The Breathe Well Program for Adults With Asthma

The Breathe Well Program to Improve Asthma Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: IVR call/text; Behavioral: Email

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 Type: Interventional
• Enrollment (Actual): 14978
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80231
      • Kaiser Permanente of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IVR call/text; Identify gaps in care and contact patients by IVR phone call or text	Behavioral: IVR call/text; For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text
Active Comparator: Email; Identify gaps in care and contact patients by email	Behavioral: Email; Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Exacerbations	Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Controller medication adherence	Days of medication possession will be calculated for each patient	12 months

Collaborators and Investigators

• Sponsor: National Jewish Health
• Collaborators: Kaiser Permanente

Publications and helpful links

General Publications

• Cvietusa PJ, Wagner NM, Shoup JA, Goodrich GK, Shetterly SM, King DK, Raebel MA, Riggs CS, Bender B. Digital Communication Technology: Does Offering a Choice of Modality Improve Medication Adherence and Outcomes in a Persistent Asthma Population? Perm J. 2020 Dec;25:1. doi: 10.7812/TPP/20.189.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimated): May 4, 2016

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: National Jewish Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No