Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): PARTICS using QVAR
Intervention type(s): Drug
Intervention description(s): Patient takes inhaled corticosteroid at the time of rescue inhaler use
Other intervention name(s): Patient Activated Reliever-Triggered Inhaled CorticoSteroid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: asthma; African Americans; Hispanics