A novel patient-facing mobile platform to collect and implement patient-reported outcomes and voice biomarkers in underserved adult patients with asthma

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.