Juan Carlos Cardet1, Paula J Busse2, Jennifer K Carroll3, Thomas B Casale4, Tamera Coyne-Beasley5, Sherrie Dixon-Williams6, Maureen Fagan7, Victoria E Forth8, Anne L Fuhlbrigge9, Michelle L Hernandez10, David Kaelber6, Barbara Kaplan11, Margarita Lorenzi12, Suzanne Madison13, Nancy E Maher8, Karen Majewski6, Brian Manning14, Melissa D McKee15, Sylvette Nazario16, Wilson D Pace3, Michael J Pencina17, Cynthia S Rand18, Jacqueline Rodriguez-Louis8, Lilin She17, Joel Shields14, Jessica E Teng8, Michael E Wechsler19, Juan P Wisnivesky2, Barbara P Yawn20, Elliot Israel8. 1. University of South Florida, Morsani College of Medicine, Division of Allergy and Immunology, Tampa, Florida. Electronic address: jcardet@health.usf.edu. 2. Department of Medicine, Mount Sinai School of Medicine, New York, New York. 3. Department of Family Medicine, University of Colorado, Denver, Colorado. 4. University of South Florida, Morsani College of Medicine, Division of Allergy and Immunology, Tampa, Florida. 5. Department of Medicine, University of North Carolina, Chapel Hill, North Carolina. 6. Center for Clinical Informatics Research and Educations, and the Departments of Internal Medicine, Pediatrics, and Population and Quantitative Health Sciences, The MetroHealth System, Case Western Reserve University, Cleveland, Ohio. 7. University of Miami Hospital and Clinics, Miller School of Medicine, Miami, Florida. 8. Brigham and Women's Hospital, Division of Pulmonary and Critical Care Medicine, Boston, Massachusetts. 9. Department of Medicine, University of Colorado, Denver, Colorado. 10. Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, University of North Carolina at Chapel Hill. Chapel Hill, North Carolina. 11. American Lung Association, Chicago, Illinois. 12. Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts. 13. Patient-Centered Outcomes Research Institute, Minneapolis, Minnsesota. 14. The American Academy of Family Physicians' National Research Network, Leawood, Kansas. 15. Albert Einstein College of Medicine, Bronx, New York. 16. Department of Internal Medicine, University of Puerto Rico, San Juan, Puerto Rico. 17. Duke Clinical Research Institute, Durham, North Carolina. 18. Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland. 19. Department of Medicine, National Jewish Health, Denver, Colorado. 20. Department of Family Medicine, University of Minnesota, Blaine, Minnesota.
Abstract
BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS:Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS:Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).
RCT Entities:
BACKGROUND: Underuse of guideline-recommended inhaled corticosteroids (ICS) controller therapy is a risk factor for greater asthma burden. ICS concomitantly used with rescue inhalers (Patient-Activated Reliever-Triggered ICS ['PARTICS']) reduced asthma exacerbations in efficacy trials, but whether PARTICS is effective in pragmatic trials is unknown. OBJECTIVE: We conducted this pilot to determine the feasibility of executing a large-scale pragmatic PARTICS trial and to improve study protocols. METHODS: Four sites recruited 33 Hispanic or black adults with persistent asthma, randomized them approximately 3:1 to intervention or usual care, and followed them for 12 weeks. All participants received asthma guideline-based educational videos; intervention participants received video-based instructions on implementing PARTICS plus usual medications. The study involved 1 randomization visit and monthly questionnaires. Timely questionnaire responses (±2 weeks) were monitored. Participants underwent qualitative phone interviews to assess self-reported adherence to PARTICS and understand barriers to completing study procedures. RESULTS: Timely questionnaire response rates were 61%, 64%, and 70% at 4, 8, and 12 weeks, respectively. Self-reported adherence to PARTICS was 76% (95% confidence interval [CI], 58%-94% [n = 21]), 88% (95%CI, 72%-100% [n = 16]), and 62% (95%CI, 36%-88% [n = 13]) at weeks 1, 6, and 12, respectively. Barriers to completing study procedures included difficulties with questionnaire access, remembering to use ICS and rescue inhalers together, and obtaining refills. Only 22% of participants recognized their short-acting bronchodilator as "reliever" or "rescue." CONCLUSION: Recruitment was feasible within the allocated period. Adherence to PARTICS was incomplete, questionnaire completion was suboptimal, and common rescue inhaler nomenclature usage was limited. We have modified the full study protocol to attempt to improve adherence to PARTICS and minimize barriers to study procedures. CLINICAL TRIALS REGISTRATION: pilot study for 'PeRson EmPowered Asthma Relief' (PREPARE, NCT02995733).
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Authors: Elliot Israel; Juan Carlos Cardet; Jennifer K Carroll; Anne L Fuhlbrigge; Wilson D Pace; Nancy E Maher; Lilin She; Frank W Rockhold; Maureen Fagan; Victoria E Forth; Paulina Arias Hernandez; Brian K Manning; Jacqueline Rodriguez-Louis; Joel B Shields; Tamera Coyne-Beasley; Barbara M Kaplan; Cynthia S Rand; Wilfredo Morales-Cosme; Michael E Wechsler; Juan P Wisnivesky; Mary White; Barbara P Yawn; M Diane McKee; Paula J Busse; David C Kaelber; Sylvette Nazario; Michelle L Hernandez; Andrea J Apter; Ku-Lang Chang; Victor Pinto-Plata; Paul M Stranges; Laura P Hurley; Jennifer Trevor; Thomas B Casale; Geoffrey Chupp; Isaretta L Riley; Kartik Shenoy; Magdalena Pasarica; Rafael A Calderon-Candelario; Hazel Tapp; Ahmet Baydur Journal: Contemp Clin Trials Date: 2020-12-11 Impact factor: 2.226