TY - JOUR
T1 - Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma
T2 - A pilot study
AU - Cardet, Juan Carlos
AU - Busse, Paula J.
AU - Carroll, Jennifer K.
AU - Casale, Thomas B.
AU - Coyne-Beasley, Tamera
AU - Dixon-Williams, Sherrie
AU - Fagan, Maureen
AU - Forth, Victoria E.
AU - Fuhlbrigge, Anne L.
AU - Hernandez, Michelle L.
AU - Kaelber, David
AU - Kaplan, Barbara
AU - Lorenzi, Margarita
AU - Madison, Suzanne
AU - Maher, Nancy E.
AU - Majewski, Karen
AU - Manning, Brian
AU - McKee, Melissa D.
AU - Nazario, Sylvette
AU - Pace, Wilson D.
AU - Pencina, Michael J.
AU - Rand, Cynthia S.
AU - Rodriguez-Louis, Jacqueline
AU - She, Lilin
AU - Shields, Joel
AU - Teng, Jessica E.
AU - Wechsler, Michael E.
AU - Wisnivesky, Juan P.
AU - Yawn, Barbara P.
AU - Israel, Elliot
N1 - Publisher Copyright:
© 2020 American College of Allergy, Asthma & Immunology
PY - 2020/5
Y1 - 2020/5
N2 - 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.
AB - 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.
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U2 - 10.1016/j.anai.2019.12.027
DO - 10.1016/j.anai.2019.12.027
M3 - Article
C2 - 31923550
AN - SCOPUS:85078855281
SN - 1081-1206
VL - 124
SP - 487-493.e1
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 5
ER -