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Clinical Trials/NCT02761837
NCT02761837
Completed
Not Applicable

The Breathe Well Program to Improve Asthma Outcomes

National Jewish Health1 site in 1 country14,978 target enrollmentOctober 2016
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
National Jewish Health
Enrollment
14978
Locations
1
Primary Endpoint
Asthma Exacerbations
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
June 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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)

Study Sites (1)

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