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Practitioner’s Edge is a registered service mark of Integrity Continuing Education, Inc.© 2013 Integrity Continuing Education, Inc. 1

Maintenance Therapy for Patients with COPD in Long-term Care Settings

1Supported by an educational grant from Sunovion Pharmaceuticals, Inc.Sponsored by Integrity Continuing Education, Inc.

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Faculty Affiliation

Meenakshi Patel, MDAssociate Professor of MedicineDepartment of MedicineDivision of GeriatricsBoonshoft School of MedicineWright State University OwnerValley Medical Primary CareDayton, Ohio

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Faculty Disclosures

Consultant: Acadia, Sanofi, Sunovion Pharmaceuticals Inc. Research support: AstraZeneca, Avanir, Avid, GlaxoSmithKline,

Janssen, Lundbeck, Navidea, Pfizer, Sanofi, Suven, Takeda Speaker: Actavis, Avanir, Boehringer Ingelheim, GlaxoSmithKline,

Sanofi, Sunovion Pharmaceuticals Inc. Collegium, Acadia

Supported by an educational grant from Sunovion Pharmaceuticals, Inc.Sponsored by Integrity Continuing Education, Inc.

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Complete Session Pre- and Post-Test Complete Online Session Evaluation at End of Sessionhttps://www.surveymonkey.com/r/Nov19_1630_Patel

**Links found in Event App

Reminder…

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Identify patients with chronic obstructive pulmonary disease (COPD) who are not receiving long-acting bronchodilators as maintenance treatment in long-term care (LTC) settings

Evaluate physical and cognitive limitations in patients with COPD

Assess the advantages and disadvantages of medication delivery options for patients needing long-acting bronchodilator therapy

Implement a management plan for patients with COPD in LTC settings

Learning Objectives

COPD in Long-term Care Settings

Epidemiology and General Management

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Retrospective analysis of US nursing home residents (N=126,121)– 21.5% had a diagnosis of COPD

Clinical profile:– 62.0% had a short-term memory

impairment

– 43.3% had moderate-to-severe cognitive impairment for daily decision making

– >65% had significant physical impairment*

COPD in LTC Settings

*Required extensive assistance or were dependent on staff for bed mobility, transfer, dressing, and personal hygiene.

Zarowitz BJ, et al. J Manag Care Pharm. 2012;18(8):598-606.

COPD

No COPD

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COPD is Associated with More ED Visits and Hospital Stays Among RCF Residents

ED, emergency department; RCF, residential care facility.Wheaton AG, et al. J Aging Health. 2015;27(3):480-499.

42.5

10.5

31.833.5

5.0

23.0

0

10

20

30

40

50

At Least 1 HospitalEmergency Room Visit

3 or More HospitalEmergency Room Visits

Overnight Stay in Hospital

Perc

ent

COPD No COPD

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Management of COPD in Nursing Homes

*Residents of the nursing homes included in the study had significant cognitive impairment. LABA, long-acting beta2-agonist, ICS, inhaled corticosteroid.Zarowitz BJ, et al. J Manag Care Pharm. 2012;18(8):598-606.

Percent

Residents* with COPD who received no respiratory medication 17.0%

Residents* treated for COPD, but who experienced ≥2 acute exacerbations during the 12-month study

≥20.0%

Residents* who did not receive guideline recommended therapy consisting of an inhaled LABA/ICS combination

60.0%

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General Approach to COPD Management in LTC Settings

Recognition Assessment Treatment Monitoring

• Tailor maintenance therapy plan (pharmacologic & nonpharmacologic)

• Manage exacerbations

• Address comorbidities

• Rule out other conditions

• Evaluate severity and stability of COPD

• Determine patient functional status

• Monitor symptoms and functional capacity

• Monitor the use of COPD medications

• Evaluate facility management of COPD

• Screen new patients for COPD and COPD risk factors

AMDA-PA/LTC Guidelines 2016 update.

