Short summary

The grand goal of this project is to build and validate a new patient monitoring system that helps clinicians to better identify patients at risk of deterioration in Emergency Departments (ED) by aggregating all automatically registered vital signs and linking it with clinical logistics. Equipping clinicians with a heightened awareness of their patients is assumed to directly lead to better outcomes, especially for patients who unexpectedly deteriorate during their admission. The system will be evaluated in a cluster randomized trial at the EDs of Odense University Hospital and Hospital of South Western Jutland from both clinical, technical, and economic assessments. 

Rationale

Patients of all sorts, and with a wide range of diagnoses, are treated in Emergency Departments (ED) around the world every single day. However, in contrast to other specialties, ED clinicians frequently have to derive a diagnosis and initiate treatment based on nothing but the patient's background story and immediately observable symptoms. Deviation of vital signs has been linked with adverse incidents, and thus observation and registration of vital signs are an essential part of patient care. To cope with this, several health information systems have been developed specifically for managing the flow and treatment of patients. Still, as many as 31 percent of acutely admitted patients who appear normal upon admission deteriorate during their stay. Such deterioration is strongly associated with an increased risk of in-hospital respiratory/heart failure, transfer to the intensive care unit, and increased mortality. Several systems and protocols have been established to swiftly deal with identifying deterioration, but these still depend on the judgement of individual clinicians. This, however, is no trivial task in an environment plagued by noise, uncertainty, and complexity. In fact, poor clinical monitoring has been identified as one of the most dominant causes for preventable in-hospital deaths. A study at a general ward in a Danish hospital found that nurses failed to notice abnormality in 43% of patients experiencing deterioration. Although the trajectories of patients' vital signs have been identified as more important than the initial scoring value, none of the most widely used Track and Trigger systems directly embed previous scorings into the aggregated scoring, and consequently lack a temporal aspect. 

Our past work has found that utilization of patient monitoring systems are used very differently - depending on the experience of the attending clinician, the specialty, and a range of other factors. Common for most clinical environments is the fact that an incomprehensible amount of data is available to the staff. A more intuitive presentation of these streams of data may improve the clinicians' situational awareness to an extent that enables them to better identify early onset of deterioration. As one possible solution for this challenge, we have built a novel monitoring system. The system is named the Patient Deterioration Warning System (PDWS), and has already been successfully validated by a representative sample of clinicians at the ED of Odense University Hospital in a previous pilot study. The system aggregates all vital values automatically measured with the ED's patient monitors, and summarizes these values into an intuitive representation of the patients' state and trajectory. The purpose of this project is to evaluate the effect of the PDWS in a realistic effect evaluation study of the PDWS in use at the EDs of OUH and Hospital of South Western Jutland (HSWJ). 

350 patients are admitted to the EDs in Odense and Esbjerg every week. Approximately two of these patients experience a serious unforeseen deterioration during their admission. We hypothesize that the PDWS will be able to reduce these unforeseen deteriorations by 50%. The clinical trial will be divided into three control periods and three intervention periods, each of a five-week duration. In total we hope to include 10,500 patients in the study. The effect the PDWS will be assessed by comparing the proportions of deteriorations in each study arm using Pearsons's chi-squared test on these two samples. 

Due to the interdisciplinary nature of this project, we apply three different perspectives; a technical perspective to deal with the challenges of health information system integration and acceptability in clinical work, a clinical perspective to assess the impact of the intervention, and an economical perspective to gain an understanding of the systemic nature of information systems in healthcare.

