Validation of the BREATHE Asthma Intervention Trial

Columbia University

Status: Completed

Conditions: Asthma

Treatments: Behavioral: BREATHE Intervention; Behavioral: Control Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03300752

AAAR5216

Details and patient eligibility

About

The overall goal of this study to preliminarily validate a novel intervention delivered by primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified health centers (FQHCs).

Full description

Nearly every asthma related hospitalization and death could be prevented with appropriate self-management that achieves and maintains disease control. However, as many as 64% of adults have uncontrolled asthma; minorities are disproportionately represented within that population. While inhaled corticosteroids (ICS) are a safe and effective treatment for uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence.

Black adults with uncontrolled asthma experience profound health disparities. Despite data that point to the critical need for enhanced asthma self-management, rates of controlled asthma are well below Healthy People 2020 targets, particularly among vulnerable populations. This Brief Evaluation of Asthma Therapy (BREATHE) intervention has the potential to offer a new avenue to asthma control via shared decision-making that supports ICS adherence.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

PROVIDER RECRUITMENT

Inclusion Criteria:

• PCPs (MDs and Nurse Practitioners (NPs)/Physician Assistants (PAs)) working in family, primary or internal medicine care services
• Who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their patient panel

Exclusion Criteria:

• PCPs whose primary focus is outside of adult health services (family, primary or internal medicine), such as behavioral health, pediatrics and Obstetrics and Gynaecology (OB-GYN)

PATIENT RECRUITMENT

Inclusion Criteria:

Patients must be

1. adults (> or = 18 years of age) who self-report race as Black or African American
2. with PCP-diagnosed persistent asthma
3. prescribed ICS
4. receiving asthma care at participating FQHCs
5. who have uncontrolled asthma
6. have erroneous personal health and/or negative ICS beliefs

Exclusion Criteria:

1. participation in Phase 1 (Part 1) of the BREATHE trial (focus groups)
2. non-English speaking
3. serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

BREATHE Intervention

Experimental group

Description:

The patient's primary care provider (PCP) will deliver the active intervention (shared decision-making discussion of asthma control status and treatment) - BREATHE Intervention.

Treatment:

Behavioral: BREATHE Intervention

Control Intervention

Active Comparator group

Description:

The patient's primary care provider (PCP) will deliver the control intervention (discussion of healthy lifestyles).

Treatment:

Behavioral: Control Intervention