Asthma Clinical Trial
Official title:
Cueing Patient-Clinician Collaboration to Improve Asthma
The purpose of this study is to improve anti-inflammatory medication adherence and asthma outcomes by using reports of peak flow monitoring to prompt communication between patients and their doctors.
BACKGROUND:
Asthma is a chronic, potentially life-threatening disease that affects 17 million people in
the United States. Asthma leads to millions of lost work days and thousands of
hospitalizations annually. For the millions of people with this disease, it is chronic but
controllable. Corticosteroids are the most effective medication for the long-term treatment
of persistent asthma, and inhaling the medication minimizes the potential for systemic side
effects. Despite convincing evidence of the benefits of inhaled corticosteroids (ICS), both
patients and doctors seem reluctant to use them regularly. Many people who are prescribed
ICS either never take them, or take them less frequently (e.g., once rather than twice
daily), less regularly (e.g., "as needed" rather than daily), or at lower doses than
prescribed. Doctors agree that at least 50% of people who are prescribed ICS fail to benefit
fully because of poor adherence. The many reasons for non-adherence are not fully
understood. The relationship between the doctor and patient, an area in which potential
impact can be made, is believed to be the strongest predictor of medication adherence.
Providing pertinent information about asthma related lung function should prompt
communication between the patient and doctor to improve adherence to ICS.
DESIGN NARRATIVE:
The overall purpose of this study is to improve anti-inflammatory medication adherence and
asthma outcomes by encouraging communication between patients and their doctor. The specific
aims of the study include the following: 1) improve adherence to ICS medication by
encouraging patient-doctor communication with feedback of objective information about
airflow obstruction to reinforce medication-taking behavior; and 2) document the impact that
the encouragement of communication has on health care outcomes, including health care
utilization, pulmonary function, need for rescue courses of oral steroids, and functional
impact. The hypothesis of the study is that informing patients and their primary care
doctors about the degree of airflow obstruction will prompt interaction between them
resulting in greater adherence to ICS medication over one year than will occur in a control
group of similar patients who do not receive feedback. Promoting communication between
adults with asthma and their doctors in a primary care clinical setting has not yet been
studied. All doctors within three general medicine practices and their adult patients with
moderate to severe asthma will be enrolled and assigned to either the intervention or usual
care. Feedback of interpreted peak flow graphs in relation to current medication therapy
will prompt the communication. The intent is to encourage and support the relationship
between the doctor and patient rather than to directly intervene. The power of encouraging
communication lies in the ensuing dialogue between the doctor and patient. Improvement of
adherence to ICS among people with moderate or severe asthma has been shown to decrease
morbidity of asthma and improve health outcomes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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