The Breathe Well Program for Adults With Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Email; Behavioral: IVR call/text

• Registration Number: NCT02761837
• Lead Sponsor: National Jewish Health

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 Timeline

• Study First Submitted: 2016-04-28
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Study Start: 2016-10
• Primary Completion: 2023-06
• Study Completion: 2023-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14978

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Email	Email	Identify gaps in care and contact patients by email
IVR call/text	IVR call/text	Identify gaps in care and contact patients by IVR phone call or text

Primary Outcome Measures

Name	Time	Method
Asthma Exacerbations	12 months	Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid

Secondary Outcome Measures

Name	Time	Method
Controller medication adherence	12 months	Days of medication possession will be calculated for each patient

Trial Locations

Locations (1)

Kaiser Permanente of Colorado; 🇺🇸 Denver, Colorado, United States