Infrastructure Development for a Randomized Clinical Trial on Dysphagia Outcomes

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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.