The Breathe Well Program for Adults With Asthma

Sponsor

National Jewish Health (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02761837

Collaborator

Kaiser Permanente (Other)

14,978

Enrollment

Location

Arms

Anticipated Duration (Months)

220.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Behavioral: IVR call/text Behavioral: Email	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14978 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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.

Primary Purpose:

Health Services Research

Official Title:

The Breathe Well Program to Improve Asthma Outcomes

Actual Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Asthma Exacerbations [12 months]
Defined as number of urgent care visits, hospitalizations, or prescriptions of an oral corticosteroid

Secondary Outcome Measures

Controller medication adherence [12 months]
Days of medication possession will be calculated for each patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente of Colorado	Denver	Colorado	United States	80231

Sponsors and Collaborators

National Jewish Health
Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Jewish Health

ClinicalTrials.gov Identifier:

NCT02761837

Other Study ID Numbers:

National Jewish Health

First Posted:

May 4, 2016

Last Update Posted:

Mar 8, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Mar 8, 2021