Official Title: “Cueing Patient-Clinician Collaboration to Improve Asthma”

To improve anti-inflammatory medication adherence and asthma outcomes by using reports of peak flow monitoring to prompt communication between patients and their doctors.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2008

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.

Intervention(s) in this Clinical Trial

• Behavioral: Status Reports
  • Interpreted Analysis of Peak-Flow Monitoring Trends

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Participants will receive feedback and peak flow monitoring reports from their doctors.
• No Intervention: 2
  • Participants will receive usual care.

Primary Measures

• Adherence to ICS medication
  • Time Frame: Measured on a monthly basis
    Safety Issue?: No

Inclusion Criteria:

• Asthma
• Currently using ICS
• Planning to live in the San Francisco Bay Area in the year following study entry

Exclusion Criteria:

• Diagnosis of any lung disease other than asthma
• Has a smoking history greater than or equal to 15 pack-years
• Psychological problems that may make monthly study visits impossible

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 72 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Susan L. Janson, DNSc, ANP, RN, FAAN Study Chair University of California, San Francisco  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00201188

Study ID Number: 279

ClinicalTrials.gov Identifier: NCT00201188

Health Authority: United States: Federal Government