Identification of Patientswith COPD

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Exposures– Tobacco smoke (smoking or

passive)– Dusts, chemical agents, or

fumes

Medical history– Recurrent pneumonia or

chronic bronchitis– Sleep-disordered breathing – Anxiety or depression– Cognitive impairment

Clinical indicators– Dyspnea affecting

performance of ADLs – Sputum production– Weight loss or gain

Use of supportive ventilation devices (eg, CPAP or biPAP) or respiratory equipment

Hospitalization for respiratory difficulties

Indicators of COPD Risk

AMDA-PA/LTC Guidelines 2016 update; Vestbo J, et al. GOLD 2016 update; Gooneratne et al. JAGS. 2010;58: 1153-1162; Wise RA. Am J Med. 2006; 119(10, suppl 1):4-11.

ADLs, activities of daily living; CPAP, continuous positive airway pressure; biPAP, bilevel positive airway pressure.

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Key Indicators for a Diagnosis of COPD

Symptoms• Progressive dyspnea (worsens over time with exercise)• Chronic cough• Sputum

History of Exposure to Risk Factors• Tobacco smoke• Smoke from household fuels• Occupational dusts and chemicals

Family History of COPD

Spirometry is required to diagnose COPD: post-bronchodilator FEV1/FVC <0.70 confirms the presence of persistent airflow limitation.

FEV1. forced expiratory volume in 1 second; FVC, forced vital capacity.Adapted from: Vestbo J, et al. GOLD 2016 update.

COPD Severity and Risk Assessment

16SNF, skilled nursing facility; PCP, primary care provider.

An 82-year-old male admitted to a SNF following a recent hospitalization for COPD

History:– Current smoker

Presentation:– Difficulty moving around– Persistently out of breath– Requires assistance with ADLs– Significant memory impairment

Refuses to see a PCP since his wife died a year ago Increasingly neglectful of health

Case Study #1: Patient Background

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What is your initial approach to evaluation of the patient at the facility?– Do you use any COPD assessments? – What tests would you order? – Do you check the EMR for past progress notes or PFTs? – Do you request a pulmonology consult?

Case Study #1: Discussion

EMR, electronic medical record; PFT, pulmonary function test.

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Estimated COPD severity is inconsistent with objective measures in a significant percentage of patients:

Spirometry resulted in a change in treatment in ~33% of patients

Estimation of COPD Severity Not Always Aligned with Objective Measures

Mapel DW, et al. Am J Med. 2015;128(6):629-637.

Assessment of Severity Patients (%)Physician < Spirometry 41

Physician = Spirometry 30

Physician > Spirometry 29

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AMDA Guidelines for Combined COPD Assessment

Group A(Low risk, fewer symptoms)

• Grade 1 or 2 (mild or moderate airflow limitation) AND/OR

• 0 to 1 exacerbations/year and no hospitalizations* AND

• CAT <10 or mMRC 0 to 1

Group B(Low risk, more symptoms)

• Grade 1 or 2 (mild or moderate airflow limitation) AND/OR

• 0 to 1 exacerbations/year and no hospitalizations* AND

• CAT >10 or mMRC ≥2

Group D(High risk, more symptoms)

• Grade 3 or 4 (severe or very severe airflow limitation) AND/OR

• ≥2 exacerbations/year or ≥1 hospitalization* AND

• CAT >10 or mMRC ≥2

Group C(High risk, fewer symptoms)

• Grade 3 or 4 (severe or very severe airflow limitation) AND/OR

• ≥2 exacerbations/year or ≥1 hospitalization* AND

• CAT <10 or mMRC 0 to 1

*For an exacerbation.CAT, COPD Assessment Test; mMRC, modified Medical Research Council Breathlessness Scale.AMDA-PA/LTC Guidelines 2016 update. Vestbo J, et al. GOLD 2016 update.

