• Philipp Bruland, Christian Forster, Bernhard Breil, Sonja Ständer, Martin Dugas, and Fleur Fritz.
• Institute of Medical Informatics, University of Münster, Germany. Electronic address: Philipp.Bruland@uni-muenster.de.
• Int J Med Inform. 2014 Dec 1;83(12):915-28.

ObjectivesThe first objective of this study is to evaluate the impact of integrating a single-source system into the routine patient care documentation workflow with respect to process modifications, data quality and execution times in patient care as well as research documentation. The second one is to evaluate whether it is cost-efficient using a single-source system in terms of achieved savings in documentation expenditures.MethodsWe analyzed the documentation workflow of routine patient care and research documentation in the medical field of pruritus to identify redundant and error-prone process steps. Based on this, we established a novel documentation workflow including the x4T (exchange for Trials) system to connect hospital information systems with electronic data capture systems for the exchange of study data. To evaluate the workflow modifications, we performed a before/after analysis as well as a time-motion study. Data quality was assessed by measuring completeness, correctness and concordance of previously and newly collected data. A cost-benefit analysis was conducted to estimate the savings using x4T per collected data element and the additional costs for introducing x4T.ResultsThe documentation workflow of patient care as well as clinical research was modified due to the introduction of the x4T system. After x4T implementation and workflow modifications, half of the redundant and error-prone process steps were eliminated. The generic x4T system allows direct transfer of routinely collected health care data into the x4T research database and avoids manual transcription steps. Since x4T has been introduced in March 2012, the number of included patients has increased by about 1000 per year. The average entire documentation time per patient visit has been significantly decreased by 70.1% (from 1116±185 to 334±83 s). After the introduction of the x4T system and associated workflow changes, the completeness of mandatory data elements raised from 82.2% to 100%. In case of the pruritus research study, the additional costs for introducing the x4T system are €434.01 and the savings are 0.48ct per collected data element. So, with the assumption of a 5-year runtime and 82 collected data elements per patient, the amount of documented patients has to be higher than 1102 to create a benefit.ConclusionIntroduction of the x4T system into the clinical and research documentation workflow can optimize the data collection workflow in both areas. Redundant and cumbersome process steps can be eliminated in the research documentation, with the result of reduced documentation times as well as increased data quality. The usage of the x4T system is especially worthwhile in a study with a large amount of collected data or a high number of included patients.Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

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