Infrastructure Development for a Randomized Clinical Trial on Dysphagia Outcomes

描述(由申请人提供)： 这项提案的总体目标是开发一个数据基础设施系统，以支持首个多点随机临床试验(RCT)，该试验将测试标准化评估和有针对性的治疗方法对中风后吞咽障碍退伍军人的吞咽和健康结局的影响。该项目将包括修改、调整和实地测试由PI和专家技术小组设计和测试的综合数据库，以输入、存储和分析计划中的随机对照试验所需的人口统计、纵向诊断和治疗结果变量。以下具体目标包括实现项目目标的系统方法：1)开发引入当前数据管理系统以选择退伍军人事务部所需的架构、数据系统增强和调整，2)执行现场和数据增强以及高级报告，3)设计和优化平板电脑兼容性和实施，增强用户体验，4)转移和过渡到退伍军人事务部-系统配置、软件和服务器设置、技术培训和Beta测试。该项目的翻译潜力对标准化临床医生培训、常规患者评估和报告以及卒中后吞咽困难患者的有针对性的治疗方法具有重要意义。建议在该试点项目和后续临床试验中使用的方法、设备和数据库程序允许将临床快速转换为吞咽困难的标准化CRE，集成到VA电子病历系统中，并促进未来的多点临床试验。

DESCRIPTION (provided by applicant): The overarching goal of this proposal is to develop a data infrastructure system to support the first multisite randomized clinical trial (RCT) that will test the effect of a standardized assessment and targeted treatment approach on swallowing and health outcomes in dysphagic Veterans following stroke. The project will include modification, adaptation, and field-testing of comprehensive database designed and tested by the PI and expert technical team for entry, storage, and analysis of demographic, longitudinal diagnostic and treatment outcome variables required for the planned RCT. The following specific aims include a systematic approach for achievement of the project goals: 1) Develop the architecture, data system enhancement, and adjustments necessary to import the current Data Management System to select VA sites, 2) Execute field and data enhancements and advanced reporting, 3) Design and optimize tablet compatibility and implementation with user experience enhancements, 4) Transfer and transition to VA - system configuration, software and server setup, tech training, and beta testing. The translational potential of this project is significant for standardization of clinician training, rutine patient assessment and reporting, and targeted treatment approach of dysphagic patients following stroke. The method, equipment, and database program proposed for use in this pilot project and subsequent clinical trials allow for rapid clinical translation into the standardized cre of dysphagics, integration into the VA electronic medical record system, and facilitation of future multi-site clinical trials.