A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial

Elliot Israel¹, Juan Carlos Cardet², Jennifer K Carroll³, Anne L Fuhlbrigge⁴, Wilson D Pace⁵, Nancy E Maher⁶, Lilin She⁷, Frank W Rockhold⁸, Maureen Fagan⁹, Victoria E Forth¹⁰, Paulina Arias Hernandez¹⁰, Brian K Manning¹¹, Jacqueline Rodriguez-Louis¹², Joel B Shields¹³, Tamera Coyne-Beasley¹⁴, Barbara M Kaplan¹⁵, Cynthia S Rand¹⁶, Wilfredo Morales-Cosme¹⁷, Michael E Wechsler¹⁸, Juan P Wisnivesky¹⁹, Mary White¹⁰, Barbara P Yawn²⁰, M Diane McKee²¹, Paula J Busse²², David C Kaelber²³, Sylvette Nazario²⁴, Michelle L Hernandez²⁵, Andrea J Apter²⁶, Ku-Lang Chang²⁷, Victor Pinto-Plata²⁸, Paul M Stranges²⁹, Laura P Hurley³⁰, Jennifer Trevor³¹, Thomas B Casale³², Geoffrey Chupp³³, Isaretta L Riley³⁴, Kartik Shenoy³⁵, Magdalena Pasarica³⁶, Rafael A Calderon-Candelario³⁷, Hazel Tapp³⁸, Ahmet Baydur³⁹

