Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Williams LK

PROVIDER: S-EPMC2917519 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Williams L Keoki LK Peterson Edward L EL Wells Karen K Campbell Janis J Wang Mingqun M Chowdhry Vimal K VK Walsh Matthew M Enberg Robert R Lanfear David E DE Pladevall Manel M

The Journal of allergy and clinical immunology 20100531 2

<h4>Background</h4>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.<h4>Objective</h4>To assess the effect of supplying patient adherence information to primary care providers.<h4>Methods</h4>Patients and providers were members of a health system serving southeast Michigan. Providers (88 intervention; 105 control) and patients (1335 intervention; ...[more]

PMID: 20569973

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Project description:Inhaled corticosteroids (ICS) are effective maintenance treatments for childhood asthma; however, many children remain uncontrolled. Vilanterol (VI) is an inhaled long-acting beta-2 agonist which, in combination with the ICS fluticasone furoate, is being explored as a once-daily treatment for asthma in children. We evaluated the dose-response, efficacy, and safety of once-daily VI (6.25 ?g, 12.5 ?g and 25 ?g) administered in the evening over 4 weeks, on background fluticasone propionate (FP) in children with asthma inadequately controlled on ICS.This was a Phase IIb, multicentre, randomised, double-blind, parallel-group, placebo-controlled study in children ages 5-11 years with persistent asthma on ICS and as-needed short-acting beta-agonist. The study comprised a 4-week run-in, 4-week treatment period, and 1-week follow-up. From study start, children replaced their current ICS with open-label FP 100 ?g twice daily. Children were randomised to receive placebo, VI 6.25 ?g, VI 12.5 ?g or VI 25 ?g once daily. Primary endpoint was treatment difference between VI 25 and placebo groups in mean change from baseline in evening peak expiratory flow averaged over the 4-week treatment. Secondary endpoints included change from baseline in trough forced expiratory volume in one second (FEV1) at Week 4 and change from baseline in percentage of rescue-free and symptom-free 24-h periods. Safety assessments included incidence of adverse events (AEs) and asthma exacerbations.In total, 456 children comprised the intention-to-treat population. The adjusted treatment difference between VI 25 and placebo groups for the primary endpoint was not statistically significant (p?=?0.227) so no statistical inference was made for other VI dose comparisons or other endpoints. No difference in change from baseline in trough FEV1 was observed for any VI treatments versus placebo; however, VI 25 resulted in an additional 0.6 rescue-free days and 0.7 symptom-free days per week versus placebo. The incidence of AEs was slightly higher in the VI groups (28-33 %) versus placebo (22 %). Nine children experienced asthma exacerbations during the treatment period.VI plus FP did not result in significant improvements in lung function versus placebo plus FP, but was well tolerated at all doses assessed.NCT01573767 (ClinicalTrials.gov).

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Dataset Information

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

Background

Objective

Methods

Results

Conclusions

Publications

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

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