Factors contributing to poor outcomes among minority patients with asthma include poverty and other social
determinants of health (SDoH), poor medication adherence and self-management skills, and environmental
exposures. There are challenges in providing asthma education in the outpatient setting, such as time constraints
and prioritizing acute symptoms or recent exacerbations. The lack of proven, guideline-based, and user-centered
mobile platforms that promote self-management and shared decision-making among patients with asthma is an
important unmet need. Vocal biomarker technology using machine learning can assess a patient’s respiratory
dysfunction and is generalizable to multiple respiratory conditions. On the basis of a 6-second voice sample, this
vocal biomarker technology has been shown to detect patients with asthma while correlating with the degree of
asthma control. Through an AHRQ-funded study, we recently created the ASTHMAXcel PRO (patient-reported
outcome) mobile app for outpatient settings to promote asthma self-management through the collection of PROs,
animated videos, goal setting, personalized algorithms, and push notifications. The present study will further
enhance our mobile platform’s capabilities to implement PROs by creating ASTHMAXcel Voice. This mobile
platform will include a respiratory symptoms risk score based on vocal biomarker technology, facilitate shared
decision-making and SDoH screening and referrals, and enable self-management and remote care coordination.
We will adapt, test, and refine ASTHMAXcel Voice (R21 phase) for the outpatient setting (Aim 1). We will
remotely conduct pre-adaptation focus groups with patients, healthcare providers (HCPs), social workers (SWs),
community health workers (CHWs), and expert stakeholders on how to best adapt ASTHMAXcel Voice. We will
test the adapted platform with 30 patients, 6 HCPs, 2 SWs and 2 CHWs and conduct formative and summative
evaluation of the platform’s functionality and usability, and iteratively refine it based on feedback. We will repeat
this process for a second round. We will then remotely conduct an RCT (R33 phase) among outpatient primary
and specialty care sites from Montefiore Medical Center to compare the adapted and refined ASTHMAXcel Voice
(n=100) to usual care (n=100) on clinical outcomes (asthma control as primary endpoint, asthma emergency
department (ED) visits), process outcomes (patient and provider satisfaction and usage, degree of shared
decision-making), SDoH screening and referral rates, asthma quality of life (QOL), medication adherence, and
self-efficacy (Aim 2). Assessments will occur at baseline, 2-, and 6-month follow-up. We will evaluate the process
of ASTHMAXcel Voice implementation within the outpatient setting using the RE-AIM framework (Aim 3). Future
enhancements of the mobile platform will include other chronic diseases, risk prediction, and widespread
dissemination.
