Improving the Quality of Care for Asthma Patients at Risk of Exacerbations, i-CARE

Asthma exacerbations – attacks – can require visits to urgent care and emergency rooms, hospitalizations and even death. Recent treatment guidelines recommend combining inhaled corticosteroids (ICS) with long-acting beta-agonist (LABA) inhaled medications for quick reliever use. The strategy is known as SMART (single maintenance and reliever therapy). SMART has not been studied in Black or Hispanic and Latino/a adults and has not been tested in patients who use the nebulized form of albuterol reliever. All of the studies showing the efficacy of SMART were done with an inhaler delivery device not approved in the United States. PARTICS (patient-activated reliever triggered ICS) is a strategy in which patients are told to use an ICS metered dose inhaler (MDI) each time they use their reliever inhaler. In addition, they are instructed to take five puffs of ICS MDI whenever they use their nebulizer for quick relief. Although PARTICS has been shown to reduce exacerbations and improve asthma control and quality of life outcomes important to patients, questions remain about if PARTICS is as effective as SMART. The study team proposes the following research questions: Is PARTICS as effective as SMART? Might PARTICS be more effective than SMART? Is the relative effectiveness of PARTICS versus SMART affected by frequent nebulizer use for asthma relief? Do PARTICS and SMART diverge in terms of their effectiveness on differing asthma outcomes important to patients? Do socioeconomic factors affect the relative effectiveness of PARTICS and SMART?   Specific Aim 1: In patients with asthma who do not frequently use a nebulizer (NFN) – less than once a week – for their asthma reliever medication and are at risk for an asthma exacerbation, the study team will assess whether aPARTICS strategy is non-inferior (or superior) to aSMART strategy. Specific Aim 2: In patients with asthma who use a nebulizer for their asthma reliever medication once a week or more and are at risk for an asthma exacerbation, the study team will assess whether a PARTICS strategy is non-inferior (or superior) to a SMARTstrategy.   The primary outcome of this study is the annualized rate of asthma exacerbations – defined as an asthma related-hospitalization or 72 hours of oral or parenteral corticosteroids – assessed over a 16-month period. Secondary outcomes will be: Asthma control. Asthma quality of life measured by validated instruments. Days lost from work or school, or inability to do usual activities The primary comparators are SMART and PARTICS. Findings have a high likelihood of affecting national and international guidelines and affecting practice. The study team's physician partners, patient advisors, advocacy groups and professional society partners all agree that – for various reasons including differential cost and availability due to insurance coverage, reluctance to change medications, perceived difficulty implementation and perceived differences in side-effect profiles – it is important to understand how these two interventions compare and whether there are populations that would benefit from one versus the other. iCARE is a two-arm, randomized, parallel-group, unblinded study comparing two known effective therapies (SMART and PARTICS) for asthma. The goal is to determine whether PARTICS can be used in place of SMART, or in preference to SMART. The unit of randomization will be patients within the 21 specialty, family medicine and general internal medicine practices. The study population is people ages 18–75 years with an asthma diagnosis for at least one year who are prescribed ICS/LABA and have had an exacerbation within the previous 12 months. Approximately one-quarter of the population from sites are African American and/or Black. The study team will collect information on health literacy, perceived discrimination, smoking status, dose of ICS used in the ICS/LABA combination, use of other asthma medications and self-reported race and ethnicity. The study team has engaged patient partner advisors; patient advocacy groups; providers, including pharmacists; professional societies, healthcare policy experts; and content experts who will advise throughout the project. Representatives from each of six advisory groups will participate in the Executive Committee, which meets monthly to monitor and govern the study. Each advisor group has a specific liaison on the Operations Committee, which is responsible for supervising operations.