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America. Electronic address: eisrael@partners.org.
² Division of Allergy and Immunology, Morsani College of Medicine, University of South Florida, 12908 Bruce B Downs Boulevard, Suite 4128, Tampa, FL, United States of America. Electronic address: jcardet@usf.edu.
³ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS 66211, United States of America; CU Anschutz Department of Family Medicine, University of Colorado, 12631 East 17th Avenue, Box F496, Aurora, CO 80045, United States of America. Electronic address: jennifer.2.carroll@cuanschutz.edu.
⁴ Department of Medicine, Pulmonary Science and Critical Care Medicine, University of Colorado School of Medicine, Fitzsimons Building, 13001 E 17th Place, Box C290, Aurora, CO, United States of America. Electronic address: anne.fuhlbrigge@cuanschutz.edu.
⁵ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS 66211, United States of America; DARTNet Institute, 12635 East Montview Boulevard, Mail Stop 3, Suite 129, Aurora, CO, United States of America. Electronic address: wilson.pace@dartnet.info.
⁶ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America. Electronic address: nmaher@bwh.harvard.edu.
⁷ Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, NC, United States of America. Electronic address: lilin.she@duke.edu.
⁸ Duke Clinical Research Institute, Duke University Medical Center, 200 Morris Street, Office 6428, Durham, NC, United States of America. Electronic address: frank.rockhold@duke.edu.
⁹ University of Miami Health System, 1150 NW 14th Street, Don Soffer Clinical Research Building, Suite 360-H, Miami, FL, United States of America. Electronic address: mfagan@miami.edu.
¹⁰ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America.
¹¹ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS, United States of America. Electronic address: bmanning@aafp.org.
¹² Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America. Electronic address: jrodriguezlouis@bwh.harvard.edu.
¹³ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS, United States of America. Electronic address: jshields@aafp.org.
¹⁴ Division of Adolescent Medicine, University of Alabama at Birmingham, Children's of Alabama, 1600 7th Avenue South, Birmingham, AL, United States of America. Electronic address: coybea@peds.uab.edu.
¹⁵ American Lung Association, 1331 Pennsylvania Avenue NW, 1425N, Washington, DC, United States of America. Electronic address: barbara.kaplan@lung.org.
¹⁶ Department of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, 1830 Building, 1830 E Monument Street, Baltimore, MD, United States of America. Electronic address: crand@jhmi.edu.
¹⁷ University of Puerto Rico: Medical Sciences Campus, P.O. Box 365067, San Juan, Puerto Rico. Electronic address: wilfredo.morales@upr.edu.
¹⁸ Department of Medicine, NJH Cohen Family Asthma Institute, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States of America. Electronic address: wechslerm@njhealth.org.
¹⁹ Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States of America; Division of Pulmonary and Critical Care Medicine, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States of America. Electronic address: juan.wisnivesky@mssm.edu.
²⁰ Department of Family and Community Health, University of Minnesota, 516 Delaware Street SE, Minneapolis, MN, United States of America.
²¹ Albert Einstein College of Medicine, 1300 Morris Park Avenue, The Bronx, NY 10461, United States of America; Department of Family Medicine and Community Health, University of Massachusetts Medical School, UMass Memorial Health Care, 55 Lake Avenue North, Worcester, MA, United States of America. Electronic address: m.diane.mckee@umassmed.edu.
²² Division of Clinical Immunology and Allergy, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, Room 11-20, New York, NY, United States of America. Electronic address: paula.busse@mssm.edu.
²³ Center for Clinical Informatics Research and Education, Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, The MetroHealth System, Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, OH, United States of America. Electronic address: david.kaelber@case.edu.
²⁴ Department of Internal Medicine, Allergy/Immunology Section, University of Puerto Rico: Medical Sciences Campus, P.O. Box 365067, San Juan, Puerto Rico. Electronic address: sylvette.nazario@upr.edu.
²⁵ Division of Allergy, Immunology, & Rheumatology, University of North Carolina School of Medicine, 5008C Mary Ellen Jones Building, 116 Manning Drive, CB #7231, Chapel Hill, NC, United States of America. Electronic address: michelle_hernandez@med.unc.edu.
²⁶ Division of Pulmonary, Allergy, Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, 829 Gates Building, Hospital of the University of Pennsylvania, 3600 Spruce Street, Philadelphia, PA, United States of America. Electronic address: andrea.apter@pennmedicine.upenn.edu.
²⁷ Department of Community Health and Family Medicine, University of Florida College of Medicine, 4197 NW 86th Terrace, Gainesville, FL, United States of America. Electronic address: changk@shands.ufl.edu.
²⁸ Division of Critical Care/Pulmonary, Baystate Health, Tolosky Center, 3300 Main Street, Suite 2B, Springfield, MA, United States of America. Electronic address: Victor.pinto-plata@baystatehealth.org.
²⁹ University of Illinois at Chicago College of Pharmacy, 833 S Wood Street, Chicago, IL, United States of America. Electronic address: pmstrang@uic.edu.
³⁰ Denver Health and Hospital Authority, 301 W 6th Avenue, MC 3251, Denver, CO, United States of America. Electronic address: laura.hurley@dhha.org.
³¹ Department of Medicine, UAB Lung Health Center, University of Alabama, 526 20th Street South, Birmingham, AL, United States of America. Electronic address: jtrevor@uabmc.edu.
³² Division of Allergy and Immunology, Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Boulevard, MDC 19, Tampa, FL, United States of America. Electronic address: tbcasale@usf.edu.
³³ Pulmonary, Critical Care & Sleep Medicine, Yale School of Medicine, PO Box 208057, 300 Cedar Street, New Haven, CT, United States of America. Electronic address: geoffrey.chupp@yale.edu.
³⁴ Division of Pulmonary, Allergy & Critical Care Medicine, Duke University School of Medicine, Box 102355, 247 Hanes House, Durham, NC, United States of America. Electronic address: isaretta.riley@duke.edu.
³⁵ Temple Lung Center, Lewis Katz School of Medicine at Temple University, 3401 N. Broad Street, Suite 710C, Philadelphia, PA, United States of America. Electronic address: kartik.shenoy@tuhs.temple.edu.
³⁶ University of Central Florida, College of Medicine, 6850 Lake Nona Boulevard, Orlando, FL, United States of America. Electronic address: magdalena.pasarica@ucf.edu.
³⁷ Miller School of Medicine, University of Miami, 1600 NW 10 Ave (Loc# R-47), 7th floor, Room 7052, Miami, FL, United States of America. Electronic address: rac268@med.miami.edu.
³⁸ Department of Family Medicine, Atrium Health, 2001 Vail Street, Suite 400B, Charlotte, NC, United States of America. Electronic address: hazel.tapp@atriumhealth.org.
³⁹ Division of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, 2020 Zonal Avenue, IRD 725, Los Angeles, CA, United States of America. Electronic address: baydur@usc.edu.

PMID: 33316456
PMCID: PMC8130188
DOI: 10.1016/j.cct.2020.106246

Randomized Controlled Trial

A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial

Elliot Israel et al. Contemp Clin Trials. 2021 Feb.

. 2021 Feb:101:106246.

doi: 10.1016/j.cct.2020.106246. Epub 2020 Dec 11.

