Abstract
Purpose: A Patient-Activated Reliever-Triggered Inhaled Corticosteroid (PARTICS) strategy of enhancing usual care with rescue short-acting beta agonist (SABA) supplemented with inhaled corticosteroid (ICS) reduces asthma exacerbations vs. usual care alone in Black and Latinx adults with moderate-severe asthma. We investigated post-trial PARTICS usage and patient perceptions of efficacy.
Methods: PREPARE trial participants randomized to the PARTICS intervention were surveyed an average of 29 months after trial exit.
Results: Of 600 PARTICS-assigned PREPARE trial participants, 505 consented to future research. Fifty-two percent (262/505) completed this survey. Forty-one percent (108/262) continued using PARTICS post-trial. Of these, 97% (105/108) reported that PARTICS helped to control their asthma. Thirty-four percent (37/108) switched from the trial provided QVAR® to other ICS brands due to insurance coverage or clinician issues (e.g., unwillingness to prescribe or misunderstanding of PARTICS; 65%, 24/37). Of those who stopped using PARTICS post-trial (59% [154/262]), 62% (95/154) reported using PARTICS until the PREPARE-provided ICS inhaler ran out, and 31% (47/154) reported not knowing that their asthma care clinician could prescribe it. Only 2% (5/154) of those not using PARTICS reported that it had not been helpful for asthma.
Conclusions: Continued PARTICS use was common >2 years post-trial despite minimal study instruction and was perceived as helpful for asthma, suggesting that patients will likely adopt this strategy if implemented at a healthcare system level.
- Asthma
- Black or African American
- Bronchodilator
- Clinical trial
- Healthcare Systems
- Implementation Science
- Latinx
- Metered Dose Inhalers
- Minority Health
- Patient-Centered Care
Introduction
Asthma is particularly burdensome among African American/Black (AA/B) and Hispanic/Latinx (H/L) people, who face higher prevalence and mortality compared with White people.1 Guidelines have distinguished daily controller therapy with inhaled corticosteroids (ICS) from as-needed rescue therapy with inhaled quick-onset bronchodilators (eg, albuterol). Recently, guidelines endorsed adding ICS to quick-onset bronchodilators for as-needed rescue therapy.2,3
Three main approaches exist for adding as-needed rescue ICS.4 First is the long-acting but quick-onset bronchodilator formoterol with ICS in a single inhaler. However, formoterol is not Food and Drug Administration (FDA)-approved for rescue, limiting implementation in the US.5 Second, the FDA recently approved an ICS/albuterol single inhaler, but this product is expensive for underinsured patients. Third is the PARTICS strategy, or Patient-Activated Reliever-Triggered Inhaled CorticoSteroid (1 rescue ICS puff for every puff of rescue bronchodilator; 5 rescue ICS puffs for every rescue bronchodilator nebulization; plus continuing usual care, which required controller therapy with at least ICS but allowing any number of additional controller therapy medicines). The PREPARE study recently reported that PARTICS reduces asthma exacerbations versus usual care in AA/B and H/L adults,6 populations who experience high asthma burden and are underrepresented in pragmatic clinical trials assessing effectiveness of newer therapies.7 PARTICS implementation, however, is untested outside clinical trials. We surveyed PREPARE participants about continuation of PARTICS post-trial and their perception of efficacy.
Methods
PREPARE was a multi-center pragmatic trial where 1201 adults with asthma who self-identified as AA/B and H/L were recruited and randomized to PARTICS plus usual care versus usual care alone.8 Participants assigned to PARTICS received a beclomethasone dipropionate HFA metered dose inhaler (beclomethasone MDI), refilled if needed. After the final trial survey, participants received an on-screen message to request prescriptions from their clinician should they want to continue PARTICS, reinforced by letter when trial results became available, but without further instruction. We surveyed (via REDCap) post-trial participants randomized to PARTICS who consented for future research. This protocol was Institutional Review Board (IRB) approved. Table 1 shows baseline characteristics.
Baseline Characteristics of Survey Respondents*
Results
Of 600 PARTICS-assigned participants, 505 consented to future research and were surveyed. Survey completion rate was 52% (262/505; 54% [131/244] among AA/B; 50% [131/261] among H/L), completed on average 29 months post trial (Figure 1).
Summary of survey results. Abbreviations: ICS, inhaled corticosteroids; PARTICS, Patient-Activated, Reliever-Triggered Inhaled Corticosteroid.
