The Provider and Organization in Asthma Guidelines
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention Arm
Organizational Interventions Arm
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Children, Self-efficacy, Organization, Process of care
Eligibility Criteria
Inclusion Criteria: Must have used Easy Breathing Disease Management Program for more than one year. Exclusion Criteria: None
Sites / Locations
- University of Connecticut Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Number of Easy Breathing Surveys Distributed
Secondary Outcome Measures
Organizational Culture
Full Information
NCT ID
NCT00345514
First Posted
June 27, 2006
Last Updated
November 8, 2012
Sponsor
UConn Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00345514
Brief Title
The Provider and Organization in Asthma Guidelines
Official Title
The Provider and Organization in Asthma Guidelines
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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. +
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Children, Self-efficacy, Organization, Process of care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention Arm
Other Intervention Name(s)
Provider Intervention Arm
Intervention Description
The arm emphasized individual provider behavior (interactive CME, feedback at the provider, clinic and program levels, expert modeling, academic detailing and opinion leaders)
Intervention Type
Behavioral
Intervention Name(s)
Organizational Interventions Arm
Other Intervention Name(s)
Organizational Arm
Intervention Description
Leadership, team building, benchmarking at the clinic and program level
Primary Outcome Measure Information:
Title
Number of Easy Breathing Surveys Distributed
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Organizational Culture
Time Frame
baseline; 12 months and 36 months after intervention phase
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have used Easy Breathing Disease Management Program for more than one year.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle M Cloutier, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
12. IPD Sharing Statement
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The Provider and Organization in Asthma Guidelines
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