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Modified MRC (mMRC) Questionnaire

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COPD Assessment Test (CAT)

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COPD is Associated with Increased Risk for Comorbidities Among RCF Residents

0

5

10

15

20

25

30

35

40

45

50

Res

iden

ts w

ith C

ondi

tion

(%) No COPD

COPD

AD, Alzheimer's disease; RA, rheumatoid arthritis; CHD, congenital heart defect; CHF, chronic heart failure; MI, myocardial infarction. Wheaton AG, et al. J Aging Health. 2015;27(3):480-499.

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Comorbidities Increase Risk of Disease Progression and Future Exacerbations

DEPRESSION

ANXIETY

LUNG CANCEROSTEOPOROSIS

CHF

SKELETAL MUSCLEWEAKNESS

COPDPROGRESSION AND

FUTUREEXACERBATION

Vestbo J, et al. GOLD 2016 update.

Exacerbations of COPD

Diagnosis and Treatment

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COPD Exacerbation

Vestbo J, et al. GOLD 2016 update.

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.

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Confirming the Diagnosis of a COPD Exacerbation

PatientHistory

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.

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O2 therapy

NIV/IMV

Bronchodilator therapy

– Increase doses/frequency of SABA therapy

– Combine SABAs with anticholinergics

– Use spacers or air-driven nebulizers

Oral corticosteroids

Antibiotics for infectious exacerbations

Adjunctive therapies

Initial Treatment of an Exacerbation

NIV, noninvasive ventilation; IMV, invasive mechanical ventilation; SABA, short-acting bronchodilator. Vestbo J, et al. GOLD 2016 update.

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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 noninferiorto 14-day regimen

Hospital stays averaged1 day shorter with 5-day regimen

14 days

5 days

Patie

nts

With

out E

xace

rbat

ion

(%)

0 50 100 150 200Time From Inclusion (days)

100

75

50

25

0

Conventional group

Short-term group

GOLD, Global Initiative for Chronic Obstructive Lung Disease. Leuppi JD, et al. JAMA. 2013;309(21):2223-2231.

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Association of Disease Severity with Frequency of COPD Exacerbations

ECLIPSE, Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints. Hurst 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)

Patie

nts

(%)

Hospitalized for exacerbation in year 1

Frequent exacerbations

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Cognitive Dysfunction in Patients Hospitalized for an Exacerbation

Patients with an exacerbation exhibited:– 57% cognitive

impairment– 20% pathological

loss of processing speed

COPD-E, patients with acute COPD exacerbation; COPD-S patients with stable COPD.Dodd, et al. CHEST. 2013;144(1):119–127.

20

20

7

4 3

0

5

10

15

20

25

COPD-E COPD-S Controls

Processing speed index (P=.002)

Working memory index (P=.8)

Perc

ent

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Recovery from COPD Exacerbation is Often Incomplete

31PEFR, peak expiratory flow rate.Seemungal, et al. Am J Respir Crit Care Med. 2000;161:1608-1613.

ExacerbationStable COPD

Dai

ly A

M P

EFR

as %

Bas

elin

e

-14 -9 -4 1 6 11 16 21 26 31Days

101

100

99

98

97

96

95Post hospital discharge

recovery phase

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Increased risk for mortality following an exacerbation Reassess disease severity and/or risk for future exacerbations Assess efficacy of the current therapeutic regimen

– Initiate long-acting bronchodilator maintenance therapy in hospital/post-acute setting

– Change(s) in current therapy or delivery methodof medications

Referral to pulmonologist Assess need for palliative or hospice care

Considerations for Patients Transitioning from the Hospital/Post-acute Care Setting

AMDA-PA/LTC Guidelines 2016 update; Groenewegen KH, et al. Chest. 2003. 124(2): 459-467; Connors AF, Jr, et al. Am J Respir Crit Care Med. 1996;154(4 Pt 1):959-967.

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Odds of Readmission 31% Lower When Nebulized LABA Initiated in Hospital

5.88.9

12.6

17.5

7.39.3 8.1

9.9

0

5

10

15

20

Minor Moderate Major Extreme

Neb-SABAArformoterol

Neb-SABA, nebulized SABA.Bollu V, et al. Int J Chron Obstruct Pulmon Dis. 2013;8:631-639.

Rea

dmis

sion

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

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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

P<.05

Hos

pita

l Sta

y (±

SD, d

ays)

2004 2006 2004 2006 2004 2006 2004 2006

*

SD, standard deviation. LAMA, long-acting muscarinic antagonist.Drescher GS, et al. Respir Care. 2008;53(12):1678-1684.

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COPD Exacerbations in the LTC Setting

LTC Facility Staff

• Recognition and report of the exacerbation

• Implementation of prn orders for rescue medications

• Assessment of episode severity

• Practitioner notification

LTC Practitioner

• Confirmation of the exacerbation

• Evaluation for hospitalization

• Additional treatment if required:

− Oral corticosteroids− Antibiotics − Adjunctive

therapies

LTC Facility Staff

• Following resolution, tapering or discontinuation of medications prescribed for the exacerbation

• Follow-up with the practitioner

prn, as needed.AMDA-PA/LTC Guidelines 2016 update.

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Daily use of SABA or SABA/SAMA treatments as maintenance therapy

Absence of long-acting bronchodilator maintenance therapy

O2 saturation dropping or O2 therapy demand increases

Escalating daily symptom burden

Respiratory infection

Increased antitussive medication use

Shortness of breath while ambulating or moving around in a wheelchair

Decreased time in ADLs or therapy

Warning Signs that Your Patient is at Risk for an Exacerbation

SAMA, short-acting muscarinic antagonist.Bahadori et al. Int J Chron Obstruct Pulmon Dis. 2007;2(3):241-251.

Treatment of COPDMaintenance Therapy

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After stabilization, the patient receives a nebulized SABA/SAMA at discharge and continues treatment in the SNF

What is your next step for the patient?– No change in therapy– Continue SABA/SAMA and add tiotropium DPI– Discontinue SABA/SAMA and add one or more of the following

• SABA prn by nebulizer• LABA by nebulizer twice daily• LABA/LAMA• LABA/ICS

Case Study #1: Discussion (cont’d)

DPI, dry powder inhaler.

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The Majority of Medicare Patients with COPD Do Not Receive Long-term Pharmacotherapy

*>93% of patients were ≥65 years of age; US Medicare population.Ach, anticholinergic; LAAC, long-acting anticholinergic; SAAC, short-acting anticholinergic.Make B, et al. Int J Chron Obstruct Pulmon Dis. 2012;7:1-9.

70.9% of patients received no long-term

pharmacotherapy

SABA alone; 4.9% SAAC; 8.9% ICS; 1.6%LAAC; 1.3%

SAAC + ICS; 2.9%LABA + ICS; 4.2%

Ach + LABA + ICS; 9.7%

Other combinations; 4%

No medication or treatment; 66%

Medicare patients with COPD (N = 8507)Mean age = 74.8 ± 7.3*

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Treatment of COPD in LTC Settings is Not Aligned with Current Guidelines

Short-acting Therapies Long-acting Therapies

HHD, hand-held device.Zarowitz BJ, et al. J Manag Care Pharm. 2012;18(8):598-606.

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90.1

1.9

23.4

3.9 2

22

0

20

40

60

80

100

SABA,HHD

SABA,nebulized

SAMA,inhalers

SAMA,nebulized

LABA,HHD

LABA,nebulized

LAMA,HHD

Patie

nts

with

CO

PD (%

)

14

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Delays in Maintenance Therapy Are Associated with Increased Risk for Future Exacerbations

*P <.01; †P <.001

Dalal AA, et al. Am J Manag Care. 2012;18(9):e338-e345.

