Enhancing Collaboration Between Doctors and Patients to Improve Asthma

NCT ID: NCT00201188

Last Updated: 2013-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2008-02-29

Brief Summary

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.

Detailed Description

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.

Conditions

Asthma; Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Participants will receive feedback and peak flow monitoring reports from their doctors.

Group Type: EXPERIMENTAL

Status Reports

Intervention Type: BEHAVIORAL

Interpreted Analysis of Peak-Flow Monitoring Trends

2

Participants will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Status Reports

Interpreted Analysis of Peak-Flow Monitoring Trends

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan L. Janson, DNSc,ANP,RN

Role: STUDY_CHAIR

University of California, San Francisco

Locations

University of California, San Francisco, Parnassus Campus

San Francisco, California, United States

Countries

United States

References

Janson SL, McGrath KW, Covington JK, Baron RB, Lazarus SC. Objective airway monitoring improves asthma control in the cold and flu season: a cluster randomized trial. Chest. 2010 Nov;138(5):1148-55. doi: 10.1378/chest.09-2394. Epub 2010 Jun 10.

Reference Type: DERIVED

PMID: 20538819 (View on PubMed)

Other Identifiers

R01HL073098

Identifier Type: NIH

Identifier Source: secondary_id

View Link

279

Identifier Type: -

Identifier Source: org_study_id