Authors

Affiliations

¹ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America. Electronic address: eisrael@partners.org.
² Division of Allergy and Immunology, Morsani College of Medicine, University of South Florida, 12908 Bruce B Downs Boulevard, Suite 4128, Tampa, FL, United States of America. Electronic address: jcardet@usf.edu.
³ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS 66211, United States of America; CU Anschutz Department of Family Medicine, University of Colorado, 12631 East 17th Avenue, Box F496, Aurora, CO 80045, United States of America. Electronic address: jennifer.2.carroll@cuanschutz.edu.
⁴ Department of Medicine, Pulmonary Science and Critical Care Medicine, University of Colorado School of Medicine, Fitzsimons Building, 13001 E 17th Place, Box C290, Aurora, CO, United States of America. Electronic address: anne.fuhlbrigge@cuanschutz.edu.
⁵ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS 66211, United States of America; DARTNet Institute, 12635 East Montview Boulevard, Mail Stop 3, Suite 129, Aurora, CO, United States of America. Electronic address: wilson.pace@dartnet.info.
⁶ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America. Electronic address: nmaher@bwh.harvard.edu.
⁷ Duke Clinical Research Institute, Duke University Medical Center, P.O. Box 17969, Durham, NC, United States of America. Electronic address: lilin.she@duke.edu.
⁸ Duke Clinical Research Institute, Duke University Medical Center, 200 Morris Street, Office 6428, Durham, NC, United States of America. Electronic address: frank.rockhold@duke.edu.
⁹ University of Miami Health System, 1150 NW 14th Street, Don Soffer Clinical Research Building, Suite 360-H, Miami, FL, United States of America. Electronic address: mfagan@miami.edu.
¹⁰ Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America.
¹¹ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS, United States of America. Electronic address: bmanning@aafp.org.
¹² Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, United States of America. Electronic address: jrodriguezlouis@bwh.harvard.edu.
¹³ American Academy of Family Physicians National Research Network, 11400 Tomahawk Creek Parkway, Leawood, KS, United States of America. Electronic address: jshields@aafp.org.
¹⁴ Division of Adolescent Medicine, University of Alabama at Birmingham, Children's of Alabama, 1600 7th Avenue South, Birmingham, AL, United States of America. Electronic address: coybea@peds.uab.edu.
¹⁵ American Lung Association, 1331 Pennsylvania Avenue NW, 1425N, Washington, DC, United States of America. Electronic address: barbara.kaplan@lung.org.
¹⁶ Department of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, 1830 Building, 1830 E Monument Street, Baltimore, MD, United States of America. Electronic address: crand@jhmi.edu.
¹⁷ University of Puerto Rico: Medical Sciences Campus, P.O. Box 365067, San Juan, Puerto Rico. Electronic address: wilfredo.morales@upr.edu.
¹⁸ Department of Medicine, NJH Cohen Family Asthma Institute, National Jewish Health, 1400 Jackson Street, Denver, CO 80206, United States of America. Electronic address: wechslerm@njhealth.org.
¹⁹ Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States of America; Division of Pulmonary and Critical Care Medicine, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States of America. Electronic address: juan.wisnivesky@mssm.edu.
²⁰ Department of Family and Community Health, University of Minnesota, 516 Delaware Street SE, Minneapolis, MN, United States of America.
²¹ Albert Einstein College of Medicine, 1300 Morris Park Avenue, The Bronx, NY 10461, United States of America; Department of Family Medicine and Community Health, University of Massachusetts Medical School, UMass Memorial Health Care, 55 Lake Avenue North, Worcester, MA, United States of America. Electronic address: m.diane.mckee@umassmed.edu.
²² Division of Clinical Immunology and Allergy, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, Room 11-20, New York, NY, United States of America. Electronic address: paula.busse@mssm.edu.
²³ Center for Clinical Informatics Research and Education, Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, The MetroHealth System, Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, OH, United States of America. Electronic address: david.kaelber@case.edu.
²⁴ Department of Internal Medicine, Allergy/Immunology Section, University of Puerto Rico: Medical Sciences Campus, P.O. Box 365067, San Juan, Puerto Rico. Electronic address: sylvette.nazario@upr.edu.
²⁵ Division of Allergy, Immunology, & Rheumatology, University of North Carolina School of Medicine, 5008C Mary Ellen Jones Building, 116 Manning Drive, CB #7231, Chapel Hill, NC, United States of America. Electronic address: michelle_hernandez@med.unc.edu.
²⁶ Division of Pulmonary, Allergy, Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, 829 Gates Building, Hospital of the University of Pennsylvania, 3600 Spruce Street, Philadelphia, PA, United States of America. Electronic address: andrea.apter@pennmedicine.upenn.edu.
²⁷ Department of Community Health and Family Medicine, University of Florida College of Medicine, 4197 NW 86th Terrace, Gainesville, FL, United States of America. Electronic address: changk@shands.ufl.edu.
²⁸ Division of Critical Care/Pulmonary, Baystate Health, Tolosky Center, 3300 Main Street, Suite 2B, Springfield, MA, United States of America. Electronic address: Victor.pinto-plata@baystatehealth.org.
²⁹ University of Illinois at Chicago College of Pharmacy, 833 S Wood Street, Chicago, IL, United States of America. Electronic address: pmstrang@uic.edu.
³⁰ Denver Health and Hospital Authority, 301 W 6th Avenue, MC 3251, Denver, CO, United States of America. Electronic address: laura.hurley@dhha.org.
³¹ Department of Medicine, UAB Lung Health Center, University of Alabama, 526 20th Street South, Birmingham, AL, United States of America. Electronic address: jtrevor@uabmc.edu.
³² Division of Allergy and Immunology, Morsani College of Medicine, University of South Florida, 12901 Bruce B Downs Boulevard, MDC 19, Tampa, FL, United States of America. Electronic address: tbcasale@usf.edu.
³³ Pulmonary, Critical Care & Sleep Medicine, Yale School of Medicine, PO Box 208057, 300 Cedar Street, New Haven, CT, United States of America. Electronic address: geoffrey.chupp@yale.edu.
³⁴ Division of Pulmonary, Allergy & Critical Care Medicine, Duke University School of Medicine, Box 102355, 247 Hanes House, Durham, NC, United States of America. Electronic address: isaretta.riley@duke.edu.
³⁵ Temple Lung Center, Lewis Katz School of Medicine at Temple University, 3401 N. Broad Street, Suite 710C, Philadelphia, PA, United States of America. Electronic address: kartik.shenoy@tuhs.temple.edu.
³⁶ University of Central Florida, College of Medicine, 6850 Lake Nona Boulevard, Orlando, FL, United States of America. Electronic address: magdalena.pasarica@ucf.edu.
³⁷ Miller School of Medicine, University of Miami, 1600 NW 10 Ave (Loc# R-47), 7th floor, Room 7052, Miami, FL, United States of America. Electronic address: rac268@med.miami.edu.
³⁸ Department of Family Medicine, Atrium Health, 2001 Vail Street, Suite 400B, Charlotte, NC, United States of America. Electronic address: hazel.tapp@atriumhealth.org.
³⁹ Division of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California, 2020 Zonal Avenue, IRD 725, Los Angeles, CA, United States of America. Electronic address: baydur@usc.edu.

