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RECRUITINGINTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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).

Locations (2)

Sun River Health
Beacon, New York, United States
Bedford Stuyvesant Family Health Center
Brooklyn, New York, United States