10.4 10.2

27.3

18.0

38.7

13.6*15.9†

31.5*

25.6†

46.2†

0.0

10.0

20.0

30.0

40.0

50.0

Hospital ED Phy + Rx Hospital/ED Any

Prop

ortio

n of

Pat

ient

s W

ith

Exac

erba

tion

(%)

Type of COPD Exacerbation

Early Delayed

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GOLD Recommendations for Pharmacotherapy

PatientGroup

RecommendedFirst Choice Alternative Choice Other Possible

Treatments

A SAMA prn or SABA prn LABA or LAMA orSABA + SAMA Theophylline

B LAMA or LABA LAMA + LABA SABA and/or SAMATheophylline

C ICS + LABA or LAMALAMA + LABA or LAMA + PDE4 or LABA + PDE4

SABA and/or SAMATheophylline

D ICS + LABA and/or LAMA

ICS + LABA + LAMA orICS + LABA + PDE4 or LABA + LAMA or LAMA + PDE4

CarbocysteineSABA and/or SAMATheophylline

PDE4, phosphodiesterase type 4 inhibitor.Vestbo J, et al. GOLD 2016 update.

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Approved Long-acting Bronchodilator Monotherapies

Agent Delivery

LABA

Arformoterol Nebulizer

FormoterolNebulizer

DPIIndacaterol DPIOlodaterol SMISalmeterol DPI

LAMA

Aclidinium DPITiotropium DPI, IS

Umeclidinium DPIGlycopyrronium DPI

IS, inhalation spray; SMI, soft mist inhaler.Vestbo J, et al. GOLD 2016 update.

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Approved Fixed-dose Combinations

Agent Delivery

LABA/LAMA

Vilanterol + umeclidinium DPIOlodaterol + tiotropium SMI

Indacaterol + glycopyrronium bromide DPI

LABA/ICS

Formoterol + budesonide MDISalmeterol + fluticasone DPIVilanterol + fluticasone DPI

Formoterol + mometasone* MDI

.

*Off-label use. Not indicated for the treatment of patients with COPD.

MDI, metered dose inhaler. Vestbo J, et al. GOLD 2016 update.

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AMDA-PA/LTC Guiding Principles for COPD Pharmacotherapy

General Guidance• Combine with nonpharmacologic approaches• Select based upon AE profiles • Employ lowest effective doses

Bronchodilator Choice• Opt for long-acting agents, which are more effective and convenient vs short-acting agents• Provide access to short-acting beta2 agonists for rescue therapy• Consider combining pharmacologic classes to improve efficacy and decrease AEs vs single

agent dose escalation• Choose delivery systems to meet individual patient needs

Treatment Considerations• Maintain treatment level unless significant AEs occur or revised management is needed (eg,

for increased symptom burden and exacerbations)• Provide additional medications as appropriate as disease state progresses• Train patients and caregivers to properly administer inhaled medications• Assess therapeutic response and AEs with goals of therapy and adjust treatment accordingly

AE, adverse event.AMDA-PA/LTC Guidelines 2016 update.

Treatment of COPDConsiderations for Choosing a Maintenance Therapy

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An 85-year-old female nursing home resident with COPD (GOLD 3) presents to the hospital for an exacerbation

Presentation:– Productive cough – Unable to catch her breath for several hours

History over the past week (from LTC nurse practitioner):– Increased frequency of coughing– Patient reporting a cold– Albuterol increased from prn to every 4 hours

Case Study #2: Patient Background

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Other medical history:– Mild dementia– Osteoarthritis (hands, shoulder, feet)– HTN– PVD

Case Study #2: Patient Background

HTN, hypertension; PVD, peripheral vascular disease.

