Assessing Decision Maker Tools for Asthma: the Asthma APGAR (Asthma APGAR)

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Use of Asthma APGAR system and tools; Behavioral: Asthma APGAR tools

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55904
      • Olmsted Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asthma APGAR; 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; Practices will use the Asthma APGAR control questionnaire and the care algorithm.
Placebo Comparator: Usual care; Usual asthma care as provided by the sites.	Behavioral: Asthma APGAR tools; Usual care

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

Collaborators and Investigators

• Sponsor: Olmsted Medical Center

Publications and helpful links

General Publications

• Yawn BP, Wollan PC, Rank MA, Bertram SL, Juhn Y, Pace W. Use of Asthma APGAR Tools in Primary Care Practices: A Cluster-Randomized Controlled Trial. Ann Fam Med. 2018 Mar;16(2):100-110. doi: 10.1370/afm.2179.
• Rank MA, Bertram S, Wollan P, Yawn RA, Yawn BP. Comparing the Asthma APGAR system and the Asthma Control Test in a multicenter primary care sample. Mayo Clin Proc. 2014 Jul;89(7):917-25. doi: 10.1016/j.mayocp.2014.02.016. Epub 2014 May 5.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): October 1, 2014
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: asthma; primary care; effectiveness; asthma care system; practice based research network
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1R01HS018431 (U.S. AHRQ Grant/Contract)