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AsthmaNCT00345514

The Provider and Organization in Asthma Guidelines

A study testing Behavioral Intervention Arm and Organizational Interventions Arm in people with Asthma, run by UConn Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. + Read more about this study

Who is it for?
Any age
Conditions the study is for
Asthma
What is being tested?
Behavioral Intervention Arm and Organizational Interventions Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Sep 2002to Sep 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

Other trials in United States

About this study

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. +

Read the 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.

Conditions
Asthma
Being tested
Behavioral Intervention Arm, Organizational Interventions Arm
Keywords
Children, Self-efficacy, Organization, Process of care
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral Intervention ArmBehavioural

    Also called Provider 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)

  • Organizational Interventions ArmBehavioural

    Also called Organizational Arm

    Leadership, team building, benchmarking at the clinic and program level

Study groups in NCT00345514
Study groupRoleWhat they receive
1No interventionNot described
2Active comparatorNot described
Receives: Behavioral: Behavioral Intervention Arm
3Active comparatorNot described
Receives: Behavioral: Organizational Interventions Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Easy Breathing Surveys Distributed

    Measured: 4 years

Secondary outcomes (1)
  1. Organizational Culture

    Measured: baseline; 12 months and 36 months after intervention phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2006 (estimated)
  2. Study startSep 2002
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00345514
Sponsor's protocol ID
5R01HL070785
Other IDs
CCMC 01-111
Status last verified
Nov 2012
First submitted
27 Jun 2006
Last updated
9 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Intervention Arm and Organizational Interventions Arm in people with Asthma, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Easy Breathing Surveys Distributed (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2012.

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