Enhancing Collaboration Between Doctors and Patients to Improve Asthma
Primary Purpose
Asthma, Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Status Reports
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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
Sites / Locations
- University of California, San Francisco, Parnassus Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Participants will receive feedback and peak flow monitoring reports from their doctors.
Participants will receive usual care.
Outcomes
Primary Outcome Measures
Adherence to ICS medication
Secondary Outcome Measures
Full Information
NCT ID
NCT00201188
First Posted
September 16, 2005
Last Updated
March 7, 2013
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00201188
Brief Title
Enhancing Collaboration Between Doctors and Patients to Improve Asthma
Official Title
Cueing Patient-Clinician Collaboration to Improve Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive feedback and peak flow monitoring reports from their doctors.
Arm Title
2
Arm Type
No Intervention
Arm Description
Participants will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Status Reports
Intervention Description
Interpreted Analysis of Peak-Flow Monitoring Trends
Primary Outcome Measure Information:
Title
Adherence to ICS medication
Time Frame
Measured on a monthly basis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L. Janson, DNSc,ANP,RN
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, San Francisco, Parnassus Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20538819
Citation
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.
Results Reference
derived
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Enhancing Collaboration Between Doctors and Patients to Improve Asthma
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