Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations

Who is this study for? Patients with asthma
What treatments are being studied? PARTICS using QVAR
Status: Completed
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
University of Alabama
Birmingham
California
University of Southern California
Los Angeles
Colorado
Denver Health and Hospital Authority
Denver
Connecticut
Yale University
New Haven
Florida
University of Florida
Gainesville
University of Miami
Miami
Grace Medical Home
Orlando
University of Central Florida
Orlando
University of South Florida
Tampa
Illinois
University of Illinois- Chicago
Chicago
Massachusetts
Baystate Health Center
Springfield
North Carolina
University of North Carolina
Chapel Hill
Atrium Health
Charlotte
Duke University
Durham
New York
Montefiore
Bronx
Mt. Sinai
New York
Ohio
MetroHealth
Cleveland
Pennsylvania
Temple University
Philadelphia
University of Pennsylvania
Philadelphia
Other Locations
Puerto Rico
University of Puerto Rico
San Juan
Time Frame
Start Date: 2017-11-27
Completion Date: 2021-04-30
Participants
Target number of participants: 1220
Treatments
Active_comparator: PARTICS
addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use
No_intervention: Usual Care
Provider-enhanced usual care arm; no change in asthma management
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: American Academy of Family Physicians, Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov