Feasibility of the BREATHE Asthma Intervention Trial
Feasibility of the BREATHE Asthma Intervention Trial
Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured
 adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn
 may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A
 brief shared decision-making intervention for use by primary care providers in Federally
 Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve
 asthma control in this high-risk patient group.
Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled
 corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in
 poor and minority populations. Non-adherence to ICS is associated with erroneous personal
 health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this,
 no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared
 decision-making interventions have not been tested in underserved Black adults, despite this
 model's success in pediatric populations and in White, privately insured patients with
 asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients
 achieve asthma control but are overlooked in asthma intervention research. Process
 evaluations are often lacking during intervention development. We will address these
 treatment and methodological gaps.

 Objectives: This pilot study will (1) develop a brief shared decision-making intervention
 delivered by primary care providers (PCPs) to improve asthma control in Black adults
 receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and
 (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence,
 forced expiratory volume in one second (FEV1) - an objective lung function measure - and
 asthma quality of life (QOL) over a 3-month follow-up period.

 Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months,
 relative to controls, patients whose PCPs are trained in the intervention will have
 significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma
 QOL (secondary outcomes).

 Methods: Using community-based participatory research and including a Patient Advocate, we
 will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention
 development is guided by patient and family/support persons of asthma patients input, as well
 as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from
 2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with
 uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs
 will be randomized within FQHC to intervention and control; patients will be followed for 3
 months. Process evaluation interviews with patients and PCPs will obtain feedback regarding
 intervention procedures.

 Significance: This study has high public health significance because it (1) targets a highly
 vulnerable population for poor asthma control - Black poor adults with erroneous asthma care
 beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a
 novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and
 negative ICS beliefs, and which has the potential to amplify intervention effects and
 increase the likelihood of sustainability; and (3) includes a process evaluation, bridging
 the gap between science and practice, and aiding in the design of a full-scale randomized
 controlled trial (RCT).
The intervention trial will be informed by focus groups

 Focus Group Inclusion Criteria:

 - Adult patients with persistent asthma or loved ones of adult patients with persistent
 asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at
 the participating FQHCs

 Focus Group Exclusion Criteria:

 - Patients with persistent asthma or loved ones of patients with persistent asthma under
 they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs

 Intervention Inclusion Criteria:

 Patients must be:

 1. Adults (18 years of age or older)

 2. PCP-diagnosed persistent asthma

 3. Currently prescribed ICS

 4. Receiving asthma care at participating FQHCs

 5. Who screen positive for uncontrolled asthma

 6. Have erroneous personal health and/or negative ICS beliefs

 Intervention Exclusion Criteria:

 1. Participation in focus groups during the development phase

 2. Non-English speaking

 3. Serious mental health conditions (e.g., psychosis) that preclude completion of study
 procedures or confound analyses