Clinical trials data collection during patient care using a novel technology solu

使用新技术解决方案在患者护理期间收集临床试验数据

• 批准号: 8001201
• 负责人: Gregory James Clary
• 金额: $ 14.31万
• 依托单位: ADVANCED DIGITAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-07 至 2011-07-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001201
• 关键词: Applications Grants; Architecture; Back; Businesses; Caring; Case Report Form; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Database; Collection; Communication; Comprehensive Cancer Center; Computer software; Consult; Costs and Benefits; Coupled; Data; Data Analyses; Data Collection; Data Quality; Databases; Destinations; Development; Devices; Discipline; Division of Cancer Treatment and Diagnosis; Doctor of Philosophy; Documentation; Electronic Health Record; Electronics; Ensure; Feasibility Studies; Feedback; Future; Genetic Transcription; Handwriting; Health; Health Insurance Portability and Accountability Act; Informatics; Institution; Letters; Malignant Neoplasms; Manuals; Medical; Medical Oncology; Medicine; Methods; National Cancer Institute; Online Systems; Outcome; Outpatients; Paper; Patient Care; Patients; Physicians; Physiologic pulse; Process; Public Health; Records; Regulation; Research; Resources; Sample Size; Savings; Secure; Small Business Innovation Research Grant; Solutions; Specific qualifier value; Speech; System; Technology; Testing; Text; Time; Universities; Visit; Writing; base; clinical care; data integration; design; digital; discrete data; experience; flexibility; improved; innovation; member; new technology; novel; oncology; preference; prototype; public health relevance; response; satisfaction; standard care; tool; transmission process; usability; user-friendly

DESCRIPTION (provided by applicant): The offeror propose to develop and test a novel hardware and software combination solution composed of the Livescribe Pulse Smartpen with Mi-Forms data collection software, for use in clinical data collection during patient care documentation at the bedside. The Livescribe Pulse Smartpen is a new commercial off the shelf hardware product providing both handwriting and speech capture, and Mi-Forms data collection software is the flagship product of the offering small business. Physicians continue to have a strong preference for recording patient information and care progress notes via pen and speech dictation. Until now, there have been no devices capable of providing electronic handwriting capture, conversion to text and speech capture in a single integrated platform. Today's Pulse Smartpen from Livescribe, not much larger than a standard ballpoint pen, is such a platform. This current proposed research is to test the simultaneous speech and pen-on-paper handwriting capture capability of the Pulse Smartpen, coupled with Mi-Co's unique software for processing pen and speech data, in a novel architecture deployed in the Duke University Cancer Clinics. More rapid and efficient than the current method of paper transcription plus dictation, but still conforming to current physician workflow preferences, this technology solution can serve to streamline the collection of patient data for clinical trials while enabling more automatic sharing of important patient care information, leading to improved patient health outcomes via both research and care. This innovative combination will allow clinicians to simultaneously collect patient data for clinical trial electronic Case Report Forms (eCRFs) and document patient progress notes via both pen and speech dictation. This system will provide busy clinicians with a familiar, easy to use system that will enable the automatic transcription of patient data from care records into case report forms and later transcription of dictated progress notes. The solution will also allow for the automated communication of CRF data and progress notes to existing systems for quicker availability to clinical trials sponsors and other members of the clinical care team, ensuring better communication and coordination for more efficient clinical trials and improved patient care. PUBLIC HEALTH RELEVANCE: The offerors propose to develop and test a novel hardware and software combination solution composed of the Livescribe Pulse Smartpen with Mi-Forms data collection software, for use in clinical data collection during patient care documentation at the bedside. This system will utilize a new hardware device that captures both handwriting and speech dictation, and create a user- friendly clinical trials data entry system that reaches the patient bedside and automatically populates back-end systems for clinical research and patient care. New systems that improve efficiency and also increase clinician satisfaction in collection of clinical trials data are beneficial to public health through more streamlined creation and testing of new medicines.

描述（由申请人提供）：要约人提议开发和测试一种新颖的硬件和软件组合解决方案，该解决方案由带有 Mi-Forms 数据收集软件的 Livescribe Pulse Smartpen 组成，用于床边患者护理记录期间的临床数据收集。 Livescribe Pulse Smartpen 是一款新的商用现成硬件产品，提供手写和语音捕获功能，Mi-Forms 数据收集软件是该小型企业的旗舰产品。医生仍然强烈倾向于通过笔和语音听写来记录患者信息和护理进度笔记。到目前为止，还没有任何设备能够在单一集成平台中提供电子手写捕捉、文本转换和语音捕捉。 Livescribe 推出的 Pulse Smartpen 比标准圆珠笔大不了多少，就是这样一个平台。目前提出的研究旨在测试 Pulse Smartpen 的同步语音和纸笔手写捕捉能力，以及 Mi-Co 独特的用于处理笔和语音数据的软件，在杜克大学癌症诊所部署的新颖架构中。该技术解决方案比当前的纸质转录加听写方法更加快速和高效，但仍符合当前医生工作流程偏好，可以简化临床试验患者数据的收集，同时能够更自动地共享重要的患者护理信息，从而通过研究和护理改善患者的健康结果。这种创新组合将使临床医生能够同时收集临床试验电子病例报告表 (eCRF) 的患者数据，并通过笔和语音听写记录患者进展情况。该系统将为忙碌的临床医生提供一个熟悉的、易于使用的系统，该系统能够将患者数据从护理记录自动转录为病例报告表，并随后转录规定的进度注释。该解决方案还允许将 CRF 数据和进度说明自动传输到现有系统，以便临床试验申办者和临床护理团队的其他成员更快地使用，确保更好的沟通和协调，以实现更高效的临床试验和改善患者护理。 公共健康相关性：供应商提议开发和测试一种新颖的硬件和软件组合解决方案，该解决方案由带有 Mi-Forms 数据收集软件的 Livescribe Pulse Smartpen 组成，用于床边患者护理记录期间的临床数据收集。该系统将利用新的硬件设备来捕获手写和语音听写，并创建一个用户友好的临床试验数据输入系统，该系统可以到达患者床边并自动填充用于临床研究和患者护理的后端系统。新系统可以提高效率并提高临床医生对临床试验数据收集的满意度，通过更简化的新药创建和测试，有利于公众健康。