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快速通道应用-项目摘要：2Morrow是一家成立于2011年的小企业，正在提出一种针对慢性疼痛的数字疗法，该疗法将利用接受和承诺疗法(ACT)技术来提高应对技能，并解决一些常见的行为并存问题，这些问题增加了慢性疼痛患者的痛苦。推荐产品：超过5000万美国人生活在慢性疼痛中。患有疼痛的患者抑郁、焦虑和物质使用障碍的发生率更高，但由于培训、机会、耻辱或成本，这些行为风险很少得到解决。我们从以前的研究中了解到，ACT可以用来提高应对技能，减少焦虑和抑郁，并治疗物质使用障碍。为了解决这一护理缺口，2Morrow将开发一种新的数字治疗产品2MRx-CP，供慢性疼痛患者使用。该计划将把已建立的慢性疼痛管理的ACT方案与针对物质使用障碍、焦虑和抑郁的自我筛查工具结合起来。它还将包括行为科学内容和患者指标的日常跟踪，这将有助于定制干预并提供数据驱动的见解，可用于患者和提供者之间的共享决策。我们的四个第一阶段具体目标是：1)对现有的2Morrow慢性疼痛自我管理数字健康计划进行量化评估，以解决适当性、可接受性和可行性的传播和实施变量；2)对初级保健提供者(PCP)核心团队进行定性研究，以：a)为第二阶段临床研究和我们的营销战略确定最适合2MRx-CP的PCP临床类型；以及b)启动提供者仪表板的开发；3)通过审查在目标I-1和2中收集的数据，启动我们新的基于处方的数字计划2MRx-CP的开发，然后制定计划核心要素的纸质协议；4)明天将聘请顾问完成对我们当前质量管理流程和程序的审计，以便为正式的第二阶段质量管理系统的实施提供信息。我们的两个第二阶段的具体目标是：1)通过整合第一阶段的数据和主题专家的输入来概念性地设计2MRx-CP，以创建内容、筛选工具、算法和用户体验。2Morrow随后将为iOS和Android构建数字治疗仪(患者APP)；2)进行一项双臂随机对照可行性研究(N=100名患者)，以评估：1)2MRx-CP数字治疗仪作为初级保健慢性疼痛患者干预措施的可行性、适当性和可接受性；2)招募过程、研究吸收和研究结果衡量标准的可行性；以及3)大型随机对照试验的可能治疗效果规模的估计。

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.