Clinical Utility of an Observation and Response Chart With Human Factors Design Characteristics and a Track and Trigger System: Study Protocol for a Two-Phase Multisite Multiple-Methods Design

Background Clinical deterioration of adult patients in acute medical-surgical wards continues to occur, despite a range of systems and processes designed to minimize this risk. In Australia, a standardized template for adult observation charts using human factors design principles and decision-support characteristics was developed to improve the detection of and response to abnormal vital signs. Objective To describe the study protocol for the clinical testing of these observation and response charts (ORCs). Methods We propose a two-phase multisite multiple-methods design to test the initial clinical utility of the charts in 10 hospitals of differing types and sizes across state jurisdictions in Australia. Data collection in the first phase includes user surveys, observations and field notes by project officers, handover de-briefs (short interviews with small groups of staff), and an audit of ORC documentation completion compared to the site’s existing observation chart. For the second phase, data will be collected using a retrospective audit of observation documentation from the previous hospital observation chart, prospective audit of observation documentation following implementation of the selected ORC, user focus groups, observational field notes, and patient outcome data from routinely collected organizational data sources. Results Site selection and preparation, project officer training, chart selection and implementation, participant recruitment, and data collection has been completed and the analysis of these results are in progress. Conclusions This detailed description of these study methods and data collection approaches will enable a comprehensive assessment of the clinical utility of these newly developed track and trigger charts and will be useful for clinicians and researchers when planning and implementing similar studies. Potential methodological limitations are also noted.