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

Official title

BREATHE: An Efficacy-implementation Trial of a Brief Shared Decision Making Intervention Among Black Adults With Uncontrolled Asthma in Federally Qualified Health Centers (Trial and Post-trial)

Overview

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.

Detailed 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.

Interventions

• Behavioral BREATHE Intervention
  BREATHE utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
• Behavioral Control Intervention
  The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).

Primary outcome measures

• Mean Asthma Control Questionnaire Score [Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)]

Secondary outcome measures (4)

• Mean Shared Decision Making-Questionnaire-9 Score [Time frame: Baseline (immediately post-intervention)]
• Mean Medication Adherence Report Scale - Asthma Score [Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)]
• Mean Asthma Quality of Life Questionnaire Score [Time frame: Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)]
• Mean Asthma Impairment and Risk Questionnaire Score [Time frame: Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)]

Eligibility criteria

Inclusion Criteria (participants):

Patients participants will

• be adults (> or = 18 years of age)
• 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
• 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
• receive asthma care at a partner FQHC and
• 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):

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

Inclusion Criterion (clinicians):

1\. those who manage a panel of adult asthma patients

Inclusion Criteria (loved ones):

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

Exclusion Criteria (loved ones):

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Sun River Health — Beacon
• Bedford Stuyvesant Family Health Center — Brooklyn

Identifiers

NCT: NCT05341726 · AAAT0939 - trial & post-trial · R01NR019275

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