The Breathe Well Program for Adults With Asthma

Asthma Clinical Trial

Official title:

The Breathe Well Program to Improve Asthma Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761837
• Other study ID #: National Jewish Health
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 2023

Study information

• Verified date: November 2023
• Source: National Jewish Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14978
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• IVR call/text
For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text
• Email
Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email

Locations

Country	Name	City	State
United States	Kaiser Permanente of Colorado	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Exacerbations	Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid	12 months
Secondary	Controller medication adherence	Days of medication possession will be calculated for each patient	12 months