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OpenTrials
Completed

NCT Number: NCT02761837

The Breathe Well Program for Adults With Asthma

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.

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Key information

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente of Colorado

Denver, Colorado, 80231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVR call/text

Behavioral

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

Email

Behavioral

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

Primary outcomes

  1. Asthma Exacerbations

    Time frame: 12 months

    Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid

Secondary outcomes

  1. Controller medication adherence

    Time frame: 12 months

    Days of medication possession will be calculated for each patient

Sponsors and collaborators

Lead sponsor

National Jewish Health

Other

Collaborators

  • Kaiser Permanente

Registry information

Official study title

The Breathe Well Program to Improve Asthma Outcomes

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
May 4, 2016
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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