setting, patients with delayed maintenance therapy had a 43% (P<.001) higher riskof future hospitalization/ED visit1
– Every 30-day delay associated with 9% increasein 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?
Delays in Maintenance TherapyAre Costly
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. 40
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Hospital Stays for Exacerbationsof COPD Following Initiation of LAMA
0
2
4
6
8
10
12
14
January February March Jan-MarCombined
Early addition of maintenance LAMA (tiotropium) to a respiratory-therapist-directed bronchodilator protocol for patients hospitalized for COPD exacerbation reduced:
– Hospital stays
– Hospital costs
No safety concerns
41Drescher GS, et al. Respir Care. 2008;53(12):1678-1684.
P<.05
Ho
spit
al S
tay
(±S
D d
)
2004 2006 2004 2006 2004 2006 2004 2006
*
SD, standard deviation.
Odds of Readmission 31% Lower When Nebulized LABA Initiated in Hospital
42
5.8
8.9
12.6
17.5
7.39.3
8.19.9
0
5
10
15
20
Minor Moderate Major Extreme
Neb-SABAArformoterol
Bollu V, et al. Int J Chron Obstruct Pulmon Dis. 2013;8:631-639.
Rea
dm
issi
on
Rat
e (%
)
Severity of Illness
P=.696P=.867
P=.031
P=.028
Overall, significantly lower (8.7% vs 11.9%)30-day readmissions with arformoterol
LABA, long-acting beta-agonists.
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Initiating LABA Therapy in Outpatient Setting Lowers Risk of All-cause Hospitalization
43Bollu V, et al. J Med Econ. 2013;16(8):1082-1088.
26% reduction in hospitalizationswith LABA vs SABA in 6-monthfollow-up period
Pro
po
rtio
n o
f P
atie
nts
0 20 40 60 80 100 120 140 160 180Time (days)
1.0
0.8
0.6
0.4
0.2
0.0
Long Acting Beta AgonistShort Acting Beta Agonist
Combined Assessment of COPD: Updated GOLD Guidelines
44
Risk
GOLD Classification
of Airflow Limitation
Risk
Exacerbation History
mMRC 0-1CAT < 10
330%-50%
1≥80%
≥ 2
1
0
(C) (D)
(A) (B)
4<30%
mMRC ≥ 2CAT ≥ 10
Symptoms(mMRC or CAT score)
250%-80%
Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
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GOLD Recommendations for Initial Pharmacotherapy
PatientGroup
RecommendedFirst Choice
AlternativeChoice
Other Possible Treatments
A SAMA prn or SABA prnLABA or LAMA or
SABA + SAMATheophylline
B LAMA or LABA LAMA + LABASABA and/or SAMA
Theophylline
C ICS + LABA or LAMA
LAMA + LABA or
LAMA + PDE4 or
LABA + PDE4
SABA and/or SAMA
Theophylline
D ICS + LABA and/or LAMA
ICS + LABA + LAMA or
ICS + LABA + PDE4 or
LABA + LAMA or
LAMA + PDE4
Carbocysteine
SABA and/or SAMA
Theophylline
Vestbo J, et al. GOLD 2015 update. 45
SAMA, short-acting muscarinic antagonist; ICS, inhaled corticosteroid; PDE4, phosphodiesterase type 4 inhibitor.
Available Long-acting Bronchodilator Monotherapies
Agent Delivery Manufacturer
LABA
Arformoterol Nebulizer Sunovion
FormoterolNebulizer Mylan
DPI Merck
Indacaterol DPI Novartis
Olodaterol SMI Boehringer Ingelheim
Salmeterol DPI GlaxoSmithKline
LAMA
Aclidinium DPI Forest
Ipratropium IA Boehringer Ingelheim
Tiotropium DPI, IS Pfizer/Boehringer Ingelheim
Umeclidinium DPI GlaxoSmithKline
DPI, dry powder inhaler; SMI, soft mist inhaler; IS, inhalation spray; IA inhalation aerosol.
Vestbo J, et al. GOLD 2015 update. 46
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Reduction in Exacerbations with LAMA Therapy (UPLIFT Study)
Tashkin DP, et al. N Engl J Med. 2008;359:1543-1554.
14% reduction in exacerbations and significant delay in the time to the first exacerbation (16.7 months vs 12.5 months)
47
CI, cardiac output; SAE, serious adverse event.
80
60
40
20
0
Hazard ratio, 0.86(95% CI, 0.81-0.91)P<0.001
Pro
bab
ility
of
Exa
cerb
atio
n (
%)
0 6 12 18 24 30 36 42 48
Month
Placebo Tiotropium
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
Pooled Long-term Safety Data for Tiotropium for COPD
48Halpin DMG, et al. Int J Chron Obstruct Pulmon Dis. 2015;10 239-259.
AE, adverse event; SAE, serious adverse event; FAE, fatal adverse event; CV, cardiovascular.
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Nebulized LABA Results in Greater Lung Function vs Placebo (12 Weeks)
Ch
ang
e in
FE
V1
(mL
)(W
eek
12)
0 2 4 6 8 10 12 22 24
Time After Study Drug Administration (hr)
400
350
300
250
200
150
100
50
0
-50
-100
x
xxx x x
x x x
xxx
Arformoterol 15 µg bidArformoterol 25 µg bidArformoterol 50 µg qdSalmeterol 42 µg bidPlacebo
x
Baumgartner RA, et al. Clinical Therapeutics. 2007;29:261-278.
