Secure web-based intake and tracking tools for CAM research and clinical practice

用于 CAM 研究和临床实践的安全网络摄入和跟踪工具

• 批准号: 7912807
• 负责人: James Brian Eberlein
• 金额: $ 24.98万
• 依托单位: RELIEFINSITE.COM, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7912807
• 关键词: Acupuncture Points; Acupuncture procedure; Acute; Address; Adherence; Adverse effects; Adverse event; Algorithms; Appointment; Arts; Characteristics; Chinese People; Chinese Traditional Medicine; Clinic; Clinical; Clinical Research; Clinical effectiveness; Communication; Complementary and alternative medicine; Computerized Medical Record; Computers; Continuity of Patient Care; Cost-Benefit Analysis; Data; Data Collection; Data Set; Databases; Diagnosis; Documentation; Dose; Frequencies; Future; Gender; Goals; Grant; Gynecology; Health; Health Insurance Portability and Accountability Act; Health Personnel; Individual; Information Systems; Insurance Coverage; Intake; Internal Medicine; International; Internet; Intervention; Interview; Japanese Population; Legal patent; Licensure; Life Style; Location; Measurement; Measures; Medical; Medicine; Meridians; Modality; Observational Study; Online Systems; Outcome; Outcome Measure; Outcome Study; Outcomes Research; Pain; Pain Measurement; Participant; Patient Outcomes Assessments; Patient-Centered Care; Patients; Personal Satisfaction; Pharmaceutical Preparations; Phase; Physicians; Play; Provider; Psyche structure; Questionnaires; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Design; Research Proposals; Role; Secure; Self Care; Self-Administered; Series; Services; Small Business Innovation Research Grant; Specific qualifier value; Structure; Surveys; Symptoms; System; Tablets; Technology; Testing; Therapeutic; Time; Translational Research; Treatment Protocols; United States National Institutes of Health; Variant; Visit; Withholding Treatment; Work; base; body map; chronic pain; clinical care; clinical decision-making; clinical practice; compliance behavior; cost; demographics; design; empowerment; follow-up; functional status; global health; impression; improved; innovation; instrument; open source; preference; prototype; public health relevance; response; safety study; standardize measure; technology development; tool; treatment effect; treatment planning; usability; user-friendly

DESCRIPTION (provided by applicant): This Phase I Small Business Innovation Research proposal is in response to RFA-AT- 09-004 Translational Tools for Clinical Studies of CAM Interventions. The proposed technology development and testing project integrates three important capabilities into one dynamic data collection and reporting system. The three components of this new system are (1) the ReliefInsite platform, a sophisticated and user-friendly secure HIPAA compliant web service, built on open-source technology, currently used for on-going patient assessment and longitudinal reporting for which new applications will be developed; (2) TEAMSI, a cutting edge documentation instrument for acupuncture charting to collect additional acupuncture-specific clinical information from patients and easily chart acupuncture treatments; and (3) incorporation of validated patient-reported outcome measures from the NIH Patient Reported Outcome Measurement Information System (PROMIS) and the RTI International CAM-PRO measures of patient-provider interaction, as well as demographics and provider information needed for research. The proposed system will provide a dynamic data collection tool that will facilitate both 1) the assessment of efficacy in randomized control trials of by operationalizing treatment protocols and 2) the study of clinical effectiveness in outcome studies by capturing what is going on in the "real world" of clinical care. Key features of the new system include: incorporation of both patient and provider documentation in a single system; a means to assess patient adherence to treatments, medications, and self-care; the opportunity to evaluate dose responses to the intervention and track adverse events; and a means to provide standardized treatment algorithms and manualization approaches necessary to support more rigorous study designs. The application will incorporate information and measures useful across conditions and treatment approaches, while creating an acupuncture-specific application to advance acupuncture research and serve as a prototype for future CAM modality-specific designs. PUBLIC HEALTH RELEVANCE: Given widespread use of complementary and alternative medicine (CAM) such as acupuncture, there is a need for translational research tools to support studies of safety, efficacy and clinical effectiveness of treatment for various conditions. The proposed project will develop a state of the art, user-friendly data collection system to seamlessly integrate data collected from patients and clinicians in clinical and research settings.

描述（由申请人提供）：本I期小型企业创新研究提案是对RFA-AT- 09-004 CAM干预临床研究转化工具的回应。拟议的技术开发和测试项目将三项重要能力纳入一个动态数据收集和报告系统。这一新系统的三个组成部分是：（1）ReliefInsite平台，这是一个先进的、用户友好的、安全的、符合《健康保险和责任法案》的网络服务，建立在开放源码技术基础上，目前用于持续的病人评估和纵向报告，为此将开发新的应用程序;（2）TEAMSI，一个尖端的针灸图表记录工具，以收集更多的针灸-从患者的具体临床信息和容易图表针灸治疗;和（3）纳入来自NIH患者报告结果测量信息系统（PROMIS）和RTI International CAM-PRO患者与提供者互动测量的经验证的患者报告结果测量，以及研究所需的人口统计和提供者信息。拟议的系统将提供一个动态的数据收集工具，这将有助于1）通过实施治疗方案来评估随机对照试验的疗效，2）通过捕获临床护理的“真实的世界”中正在发生的事情来研究结局研究中的临床有效性。新系统的主要功能包括：将患者和提供者的文档合并到一个系统中;评估患者对治疗，药物和自我护理的依从性的方法;评估干预的剂量反应和跟踪不良事件的机会;以及提供支持更严格研究设计所需的标准化治疗算法和手动方法的方法。该应用程序将整合在各种条件和治疗方法中有用的信息和措施，同时创建一个特定于针灸的应用程序，以推进针灸研究，并作为未来CAM模式特定设计的原型。 公共卫生相关性：鉴于针灸等补充和替代医学（CAM）的广泛使用，需要转化研究工具来支持各种疾病治疗的安全性，有效性和临床有效性研究。拟议项目将开发一个最先进的、用户友好的数据收集系统，以无缝整合从临床和研究环境中的患者和临床医生收集的数据。