An interventional study of PDWS Intervension in Patient Transfer to Intensive Care Unit (Procedure), Respiratory Arrest (Disorder) and Cardiac Arrest (Disorder), sponsored by University of Southern Denmark. Status unknown at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Supportive care
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The overall goal of the project is to reduce the number of unexpected patient deteriorations by 50% at Emergency Departments (ED) by investigating if the novel Patient Deterioration Warning Systems (PDWS), can improve clinicians' ability to identify deterioration at an earlier stage.
A third of all acute medical patients with normal vital signs at arrival, experience a deterioration in vital signs during the 24 first hours. This can potentially lead to dire consequences for these patients, as the risk of deterioration is present across all severity levels. The utilization of patient monitoring systems in the dispersed and shared working environments of EDs and acute wards may help to identify some of the reasons for failure to rescue patients. Thus, quantifying the extent to which a patient is being monitored, may be an aid to bridge the current gap between usage of automated and manual monitoring as clinical work will continue to depend on tacit knowledge and intuition.
Several systems and protocols have been established to swiftly deal with identified deterioration. Most systems struggle with issues of clinical adherence and are difficult to assess on-the-fly, and in some cases 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, most of the widely used Track and Trigger systems lack a temporal aspect. Furthermore, a limited number of these Track and Trigger systems have been integrated into real time clinical decision support systems, which has not evolved much in the last decades.
The PDWS deals with these challenges by aggregating and summarizing all vital values measured with the ED's patient monitors in the ongoing admission to intuitively present the state and trajectory. The investigators intend to determine if making the PDWS system available to nurses and physicians throughout the entire ED improves their ability to identify patients at risk of deterioration. To make this assessment, the PDWS will be evaluated in a cluster randomized trial (CRT) at two ED facilities in Denmark. The CRT is structured in three 5-week intervention, and three 5-week control periods, separated by a washout period of at least one week. The primary outcome is in-hospital deterioration - defined as transfer to the intensive care unit, heart/respiratory failure or death. The effect the PDWS will be assessed by comparing the proportions of events in each study arm using Pearsons's chi-squared test on these two samples. Furthermore, the technical and economical effects are evaluated using the Technology Acceptance Model, and the Model for Assessment of Telemedicine.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's enrollment of 6,500 is above the median of 60 across 195 interventional studies indexed under Apnea.
Browse Apnea studies →University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
All vital signs registered as part of usual care are used for modelling patients state and trajectories and made available to clinicans via the Patient Deterioration Warning System in nursing and physician offices.
Other: PDWS Intervension
Usual care
Patients admitted to the emergency department in the intervention period will have their vital values presented on the PDWS in addition to existing patient monitoring systems
In-hospital deterioration
Defined as transfer to intensive care units, heart/respiratory failure, and in-hospital mortality. Events are reviewed by experts to exclude cases expected of deterioration at time of arrival.
Time frame: Admission length (1-7 days)
Economic effect of PDWS
Cost effective analysis of savings in DKK between differences in primary outcomes in intervention and control arms of the study when inspecting DRG associations.
Time frame: 35 weeks
Acceptance of novel patient monitoring system
Technology Acceptance Model based evaluation of the clinicians' perception of the novel system's usefulness and ease of use.
Time frame: 35 weeks
Reduction in length of stay
Evaluation of differences in length of stay for patients admitted during the intervention and control arms respectively.
Time frame: Admission length (1-7 days)
Monitoring load effect
Does the automatic presentation of patients average severity defined by registered vital signs affect how much patients are monitored during their admission. Degree of monitoring as defined as monitor load.
Time frame: Admission length (1-7 days)
Plan to share: No
Ran from May 2018 to primary completion in Apr 2019, 10 months.
Of 69 non-industry interventional studies with no phase under Apnea, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 10 months is below that.
Counting every sponsor, half of 78 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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