The Breathe Well Program for Adults With Asthma

Study Overview
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Brief Summary
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The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness, cost-effectiveness, and implementation of the Breathe Well intervention, which combines evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to improve asthma outcomes.

Detailed Description
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Breathe Well uses the Kaiser Permanente Electronic Health Record (EHR) to identify asthma exacerbation risk factors. For patients with a history of frequent exacerbations or B-agonist overuse, the EHR notifies a nurse who uses an EHR-generated tailored clinical report and patient directed decision support tool to engage and empower patients to develop an action plan in collaboration with providers. EHR-templated notes and order sets facilitate care plan execution. Poor controller medication adherence or unaddressed smoking results in the patient being automatically enrolled in an IBCT medication refill or smoking cessation program. Breathe Well uses multiple EHR functions and a patient and provider team to address barriers to evidence-based asthma care for providers.The study will be conducted in 26 primary care clinics of Kaiser Permanente Colorado (KPCO) using a pragmatic clinical trial design. Up to 15,000 high-risk asthma patients will be assigned to Breathe Well or guideline-based usual care based on their clinic.

Official Title
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The Breathe Well Program to Improve Asthma Outcomes

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: IVR call/text
* Behavioral: Email


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with ≥1 EHR of these indicators of an asthma care gap in the EHR will be eligible. B-agonist overfilling inhaled corticosteroid (ICS) underfilling current smoker asthma exacerbation in the last year Exclusion Criteria: limited life expectancy diagnosis of chronic obstructive pulmonary disease lack of a pharmacy benefit because medication use cannot be captured.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 99 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
Interventional Model Description: Participants were randomized to either 1) usual care or 2) Interactive Voice Response (IVR) or 3) email. Those in the groups 2 or 3 will receive the intervention only if they smoke, underuse controller medication, or overuse rescue medication.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IVR call/text<br>Identify gaps in care and contact patients by IVR phone call or text | Behavioral: IVR call/text<br>* For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text<br>|
| Active Comparator: Email<br>Identify gaps in care and contact patients by email | Behavioral: Email<br>* Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Exacerbations | Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controller medication adherence | Days of medication possession will be calculated for each patient | 12 months |