Description of the cohort

Patients of all sorts, and with a wide range of diagnoses, are treated in Emergency Departments (ED) around the world every single day. However, in contrast to other specialties, ED clinicians frequently have to derive a diagnosis and initiate treatment based on nothing but the patient's background story and immediately observable symptoms. Deviation of vital signs has been linked with adverse incidents, and thus observation and registration of vital signs are an essential part of patient care. To cope with this, several health information systems have been developed specifically for managing the flow and treatment of patients. Still, as many as 31 percent of acutely admitted patients who appear normal upon admission deteriorate during their stay. Such deterioration is strongly associated with an increased risk of in-hospital respiratory/heart failure, transfer to the intensive care unit, and increased mortality. Several systems and protocols have been established to swiftly deal with identifying deterioration, but these still depend on the judgement of individual clinicians. This, however, is no trivial task in an environment plagued by noise, uncertainty, and complexity. In fact, poor clinical monitoring has been identified as one of the most dominant causes for preventable in-hospital deaths. A study at a general ward in a Danish hospital found that nurses failed to notice abnormality in 43% of patients experiencing deterioration. Although the trajectories of patients' vital signs have been identified as more important than the initial scoring value, none of the most widely used Track and Trigger systems directly embed previous scorings into the aggregated scoring, and consequently lack a temporal aspect. 

Our past work has found that utilization of patient monitoring systems are used very differently - depending on the experience of the attending clinician, the specialty, and a range of other factors. Common for most clinical environments is the fact that an incomprehensible amount of data is available to the staff. A more intuitive presentation of these streams of data may improve the clinicians' situational awareness to an extent that enables them to better identify early onset of deterioration. As one possible solution for this challenge, we have built a novel monitoring system. The system is named the Patient Deterioration Warning System (PDWS), and has already been successfully validated by a representative sample of clinicians at the ED of Odense University Hospital in a previous pilot study. The system aggregates all vital values automatically measured with the ED's patient monitors, and summarizes these values into an intuitive representation of the patients' state and trajectory. The purpose of this project is to evaluate the effect of the PDWS in a realistic effect evaluation study of the PDWS in use at the EDs of OUH and Hospital of South Western Jutland (HSWJ). 

350 patients are admitted to the EDs in Odense and Esbjerg every week. Approximately two of these patients experience a serious unforeseen deterioration during their admission. We hypothesize that the PDWS will be able to reduce these unforeseen deteriorations by 50%. The clinical trial will be divided into three control periods and three intervention periods, each of a five-week duration. In total we hope to include 10,500 patients in the study. The effect the PDWS will be assessed by comparing the proportions of deteriorations in each study arm using Pearsons's chi-squared test on these two samples. 

Due to the interdisciplinary nature of this project, we apply three different perspectives; a technical perspective to deal with the challenges of health information system integration and acceptability in clinical work, a clinical perspective to assess the impact of the intervention, and an economical perspective to gain an understanding of the systemic nature of information systems in healthcare.

Data and biological material

For all patients who consent to participate in the project, we will utilize the following data:

• all vital signs registered automatically using the department patient monitors (heart rate, respiration rate, peripheral arterial blood oxygen saturation, systolic and diastolic blood pressure).
• admission information from clinical logistics: gender, admission time, triage, bed occupied during admission, diagnostic notes, discharge time, observation regimens
• outcome information from landspatientregisteret: (ICU transfer, heart/respiratory failure, mortality). ICD-10 codes.
• questionnarie data from attending clinicians based on the technology acceptance model.

Collaborating researchers and departments

Mærsk Mc-Kinney Møller Instituttet, University of Southern Denmark

• Assistant professor Thomas Schmidt

Department of Emergency Medicine, Hospital of South Western Jutland

• Associate professor Mikkel Brabrand

Mærsk Mc-Kinney Møller Instituttet, University of Southern Denmark

• Professor Uffe Kock Wiil

Publications associated with the project

Factors Related to Monitoring During Admission of Acute Patients. Schmidt T, Beck CLN, Brabrand M, Wiil, UK, Lassen AT (2016). Journal of Clinical Monitoring and Computing. Springer. Identifying Patients at Risk of Deterioration in the Joint Emergency Department. Schmidt T & Wiil UK (2015). Cognition, Technology and Work. 17, 4, 529-545. Springer.