Palazzo Lorella, Dorsey Caitlin N, Mogk Jess, Beatty Tara, King Deborah, Stefanik-Guizlo Kelsey, Key Dustin, Matson Tessa E, Shea Mary, Caldeiro Ryan M, McWethy Angela Garza, Wong Edwin S, Idu Abisola E, Glass Joseph E
Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Kaiser Permanente Washington Mental Health & Wellness Services, Seattle, WA, USA.
Implement Res Pract. 2024 Dec 12;5:26334895241301670. doi: 10.1177/26334895241301670. eCollection 2024 Jan-Dec.
Substance use disorders (SUDs) result in individual and societal burden. However, most individuals with SUD receive no treatment. Implementing SUD interventions in primary care could address this population's treatment needs. In the USA, reSET and reSET-O were the first prescription digital therapeutics (PDTs) for SUDs and opioid use disorder (OUD), respectively. The Digital Treatments for Substance Use Disorder (DIGITS) study tested the effectiveness of practice facilitation and health coaching strategies to support reSET and reSET-O implementation into primary care. A formative evaluation was conducted to monitor implementation, inform adaptations, and learn what promotes PDT sustainment.
The Dynamic Sustainability Framework and the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies guided the evaluation. Using rapid qualitative methods, we collected and analyzed observational fieldnotes, key informant interviews, and document sources (e.g., meeting minutes) for synthesis and dissemination to clinical partners and the study team via formative reports. We analyzed the reports to generate evaluation results.
Twenty-four primary care clinics participated. Evaluation data included 98 observational fieldnotes, 16 interviews, and 253 document sources. We produced nine formative reports. The study encountered barriers and facilitators in each DSF domain (ecological system, practice setting, and intervention). In the ecological system, the PDT vendor enabled the study, but the COVID-19 pandemic, laws, regulations, and contracting delayed implementation. In the practice setting, staff shortages and low clinic capacity were implementation challenges, while electronic health record capabilities were both barriers and facilitators. At the intervention level, non-routine workflows, clinician burden, and low patient engagement were barriers despite clinicians' efforts.
Digital therapeutics are promising SUD and OUD treatments, but integration into primary care requires conducive laws and regulations, organizational capacity, and patient and clinician engagement. Formative evaluation identified important lessons for future PDT implementation.
物质使用障碍（SUDs）给个人和社会带来负担。然而，大多数患有物质使用障碍的人未接受治疗。在初级保健中实施物质使用障碍干预措施可以满足这一人群的治疗需求。在美国，reSET和reSET - O分别是首批用于物质使用障碍和阿片类物质使用障碍（OUD）的处方数字疗法（PDTs）。物质使用障碍数字疗法（DIGITS）研究测试了实践促进和健康指导策略对支持将reSET和reSET - O纳入初级保健的有效性。进行了一项形成性评估，以监测实施情况、为调整提供信息，并了解促进数字疗法持续应用的因素。
动态可持续性框架以及基于证据的实施策略的调整和修改报告框架指导了此次评估。我们采用快速定性方法，收集并分析了观察性现场记录、关键信息提供者访谈以及文档资料（如会议记录），以便通过形成性报告进行综合分析并传达给临床合作伙伴和研究团队。我们分析这些报告以得出评估结果。
24家初级保健诊所参与了研究。评估数据包括98份观察性现场记录、16次访谈和253份文档资料。我们撰写了9份形成性报告。该研究在动态可持续性框架的每个领域（生态系统、实践环境和干预措施）都遇到了障碍和促进因素。在生态系统方面，数字疗法供应商推动了研究，但新冠疫情、法律法规和合同签订延误了实施进程。在实践环境中，人员短缺和诊所能力低下是实施过程中的挑战，而电子健康记录功能既是障碍也是促进因素。在干预层面，尽管临床医生付出了努力，但非常规工作流程、临床医生负担以及患者参与度低仍是障碍。
数字疗法对于物质使用障碍和阿片类物质使用障碍是很有前景的治疗方法，但要纳入初级保健需要有利的法律法规、组织能力以及患者和临床医生的参与。形成性评估为未来数字疗法的实施提供了重要经验教训。
