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

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ClinicalTrials.gov Identifier: NCT02995733
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : February 11, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
American Academy of Family Physicians
Information provided by (Responsible Party):
Elliot Israel, MD, 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.


Condition or disease Intervention/treatment Phase
Asthma Drug: PARTICS using QVAR Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
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
Drug: PARTICS using QVAR
Patient takes inhaled corticosteroid at the time of rescue inhaler use
Other Name: Patient Activated Reliever-Triggered Inhaled CorticoSteroid

No Intervention: Usual Care
Provider-enhanced usual care arm; no change in asthma management



Primary Outcome Measures :
  1. Rate of Asthma Exacerbations per year [ Time Frame: 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 :
  1. days lost from work or school/ days unable to carry out usual activities due to asthma [ Time Frame: 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

  2. Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI) [ Time Frame: 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 (Revicki 1998

  3. Asthma Control: Asthma Control Test (ACT) score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995733


Contacts
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Contact: Nancy Maher, MPH 857-307-3892 NMAHER@BWH.HARVARD.EDU
Contact: Elliot Israel, MD 617-732-8110 eisrael@partners.org

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Contact: Renita Holmes    205-934-6683    rlholmes@uabmc.edu   
Principal Investigator: Jennifer Trevor, MD         
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80209
Contact: Hilde Heyn    303-602-4859    hilde.heyn@dhha.org   
Principal Investigator: Laura Hurley, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Emma Stewart    203-499-9260    emma.stewart@yale.edu   
Principal Investigator: Geoffrey Chupp, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Ben Rooks    352-273-8025    brooks@ufl.edu   
Principal Investigator: Ku-Lang Chang, MD         
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Patricia Rebolledo       PRebolledo@med.miami.edu   
Principal Investigator: Rafael Calderon Candelario, MD         
Grace Medical Home Recruiting
Orlando, Florida, United States, 32827
Contact: Monica D'Apice    407-936-2785 ext 2061    mdapice@gracemedicalhome.org   
Principal Investigator: Magdalena Pasarica, MD         
University of Central Florida Recruiting
Orlando, Florida, United States, 32827
Contact: Zinnia Valdes    407-823-3702    Zinnia.Valdes@ucf.edu   
Principal Investigator: Magdalena Pasarica, MD         
University of South Florida Recruiting
Tampa, Florida, United States, 33613
Contact: Tiffani Kaage    813-631-4024 ext 200    tiffanik@health.usf.edu   
Principal Investigator: Thomas Casale, MD         
United States, Illinois
University of Illinois- Chicago Recruiting
Chicago, Illinois, United States, 60607
Contact: Jasmin Sanchez    608-438-6830    jsanch59@uic.edu   
Principal Investigator: Paul Stranges, MD         
United States, Massachusetts
Baystate Health Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Sarah Romain    413-794-4889    sarah.romain@baystatehealth.org   
Contact: Sherell Thornton-Thompson       Sherell.Thornton-Thompson@baystatehealth.org   
Principal Investigator: Victor Pinto Plata, MD         
United States, New York
Montefiore Recruiting
Bronx, New York, United States, 10461
Contact: Claudia LeChuga    718-430-2023    CLECHUGA@montefiore.org   
Contact: Luciana Stumpf    718-430-2450    luciana.stumpf@einstein.yu.edu   
Principal Investigator: Dianne McKee, MD         
Mt. Sinai Recruiting
New York, New York, United States, 10029
Contact: Daritza De Los Santos       Daritza.DeLosSantos@mountsinai.org   
Contact: Jose Diarte    212-824-7451    jose.diarteortiz@mountsinai.org   
Principal Investigator: Paula Busse, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 25799
Contact: Jennifer Rees    919-843-4401    jennifer_rees@med.unc.edu   
Contact: Michelle Hayes       mhayes@schsr.unc.edu   
Principal Investigator: Michelle Hernandez, MD         
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Jeremy Thomas       Jeremy.Thomas@atriumhealth.org   
Principal Investigator: Hazel Tapp, MD         
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Erika Coleman    919-613-7699    erika.coleman@duke.edu   
Principal Investigator: Isaretta Riley, MD         
Principal Investigator: Rowena Dolor, MD         
United States, Ohio
MetroHealth Recruiting
Cleveland, Ohio, United States, 44109
Contact: MaryJo Day    216-778-8456    mday@metrohealth.org   
Contact: Cindy Newman       cnewman@metrohealth.org   
Principal Investigator: David Kaelber, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Grace Ndicu       grace.ndicu@uphs.upenn.edu   
Principal Investigator: Andrea Apter, MD         
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Sylvia Johnson    215-707-4679    sylvia.johnson@tuhs.temple.edu   
Principal Investigator: Kartik Shenoy, MD         
Puerto Rico
Ponce Health Sciences University Recruiting
Ponce, Puerto Rico, 00717
Contact: Mercedes Negron Mariani    787-840-2575 ext 5666    mnegron@psm.edu   
Principal Investigator: Domingo Chardon, MD         
University of Puerto Rico Recruiting
San Juan, Puerto Rico, 00926
Contact: Bonnie Telon    787-379-5490    bonnie.telon@upr.edu   
Principal Investigator: Sylvette Nazario, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Patient-Centered Outcomes Research Institute
American Academy of Family Physicians
Investigators
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Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Elliot Israel, MD, Brigham and Women's Hospital:

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Responsible Party: Elliot Israel, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02995733     History of Changes
Other Study ID Numbers: 2016P001839
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Elliot Israel, MD, Brigham and Women's Hospital:
asthma
African Americans
Hispanics

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases