HEAL - Development and implementation of a provider prescribed, behavioral digital therapeutic designed to support, educate, screen and remotely monitor patients with chronic pain

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2Morrow, Inc. SBIR Fast-Track Application – Project Summary: 2Morrow, a small business established in 2011, is proposing a digital therapeutic for chronic pain that will utilize Acceptance and Commitment Therapy (ACT) techniques to improve coping skills and to address some of the common behavioral comorbidities that increase suffering in patients living with chronic pain. Proposed Product: Over 50M Americans are living with chronic pain. Patients living with pain have higher rates of depression, anxiety and substance use disorder, yet these behavioral risks are seldom addressed due to training, access, stigma or cost. We have learned from previous research that ACT can be used to improve coping skills, reduce anxiety and depression, and treat substance use disorder. To address this gap in care, 2Morrow will develop a new digital therapeutic product, 2MRx-CP, for use by patients with chronic pain. The program will combine established ACT protocols for chronic pain management with self screening tools for substance use disorders, anxiety and depression. It will also include behavioral science content, and daily tracking of patient metrics that will help to customize the intervention and provide data driven insights that can be used for shared decision making between the patient and provider. Our four Phase I specific aims are: 1) Conduct a quantitative evaluation of the existing 2Morrow Chronic Pain Self-Management Digital Health Program to address dissemination and implementation variables of appropriateness, acceptability, and feasibility; 2) Conduct a qualitative study of primary care provider (PCP) core teams to: a) determine best fit PCP clinic types for 2MRx-CP for the Phase II clinical study and our marketing strategy; and b) initiate development of the provider dashboard; 3) To initiate development of our new prescription-based digital program, 2MRx-CP, by reviewing data collected in Aims I-1 and 2, then developing a paper protocol of program core elements; and 4) 2Morrow will contract consultants to complete an audit of our current quality management processes and procedures to inform the formalized Phase II quality management system implementation. Our two Phase II specific aims are: 1) Conceptually design 2MRx-CP by incorporating data from Phase I and input from subject matter experts to create content, screening tools, algorithms and user experience. 2Morrow will then build a digital therapeutic for IOS and Android (patient apps); 2) Conduct a 2-arm randomized control feasibility study (N = 100 patients) to assess: 1) feasibility, appropriateness, and acceptability of 2MRx-CP digital therapeutic as an intervention for primary care patients with chronic pain; 2) feasibility of recruitment processes, study uptake, and completion of study outcome measures; and 3) estimate of the likely treatment efficacy effect size for a large RCT.