A cluster-randomized trial to provide clinicians inhaled corticosteroid adherence information for their patients with asthma

doi:10.1016/j.jaci.2010.03.034

Journal of Allergy and Clinical Immunology

Volume 126, Issue 2, August 2010, Pages 225-231.e4

https://doi.org/10.1016/j.jaci.2010.03.034 Get rights and content

Background

Inhaled corticosteroid (ICS) nonadherence is common among patients with asthma; however, interventions to improve adherence have often been complex and not easily applied to large patient populations.

Objective

To assess the effect of supplying patient adherence information to primary care providers.

Methods

Patients and providers were members of a health system serving southeast Michigan. Providers (88 intervention; 105 control) and patients (1335 intervention; 1363 control) were randomized together by practice. Patients were age 5 to 56 years, had a diagnosis of asthma, and had existing prescriptions for ICS medication. Adherence was estimated by using prescription and fill data. Unlike clinicians in the control arm, intervention arm providers could view updated ICS adherence information on their patients via electronic prescription software, and further details on patient ICS use could be viewed by selecting that option. The primary outcome was ICS adherence in last 3 months of the study period.

Results

At the study end for the intention-to-treat analysis, ICS adherence was not different among patients in the intervention arm compared with those in the control arm (21.3% vs 23.3%, respectively; P = .553). However, adherence was significantly higher among patients whose clinician elected to view their detailed adherence information (35.7%) compared with both control arm patients (P = .026) and intervention arm patients whose provider did not view adherence data (P = .002).

Conclusions

Overall, providing adherence information to clinicians did not improve ICS use among patients with asthma. However, patient use may improve when clinicians are sufficiently interested in adherence to view the details of this medication use.

Section snippets

Study participants

The primary purpose of this trial was to determine whether providing individual patient medication adherence information to physicians electronically for discussion with their patients with asthma could result in improved inhaled corticosteroid use. This study was approved by the Henry Ford Health System institutional review board and was in compliance with its Health Insurance Portability and Accountability Act policy. The study was implemented in a single, large, integrated health system

Results

We enrolled 193 (93.2%) of 207 primary care providers from 34 practice groups throughout the health system (Fig 1). This group of providers included 49 family medicine practitioners, 88 internists, 5 internists/pediatricians, 41 pediatricians, 9 physician assistants, and 1 nurse practitioner. One pediatrician from the intervention group withdrew after enrollment. Seventeen practices (88 providers) were randomly assigned to the intervention arm, and 17 practices (105 providers) were assigned

Discussion

To our knowledge, this is the first large-scale, controlled study to test the effectiveness of routinely providing patient medication adherence information to clinicians. Although smaller studies have suggested that medication use improves when clinicians are provided measures of adherence to discuss with their patients,10, 20, 21, 22, 23 the processing and delivery of these data to health care providers in these earlier interventions were more labor-intensive, thus limiting their applicability

