Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief (PREPARE)

1210840
Pulmonary/ Critical Care
Victor Pinto-Plata, MD
Baystate Medical Center, 759 Chestnut St, Springfield, MA
Asthma imposes a significant burden in the US in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions. Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. The Investigators call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies have been done with repeated education and adherence checks in both the intervention and control arms. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.

Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:
• Black or Hispanic based on self-identification (Hispanic if identify as both)
• Male and female, ages 18-75 years
• Ability to provide informed consent
• Clinical history consistent with asthma for > 1 year.
• Prescribed ICS as daily maintenance therapy
• Participant must also have an ACT score of 19 or less, or a history of one or more exacerbations in the past year that required patient report of systemic corticosteroid use.

Exclusion Criteria:
• Life expectancy less than one year
• Known allergy to the ICS inhaler used in the study
• Having COPD or other chronic lung disease other than asthma; with the exception of the following:
◦ Dx of COPD in a never smoker without any other lung disease or any other disease that might cause airway obstruction such as: Cystic Fibrosis, Connective Tissue Disease, premature birth, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis
◦ Dx of COPD in former smoker with normal PFTs done after the person quit smoking
◦ Dx of COPD in current smoker with normal PFTs done in past 24 months
◦ Dx of COPD IN CURRENT OR FORMER SMOKER with obstruction on PFTs: normal diffusing capacity in past 24 months and demonstrated reversibility of 12% or more at any time
• Regular systemic corticosteroid use daily or every other day for any reason—including asthma or other medical reasons
• Use of systemic corticosteroid, or visit to the doctor's office, emergency department (ED) or urgent care, or overnight hospitalization for an asthma exacerbation in the past month (can wait and re-check eligibility after one month)
• Use of biologics (injections or infusion medicines): with the exception of the following:
◦ the patient has been on a stable dose of a biologic for at least 6 months and,
◦ must have had an exacerbation at least 2 months after starting on a biologic to be considered eligible OR
◦ must have a current ACT score <=19 to be considered eligible.
• Bronchial thermoplasty less than 6 months ago (can re-check eligibility 6 months after procedure)
• Another family member living in the same household already enrolled in study

Recruiting
Interventional (Clinical Trial), Randomized
4
Sarah Romain
413-794-4889