TY - JOUR
T1 - A randomized, open-label, pragmatic study to assess reliever-triggered inhaled corticosteroid in African American/Black and Hispanic/Latinx adults with asthma
T2 - Design and methods of the PREPARE trial
AU - Israel, Elliot
AU - Cardet, Juan Carlos
AU - Carroll, Jennifer K.
AU - Fuhlbrigge, Anne L.
AU - Pace, Wilson D.
AU - Maher, Nancy E.
AU - She, Lilin
AU - Rockhold, Frank W.
AU - Fagan, Maureen
AU - Forth, Victoria E.
AU - Hernandez, Paulina Arias
AU - Manning, Brian K.
AU - Rodriguez-Louis, Jacqueline
AU - Shields, Joel B.
AU - Coyne-Beasley, Tamera
AU - Kaplan, Barbara M.
AU - Rand, Cynthia S.
AU - Morales-Cosme, Wilfredo
AU - Wechsler, Michael E.
AU - Wisnivesky, Juan P.
AU - White, Mary
AU - Yawn, Barbara P.
AU - McKee, M. Diane
AU - Busse, Paula J.
AU - Kaelber, David C.
AU - Nazario, Sylvette
AU - Hernandez, Michelle L.
AU - Apter, Andrea J.
AU - Chang, Ku Lang
AU - Pinto-Plata, Victor
AU - Stranges, Paul M.
AU - Hurley, Laura P.
AU - Trevor, Jennifer
AU - Casale, Thomas B.
AU - Chupp, Geoffrey
AU - Riley, Isaretta L.
AU - Shenoy, Kartik
AU - Pasarica, Magdalena
AU - Calderon-Candelario, Rafael A.
AU - Tapp, Hazel
AU - Baydur, Ahmet
N1 - Funding Information:
Juan Carlos Cardet's contribution to the manuscript was funded by grant # K23AI125785 from the National Institute of Allergy and Infectious Diseases (NIAID) .
Funding Information:
This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award ( PCS-1504-30283 ). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.
Funding Information:
We acknowledge Julia Harder, PharmD who provided medical writing assistance and Jean M. Kruse, BA who provided logistical support. We also acknowledge the several stakeholders listed below who were active in developing the study design and implementation of this study, offering expert advice throughout this project. Our Patient Partner Stakeholders (Aracelis Diaz, Bridget Hickson, Margarita Lorenzi, Suzanne Madison, Kathy Monteiro, Alex Colon Moya, Alexander Muniz Ruiz, Addie Perez, Richard Redondo, Dennis Reid, Janet Robles, Marsha Santiago, Opal Thompson, and Joyce Wade) ensured that the patient voice is heard and incorporated into all aspects of the PREPARE study. Our Professional Society Stakeholders (Rubin Cohen, MD, MSc, FACP, FCCP, FCCM; Patricia Finn, MD; Michael Foggs, MD; Robert Lemanske, MD; Folashade Omole, MD, FAAFP) provided their expertise in asthma and the population begin enrolled. Our Patient Advocacy Stakeholders (Sharon Schumack, MEd; Cara Kraft, RRT/RCP, AE-C; Flor McKinley, RN, MSN/NE; Tonya Winders, MBA) contributed their expertise regarding the populations of interest and affirmed the patient voice is being heard. Our Expert Scientific Advisors (Juan C. Celed?n, MD, DrPH; Giselle Mosnaim, MD; Wanda Phipatanakul, MD, MS) ensured all aspects of PREPARE are scientifically valid and relevant. Our Health Policy Experts (Sarah Alwardt, PhD; Tangita Daramola, MD, CFMM; Troy Trygstad, MD, CCNC; Sreekanth Chaguturu, MD) strengthened our pragmatic approach to the introduction of PARTICS into the daily flow of health care. Our Pilot Study Site Research Managers (Sherrie Dawson-Williams, MD, co-investigator; Mary Jo Day, LPN; Jose Diart?, MPH; Claudia Lechuga, MS; Jennifer Rees, RN) provided essential feedback during the pilot study that was implemented into the study methods for the full PREPARE study. This work was supported by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (PCS-1504-30283). All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. Juan Carlos Cardet's contribution to the manuscript was funded by grant #K23AI125785 from the National Institute of Allergy and Infectious Diseases (NIAID).
Publisher Copyright:
© 2020
PY - 2021/2
Y1 - 2021/2
N2 - Background: 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.
AB - Background: 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.
KW - African American
KW - Asthma
KW - Exacerbations
KW - Hispanic
KW - Patient-centered
KW - Pragmatic trial
UR - http://www.scopus.com/inward/record.url?scp=85098230477&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2020.106246
DO - 10.1016/j.cct.2020.106246
M3 - Article
C2 - 33316456
AN - SCOPUS:85098230477
SN - 1551-7144
VL - 101
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106246
ER -