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8/20/2013
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The Role of Bedside Spirometry and Other Tools in Promoting Optimal
Peak Inspiratory Flow Measures in a Subset of Patients with Chronic Obstructive Pulmonary Disease
Duquesne University Mylan School of Pharmacy Pittsburgh, Pennsylvania IRB Approval May 2013
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Co-Investigators
Mary Mihalyo BS, PharmD, CGP, BCPS
Holly Lassila BS, Dr.P, RPH
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Why: CMS Readmissions Reduction Program
Section 3025 of the Affordable Care Act added section 1886(q) to the Social Security Act establishing the Hospital Readmissions Reduction Program, which requires CMS to reduce payments to IPPS hospitals with excess readmissions, effective for discharges beginning on October 1, 2012. The regulations that implement this provision are in subpart I of 42 CFR part 412 (§412.150 through §412.154).
Exercise Testing: Objectively measured exercise impairment, assessed by a reduction in self-paced walking distance (such as the 6 min walking test) or during incremental exercise testing in a laboratory, is a powerful indicator of health status impairment and predictor of prognosis.
Composite Scores: Several variables (FEV1, exercise tolerance assessed by walking distance or peak oxygen consumption, weight loss and reduction in the arterial oxygen tension) identify patients at increased risk for mortality.
Global Strategy for Diagnosis, Management and Prevention of COPD
Approximately fourteen percent of individuals over the age
of 65 have Chronic Obstructive Pulmonary Disease (COPD).
COPD is a chronic disease with signs and symptoms such
as dyspnea, chronic cough, chronic sputum production, and
airflow limitations and accounts for 19.9% of hospitalizations
in adults aged 65-75. (1)
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Inhalation therapy consisting of bronchodilators and corticosteroids
has been the mainstay of treatment for patients with COPD. These
agents are administered to the patient in 3 different types
of delivery systems:
Metered-dose inhaler (MDI),
dry-power inhaler (DPI),
or nebulizer.
The efficacy of the inhaled products is dependent of drug that is
delivered to the lower airways. The ability to use both MDI and DPI
systems requires significant cognitive function, physical strength and
manual dexterity.
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The efficacy of these delivery systems are dependent upon the patients
inspiratory flow rate which is compromised
in patients with COPD due to diaphragmatic weakness
or other physiologic changes.
The minimum required inspiratory flow rate
for adequate use of MDI is 25 L/min and for DPI it is 30-60 L/min.
If a patients inspiratory flow rate is below the threshold for these
delivery systems, the efficacy of the medications
they are receiving may be compromised which
can lead to suboptimal treatment, acute exacerbations,
increase in hospitalizations, and decreased quality of life.
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Research Question
Do COPD patients have the minimum required peak
inspiratory flow for adequate use of metered-dose inhalers
and dry-powder inhalers?
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Hypothesis
Hospitalized stage D COPD patients older than 65 years old do not have the minimum required peak inspiratory flow for adequate use of metered-dose inhalers and dry-powder inhalers.
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Endpoints
Descriptive analysis will be done summarizing the data
as means and standard deviation or means and range
and percentages.
Stepwise multivariate linear regression will be done to
assess the effects of age and COPD stage on
inspiratory flow rates
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METHODS
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Inclusion/Exclusion Criteria
The sample size : patients.
The inclusion criteria include patients with documented COPD diagnosis who are over the age of 65 years admitted to Trinity Health System from June 2013 thru September 15 2013.
The exclusion criteria pertaining to this study includes any patient with a documented co morbid diagnosis of dementia and any patient that is unable to provide informed consent.
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Data Collection
The following (7) data points were collected for each
participant in the study:
Age
Gender
COPD stage as defined by the pulmonologist or
respiratory therapist using the GOLD guidelines
Inspiratory flow rate as measured by the In-Check Oral
Copyright 2013 Clement Clarke International Limited
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How to Use
• Set the device to laminar flow to obtain baseline for patient and add mouth piece
• One way mouth piece – Patients can breathe in through mouth piece but cannot breathe
out into device
• Patient breathes through device and In-Check records inspiration in L/min
• Device can then be set to each inhaler a patient uses and the resistance matches the product
• Each inhaler has a peak inspiratory flow rate and the patient’s inspiration on the device is compared to the range for the product
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RESULTS
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Data Collected
• N =
• Age Range – Age 60 – 69:
– Age 70 – 79:
– Age > 80:
• Gender:
• COPD stage: D
• Serum creatinine – Range:
– Average:
• Inspiratory flow rate as measured by the In-Check Oral Inspiratory Flow Meter
• Pulmonary function testing:
• Current medications – # of patients taking more
than 9 medications per day
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Conclusion
Hospice patients with a diagnosis of end-stage COPD are likely to be too weak to use and benefit from the use of meter dose and or dry powder inhalers.
