The Provider and Organization in Asthma Guidelines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345514
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : November 9, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michelle Cloutier, UConn Health

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. +

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Behavioral Intervention Arm Behavioral: Organizational Interventions Arm Not Applicable

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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Provider and Organization in Asthma Guidelines
Study Start Date : September 2002
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Active Comparator: 2 Behavioral: Behavioral Intervention Arm
The arm emphasized individual provider behavior (interactive CME, feedback at the provider, clinic and program levels, expert modeling, academic detailing and opinion leaders)
Other Name: Provider Intervention Arm
Active Comparator: 3 Behavioral: Organizational Interventions Arm
Leadership, team building, benchmarking at the clinic and program level
Other Name: Organizational Arm

Primary Outcome Measures :
  1. Number of Easy Breathing Surveys Distributed [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Organizational Culture [ Time Frame: baseline; 12 months and 36 months after intervention phase ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have used Easy Breathing Disease Management Program for more than one year.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345514

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michelle M Cloutier, MD UConn Health

Responsible Party: Michelle Cloutier, Professor of Pediatrics, UConn Health Identifier: NCT00345514     History of Changes
Other Study ID Numbers: 5R01HL070785 ( U.S. NIH Grant/Contract )
CCMC 01-111
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Michelle Cloutier, UConn Health:
Process of care

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases