BREATHE: An Efficacy-implementation Trial Among Black Adults With Uncontrolled Asthma

Columbia University

Status: Enrolling

Conditions: Asthma

Treatments: Behavioral: BREATHE Intervention; Behavioral: Control Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05341726

AAAT0939 - trial & post-trial

R01NR019275 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is an efficacy-implementation trial to:

1. evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and
2. identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.

Full description

Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as Black adults experience a higher asthma burden and worse clinical outcomes than non-Black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting Black adults have failed to address these disparities. Therefore, the investigator used patient input to develop BREATHE - BRief intervention to Evaluate Asthma THErapy - a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. This intervention is unique in that it is a one-time brief, tailored intervention integrated into office visits, using the patient's own provider as the interventionist (e.g. scalable). A previously conducted pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among BREATHE participants compared to a dose-matched attention control condition.

We will conduct post-trial mixed-method interviews with patient participants, their loved ones, and PCPs using evaluation frameworks to determine satisfaction with, and acceptability of, the active and control interventions.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (participants):

Patients participants will

1. be adults (> or = 18 years of age)
2. self-report race as 'Black' race (African American, African, Caribbean, West Indian, multi-racial [Black AND one or more additional races]); identify their ethnicity as Hispanic OR non-Hispanic
3. have clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 48 months) or have had an asthma exacerbation (e.g., ER visit, course of Prednisone) regardless of controller medicine use
4. receive asthma care at a partner FQHC and
5. screen positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.

Exclusion Criteria (participants):

1. non-English speaking
2. serious mental health conditions that preclude completion of study procedures or confound analyses or
3. participation in a listening session

Inclusion Criterion (clinicians):

1. those who manage a panel of adult asthma patients

Inclusion Criteria (loved ones):

1. must be identified by patient participant as a loved one and
2. loved one must be a family member or friend of the patient participant.

Exclusion Criteria (loved ones):

1. non-English speaking or
2. serious mental health conditions that preclude completion of study procedures or confound analyses

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups

BREATHE intervention

Experimental group

Description:

The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.

Treatment:

Behavioral: BREATHE Intervention

Control Intervention

Active Comparator group

Description:

The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.

Treatment:

Behavioral: Control Intervention