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Patient was initiated on antibiotics and corticosteroids (in the hospital)

How would you approach management of the patient upon return to the LTC facility?– Consider long-acting bronchodilator maintenance therapy– What factors would you take into consideration in choosing a therapy– Discuss strategies to maintain patient and prevent hospitalization during

the critical post-exacerbation window

Case Study #2: Discussion

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Factors Influencing Appropriate Use of Inhaled Therapy in Older Individuals

Taffet GE, et al. Clin Interv Aging. 2014;9:23-30.

Cognitive Factors• Cognitive impairment• Mood disorder

Physical Factors• Loss of physical strength• Worsening hypoxia or

hypercapnia from COPD

Additional Factors• Comorbid conditions• Complexity of regimen

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Activities Requiring Assistance Among LTC Residents

0 20 40 60 80 100

Bathing

Walking or locomotion

Dressing

Toileting

Transferring in or out of bed

Eating

Residents Requiring Task Assistance (%)

Residential Care Community Nursing home

Harris-Kojetin L, et al. Vital Health Stat. 2016;3(38).

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Approximately 1 in 5 patients with advanced COPD and ≥60 years old exhibit suboptimal PIFR against DPI resistance (<60 L/min)1

Arformoterol treatment resulted in greater lung function improvements vs salmeterol at 15 minutes in patients with suboptimal PIFR2

Patients with suboptimal PIFR may have difficulty actuating a DPI, which may reduce medication delivery

Inspiratory Flow Rates in Patientswith COPD

PIFR, peak inspiratory flow rate; IC, inspiratory capacity. 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.

Arformoterol Salmeterol P value

ΔFEV 70 ± 65 37 ± 74 .02ΔFVC 163 ± 174 96 ± 129 .05ΔIC 170 ± 129 94 ± 139 .02

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Older Patients Are at Increased Risk for Medication Device Errors

Among patients with COPD and ≥65 years of age, critical errors were made during 79% of pMDI observations and 88% of DPI observations

Successful DPI and pMDI(graph) use decreases with increasing age

pMDI, pressurized metered dose inhaler.Mahler DA, et al. J Aerosol Med Pulm Drug Deliv. 2013;26(3):174-179; Vanderman AJ, et al. Consult Pharm. 2015;30(2): 92-100; Wieshammer S, et al. Respiration. 2008;75(1):18-25; Giraud V, et al. Eur Respir J. 2002;19(2):246-251.

05

1015202530354045

15–30 30–60 60–75 >75

Rat

e of

Suc

cess

ful

pMD

IUse

(%)

Age (years)

P<.00001

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Specific Characteristics Associated with Incorrect MDI Use Among the Elderly

Characteristic Correct Users Incorrect Users P Value

Age (y) 67.2±8.8 72.1±7.7 .1

M (%) 55.6 44.4.86

F (%) 57.7 42.3

MMSE Score (pt) 26.2±2.9 23.5±3.7 .002

Education (y) 10.2±3 9.6±3 .4

Tip pinch gauge (lb) 12.7±3.7 10.1±3.3 .01

Palmar pinch gauge (lb) 16±4.7 11.6±3.3 .001

Dynamometer (lb) 72.3±23.7 54.9±18.7 .001

Note: The pinch gauge measures the strength between the thumb and fingers, whereas the dynamometer measures overall hand strength.

MMSE, mini-mental status examination.Gray SL, et al. Arch Intern Med. 1996;156(9):984-988.

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Strategies for Addressing Difficulties with Administration of Inhaled Medications

Problem ApproachLack of hand-breath coordination Use a spacer for MDI or consider DPI or nebulizer

Lack of hand strength and dexterity Use a spacer for MDI or consider nebulizer

Difficulty generating an adequate inspiratory force Consider using an MDI or nebulizer

Possible cognitive impairment

Have the patient demonstrate proper techniqueEvaluate cognitive impairment (AMTS or MMSE)

Multiple inhaler regimen Ensure proper technique and use Involve caregivers in counseling sessions

AMTS, abbreviated mental test score.Nobles J, et al. Consult Pharm. 2014;29(11):753-756.

