BREATHE: An Efficacy-implementation With Listening Sessions

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

Listening sessions: The research team will collect qualitative data from the listening sessions (focus groups) using a semi-structured iterative focus group guide.

Study Overview

• Status: Completed
• Conditions: Asthma

Detailed Description

The trial will be informed by 4-8 listening sessions (research focus groups) with 4-8 adults with asthma at each of four sites (N=32). The trial will also include interviews with approximately 1-2 providers and 1-2 administrators at each site (N=8-16).

Adults with asthma and providers/administrators will participate in pre-trial listening sessions (focus groups) prior to recruiting for other phases in this project. They will share their experience with asthma and clinical research. This will aid in gaining the identification of possible barriers to participation and will provide the opportunity for the patients and providers/administrators to identify which of the planned outcomes they consider to be most meaningful. After obtaining informed consent from participants, the research team will collect demographic and diagnosis information, administer surveys and conduct listening sessions.

The research team will collect demographic information and administer questionnaires to characterize the participants. These include: Demographic form, Asthma history (patient), Asthma history (family), Asthma Control Questionnaire, Shared Decision Making Questionnaire, Medication Adherence Record Scale (preventer), Conventional and Alternative Management for Asthma (patient), Conventional and Alternative Management for Asthma (family), Asthma Quality of Life Questionnaire, Newest Vital Sign, and Short Assessment of Health Literacy. Pre-trial listening sessions: one 2-hour session.

Providers/administrators will participate in one 30-minute session interview.

This pre-trial is an informative research that will help design an RCT with masking and allocation in the future.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10018
      • Clinical Directors Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from federally qualified health centers (FQHCs)

Description

Inclusion Criteria:

1. be adults (> 18 years of age or emancipated)
2. self-report '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 asthma
4. receive asthma care at a partner federally-qualified health center (FQHC)

Exclusion Criteria:

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

Inclusion Criteria (provider/administrator): Providers who manage a panel of adult asthma patients (i.e., eligible for randomization in the trial) and administrators at that site will be recruited to participate in the interviews.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who completed listening sessions	Listening sessions (research focus groups) will be held pre-trial to explore experiences with asthma and clinical research. Sharing from these sessions will be observational in nature where information will be collected to aid the design/implementation of other portions in this project.	Visit 1 (approximately 120 minutes)
Number of participants who completed clinician/administrator pre-trial interviews	Interviews will be held pre-trial to explore experiences with asthma and clinical research. Sharing from these sessions will be observational in nature where information will be collected to aid the design/implementation of other portions in this project.	Visit 1 (approximately 30 minutes)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Nursing Research (NINR); Clinical Directors Network
• Investigators: Principal Investigator: Maureen T George, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2021
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AAAT0939 - pre-trial; 1R01NR019275 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No