Khatib Rasha, McCue Maggie, Blair Chris, Roy Anit, Franco John, Fehnert Ben, King James, Sarkey Sara, Chrones Lambros, Martin Michael, Kabir Christopher, Kemp David E
Advocate Aurora Research Institute, Advocate Health, Milwaukee, WI, United States.
Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA, United States.
JMIR Res Protoc. 2023 Jun 23;12:e43788. doi: 10.2196/43788.
Major depressive disorder (MDD) is a serious public health concern worldwide. A treatment approach that incorporates measurement-based care (MBC) and shared decision-making between patients with MDD and their providers may foster patient engagement and improve clinical outcomes. While digital tools such as mobile apps show promise for expanding health interventions, these apps are rarely integrated into clinical practice.
The primary objective of this ongoing study is to determine whether implementation of a digital tool-the Pathway Platform-in primary care improves adherence to MBC practices; here, we present the study methods.
This large-scale, real-world implementation study is based on a pilot study of an earlier iteration of a mobile app (the Pathway app) that confirmed the feasibility of using the app in patients with MDD and showed a positive trend in patient engagement in the app arm. In addition, a user-centered design approach that included qualitative assessments from patients and providers was used to improve understanding of the patient journey and care team workflows. User feedback highlighted the need for enhanced features, education modules, and real-time data sharing via integration with the electronic health record. The current iteration of the Platform includes the newest version of the Pathway app, education modules for both patients and providers, and real-time patient-level data sharing with the electronic health record. The study takes place in primary care sites within the Advocate Aurora Health system in Illinois and includes adult patients with MDD who were recently prescribed monotherapy antidepressant medication (defined as a new start, medication switch, or dose change in the past 3 months). Clinical performance and selected patient outcomes will be compared before and after the implementation of the Platform.
Patient recruitment was completed in July 2022, with initial results expected in mid-2023.
This study will provide useful insights into real-world integration of a digital platform within a large health system. The methods presented here highlight the unique user-centric development of the Pathway Platform, which has resulted in an enhanced digital tool with the potential to foster MBC and shared decision-making, improve patient-provider communication, and ultimately lead to optimized treatment outcomes for patients with MDD.
ClinicalTrials.gov NCT04891224; https://clinicaltrials.gov/ct2/show/NCT04891224.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43788.
重度抑郁症(MDD)是全球范围内严重的公共卫生问题。一种将基于测量的护理(MBC)以及MDD患者与其医疗服务提供者之间的共同决策纳入其中的治疗方法,可能会促进患者参与并改善临床结果。虽然移动应用程序等数字工具在扩大健康干预方面显示出前景,但这些应用程序很少被整合到临床实践中。
这项正在进行的研究的主要目的是确定在初级保健中实施一种数字工具——路径平台(Pathway Platform)是否能提高对MBC实践的依从性;在此,我们介绍该研究方法。
这项大规模的现实世界实施研究基于对一款移动应用程序(路径应用程序,Pathway app)早期版本的试点研究,该试点研究证实了在MDD患者中使用该应用程序的可行性,并显示出应用程序组患者参与度呈积极趋势。此外,采用了以用户为中心的设计方法,包括来自患者和医疗服务提供者的定性评估,以增进对患者就医过程和护理团队工作流程的理解。用户反馈突出了增强功能、教育模块以及通过与电子健康记录集成实现实时数据共享的必要性。该平台的当前版本包括路径应用程序的最新版本、针对患者和医疗服务提供者的教育模块,以及与电子健康记录的实时患者层面数据共享。该研究在伊利诺伊州倡导者奥罗拉医疗系统(Advocate Aurora Health system)内的初级保健场所进行,纳入最近开具单药抗抑郁药物治疗的成年MDD患者(定义为在过去3个月内开始新药治疗、换药或改变剂量)。将在平台实施前后比较临床绩效和选定的患者结果。
患者招募于2022年7月完成,初步结果预计在2023年年中得出。
这项研究将为数字平台在大型医疗系统中的实际整合提供有用的见解。此处介绍的方法突出了路径平台独特的以用户为中心的开发过程,这产生了一个增强的数字工具,有可能促进MBC和共同决策,改善患者与医疗服务提供者之间的沟通,并最终为MDD患者带来优化的治疗结果。
ClinicalTrials.gov NCT04891224;https://clinicaltrials.gov/ct2/show/NCT
国际注册报告识别码(IRRID):DERR1-10.2196/43788。