The Breathe Well Program for Adults With Asthma
Primary Purpose
Asthma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVR call/text
Email
Sponsored by
About this trial
This is an interventional health services research trial for Asthma
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.
Sites / Locations
- Kaiser Permanente of Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IVR call/text
Arm Description
Identify gaps in care and contact patients by IVR phone call or text
Identify gaps in care and contact patients by email
Outcomes
Primary Outcome Measures
Asthma Exacerbations
Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid
Secondary Outcome Measures
Controller medication adherence
Days of medication possession will be calculated for each patient
Full Information
NCT ID
NCT02761837
First Posted
April 28, 2016
Last Updated
September 28, 2022
Sponsor
National Jewish Health
Collaborators
Kaiser Permanente
1. Study Identification
Unique Protocol Identification Number
NCT02761837
Brief Title
The Breathe Well Program for Adults With Asthma
Official Title
The Breathe Well Program to Improve Asthma Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Jewish Health
Collaborators
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized to either 1) usual care or 2) IVR or 3) email. Those in the groups 2 or 3 will receive the intervention only if they smoke, underuse controller medication, or overuse rescue medication.
Masking
None (Open Label)
Masking Description
This is a pragmatic controlled trial. Participants randomized to the intervention group will know when they receive the intervention, which will consist of an automated contact by IVR call/text, or email.
Allocation
Randomized
Enrollment
14978 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVR call/text
Arm Type
Active Comparator
Arm Description
Identify gaps in care and contact patients by IVR phone call or text
Arm Title
Email
Arm Type
Active Comparator
Arm Description
Identify gaps in care and contact patients by email
Intervention Type
Behavioral
Intervention Name(s)
IVR call/text
Intervention Description
For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text
Intervention Type
Behavioral
Intervention Name(s)
Email
Intervention Description
Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email
Primary Outcome Measure Information:
Title
Asthma Exacerbations
Description
Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Controller medication adherence
Description
Days of medication possession will be calculated for each patient
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kaiser Permanente of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33635779
Citation
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.
Results Reference
derived
Learn more about this trial
The Breathe Well Program for Adults With Asthma
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