PMID: 33316456
PMCID: PMC8130188
DOI: 10.1016/j.cct.2020.106246

Abstract

Asthma prevalence, morbidity, and mortality disproportionately impact African American/Black (AA/B) and Hispanic/Latinx (H/L) communities. Adherence to daily inhaled corticosteroid (ICS), recommended by asthma guidelines in all but the mildest cases of asthma, is generally poor. As-needed ICS has shown promise as a patient-empowering asthma management strategy, but it has not been rigorously studied in AA/B or H/L patients or in a real-world setting. Design and Aim The PeRson EmPowered Asthma RElief (PREPARE) Study is a randomized, open-label, pragmatic study which aims to assess whether a patient-guided, reliever-triggered ICS strategy called PARTICS (Patient-Activated Reliever-Triggered Inhaled CorticoSteroid) can improve asthma outcomes in AA/B and H/L adult patient populations. In designing and implementing the study, the PREPARE research team has relied heavily on advice from AA/B and H/L Patient Partners and other stakeholders. Methods PREPARE is enrolling 1200 adult participants (600 AA/Bs, 600H/Ls) with asthma. Participants are randomized to PARTICS + Usual Care (intervention) versus Usual Care (control). Following a single in-person enrollment visit, participants complete monthly questionnaires for 15 months. The primary endpoint is annualized asthma exacerbation rate. Secondary endpoints include asthma control; preference-based quality of life; and days lost from work, school, or usual activities. Discussion The PREPARE study features a pragmatic design allowing for the real-world assessment of a patient-centered, reliever-triggered ICS strategy in AA/B and H/L patients. Outcomes of this study have the potential to offer powerful evidence supporting PARTICS as an effective asthma management strategy in patient populations that suffer disproportionately from asthma morbidity and mortality.

Keywords: African American; Asthma; Exacerbations; Hispanic; Patient-centered; Pragmatic trial.

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Figures

**Fig. 1.**
PREPARE study design. AA/B: African American/Black; H/L: Hispanic/Latinx.

See this image and copyright information in PMC

References

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A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial

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A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma: Design and methods of the PREPARE trial

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