Effective Date: 4/27/2016 Version: 1.0 Approval By: CCC Clinical Delivery Steering Planned Review Date: 4/27/2017

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1 Protocol Title: Adult Asthma Protocol Effective Date: 4/27/2016 Version: 1.0 Approval By: CCC Clinical Delivery Steering Planned Review Date: 4/27/ Purpose & Objective This protocol provides evidence-based care recommendations in the screening and treatment of asthma in the primary care setting. The protocol seeks to assist in early diagnosis and effective treatment of asthma. The asthma protocol should provide primary care physicians, family nurse practitioners, and physician s assistants with a guide that is evidence-based and cost effective. 2 Scope of Protocol 2.1 Target Population This protocol was derived from clinical guidelines for individuals in the CCC population diagnosed with asthma who are 18 years of age or older. 2.2 Target Users This protocol is developed for use in primary care settings. Family physicians, internists, primary care physician assistants and nurse practitioners should use this protocol. 2.3 Excluded Topics This protocol does not address the clinical management of adult patients with asthma exacerbation and COPD. 2.4 Related Guidelines U.S. Department of Health and Human Services, National Heart, Lung, and Blood Institute (2007). Guidelines for the diagnosis and management of asthma. Retrieved from Nathan, R. A., Sorkness, C. A., Kosinski, M., Schatz, M., Li, J. T., Pendergraft, T. B. (2004). Development of the asthma control test: A survey for assessing asthma control. Journal of Allergy and Clinical Immunology, 113(1), doi: /j.jaci U.S. Department of Health and Human Services, National Heart Lung and Blood Institute. (2007). Asthma action plan. Retrieved from 1

2 3 Protocol Development & Approval Process This protocol originated in the CCC Clinical Protocol Subcommittee, led by a pulmonologist. A group of clinical staff met and converged on the items in this document via a Rapid Design Session. In this session, a clinical champion guided the group through the process to extract evidence-based elements to adequately care for the CCC population impacted by asthma. The above depiction describes the approval and subsequent review process for this protocol. Group Name Approval Date CCC Asthma Protocol Subcommittee 11/12/15 CCC Clinical Protocols Workgroup 11/12/15 CCC Clinical Delivery System Steering Group (11/2015; 12/2015; 2/2016) Approved: 4/27/2016 CCC Advisory Committee CCC Board of Directors 2

3 4 Screening Criteria & Risk Factors 4.1 Assessing Risk: History: Cough, worse at night Recurrent: Wheezing Chest tightness, and Shortness of breath Symptoms are: Seasonal Worse with infections and exposures Worse late at night or early in morning Co-morbitities: Diagnosis and modify treatment based on co-morbidities: Allergies Eczema Hay fever Sleep apnea Acid reflux Obesity Family history of asthma Allergies History of smoking 5 Screening Tests: Asthma Control Test (ACT) The Asthma Control Test should be administered at every visit A five question validated tool to assess asthma control that is self-administered by the patient Clinically validated (Nathan, R. A., Sorkness, C. A., Kosinski, M., Schatz, M., Li, J. T., Pendergraft, T. B. (2004). Development of the asthma control test: A survey for assessing asthma control. Journal of Allergy and Clinical Immunology, 113(1), doi: /j.jaci ) Responses: Measured on a 1-5 Likert Scale where lower scores equate to lower control A score of 19 or less indicates the patients asthma many not be as controlled as is possible See Appendix A: Asthma Control Test Spirometry Peak flow/expiratory flow (best performance 80% or above) Allergy testing if significant history of allergies: Determination of sensitivity to a perennial indoor allergen Allergy skin or in vitro testing Test only for sensitivity to the allergens to which the patient may be exposed Order Allergy Panel 10 available in NextGen Most common allergens: o House-dust mites o Pollens o Molds 3

4 o o o Cat or dog (Animal dander) Both cat and dog Cockroaches (inner-city and southern United States) 6 Criteria for Diagnosis of 6.1 A. History Clinical characteristics of asthma o Symptoms o Airway obstruction o Inflammation o Hyper-responsiveness History of any of the following: o Cough, worse at night o Recurrent wheeze o Recurrent difficulty in breathing o Recurrent chest tightness B. Spirometry with obstruction Spirometry measurements: FEV 1 forced expiratory volume in 6-seconds (FEV 6), FEV, FEV 1/FVC before and after the patient inhales a short-acting bronchodilator should be undertaken for patients in whom the diagnosis of asthma is being considered C. Response to asthma treatment 7 History and Assessment of Severity and Management The functions of assessment and monitoring are based on the concepts of severity, control, and responsiveness to treatment: Severity: intrinsic intensity of the disease process Control: degree to which the manifestations of asthma (symptoms, functional impairments, and risk of untoward events) are minimized and the goals of therapy are met Responsiveness: the ease with which asthma control is achieved by therapy Severity and control include the domains of current impairment and future risk: Impairment: frequency and intensity of symptoms and functional limitations the patient is experiencing or has recently experienced Risk: likelihood of either asthma exacerbation, progressive decline in lung function or risk of adverse effects from medication 4