Drug administered
49
bid, twice daily; qd, once daily.
x
x
x
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 were9.0% (arformoterol) vs 14.3% (placebo)
Risk for first respiratory SAE was50% lower with arformoterol with placebo (P=.003)
Overall, arformoterol had an approximately 40% lower riskof respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo
1-year Safety of Nebulized LABA Therapy (Arformoterol) vs Placebo
50Donohue JF, et al. Chest. 2014;146(6):1531-1542.
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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
52Donohue JF et al. Respir Res. 2014;15:78.
~50% reduction in exacerbations overall and exacerbations resulting in hospitalizations
Per
cen
tag
e o
f P
atie
nts
Wit
h
an E
xace
rbat
ion
0 31 62 93 124 155 186 217 248 279 310 341 372Time to Event (days)
30
25
20
15
10
5
0
Placebo UMEC 125 UMEC/VI 125/25
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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)
54
Primary endpoint of mortalitynot reached in this study.
↓ annual rate of exacerbationsfrom 1.13 to 0.85 (P<.001)
Calverley P, et al. N Engl J Med. 2007;356:775-789.
Ad
just
ed M
ean
Ch
ang
e in
FE
V1
(mL
)
0 24 48 72 96 120 156Weeks
100
50
0
–50
–100
–150
Combinationtherapy
FluticasoneSalmeterol
Placebo
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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
PDE4 Inhibition
55
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, managementand prevention of chronic obstructive pulmonary disease. 2010 update. Available at: www.goldcopd.com.
Therapies on the Horizon
Type Agent Delivery Manufacturer
LAMAGlycopyrronium bromide
Nebulizer Sunovion
DPI Vectura, Sosei/Novartis
MDI Pearl
LABA /LAMA
Indacaterol + glycopyrronium bromide
DPI Vextura, Sosei/Novartis
Aclidinium +formoterol
DPI Almirall/Forest
56
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Device Selection
57
COPD patient population is diverse with various levels of functioning
Handheld devices assume patient is ableto use correctly
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.
85%
81%
50%
55%
60%
65%
70%
75%
80%
85%
MDI FP/SAL
Misuse Rate for Hospitalized Patients with COPD (N=40)
Misuse of Handheld Devices in Hospitalized COPD Patients is Common
MDI DPI
58
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~1 of 5 patients with advanced COPD and ≥ 60 yearsof 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
Inspiratory Flow Rates in Patientswith COPD
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
Sharafkhaneh A, et al. J COPD. 2013;10(4):482-492.
Patients were “Highly satisfied with their current nebulized treatment” (89%) and had “Easierbreathing” (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 easierto care for their friend/family member” (86%)
Patient/Caregiver Experienceswith Nebulized Therapy
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Clinical Scenarios Where Nebulized Therapy May Be Preferred
61Dhand R et al. J COPD. 2012;9(1):58-72.
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 DPIspMDI, pressurized metered dose inhaler.
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
Quality of Life (QOL) Improvements with Nebulized Therapy
621. Gross NJ, et al. Respir Med. 2008;102(2):189-197.2. Tashkin DP, et al. Am J Med. 2007;120(5):435-441.
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Discharge & TransitionalCare Planning
63
Case Study #2: 72-year-old Male
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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 exacerbationfor the second time in <3 weeks
Case Study #2: Background
65
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%
Case Study #2: Presentation and Exam
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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
Case Study #2: Management
67SAMA, short-acting anticholinergic.
Follow up and Other Key Items to Consider at Discharge
Vestbo J, et al. GOLD 2015 update.
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
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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
Reported Patient Outcomes Associated with Scheduled Follow up
69
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.
At discharge:– 55% of patients not prescribed maintenance
bronchodilators
– 23% of patients not prescribed an inhaled therapy
Recommendations at Discharge Not Carried Through Despite Guidelines
70Yip NH, et al. COPD. 2010;7(2):85-92.
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Additional Strategies to PreventHospital Readmissions
71
Collaborative Care Team:1- to 2-week
post-dischargefollow-up
COPD Patient Care Pathway:Identifying Additional Strategies
Slide courtesy of: Stanley B. Fiel, MD.
Transition Management
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
PharmacyMedication reconciliation
Medication Management• Assess patient tolerability• Assess patient response to medications• Assess for medication nonadherence• Reconcile any new medications
Reassess with spirometry if patient shows improvement
Evaluate patient health literacy
Consider including therapy known to reduce exacerbation risk (long-acting inhaled bronchodilators, with or without inhaled steroids, and possible PDE4 inhibitors)
Post-discharge
Setting
Consider 72-hour postdischarge follow-up call
Patient Education/Counseling• Cultural competency• Health literacy
72
HCP, healthcare provider.
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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 high-complexity 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
Changes in Post discharge Care Policy (2013)
73
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
Identify patients at high risk forrehospitalization and target specificinterventions to mitigate potentialadverse 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’s Project BOOST: Goals
74SHM, Society of Hospital Medicine; HCAHPS, Hospital Consumer Assessment of Healthcare Providers.
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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
Exercise training
Nutrition counseling
Education
Pulmonary Rehabilitation:Program Essentials (cont’d)
76Vestbo J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.
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Pulmonary Rehabilitation Reduces COPD Exacerbation Frequency
77
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.
*P<.0005
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
4.50
5.00
Exacerbations Hospitalizations Exacerbations Outof Hospital
Mea
n N
um
ber
of
Exa
cerb
atio
ns
Pre-PR
Post-PR
*
*
*
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
Vaccinations to Prevent Future COPD Exacerbations
78Yip 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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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
Summary
79
SHM Project BOOST– www.hospitalmedicine.org/boost
Project RED (Re-Engineered Discharge)– www.bu.edu/fammed/projectred/
COPD Foundation– www.copdfoundation.org
Additional Resources
80Krishnan JA, et al. J COPD F. 2015;2(1):70-80.