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

2Morrow, Inc. SBIR Fast-Track Application ?

Project Summary: 2Morrow, Inc. was established in 2011 to develop mobile technology for increasing access to evidence-based healthcare. 2Morrow?s programs use Acceptance and Commitment Therapy (ACT), a behavioral approach that helps guide users through unhelpful thoughts, feelings and urges.

Using ACT, we have created and marketed highly successful self-management programs for multiple disorders including chronic pain.

Proposed Product: We have learned from our Chronic Pain Self-Management Program that ACT reduces anxiety disorders and depression which typically accompany chronic pain and provides the patient with coping strategies for managing their CP.

These CP-associated problems challenge primary care providers (PCPs) who do not have the capacity to manage the mental health and behavioral components of chronic pain.

To address these challenges, we will develop a new product, 2MRx- CP, a Prescription Digital Therapeutic (PDT), that will combine our established ACT protocols for CP management with screening tools for SUD, anxiety, and depression.

It will also include: 1) behavioral science content; and 2) remote patient monitoring (RPM) that evaluates CP patient outcome metrics and sends them to a Provider Dashboard to inform PCPs.

We are seeking a Fast-Track SBIR Application as 2Morrow has already established itself in the digital health realm and will use their existing platforms to inform our 2MRx-CP product development.

Our 4 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 PCP Core Teams to: a) determine best fit PCP clinic types for 2MRx-CP for the Phase II clinical study & 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 QMS implementation.

Our 4 Phase II specific aims are: 1) Conceptually design and build 2MRx-CP by incorporating the outcomes from Phase I to create final content, screening tools, algorithms, and user experiences in an FDA compliant QMS IOS and Android mobile application; 2) Conduct a clinical trial of 20 providers and 100 patients, as determined by our power analysis, that will focus on impact of app use on change in primary patient reported outcomes and to describe patient reported implementation outcomes: 1) patient outcomes on pain interference, function, depression, and anxiety, and 2) implementation outcomes on acceptability, appropriateness, feasibility, fidelity, costs, and sustainability of use by patients; and 4) Conduct Likert-based on-line surveys of PCP use of the Provider Dashboard each month for 6 mos of the SA II-2 clinical study followed by tracking PCP post-study PDT use and by PCP interviews.