The Breathe Well Program to Improve Asthma Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- National Jewish Health
- Enrollment
- 14,978
- Locations
- 1
- Primary Endpoint
- Asthma Exacerbations
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 19 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
IVR call/text
Identify gaps in care and contact patients by IVR phone call or text
Intervention: IVR call/text (Behavioral)
Identify gaps in care and contact patients by email
Intervention: Email (Behavioral)
Outcomes
Primary Outcomes
Asthma Exacerbations
Time Frame: 12 months
Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid
Secondary Outcomes
- Controller medication adherence(12 months)