Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 75
Updated:2/13/2019
Start Date:November 27, 2017
End Date:May 2021
Contact:Nancy Maher, MPH
Email:NMAHER@BWH.HARVARD.EDU
Phone:857-307-3892

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Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations

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
We found this trial at
19
sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Thomas Casale, MD
Phone: 813-631-4024
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Isaretta Riley, MD
Phone: 919-613-7699
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Ku-Lang Chang, MD
Phone: 352-273-8025
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Rafael Calderon Candelario, MD
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Birmingham, Alabama 35294
Principal Investigator: Jennifer Trevor, MD
Phone: 205-934-6683
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Birmingham, AL
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Bronx, New York 10467
Principal Investigator: Dianne McKee, MD
Phone: 718-430-2023
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Bronx, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Michelle Hernandez, MD
Phone: 919-843-4401
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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208 East Boulevard
Charlotte, North Carolina 28203
Principal Investigator: Hazel Tapp, MD
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Charlotte, NC
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Paul Stranges, MD
Phone: 608-438-6830
University of Illinois at Chicago A major research university in the heart of one of...
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Cleveland, Ohio 44109
Principal Investigator: David Kaelber, MD
Phone: 216-778-8456
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Cleveland, OH
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Denver, Colorado 80204
Principal Investigator: Laura Hurley, MD
Phone: 303-602-4859
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Denver, CO
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Geoffrey Chupp, MD
Phone: 203-499-9260
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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New York, New York 10029
Principal Investigator: Paula Busse, MD
Phone: 212-824-7972
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Orlando, Florida
Principal Investigator: Magdalena Pasarica, MD
Phone: 407-823-3702
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Orlando, Florida 32827
Principal Investigator: Magdalena Pasarica, MD
Phone: 407-936-2785
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Andrea Apter, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Kartik Shenoy, MD
Phone: 215-707-4679
Temple University Temple University is many things to many people. A place to pursue life's...
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Ponce, 00717
Principal Investigator: Domingo Chardon, MD
Phone: 787-840-2575
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759 Chestnut Street
Springfield, Massachusetts 01199
Principal Investigator: Victor Pinto Plata, MD
Phone: 413-794-4889
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