Using Information Technology to Improve Asthma Adherence (AFFIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459368
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : August 10, 2010
Last Update Posted : August 17, 2010
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Henry Ford Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Patient Compliance Behavioral: Feedback of patient adherence information Behavioral: Active control group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2698 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adherence Feedback for Improving Respiratory Medication Use
Study Start Date : May 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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.
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
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.
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

Primary Outcome Measures :
  1. Patient Adherence to Inhaled Corticosteroids (ICS) [ Time Frame: 1 year ]
    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%.

Secondary Outcome Measures :
  1. Asthma-related Emergency Room Visits [ Time Frame: 1 year ]
  2. Asthma-related Hospitalizations [ Time Frame: 1 year ]
  3. Oral Steroid Use [ Time Frame: 1 year ]
  4. Patient Self-efficacy to ICS Treatment [ Time Frame: survey following intervention period ]
  5. Readiness to Improve ICS Adherence (Transtheoretical Model) [ Time Frame: survey following intervention period ]
  6. Patient-physician Communication (Patient Reported Measure) [ Time Frame: survey following intervention period ]
  7. Patient Medical Care Costs [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 56 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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):

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459368

United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: L. Keoki Williams, MD, MPH Henry Ford Health System


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: L. Keoki Williams, MD, MPH, Henry Ford Health System Identifier: NCT00459368     History of Changes
Other Study ID Numbers: R01HL079055 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2007    Key Record Dates
Results First Posted: August 10, 2010
Last Update Posted: August 17, 2010
Last Verified: June 2010

Keywords provided by Henry Ford Health System:
patient compliance
metered dose inhalers
health behaviour
prevention & control

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases