Using Information Technology to Improve Asthma Adherence
Condition: Asthma; Patient Compliance
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether providing patient medication adherence
      information on inhaled corticosteroid use to clinicians will result in improved patient
      adherence and asthma control.
    

Detailed description: 
      In 2001 an estimated 31.1 million people in the United States reported ever having had an
      asthma diagnosis. Asthma is a leading cause of preventable hospitalizations, and it accounts
      for an estimated 14 million days of missed school and 100 million days of restricted activity
      yearly.

      The routine use of anti-inflammatory medications, particularly inhaled corticosteroids (ICS),
      in the treatment of asthma can markedly improve symptoms and reduce complications. Yet,
      evidence suggests that these medications are under-prescribed by physicians and poorly taken
      by patients. For example, in one study of asthma patients enrolled in a large, California HMO
      only 71.7% of patients with severe symptoms reported having a steroid inhaler, and only 53.6%
      of those reported using it daily in the preceding month. Using electronic monitoring devices
      to record inhaler use, researchers have estimated that patients use their ICS as directed 20
      to 73% of the time. Using claims-based measures of adherence we have shown that adherence to
      inhaled steroids is inversely correlated with the frequency of oral steroid use and
      asthma-related emergency room visits. In addition, these measures suggest that non-adherence
      to ICS is an independent predictor of asthma-related hospitalizations. In our study
      population, we estimated that 60% of asthma-related hospitalizations were attributable to
      poor adherence to ICS. Together these findings suggest that increasing ICS use may improve
      asthma outcomes.

      Studies employing health-behavioral models of adherence suggest that medication adherence is
      associated with treatment-related concerns regarding complications, efficacy, and benefits.
      Unfortunately, the results of behavioral and educational interventions to improve adherence
      have been disappointing. Despite, in some cases, considerable time spent with patients, these
      interventions have at best resulted in modest adherence improvements. Given the time,
      training, and resources required to implement these interventions, they are unlikely to be
      widely adopted in the clinical setting. Some recent studies, however, suggest that providing
      adherence data to clinicians may improve patient adherence. In one, clinicians gave repeated
      feedback to patients regarding ICS adherence; this resulted in sustained improvements over
      the study period. Unfortunately, this small study did not find differences in asthma
      outcomes.

      In this proposal we seek to test an asthma adherence intervention specifically designed for
      use in the clinical setting. Adherence measures will be generated by linking currently
      available electronic data. In this cluster-randomized trial, primary care physician-practice
      groups will be randomized to receive asthma medication adherence information electronically
      for patients with asthma associated with these practices. In addition to ICS adherence
      information, clinicians in intervention practices will have data on patient beta-agonist use
      to better tailor ICS therapy to disease severity.

      Eligible patients with asthma will be identified prior to randomizing practices and will be
      invited to participate. Patient surveys will be sent in the pre-intervention survey and in
      the post-intervention period. Patient-level outcomes will be assessed through the medical
      record, patient surveys, and claims data.

      We will perform an intention-to-treat analysis with all eligible patients identified
      pre-randomization included in the analysis (the primary analysis). This study is powered to
      allow for only 60% of the eligible patient population being seen within the first 6-months
      (i.e., no effect in 40% of the patient population). As a secondary analysis, we will perform
      a modified intention-to-treat (or per protocol) analysis, whereby we will analyze the results
      of only those patients in both study arms seen within the first 6-months of the intervention.
    

Intervention name(s): Feedback of patient adherence information; Active control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patient inhaled corticosteroid adherence information is being provided to physicians at clinic sites randomized to the intervention arm. Adherence information is available via electronic prescribing software, and so is available to physicians when writing, renewing, or viewing medications. Physicians at intervention sites also receive standard training in how to interpret adherence metrics and how to intervene on poor adherence.; Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
Other intervention name(s): Adherence feedback; Standard care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; patient compliance; metered dose inhalers; corticosteroids; health behaviour; prevention & control