The Breathe Well Program for Adults With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14978 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2023-06-30

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

This is a pragmatic controlled trial. Participants randomized to the intervention group will know when they receive the intervention, which will consist of an automated contact by IVR call/text, or email.

Study Groups

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IVR call/text

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Group Type ACTIVE_COMPARATOR

IVR call/text

Intervention Type BEHAVIORAL

For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text

Email

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Group Type ACTIVE_COMPARATOR

Email

Intervention Type BEHAVIORAL

Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email

Interventions

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IVR call/text

For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text

Intervention Type BEHAVIORAL

Email

Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. B-agonist overfilling
2. inhaled corticosteroid (ICS) underfilling
3. current smoker
4. asthma exacerbation in the last year

Exclusion Criteria

1. limited life expectancy
2. diagnosis of chronic obstructive pulmonary disease
3. lack of a pharmacy benefit because medication use cannot be captured.

Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No