5 (NHLBI Guidelines for the Diagnosis and Treatment of Asthma Expert Panel Report 3, 2007) 1. Initial visit a. Diagnosis of asthma b. Give the asthma action plan (Paste link here) (English and Spanish) c. Provide asthma education (initial and follow-up visits) d. Lifestyle changes and modification of exposures (education on initial and follow-up) e. Identify and address co-morbid conditions f. Assessment of side effects of medications g. Vaccinations 2. Subsequent visits a. Asthma control (See above) (Decision to step up and/or step down) b. Ensure use of inhaler correctly (use of spacer initial and follow-up) c. Education d. Asthma action plan (reinforce) e. Spirometry every 1-2 years depending on symptoms (repeating) (if they are well controlled you may not need to repeat) f. Subsequent visits every 2-6 weeks until asthma controlled and then every 1-6 months a. When initiating therapy, monitor at 2-6 week intervals to ensure that asthma control is achieved b. Regular follow-up contacts at 1-6 month intervals (based on level of control) are recommended to ensure that control is maintained g. Co-morbid conditions (continue to address) a. Assessment of side effects of medications b. Vaccinations a. Influenza vaccination b. Pneumococcal vaccination 3. Asthma Action Plan a. Appendix A: Asthma Action Plan i. U.S. Department of Health and Human Services, National Heart Lung and Blood Institute. (2007). Asthma action plan. Retrieved from 5

6 8 Goals of Therapy Reduction in impairment: Prevent chronic and troublesome symptoms Require infrequent use (< 2 days/week) of inhaled short-acting beta 2 agonist (SABA) for rapid relief of symptoms (excluding prevention of exercise-induced bronchospasm (EIB)) Maintain (near) normal pulmonary function (Asthma Control Test score of 20 or >) Maintain normal activity levels (exercise and attendance at work or school) Meet patients and families expectations of satisfaction with asthma care Reduction in risk: Prevent recurrent exacerbations of asthma and minimize the need for Emergency department (ED) visits and/or hospitalizations Prevent progressive loss of lung function Provide optimal pharmachotherapy with minimal or no adverse effects 6

7 9 Medication Table Class Medication Dosages (Refer to Key Below) Pharmacy Leukotriene Modifiers Respiratory Smooth Muscle Relaxants Inhaled Corticosteroids Combinations Steroid/Longacting B 2 Agonist Long-acting B 2 Agonist Singulair (Montelukast) 10 mg/qhs Retail Zyflo (Zileuton) 600 mg/ QID PAP Theophylline ER SD-10 mg/kg/day up to 300mg Retail maximum Max Dose-[Usual] 800 mg/day QVAR MDI LD-80 mcg/1 puffs BID Retail (Beclomethasone MD-80 mcg/2 to 3 puffs BID Dipropionate) HD-80 mcg/4 puffs BID Asmanex Twisthaler DPI (Mometasone Furoate) Pulmicort Flexhaler DPI (Budesonide) Flovent Diskus DPI (Fluticasone Propionate) Flovent HFA MDI (Fluticasone Propionate) Dulera MDI (Mometasone/ Formoterol) Advair Diskus DPI (Fluticasone/Salmeterol) Advair HFA MDI (Fluticasone/Salmeterol) Serevent Diskus DPI (Salmeterol) Serevent HFA MDI (Salmeterol) LD-220 mcg/1 puff daily MD-220 mcg/2 puffs daily HD-220 mcg/2 puffs BID LD-180 mcg/1 puffs BID MD-180 mcg/2 to 3 puffs BID HD-180 mcg/4 puffs BID LD-100 mcg/1 puff BID MD-100 mcg/2 puffs BID OR 250 mcg/1 puff BID HD-250 mcg/2 puffs BID LD-110 mcg/1 puff BID MD-110 mcg/2 puffs BID OR 220 mcg/1 puff BID HD-110 mcg/4 puffs BID OR 220 mcg/2 puffs BID LD-100 mcg/5 mcg/1 puff BID MD-100 mcg/5 mcg/2 puffs BID OR 200 mcg/5 mcg/1 puff BID HD-200 mcg/5 mcg/2 puffs BID LD-100 mcg/50 mcg/1 puff BID MD-250 mcg/50 mcg/1 puff BID HD-500 mcg/50 mcg/1 puff BID LD-45 mcg/21 mcg/2 puffs BID MD-115 mcg/21 mcg/2 puffs BID HD-230 mcg/21 mcg/2 puffs BID CENTRAL CENTRAL PAP PAP CENTRAL PAP PAP 50 mcg/1 puff BID PAP 21 mcg/2 puffs BID PAP SD Starting Dose/LD Low Dose/MD Medium Dose/HD High Dose 7

