Intravenous (IV) medications are important in the management of hospitalized patients. Intravenous medications, especially continuous drips, are commonly managed with infusion pump systems. While these potent medications can be life saving, errors associated with their administration also present a greater risk for severe adverse events. To our knowledge, there have been no prospective studies of the incidence and nature of medication errors (MEs) associated with IV infusion pump delivery systems. We plan to study serious MEs associated with the use of IV infusion pump delivery systems in critically ill patients. In addition, we will conduct a prospective interventional trial to evaluate the impact of a """"""""smart"""""""" infusion system on serious MEs. """"""""Smart"""""""" infusion pumps have decision support capability and can provide real-time user feedback to nursing personnel. This study will be conducted in conjunction with Alaris, a leader in the development of safe IV infusion systems. Our study will be conducted in two phases in order to accomplish our two main aims: 1) a prospective observational of the incidence and epidemiology of serious MEs associated with IV infusion pump delivery systems in critically ill patients; and 2) a randomized control interventional trial to evaluate the impact of a """"""""smart"""""""" infusion system on the incidence of serious MEs in critically ill patients. We hypothesize that: 1) serious MEs occur during the administration of IV medications via infusion pumps, and 2) serious MEs can be reduced with the use of """"""""smart"""""""" pumps providing real-time, point-of-care feedback to bedside nurses. The Alaris infusion pump can be programmed to record data associated with IV drug infusion either with the feedback decision support in the """"""""off"""""""" mode (observation or control settings) or """"""""on"""""""" mode (intervention setting). During the observation phase, the pump's program will only capture and document pump events that could trigger the decision support, when fully operational, to provide feedback, such as patient-specific recommendations. The enhanced feedback program will not be in the operational/interactive mode. Evaluation during the observation phase will provide opportunities for iterative improvements in the software design for implementation in the intervention trial during the second study phase. During the intervention phase, the units will be divided into the control group (without change from the observation phase) and the intervention group. The IV pumps' feedback mode with decision support will be fully operational for the intervention group. We will evaluate the impact of the IV pump's decision support and feedback on safe IV drug delivery. Primary outcome measures will be the incidence of serious MEs, and length of stay and total costs as secondary outcomes.
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