Forty-one percent (108/262; 43% [56/131] among AA/B; 40% [52/131] among H/L) of respondents continued using PARTICS. Of these, 97% (105/108; 100% [56/56] among AA/B; 94% [49/52] among H/L) reported that PARTICS helped control their asthma—96% of exclusive rescue inhaler users and 98% of nebulizer users. Thirty-four percent (37/108; 30% [17/56] among AA/B; 38% [20/52] among H/L) reported using ICS brands other than the trial-provided beclomethasone MDI. Of these, 65% (24/37; 59% [10/17] among AA/B; 70% [14/20] among H/L) switched from beclomethasone MDI due to insurance or clinician issues (eg, unwillingness to prescribe or misunderstanding of PARTICS) or used their usual care ICS for PARTICS.
Of the 59% (154/262; 57% [75/131] among AA/B; 60% [79/131] among H/L) of participants who discontinued PARTICS, most reported either using PARTICS until the trial-provided beclomethasone MDI ran out (62% [95/154]; 55% [41/75] among AA/B; 68% [54/79] among H/L) or not knowing their clinician could prescribe it (31% [47/154]; 37% [28/75] among AA/B; 24% [19/79] among H/L) as reasons for its discontinuation. Only 3% (5/154; 5% [4/75] among AA/B; 1% [1/79] among H/L) of those not using PARTICS reported it was unhelpful (Figure 1).
Discussion
As-needed ICS rescue has not been widely implemented in the US. In this ancillary study, >40% of respondents continued the as-needed ICS PARTICS strategy >2 years post-trial despite minimal instructions, suggesting that patients perceive PARTICS as effective and that PARTICS can be used outside clinical trials and in highly-impacted populations.
Almost all (97%) respondents who continued PARTICS post-trial reported it as helpful, including nebulizer users. Many continued PARTICS with alternative ICS brands (34%), demonstrating flexibility of this strategy. Few respondents who stopped PARTICS (3%) did so because they found it unhelpful. Findings were similar between AA/B and H/L participants. These results suggest that participants overwhelmingly perceive PARTICS as helpful, and that discontinuation is not due to ineffectiveness.
Study limitations include social desirability and recall bias, and response rate. However, the >50% response rate nearly 2.5 years post-trial was higher than expected. Although this study was conducted only among AA/B and H/L adults, we believe that PARTICS may be useful for patients from other racial and ethnic groups and other patients facing fewer barriers to care and less asthma-related morbidity and mortality. The parent PREPARE trial noted that the PARTICS strategy was achieved with an average of 1.1 additional canisters of ICS/person/year compared with the usual care group, which is cost-effective and accessible to most patients, especially considering the recent price cap placed on several asthma inhalers.
In summary, PARTICS was commonly used >2 years post-trial despite minimal instructions for continuation, was perceived as helpful and used with nebulizers and different ICS brands, suggesting its feasibility if widely implemented.
Acknowledgments
We acknowledge all study participants and their families for trusting us with their time and dedication.
Patient Partner Stakeholders: Alex Colon Moya, MPH; Aracelis Diaz; Bridget Hickson; Margarita Lorenzi, MS; Suzanne Madison, PhD, MPH; Kathy Monteiro; Wilfredo Morales-Cosme, MPH; Alexander Muniz Ruiz; Addie Perez; Richard Redondo; Dennis Reid; Janet Robles; Marsha Santiago; Opal Thompson; Joyce Wade; and Mary White who ensured that the patient voice is heard and incorporated into all aspects of the PREPARE study.
Patient Advocacy Stakeholders: Mary K. Hart, MS, RRT, RCP, AE-C, FAARC, FCCP; Mario Herrera, MD, MPH; Barbara M. Kaplan, MPH; Sharon Schumack, Med who contributed their expertise regarding the populations of interest and affirmed the patient voice is being heard.
Professional Society Stakeholders: Rubin Cohen, MD, MSc, FACP, FCCP, FCCM; Patricia Finn, MD; Michael Foggs, MD; Robert Lemanske, MD; Folashade Omole, MD, FAAFP who provided their expertise in asthma and the population being enrolled.
Study Sites Staff: Tiffany Bendelow, MPH, CCRP; Lauren Bielick; Michelle Campbell Hayes; Erika M. Coleman, BS; Jose Diarte Ortiz, MPH; Lynn Fukushima, RN, MSN; Nicole P. Grant, MS, CCRP; Hernidia Guerra, BA; Hilde Heyn; Renita Holmes; Bryonna Jackson, MS; Mary Jo Day, LPN; Sylvia Johnson; Tiffani Kaage, CCRC; Claudia Lechuga, MS; Carese Lee; Brianna M. McQuade, PharmD, BCACP, MHPE; Kathleen Mottus, PhD; Melissa Navarro, RN; Grace Ndicu; Angela Nuñez, MA; Pamela Pak; Luzmercy Perez; Matias E. Pollevick, BS; Walter Ramos-Amador, MPH, MS; Patricia Rebolledo; Jennifer Rees, RN, CPF, CRN; Sarah B.
Study Site Investigators: Andrea J. Apter, MD; Ahmet Baydur, MD, FACP, FCCP; Paula J. Busse, MD; Rafael A. Calderon-Candelario, MD, MSc; Thomas B. Casale, MD; Geoffrey Chupp, MD; Michelle L. Hernandez, MD; Laura P. Hurley, MD, MPH; Sunit Jariwal, MD; Elina Jerscow, MD; David C. Kaelber, MD, PhD, MPH; Sybille M. Liautaud, MD; M. Diane McKee, MD, MS; Sylvette Nazario, MD; Magdalena Pasarica, MD, PhD; Victor Pinto-Plata, MD; Isaretta L. Riley, MD, MPH; Paul M. Stranges, PharmD; Kartik Shenoy, MD; Hazel Tapp, PhD; Jennifer Trevor, MD who helped with study implementation and recruited the population of interest.
Health Policy Experts: Sarah Alwardt, PhD; Tangita Daramola, MD, CFMM; Gretchen Hammer, MPH; Arif M. Khan, MD; Troy Trygstad, MD, CCNC; Sreekanth Chaguturu, MD who strengthened our pragmatic approach to the introduction of PARTICS into the daily flow of health care.
Coordinators from the American Academy of Family Physicians: Alicia Brooks-Greisen, BA; Ileana Cepeda, MP; Angie Lanigan, MPA, RD, LD; Cory Lutgen, BA; Elizabeth Staton, MSTC; Carolyn Valdez, BSN, RN who ensured monthly surveys were completed and followed up on reported exacerbations.
Colleagues from the DartNet Institute: Shaddai Amolitos, BS; Gabriela Gaona Villarreal, MPH who designed and maintained the database and provided data support.
and
Expert Scientific Advisors: Giselle Mosnaim, MD; Cynthia S. Rand, PhD; Michael E. Wechsler, MD; Barbara P. Yawn, MD, MSc, who ensured all aspects of PREPARE are scientifically valid and relevant.
Notes
This article was externally peer reviewed.
↵*Other PREPARE investigators include: Andrea J. Apter, MD, MA, MSc, FAAAAI, Phuong Bradford, DNP, Rafael A. Calderon-Candelario, MD, Jennifer K. Carroll, Geoffrey L. Chupp, MD, Rubin Cohen, Brianna Ericson, Anne L. Fuhlbrigge, MD, MS, Barbara M. Kaplan, MPH, Jean M. Kruse, BA, Sylvette Nazario, MD, Wilson D. Pace, MD Magdalena Pasarica, MD, PhD, Wanda Phipatanakul, MD, MS, FAAAAI, Isaretta L. Riley, MD, MPH, Jacqueline Rodriguez-Louis, MPH, MEd, CTTS, Kartik Shenoy, MD, Paul M. Stranges, PharmD, MSHI, BCACP, FCCP, Hazel Tapp, PhD, Michael E. Wechsler, MD.
Funding: This work was funded by a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (PCS-1504-30283) (Dr. Israel). 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. Additional funding was provided by the Anthony C. Simboli Distinguished Chair in Asthma Research award to Dr. Israel; NIAID K23AI125785, ALA (American Lung Association)/AAAAI (American Academy of Allergy, Asthma & Immunology) Allergic Respiratory Diseases Research Award AI-835475, and the Bristol Myers Squibb Foundation Winn Award to JCC.
Conflict of interest: J. C. Cardet reports receiving honoraria from AstraZeneca, Chiesi, GSK, Genentech, and Sanofi for work on advisory boards, steering committees, and educational lectures on asthma. M. Pasarica reports receiving honoraria from NovoNordisk for an educational project on obesity medicine. S. Zaeh served on advisory boards for Astra Zeneca.
To see this article online, please go to: http://jabfm.org/content/38/2/378.full.
- Received for publication January 12, 2024.
- Revision received February 6, 2024.
- Revision received August 26, 2024.
- Accepted for publication August 26, 2024.
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