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THERAPEUTIC MANAGEMENT OF COPD
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Global Strategy for Diagnosis, Management and Prevention of COPD
Therapeutic Options: COPD Medications
Beta2-agonists
Short-acting beta2-agonists
Long-acting beta2-agonists
Anticholinergics
Short-acting anticholinergics
Long-acting anticholinergics
Combination short-acting beta2-agonists + anticholinergic in one inhaler
Methylxanthines
Inhaled corticosteroids
Combination long-acting beta2-agonists + corticosteroids in one inhaler
Regular treatment with inhaled corticosteroids (ICS) improves symptoms, lung function and quality of life and reduces frequency of exacerbations for COPD
patients with an FEV1 < 60% predicted.
Inhaled corticosteroid therapy is associated with an increased risk of pneumonia.
Withdrawal from treatment with inhaled corticosteroids may lead to exacerbations in some
patients.
Global Strategy for Diagnosis, Management and Prevention of COPD
An inhaled corticosteroid combined with a long-acting beta2-agonist is more effective than the individual components in improving lung function and health
status and reducing exacerbations in moderate to very severe COPD.
Combination therapy is associated with an increased risk of pneumonia.
Addition of a long-acting beta2-agonist/inhaled glucorticosteroid combination to an anticholinergic (tiotropium) appears to provide additional benefits.
Global Strategy for Diagnosis, Management and Prevention of COPD
Global Strategy for Diagnosis, Management and Prevention of COPD
Therapeutic Options: Theophylline
Theophylline is less effective and less well tolerated than inhaled long-acting bronchodilators and is not recommended if those drugs are available and
affordable.
There is evidence for a modest bronchodilator effect and some symptomatic benefit compared with placebo in stable COPD. Addition of theophylline to
salmeterol produces a greater increase in FEV1 and breathlessness than salmeterol alone.
Low dose theophylline reduces exacerbations but does not improve post-bronchodilator lung function.
Alpha-1 antitrypsin augmentation therapy: not recommended for patients with COPD that is unrelated
to the genetic deficiency.
Mucolytics: Patients with viscous sputum may
benefit from mucolytics; overall benefits are very small.
Antitussives: Not recommended.
Vasodilators: Nitric oxide is contraindicated in stable COPD. The use of endothelium-modulating agents for the treatment of pulmonary hypertension associated
with COPD is not recommended.
Global Strategy for Diagnosis, Management and Prevention of COPD
Therapeutic Options: Other Pharmacologic Treatments
Long-acting formulations of beta2-agonists and anticholinergics are preferred over short-acting formulations. Based on efficacy and side effects, inhaled bronchodilators are preferred over oral bronchodilators.
Long-term treatment with inhaled corticosteroids added to long-acting bronchodilators is recommended for patients with high risk of exacerbations.
Global Strategy for Diagnosis, Management and Prevention of COPD
Long-term monotherapy with oral or inhaled corticosteroids is not recommended in COPD.
The phospodiesterase-4 inhibitor roflumilast may be useful to reduce exacerbations for patients with FEV1 < 50% of predicted, chronic bronchitis, and frequent exacerbations.
Global Strategy for Diagnosis, Management and Prevention of COPD
• New York-Presbyterian Healthcare System. The COPD Pocket Consultant. www.nypsystem.org. Updated January 2012. Accessed August 20, 2013.
• Global initiative for chronic obstructive lung disease (GOLD) Teaching Slide Set. www.goldcopd.org. Published January 2013. Accessed August 20, 2013.
• GlaxoSmithKline Services Unlimited. COPD Assessment Test. www.catestonline.org. Published September 2009. Accessed August 20, 2013
• Centers for Medicare & Medicaid Services. Readmissions reduction program. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html. Updated August 2, 2013. Accessed August 20, 2013