Using Information Technology to Improve Asthma Adherence (AFFIRM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00459368
First received: April 9, 2007
Last updated: August 10, 2010
Last verified: June 2010

April 9, 2007
August 10, 2010
May 2007
August 2008   (final data collection date for primary outcome measure)
Patient Adherence to Inhaled Corticosteroids (ICS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Adherence to ICS medication was measured during the last 3 months of the intervention (i.e., for the time period of 9-12 months post-randomization). Adherence was measured using pharmacy claims data, and represents the percent of prescribed medication taken. The normal range for this value is 0-100%.
patient adherence to inhaled corticosteroids
Complete list of historical versions of study NCT00459368 on ClinicalTrials.gov Archive Site
  • Asthma-related Emergency Room Visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Asthma-related Hospitalizations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Oral Steroid Use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patient Self-efficacy to ICS Treatment [ Time Frame: survey following intervention period ] [ Designated as safety issue: No ]
  • Readiness to Improve ICS Adherence (Transtheoretical Model) [ Time Frame: survey following intervention period ] [ Designated as safety issue: No ]
  • Patient-physician Communication (Patient Reported Measure) [ Time Frame: survey following intervention period ] [ Designated as safety issue: No ]
  • Patient Medical Care Costs [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • asthma-related emergency room visits
  • asthma-related hospitalizations
  • oral steroid use
  • patient self-efficacy to ICS treatment
  • readiness to improve ICS adherence (transtheoretical model)
  • patient-physician communication (patient reported measure)
  • patient medical care costs
Not Provided
Not Provided
 
Using Information Technology to Improve Asthma Adherence
Adherence Feedback for Improving Respiratory Medication Use

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Asthma
  • Patient Compliance
  • Behavioral: Feedback of patient adherence information
    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.
    Other Name: Adherence feedback
  • Behavioral: Active control group
    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 Name: Standard care
  • Experimental: I
    In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
    Intervention: Behavioral: Feedback of patient adherence information
  • Active Comparator: II
    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.
    Intervention: Behavioral: Active control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2698
November 2009
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria (patient-level):

  • Age 5-56 years
  • Physician diagnosis of asthma
  • Continuous HMO enrollment with prescription drug rider
  • Electronic prescription of an inhaled corticosteroid

Exclusion Criteria (patient-level):

  • Diagnosis of chronic obstructive pulmonary disease
  • Diagnosis of congestive heart failure

Inclusion Criteria (practice-level):

  • Primary care practice (i.e., pediatrics, family practice, or internal medicine) within the health system. A practice is defined as a group of physicians who by virtue of speciality or geography care for a relatively contained population of patients and who cross-cover the care of these patients.

Exclusion Criteria (practice-level):

  • None
Both
5 Years to 56 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00459368
R01HL079055
No
L. Keoki Williams, MD, MPH, Henry Ford Health System
Henry Ford Health System
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: L. Keoki Williams, MD, MPH Henry Ford Health System
Henry Ford Health System
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP