- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00345514
The Provider and Organization in Asthma Guidelines
November 8, 2012 updated by: Michelle Cloutier, UConn Health
The purpose of this study is to examine the interaction between the personal attributes of clinicians and the organizations in which they work and the effect of interventions on their ability to implement an asthma disease management program.
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Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Less than 20% of primary care providers adhere to national asthma guidelines.
Interventions to improve provider adherence to guidelines have had modest success.
We believe that changing provider behavior must be viewed in the context of the provider's environment.
We hypothesize that providers who are most successful in implementing and sustaining asthma management programs will have a set of personal attributes, related to asthma, characterized by readiness to change, high self-efficacy, positive outcome expectancies and high outcome value AND will work within organizations that facilitate and support such activities.
We propose a two phase study.
In Phase 1 (Year 1) survey instrument development and testing and provider meetings to discuss the interventions will occur.
Providers in 49 practices/clinics that are using an asthma management program called Easy Breathing, will complete these surveys that will characterize the organization and organizational culture of the clinics/practices and the provider personal attributes surrounding asthma.
In Years 2-5, a randomized, controlled study of either a behavioral intervention, an organizational intervention or no intervention (control) will be performed in 36 of these clinics/practices.
Clinics/practices in the behavioral arm will receive an intervention consisting of expert modeling, program-, clinic- and provider-specific feedback, and use of opinion leaders and academic detailing.
Clinics/practices in the organizational arm will receive an intervention consisting of benchmarking, leadership capability training and team building and incentives/ rewards.
The primary outcome variable is the number of Easy Breathing surveys completed by provider and by clinic/unit of time.
We have previously shown that enrollment in Easy Breathing (which was adapted directly from the national asthma guidelines) as demonstrated by completion of a survey is a surrogate indicator of inhaled corticosteroid use and is associated with decreased medical services utilization.
This study will thus investigate the complex interactions between provider personal attributes and the organization and the effect of targeted interventions on provider performance to implement an asthma disease management program.
These data will then be used in future studies to determine how to better tailor interventions in a cost constrained environment.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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Farmington, Connecticut, United States, 06030
- University of Connecticut Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must have used Easy Breathing Disease Management Program for more than one year.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 2
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The arm emphasized individual provider behavior (interactive CME, feedback at the provider, clinic and program levels, expert modeling, academic detailing and opinion leaders)
Other Names:
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Active Comparator: 3
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Leadership, team building, benchmarking at the clinic and program level
Other Names:
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No Intervention: 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of Easy Breathing Surveys Distributed
Time Frame: 4 years
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4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Organizational Culture
Time Frame: baseline; 12 months and 36 months after intervention phase
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baseline; 12 months and 36 months after intervention phase
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle M Cloutier, MD, UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
June 27, 2006
First Submitted That Met QC Criteria
June 27, 2006
First Posted (Estimate)
June 28, 2006
Study Record Updates
Last Update Posted (Estimate)
November 9, 2012
Last Update Submitted That Met QC Criteria
November 8, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01HL070785 (U.S. NIH Grant/Contract)
- CCMC 01-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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