Self-care decision-making: Feasibility of the BREATHE asthma intervention trial

Columbia University Health Sciences, New York NY

Investigators

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Abstract

PROJECT SUMMARY Background. Nearly every hospitalization and death due to asthma could be prevented with appropriate self- management. However, many adults have uncontrolled disease and minorities are disproportionately represented within that population, due in part, to lower rates of inhaled corticosteroid (ICS) adherence. Personal beliefs about asthma and its pharmacologic treatment contribute to ICS non-adherence. In our earlier work, we developed and validated a brief self-administered instrument that identified ICS beliefs and asthma self-management practices associated with uncontrolled asthma. When this information was shared, their providers initiated conversations with their patients about these beliefs and practices. However, we do not know if these discussions are effective in engaging patients in self-management decision-making that would foster improved asthma control and quality of life (QoL) via increased ICS adherence. Goal: We propose to adapt and pilot a brief evidence-based patient-informed decision-making intervention with urban minority adults with uncontrolled asthma receiving care in primary care and federally qualified health clinics. Methods: Using community-based participatory research and a Patient Advisor on our study team, we will design and implement a feasibility trial of the Brief Evaluation of Asthma Therapy (BREATHE) as compared to usual care in patients receiving routine asthma care. Using motivational interviewing techniques, PCPs will engage patients to assume greater autonomy for self-management decision-making regarding health and medication beliefs that support asthma control and QoL. Our aims: Aim 1. To evaluate whether the intervention is feasible as measured by recruitment, randomization, retention, assessment procedures, and implementation of the novel BREATHE intervention; Aim 2. To evaluate whether the intervention is acceptable to patients and PCPs a multivariable linear mixed model will be used to compare the mean score of the Client Satisfaction Survey-8 across intervention groups. In addition, nested qualitative interviews, post-trial, will provide data on acceptability; Aim 3. Exploration of efficacy. While the study is not powered to provide a definitive test of differences in outcomes between the groups, we will examine differences across groups in asthma control, using the Asthma Control Questionnaire which includes a physiologic measure of lung function, in ICS adherence using the Medication Adherence Scale-Asthma which correlates with objective measures of ICS use and in asthma QoL using the Asthma Quality of Life Questionnaire, taking note of the suggested direction and magnitude of the effects for planning a future RCT.