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Treatment of COPDNonpharmacologic Interventions

58

Smoking Cessation Decreases the Rate of Lung Function Decline Among Patients with COPD

Scheme of mean changes in FEV1 in continuing smokers and sustained quitters in the Lung Health Study.

Scanlon PD, et al. Am J Respir Crit Care Med. 2000;161(2, pt 1):381-390.

FEV 1

(litr

es)

0 1 5Year

2.78

2.83

2.73

2.71

2.48

31 mL/yr

62 mL/yr

Sustained quittersContinuing smokers

59

Smoking cessation – As noted, most important therapeutic intervention – Health benefits are immediate and substantial

Exercise training– Significant improvements of dyspnea, health-related QOL, and mobility, and decreased

loss of lung function Nutrition counseling

– COPD-related malnutrition is frequently observed– May contribute to wasting of peripheral and respiratory muscles involved in breathing or

immune impairment Education of the patient and family members about the disease

Components of a Comprehensive Pulmonary Rehabilitation Program

QOL, quality of life.Vestbo, J, et al. Am J Respir Crit Care Med. 2013;187(4):347-365.

20

60

Pulmonary Rehabilitation Reduces COPD Exacerbation Frequency

Mean number of exacerbations (total), hospitalizations, and exacerbations out of hospital 1 year before and 1 year after PR.PR, pulmonary rehabilitation.van Ranst D, et al. Int J Chron Obstruct Pulmon Dis. 2014;9:1059-1067.

*P<.0005.

0.00.51.01.52.02.53.03.54.04.55.0

Exacerbations Hospitalizations ExacerbationsOut of Hospital

Mea

n No

. of E

xace

rbat

ions

Pre-PRPost-PR

*

*

*

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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

Yip NH, et al. COPD. 2010;7(2):85-92.Nantsupawat T, et al. Chron Respir Dis. 2012;9(2):93-98.

Long-term Monitoring of COPD

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66

Regular patient reassessment is vital due to the progressive nature of COPD

Reassessment should occur regularly or when the patient’s condition changes:– Physical status and overall functioning

– Adherence to therapy• Pharmacologic and nonpharmacologic treatments

• Assess individual patient needs for best drug administration device

– History of recent exacerbation

Goals of therapy should be periodically reappraisedto align with the revised plan of care

The Importance of Long-term Monitoring

AMDA-PA/LTC Guidelines 2016 update.Vestbo J, et al. GOLD 2016 update.

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Severity of respiratory symptoms (eg, cough, dyspnea, sputum)

Sputum production/color

Vital signs

Pulse oximetry readings at rest and with exertion

Mental status

Anxiety or depression

Ability to speak in full sentences without breathlessness

Ability to perform ADLs independently

Endurance

Food intake and hydration

Weight (unintended loss is a poor prognostic sign)

Items to Monitor Regularly

AMDA-PA/LTC Guidelines 2016 update.Vestbo J, et al. GOLD 2016 update.

68

COPD is associated with increased risk for morbidity and mortality, particularly following exacerbations

Despite guideline recommendations for long-acting bronchodilator maintenance therapy, the vast majority of patients with COPD in LTC settings continue to receive short-acting therapies as maintenance treatment

Along with appropriate treatment, long-term monitoring that includes regular symptom and functional assessments is critical for reducing the risk for future exacerbations

Better transitional care coordination and site-specific COPD protocols are also necessary to prevent hospitalizations and improve COPD patient outcomes

Summary

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Complete Session Pre- and Post-Test Complete Online Session Evaluation at End of Sessionhttps://www.surveymonkey.com/r/Nov19_1630_Patel

**Links found in Event App

Reminder…

Thank You!

Back Up

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72

In 2014, nearly 9 million people in the US received care from approximately 67,000 regulated LTC services providers

LTC service providers include the following:– Adult day services centers

– Home health agencies

– Hospice facilities

– Nursing homes

– Residential care communities

Long-term Care Settings

Harris-Kojetin L, et al. Vital Health Stat. 2016;3(38).

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Prevalence of COPD Among the Elderly

4.0

8.2

11.210.4

2.2

5.3

8.69.7

0

2

4

6

8

10

12

14

16

18-44 years 45-64 years 65-74 years Over 75 years

% o

f adu

lts

COPD Among Adults ≥18 years old, 2009-2011

WomenMen

Available at: http://mchb.hrsa.gov/whusa13/health-status/health-indicators/p/chronic-obstructive-pulmonary-disease.html

74

Nebulized LABA Results in Greater Lung Function vs Placebo (12 Weeks)

Cha

nge

in F

EV1

(mL)

(Wee

k 12

)

0 2 4 6 8 10 12 22 24Time After Study Drug Administration (hour)

400

350

300

250

200

150

100

50

0

-50

-100

x

Baumgartner RA, et al. Clin Ther. 2007;29:261-278.

Drug administered

bid, twice daily; qd, once daily.

Arformoterol 15 µg bid

Arformoterol 25 µg bid

Arformoterol 50 µg qd

Salmeterol 42 µg bid

Placebox

xx

x

xx

x x xx x x

xxx

24

75

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)

CI, confidence interval; UPLIFT, Understanding Potential Long-Term Impacts on Function with Tiotropium.

80

60

40

20

0

Hazard ratio, 0.86(95% CI, 0.81–0.91)

P<.001

Prob

abili

ty o

f Exa

cerb

atio

n (%

)

0 6 12 18 24 30 36 42 48Month

Placebo Tiotropium

76

PDE4 Inhibition: Roflumilast

Martinez FJ, et al. Lancet. 2015;385(9971):857-866.

Roflumilast reduces exacerbations and hospital admissions in patients with severe COPD and chronic bronchitis receiving ICS/LABA therapy ± tiotropium.

0.32 0.33 0.31

0.240.22

0.24

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

Intention to Treat Per Protocol Intention to Treat

Placebo group Roflumilast group

Severe exacerbations Exacerbations leading to hospital admission

Mea

n R

ate

of C

OPD

Ex

acer

batio

ns P

er P

atie

nt

Per Y

ear

77

Combined ICS/LABA Therapy Decreases the Risk for Future Exacerbations

FLU, fluticasone propionate; HR; hazard ratio; PBO, placebo; SAL, salmeterol; TORCH, Towards aRevolution in COPD Health. Calverley P, et al. N Engl J Med. 2007;356:775-789.

Comparison HR (95% CI) P valueCombination therapy vs PBO 0.75 (0.69–0.81) <.001

Combination therapy vs SAL 0.88 (0.81–0.95) .00

Combination therapy vs FLU 0.91 (0.84–0.99) .02

SAL vs PBO 0.85 (0.78–0.93) <.001

FLU vs PBO 0.82 (0.76–0.89) <.001

TORCH Study

Annual rate of exacerbation: PBO=1.13; SAL=0.97; FLU=0.93; SAL+FLU=0.85

Combined SAL+FLU therapy was associated with a decrease in the risk for moderate or severe exacerbations vs PBO or either component alone.

25

78

Disabling shortness of breath at rest Increased ED visits or hospitalizations Low oxygenation at rest (PaO2 <55 mm Hg or SaO2

<88%) Right heart failure secondary to pulmonary disease Unintentional progressive weight loss >10%

in last 6 months Resting heart rate >100 beats/minute

Prognostic Indicators of the Need for Palliative or Hospice Care

PaO2: arterial oxygen pressure; SaO2: arterial oxygen percent saturation.

AMDA-PA/LTC Guidelines 2016 update; Fox et al. JAMA.1999; 282(17):1638-1645; Maxwell et al. UNIPAC One: The Hospice/Palliative Medicine Approach to Life-limiting Illness, 3rd ed. 2008