Assessment of Shared Decision Making Aids in Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the use of shared decision making aids is more effective than usual care in improving asthma knowledge, lessening decisional conflict, and enhancing adherence to treatments and asthma control in adult patients with mild to severe asthma.

Official Title
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Utility of Two Patients Decision Aids About Asthma Inhaled Controller Medication Use in Adult Patients With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: Patient decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, aged 18 to 65 years; Current diagnosis of mild to severe asthma; 2.1) Asthma diagnosis will be made upon one of the following criteria: 2.1.1) Forced expiratory volume in one second (FEV1) increases by at least 12% after the use of a bronchodilator (and a minimum ≥ 200 mL); 2.1.2) Current asthma symptoms and a positive methacholine challenge test (20% fall in FEV1 after inhalation of a provocative dose of methacholine 16 mg/mL); 2.1.3) A respirologist's current diagnosis of asthma found in the patient's medical report. 2.2) Severity of asthma will be assessed according to prescribed pharmacotherapy, as suggested by the 2012 Canadian Thoracic Society Guidelines: 2.2.1) Patients with mild asthma using SABA as well as low doses (≤250 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids; 2.2.2) Patients with moderate asthma using SABA as well as low to moderate doses (250mcg/day < dose ≤500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, with or without additional therapy (LABA or LTRA); 2.2.3) Patients with severe asthma using high doses (>500 mcg/day beclomethasone or equivalent) of inhaled glucocorticosteroids, and additional pharmacotherapy (LABA, LTRA, or Prednisone), and SABA. Exclusion Criteria: Chronic obstructive pulmonary disease (COPD); Education on asthma in the last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient decision aids<br>Participants read and fill a patient decision aid before being provided education on asthma. | Other: Patient decision aid<br>* The patient decision aid is a 12-page A3 size color-printed booklet entitled Should I take asthma inhaled controller medication to optimize asthma control?<br>|
| No Intervention: Usual care<br>Participants do not read and fill a patient decision aid before being provided education on asthma. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in asthma knowledge at 2 months, measured by QCALF score |  | Visit 1 (baseline) and visit 2 (2-month follow-up) | 
| Change from baseline in decisional conflict at 2 months, measured by DCS score |  | Visit 1 (baseline) and visit 2 (2-month follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in adherence to treatment at 2 months, measured by questionnaire |  | Visit 1 (baseline) and visit 2 (2-month follow-up) | 
| Change from baseline in asthma control at 2 months, measured by ACSS score |  | Visit 1 (baseline) and visit 2 (2-month follow-up) |