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

HEAL - 开发和实施提供者处方的行为数字治疗，旨在支持、教育、筛查和远程监测慢性疼痛患者

• 批准号: 10258906
• 负责人: Jo Masterson
• 金额: $ 25.2万
• 依托单位: 2MORROW, INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258906
• 关键词: Address; Algorithms; Android; Anxiety; Anxiety Disorders; Behavioral; Behavioral Sciences; Businesses; Cellular Phone; Clinic; Clinical; Clinical Research; Clinical Trials; Collection; Contracts; Country; Custom; Data; Dependence; Development; Disease; Dissemination and Implementation; Eating Disorders; Economic Burden; Elements; Feasibility Studies; Feedback; Feeling; Foundations; Funding; Goals; Health Insurance Portability and Accountability Act; Healthcare; Industry; Intervention; Interview; Marketing; Mental Depression; Mental Health; Methodology; Monitor; Nicotine Dependence; Outcome; Pain interference; Pain management; Paper; Patient Care; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Phase; Problem behavior; Procedures; Process; Protocols documentation; Provider; Quantitative Evaluations; Recommendation; Reporting; Risk; Screening procedure; Secure; Sensitivity Training Groups; Small Business Innovation Research Grant; Social Distance; Social Impacts; Substance Use Disorder; Surveys; System; Technology; Testing; Therapeutic Uses; Thinking; Time; Training; Wellness Program; acceptability and feasibility; addiction; algorithm development; base; behavioral health; care providers; chronic pain; chronic pain management; chronic pain patient; commercialization; coping; cost; dashboard; data sharing; design; digital; digital health; digital treatment; evidence base; experience; health care availability; health goals; health management; implementation outcomes; implementation process; mobile application; mobile computing; non-opioid analgesic; opioid epidemic; pain self-management; pandemic disease; participant enrollment; power analysis; product development; programs; remote patient monitoring; self-management program; statistics; tool; usability

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.

2Morrow，Inc. SBIR快速通道应用程序-项目摘要：2 Morrow是一家成立于2011年的小企业，正在提出一种慢性疼痛的数字治疗方法，该方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合并症，这些合并症会增加慢性疼痛患者的痛苦。拟议产品：超过5000万美国人患有慢性疼痛。患有疼痛的患者有更高的抑郁，焦虑和物质使用障碍的发生率，但由于培训，访问，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，治疗物质使用障碍。为了解决这一护理差距，2 Morrow将开发一种新的数字治疗产品2 MRx-CP，供慢性疼痛患者使用。该计划将结合联合收割机建立ACT协议的慢性疼痛管理与自我筛选工具的物质使用障碍，焦虑和抑郁症。它还将包括行为科学内容，以及对患者指标的日常跟踪，这将有助于定制干预措施，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2 Morrow慢性疼痛自我管理数字健康计划进行定量评估，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）确定II期临床研究和我们的营销策略中最适合2 MRx-CP的PCP诊所类型;以及B）启动供应商仪表板的开发; 3）通过审查目标I-1和2中收集的数据，启动我们新的基于处方的数字程序2 MRx-CP的开发，然后开发程序核心元素的纸质协议;和4）2 Morrow将聘请顾问完成对我们当前质量管理流程和程序的审计，以通知正式的第二阶段质量管理体系的实施。我们的两个第二阶段具体目标是：1）通过整合第一阶段的数据和主题专家的输入来创建内容、筛选工具、算法和用户体验，从而对2 MRx-CP进行概念设计。2 Morrow将为iOS和Android构建数字治疗（患者应用）; 2）进行2组随机对照可行性研究（N = 100例患者）评估：1）2 MRx-CP数字治疗作为慢性疼痛初级保健患者干预的可行性、适当性和可接受性; 2）招募过程、研究吸收和完成研究结局指标的可行性;和3）估计大型RCT的可能治疗疗效效应量。