Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
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.
Asthma imposes a significant burden on the US population 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 introduction
 of 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.
 We 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. However,
 these studies have been performed in pre- selected populations, which represent less than 5%
 of patients with asthma. They 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 it was demonstrated that implementing PARTICS improves important asthma outcomes
 such as reducing rates of exacerbations. Together with our partners and stakeholders, the
 investigators have designed a study to determine whether PARTICS can improve outcomes that
 are important to patients when superimposed on a background provider-educated standard care
 through the Asthma IQ system. The investigators therefore propose a study entitled PREPARE:
 Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The aim
 is to determine whether a PARTICS strategy can reduce asthma morbidity in AA and H/L. The
 primary outcome will be asthma exacerbations which have been shown to be important to patient
 and healthcare stakeholders. The secondary outcomes will include additional outcomes
 important to patients (i.e. days lost from work or school, asthma control, & asthma quality
 of life). The investigators have broad input and involvement from multiple stakeholder groups
 in study design, implementation, and commitments for dissemination. AA and H/L patients and
 their advocates have been involved and will continue to play a central role in all phases of
 the study.
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