Real World Adoption of an OUD Digital Health Therapeutic

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PROJECT SUMMARY / ABSTRACT The opioid crisis is an epidemic with devastating health, social, and economic consequences for the United States. In 2020, 2.7 million people over the age of 12 were reported to suffer from opioid use disorder (OUD). The total economic burden of the opioid crisis in the US was recently estimated to be nearly $1.5 trillion. Treatment for OUD involves medication (MOUD) combined with counseling or behavioral therapy to manage the illness, achieve and sustain better health, and improve quality of life. Rates of recurrent drug use are high, and access to counseling is limited and costly. While MOUD is standard of care and highly effective at reducing acute morbidity and mortality, there are advantages to treatment approaches tailored to address an individual patient’s drug use patterns and drug-related medical, psychiatric, and social problems. While mobile tools exist to support OUD treatment, these products offer only generalized information and not personalized feedback that is responsive to each person’s current status to support his/her individual recovery. In a currently funded NIDA Phase II STTR grant, we are clinically evaluating KIOS, an innovative software platform using nonlinear control theory, to satisfy requirements for FDA 510(k) device clearance. KIOS is a digital health therapeutic that tracks multiple interacting symptoms (e.g., craving, mood, pain) to map patient trajectories and deliver timely evidence-based intervention strategies, responding directly to patient-reported needs. Accessible via mobile devices, KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to improve self-management concomitant to MOUD. This proposed Fast-Track project is the next step in the development of KIOS, designed to demonstrate its real-world adoption including endpoints to support positive coverage decisions from payors. This innovative tool to help patients manage OUD has the potential to have a profound impact on public health and achieve significant commercial success. Phase I of this application examines barriers and facilitators to payor and other non-patient stakeholder adoption, and incorporates the results into the software and trial design accordingly. It has three Specific Aims: Aim 1. Perform Rapid Qualitative Analysis to Define Stakeholder Needs Aim 2. Implement Applicable Software Changes Aim 3. Finalize Clinical Trial Design for Phase II Phase II evaluates the effectiveness of KIOS in clinical studies using a hybrid type 2 design. The Phase II effort is comprised of three Specific Aims: Aim 1. Optimize Implementation Program Aim 2. Demonstrate Effectiveness in a Randomized Clinical Trial Aim 3. Examine Implementation of KIOS in a Real World Context