Assessing Decision Maker Tools for Asthma: the Asthma APGAR

Study Overview
=================
Brief Summary
-----------------
Asthma is a common problem among US adults and children. Unfortunately many people with asthma continue to suffer from asthma symptoms that could be control with better asthma care and more attention to details such as triggers, and adherence. To date the only tools available and recommended by groups such as the national asthma guideline group consider only asthma burden and do not include information on the most common factors that adversely affect asthma control. This study provides one half of the enrolled primary care offices with the Asthma APGAR which is a system of patient completed questions and a care flow sheet. The other half of the enrolled practices will continue to provide usual care without the support of the Asthma APGAR system. The research questions is whether or not asthma control and asthma related quality of life will be improved in people with asthma who are cared for in the intervention practices that use the Asthma APGAR system.

Detailed Description
-----------------
Since this is a practice intervention study, the practices are randomized and all patients enrolled within each practice receive either the intervention based care or the usual care. The primary outcome is asthma related quality of life obtained from patient report. Other outcomes include asthma control, also a patient reported outcome, and number of exacerbations which is obtained from patient medical record review.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Use of Asthma APGAR system and tools
* Behavioral: Asthma APGAR tools


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have physician diagnosed asthma Male or female between ages 5 through 60 years Have persistent asthma as assessed by daily use of controller medication Receive continuity care at practice where enrolled. Not have been in ICU for asthma ever Do not require daily or every other day oral steroids for asthma control Exclusion Criteria: Cannot read and speak English Child refuses assent

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asthma APGAR<br>Use of new asthma care tools. Primary care practices will be provided and educated about the Asthma APGAR tool system to guide asthma care. The practices will adopt this system for all people in their practices with asthma. Outcomes will be assessed only for those who meet enrollment criteria and sign informed consent. | Behavioral: Use of Asthma APGAR system and tools<br>* Practices will use the Asthma APGAR control questionnaire and the care algorithm.<br>|
| Placebo Comparator: Usual care<br>Usual asthma care as provided by the sites. | Behavioral: Asthma APGAR tools<br>* Usual care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Quality of Life Questionnaire (AQLQ) | Chagne in asthma relted quality of life from basline (enrollment date) to 12 months later | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire | Change in asthma control from baseline to 12 month follow up. | 12 months | 
| Exacerbation rate | Number of emergency department visits, hospitalization and episodes of oral steroid bursts--all related to asthma, during the 12 months of follow as obtained from patient report and medical record review. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, asthma care system, effectiveness, primary care, practice based research network