Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
Condition: Asthma
MeSH terms: Asthma
Intervention: PARTICS using QVAR
Intervention description: Patient takes inhaled corticosteroid at the time of rescue inhaler use
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1220.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: asthma; African Americans; Hispanics

Summary:

      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 have consulted with AA and H/L patients, health care providers, leaders of
      professional societies, advocacy groups, health policy leaders, pharmacists, and
      pharmaceutical manufacturers. All groups have indicated that asthma decision making would be
      changed if we demonstrated that implementing PARTICS improves important asthma outcomes such
      as reducing exacerbations. The Investigators have designed a study with the stakeholders to
      determine whether PARTICS can improve outcomes that are important to patients when
      superimposed on a background provider-educated standard of care through the Asthma IQ system.
      The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce
      Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether
      PARTICS can reduce asthma morbidity in AA and H/L.
    

Eligibility criteria:

        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