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Evaluation of the Patient Deterioration Warning System

Cluster Randomized Trial of the Patient Deterioration Warning System in Emergency Departments

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03375658
Acronym
PDWS
Enrollment
6500
Registered
2017-12-18
Start date
2018-05-18
Completion date
2021-12-31
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest (Disorder), Patient Died in Hospital (Finding), Patient Transfer to Intensive Care Unit (Procedure), Respiratory Arrest (Disorder)

Keywords

Information Science: Algorithms, Information Science: Informatics: Nursing Informatics, Information Science: Data Display: Computer graphics, Diagnosis: Diagnostic Techiques and Procedures: Monitoring, Physiologic, Health care facilities, Manpower and services: Health services: Emergency Medical Services: Triage

Brief summary

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.

Interventions

OTHERPDWS Intervension

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

Sponsors

Odense University Hospital
CollaboratorOTHER
Hospital of South Western Jutland
CollaboratorUNKNOWN
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult patients admitted to the emergency department

Exclusion criteria

* Critically ill patients who die during their admission * Orthopedic patients with minor injuries

Design outcomes

Primary

MeasureTime frameDescription
In-hospital deteriorationAdmission length (1-7 days)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.

Secondary

MeasureTime frameDescription
Economic effect of PDWS35 weeksCost effective analysis of savings in DKK between differences in primary outcomes in intervention and control arms of the study when inspecting DRG associations.
Acceptance of novel patient monitoring system35 weeksTechnology Acceptance Model based evaluation of the clinicians' perception of the novel system's usefulness and ease of use.
Reduction in length of stayAdmission length (1-7 days)Evaluation of differences in length of stay for patients admitted during the intervention and control arms respectively.
Monitoring load effectAdmission length (1-7 days)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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026