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The Breathe Well Program for Adults With Asthma

The Breathe Well Program to Improve Asthma Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02761837
Enrollment
14978
Registered
2016-05-04
Start date
2016-10-31
Completion date
2023-06-30
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

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.

Interventions

BEHAVIORALIVR call/text

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

BEHAVIORALEmail

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

Sponsors

Kaiser Permanente
CollaboratorOTHER
National Jewish Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
19 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

Adults with ≥1 EHR of these indicators of an asthma care gap in the EHR will be eligible. 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.

Design outcomes

Primary

MeasureTime frameDescription
Asthma Exacerbations12 monthsDefined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid

Secondary

MeasureTime frameDescription
Controller medication adherence12 monthsDays of medication possession will be calculated for each patient

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026