Clinical trial NCT05045690: BREATHE: An Efficacy-implementation With Listening Sessions
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 (Pre-Trial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Clinical Directors Network
name: National Institute of Nursing Research (NINR)
First posted: 2021-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from federally qualified health centers (FQHCs)

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who completed listening sessions
timeFrame: Visit 1 (approximately 120 minutes)
measure: Number of participants who completed clinician/administrator pre-trial interviews
timeFrame: Visit 1 (approximately 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical Directors Network
state: New York
Study officials:
affiliation: Columbia University
name: Maureen T George, PhD
role: PRINCIPAL_INVESTIGATOR
References: