Lawrence Katharine, Rodriguez Danissa V, Feldthouse Dawn M, Shelley Donna, Yu Jonathan L, Belli Hayley M, Gonzalez Javier, Tasneem Sumaiya, Fontaine Jerlisa, Groom Lisa L, Luu Son, Wu Yinxiang, McTigue Kathleen M, Rockette-Wagner Bonny, Mann Devin M
Healthcare Innovation Bridging Research, Informatics, and Design Lab, Department of Population Health, NYU Langone Health, New York, NY, United States.
Clinical Systems & Clinical Transformation, Medical Center Information Technology Clinical Informatics Department, NYU Langone Health, New York, NY, United States.
JMIR Res Protoc. 2021 Feb 9;10(2):e26750. doi: 10.2196/26750.
Digital diabetes prevention programs (dDPPs) are effective behavior change tools to prevent disease progression in patients at risk for diabetes. At present, these programs are poorly integrated into existing health information technology infrastructure and clinical workflows, resulting in barriers to provider-level knowledge of, interaction with, and support of patients who use dDPPs. Tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient engagement and adherence to these programs and improved health outcomes.
This study aims to use a rigorous, user-centered design (UCD) methodology to develop a theory-driven system that supports patient engagement with dDPPs and their primary care providers with their care.
This study will be conducted in 3 phases. In phase 1, we will use systematic UCD, Agile software development, and qualitative research methods to identify key user (patients, providers, clinical staff, digital health technologists, and content experts) requirements, constraints, and prioritization of high-impact features to design, develop, and refine a viable intervention prototype for the engagement system. In phase 2, we will conduct a single-arm feasibility pilot of the engagement system among patients with prediabetes and their primary care providers. In phase 3, we will conduct a 2-arm randomized controlled trial using the engagement system. Primary outcomes will be weight, BMI, and A at 6 and 12 months. Secondary outcomes will be patient engagement (use and activity) in the dDPP. The mediator variables (self-efficacy, digital health literacy, and patient-provider relationship) will be measured.
The project was initiated in 2018 and funded in September 2019. Enrollment and data collection for phase 1 began in September 2019 under an Institutional Review Board quality improvement waiver granted in July 2019. As of December 2020, 27 patients have been enrolled and first results are expected to be submitted for publication in early 2021. The study received Institutional Review Board approval for phases 2 and 3 in December 2020, and phase 2 enrollment is expected to begin in early 2021.
Our findings will provide guidance for the design and development of technology to integrate dDPP platforms into existing clinical workflows. This will facilitate patient engagement in digital behavior change interventions and provider engagement in patients' use of dDPPs. Integrated clinical tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient adherence to these programs and improved health outcomes by addressing barriers faced by both patients and providers. Further evaluation with pilot testing and a clinical trial will assess the effectiveness and implementation of these tools.
ClinicalTrials.gov NCT04049500; https://clinicaltrials.gov/ct2/show/NCT04049500.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26750.
数字糖尿病预防项目（dDPPs）是有效的行为改变工具，可预防糖尿病高危患者的疾病进展。目前，这些项目在很大程度上未融入现有的健康信息技术基础设施和临床工作流程，导致医疗服务提供者对使用dDPPs的患者缺乏了解、难以与之互动并提供支持。能够促进围绕dDPPs的患者与医疗服务提供者互动的工具，可能有助于提高患者对这些项目的参与度和依从性，并改善健康结局。
本研究旨在运用严谨的、以用户为中心的设计（UCD）方法，开发一个理论驱动的系统，以支持患者参与dDPPs并与他们的初级保健提供者共同接受治疗。
本研究将分三个阶段进行。在第一阶段，我们将运用系统的UCD、敏捷软件开发和定性研究方法，确定关键用户（患者、医疗服务提供者、临床工作人员、数字健康技术专家和内容专家）的需求、限制因素以及对高影响力功能的优先级排序，以设计、开发和完善参与系统的可行干预原型。在第二阶段，我们将在糖尿病前期患者及其初级保健提供者中对参与系统进行单臂可行性试点。在第三阶段，我们将使用参与系统进行双臂随机对照试验。主要结局指标将是6个月和12个月时的体重、体重指数（BMI）和糖化血红蛋白（A）。次要结局指标将是患者在dDPP中的参与度（使用情况和活动）。将对中介变量（自我效能感、数字健康素养和患者与医疗服务提供者的关系）进行测量。
该项目于2018年启动，并于2019年9月获得资助。根据2019年7月获得的机构审查委员会质量改进豁免，第一阶段的入组和数据收集于2019年9月开始。截至2020年12月，已有27名患者入组，预计2021年初将提交初步结果以供发表。该研究于2020年12月获得机构审查委员会对第二阶段和第三阶段的批准，预计第二阶段将于2021年初开始入组。
我们的研究结果将为将dDPP平台整合到现有临床工作流程的技术设计和开发提供指导。这将促进患者参与数字行为改变干预，并促进医疗服务提供者参与患者使用dDPPs。能够促进围绕dDPPs的患者与医疗服务提供者互动的综合临床工具，可能通过解决患者和医疗服务提供者面临的障碍，有助于提高患者对这些项目的依从性并改善健康结局。通过试点测试和临床试验进行的进一步评估将评估这些工具的有效性和实施情况。
ClinicalTrials.gov NCT04049500；https://clinicaltrials.gov/ct2/show/NCT04049500。
国际注册报告识别号（IRRID）：DERR1-10.2196/26750。
