Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
- Conditions
- Asthma
- Interventions
- Drug: PARTICS using QVAR
- Registration Number
- NCT02995733
- Lead Sponsor
- Brigham and Women's Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1220
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PARTICS PARTICS using QVAR addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use
- Primary Outcome Measures
Name Time Method Rate of Asthma Exacerbations Per Year monthly through study completion an average of 15 months Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year
- Secondary Outcome Measures
Name Time Method Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma Monthly through study completion an average of 15 months Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma
Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline Monthly through study completion an average of 15 months Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points
Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline Monthly through study completion an average of 15 months The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.
Trial Locations
- Locations (20)
MetroHealth
🇺🇸Cleveland, Ohio, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States
University of Miami
🇺🇸Miami, Florida, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
University of Illinois- Chicago
🇺🇸Chicago, Illinois, United States
Baystate Health Center
🇺🇸Springfield, Massachusetts, United States
Mt. Sinai
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Grace Medical Home
🇺🇸Orlando, Florida, United States
University of Central Florida
🇺🇸Orlando, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Montefiore
🇺🇸Bronx, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States