Assessing Decision Maker Tools for Asthma: the Asthma APGAR

Olmsted Medical Center

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Behavioral: Use of Asthma APGAR system and tools; Behavioral: Asthma APGAR tools

Study type: Interventional

Funder types: Other

Identifiers

NCT01446315

1R01HS018431

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have physician diagnosed asthma
2. Male or female between ages 5 through 60 years
3. Have persistent asthma as assessed by daily use of "controller" medication
4. Receive continuity care at practice where enrolled.
5. Not have been in ICU for asthma ever
6. Do not require daily or every other day oral steroids for asthma control

Exclusion criteria

1. Cannot read and speak English
2. Child refuses assent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups, including a placebo group

Asthma APGAR

Experimental group

Description:

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.

Treatment:

Behavioral: Use of Asthma APGAR system and tools

Usual care

Placebo Comparator group

Description:

Usual asthma care as provided by the sites.

Treatment:

Behavioral: Asthma APGAR tools