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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.
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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.
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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.”
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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Literature searches were conducted in five databases in August 2018. Included studies were randomized controlled trials comparing eHealth interventions versus usual care in improving adherence among patients prescribed ICS for persistent asthma. Quantitative synthesis was performed using a random effects model.
Eighty records were identified after removal of duplicates. Fifteen trials were eligible for qualitative synthesis. Included trials utilized: social media (n = 1), electronic health records (n = 1), telehealth (n = 6), and mHealth (n = 7). Twelve trials were eligible for quantitative synthesis. Results show a small but significant overall effect of eHealth interventions on adherence to ICS (Standardized Mean Difference (SMD) = 0.41, 95%CI = 0.02–0.79). Among the different types of eHealth interventions, a significant improvement in adherence was observed for mHealth interventions compared to usual care in a pooled analysis of 4 trials (SMD = 0.96, 95%CI = 0.28–1.64). However, there was considerable heterogeneity among studies. Patient satisfaction was evaluated in 5 trials comparing telehealth (n = 2) and mHealth (n = 3) with usual care. Participants found the interventions to be helpful and satisfactory.
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2016, Presse Medicale
L’asthme est une maladie fréquente avec des caractéristiques cliniques et immunopathologiques hétérogènes et complexes. La thérapeutique actuelle, qui repose sur la corticothérapie inhalée plus ou moins associée aux β2-mimétiques de longue durée d’action, est efficace et permet de contrôler les symptômes d’asthme de la grande majorité des patients. L’asthme sévère est caractérisé par un mauvais contrôle des symptômes, des exacerbations récurrentes et parfois un trouble ventilatoire obstructif chronique malgré une prise en charge optimale. Les choix thérapeutiques concernant ces patients reposent de plus en plus sur les biothérapies. Nous disposons maintenant d’études solides prouvant l’efficacité clinique des traitements ciblant les IgE et l’interleukine-5 et des données prometteuses concernant les traitements ciblant les interleukines 4 et 13. Mais l’utilisation de ces traitements reste encore limitée par la difficulté de confirmer le diagnostic d’asthme sévère et par l’absence de critères simples permettant de sélectionner le traitement de première intention qui a le plus de chance d’être efficace chez un patient. Actuellement la plupart de ces biothérapies disponibles ou prometteuses sont dirigées contre des mécanismes inflammatoires de type Th2 et nous ne disposons pas encore de traitement dirigé contre l’inflammation non éosinophile ou de type Th1. Il sera également indispensable d’évaluer précisément le rapport coût/efficacité de ces traitements onéreux afin de mieux identifier et quantifier la population cible, et chiffrer son impact financier pour la collectivité.
Asthma is a very frequent disease with complex and heterogenous immunological and clinical features. Daily inhaled steroids are the cornerstone of the current therapeutics sometimes associated with long-acting β2-agonist. This controller treatment is effective and allows to control asthma symptoms for the vast majority of the patients. Severe asthma is characterized by a poor level of control of symptoms, with recurrent exacerbations or a chronic airflow limitation despite an optimal management. Severe asthma remains a difficult diagnosis but we have now studies proving the clinical efficacy or promising data about monoclonal antibodies targeting IgE, IL-5, IL-4 or IL-13. Most of these monoclonal antibodies target the Th2 type eosinophilic inflammation without any treatment against non-eosinophilic or Th1 inflammation. Last, it will be essential to assess accurately the cost effectiveness of these expensive treatments, to identify and to qualify the target population for each molecule and to assess its financial impact for the community.

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: Supported by grants from the National Heart, Lung, and Blood Institute (HL79055), the National Institute of Allergy and Infectious Diseases (AI61774, AI79139), the National Institute of Diabetes and Digestive and Kidney Diseases (DK64695), National Institutes of Health; the Fund for Henry Ford Hospital; and the Strategic Program for Asthma Research of the American Asthma Foundation.

: Disclosure of potential conflict of interest: L. K. Williams has received research support from the National Institutes of Health and has served on an advisory board for Merck. E. L. Peterson has received research support from the National Institutes of Health. D. E. Lanfear has received research support from Merck and the National Institutes of Health (NHLBI). The rest of the authors have declared that they have no conflict of interest.

: Trial registration: clinicaltrials.gov identifier: NCT00459368.

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Asthma and lower airway diseaseA cluster-randomized trial to provide clinicians inhaled corticosteroid adherence information for their patients with asthma

Background

Objective

Methods

Results

Conclusions

Section snippets

Study participants

Results

Discussion

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

J Allergy Clin Immunol

Ann Allergy Asthma Immunol

J Allergy Clin Immunol

J Clin Epidemiol

Ann Allergy Asthma Immunol

Am J Med Sci

Behav Res Ther

Am Heart J

J Allergy Clin Immunol

J Allergy Clin Immunol

Adherence to medication

N Engl J Med

The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication

Psychol Health

Expert Panel Report 3 (EPR-3): guidelines for the diagnosis and management of asthma-summary report 2007

J Allergy Clin Immunol

Asthma and lower airway disease
A cluster-randomized trial to provide clinicians inhaled corticosteroid adherence information for their patients with asthma