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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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.

• must be identified by patient participant as a loved one and

• loved one must be a family member or friend of the patient participant.

Locations
United States
New York
Sun River Health
RECRUITING
Beacon
Bedford Stuyvesant Family Health Center
RECRUITING
Brooklyn
Contact Information
Primary
Maureen George, PhD
mg3656@cumc.columbia.edu
2123051175
Time Frame
Start Date: 2023-01-19
Estimated Completion Date: 2026-07
Participants
Target number of participants: 400
Treatments
Experimental: BREATHE intervention
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.
Active_comparator: Control Intervention
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.
Authors
Maureen George
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR)
Leads: Columbia University

This content was sourced from clinicaltrials.gov