8 10 Medication Algorithm Step 1: Intermittent asthma Preferred Treatment: Inhaled SABA as needed Step 2: Persistent asthma Preferred Treatment: Daily Medication o Low-dose inhaled corticosteroid (ICS) Alternative Treatment: Cromolyn, Leukotriene receptor antagonist (LTRA) or Theophylline* Step 3: Persistent asthma Preferred Treatment: Daily Medication o Medium-dose steroids o Low-dose ICS + LABA *Theophylline is less desirable due to monitoring serum levels Alternative Treatment: Low-dose ICS + LTRA, Theophylline*, or Zileuton *Theophylline is less desirable due to monitoring serum levels Step 4: Persistent asthma Preferred Treatment: Daily Medication o Medium-dose ICS + LABA Alternative Treatment: Medium-dose ICS + LTRA, Theophylline*, or Zileuton *Theophylline is less desirable due to monitoring serum levels Step 5: Persistent asthma Preferred Treatment: Daily Medication o High-dose ICS + LABA AND consider Omalizumab (Potential anaphylaxis) Step 6: Persistent asthma Preferred Treatment: Daily Medication o High-dose ICS + LABA+ Steroids AND consider Omlizumab 8 Prior to oral corticosteroids a trial of High-dose ICS + LABA, Theophylline, or Zileuton may be considered (Not studied in clinical trials)

9 10 Referrals Referral to an Asthma Specialist for Consultation or Co-management The Expert Panel recommends referral for consultation or care to a specialist in asthma care (usually, a fellowship-trained allergist or pulmonologist; occasionally, other physicians who have expertise in asthma management, developed through additional training and experience) when (Evidence D): Patient has had a life-threatening asthma exacerbation. Patient is not meeting the goals of asthma therapy after 3 6 months of treatment. An earlier referral or consultation is appropriate if the physician concludes that the patient is unresponsive to therapy. Signs and symptoms are atypical, or there are problems in differential diagnosis. Other conditions complicate asthma or its diagnosis (e.g., sinusitis, nasal polyps, aspergillosis, severe rhinitis, VCD, GERD, and COPD). Additional diagnostic testing is indicated (e.g., allergy skin testing, rhinoscopy, complete pulmonary function studies, provocative challenge, and bronchoscopy). Patient requires additional education and guidance on complications of therapy, problems with adherence, or allergen avoidance. Patient is being considered for immunotherapy. Patient requires step 4 care or higher. Consider referral if patient requires step 3 care. Patient has required more than two bursts of oral corticosteroids in 1 year or has an exacerbation requiring hospitalization. Patient requires confirmation of a history that suggests that an occupational or environmental inhalant or ingested substance is provoking or contributing to asthma. Depending on the complexities of diagnosis, treatment, or the intervention required in the work environment, it may be appropriate in some cases for the specialist to manage the patient over a period of time or to co-manage with the PCP. Community Health Paramedics (CHP): o o Educating patients in the field Reinforce training and education (peak flow will be important in the field) 9

10 11 Special Situations Asthma in Pregnancy: Headings 1-8 remain the same nothing changes. With ANY signs of changes refer early Medications: Budesonide is Cat B Montelukast is Cat B o Caveat: asthma control is more important than choice of medication as long as they are Cat B or C Check asthma control at all prenatal visits Treating asthma with medications is safer for both mother and baby compared to poorly controlled asthma Inhaled corticosteroids are the treatment of choice Patient education: Avoid exposure to tobacco smoke 12 Metrics Reduce Impairment o Prevent chronic symptoms o Require infrequent use of short-acting beta 2 agonist (SABA) o Maintain [near] normal lung function and normal activity levels Reduce Risk o Prevent exacerbations o Minimize need for ED care and/or hospitalization o Prevent loss of lung function o Minimize adverse effects of therapy Asthma Control Test Post (19 or >) Asthma Education o Self-monitoring to assess level of control o Taking medication correctly o Inhaler use and technique o Avoiding environmental factors that worsen asthma Outcome Outcome Process Outcome Outcome 10

11 13 Protocol Development Team Name Mark Hernandez, MD Hash Babbar, MD Claudia Ruiz, MD Maaya Srinivasa, PharmD Andy Hofmeister, Commander Joanne Scanlon, FNP Veronica Buitron-Camacho, MSN, RN Curk McFall, MSN, RN Affiliation *Chief Medical Officer *Clinical Champion Peoples Community Clinic CommUnityCare Austin-Travis County EMS/ATCEMS Community Health Paramedic Program CommUnityCare CCC Program Manager CCC Director Integrated Delivery System Implementation 14 References U.S. Department of Health and Human Services, National Heart, Lung, and Blood Institute (2007). Guidelines for the diagnosis and management of asthma. Retrieved from Nathan, R. A., Sorkness, C. A., Kosinski, M., Schatz, M., Li, J. T., Pendergraft, T. B. (2004). Development of the asthma control test: A survey for assessing asthma control. Journal of Allergy and Clinical Immunology, 113(1), doi: /j.jaci U.S. Department of Health and Human Services, National Heart Lung and Blood Institute. (2007). Asthma action plan. Retrieved from 11

12 15 Glossary of Abbreviations Abbreviation ACT Term Asthma Control Test 12

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