Evaluation of the Patient Deterioration Warning System (PDWS)

February 20, 2021 updated by: Thomas Schmidt, University of Southern Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Odense University Hospital
    • Jylland
      • Esbjerg, Jylland, Denmark, 6700
        • Hospital of South Western Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Usual care
Experimental: Intervention arm
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital deterioration
Time Frame: Admission 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.
Admission length (1-7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic effect of PDWS
Time Frame: 35 weeks
Cost effective analysis of savings in DKK between differences in primary outcomes in intervention and control arms of the study when inspecting DRG associations.
35 weeks
Acceptance of novel patient monitoring system
Time Frame: 35 weeks
Technology Acceptance Model based evaluation of the clinicians' perception of the novel system's usefulness and ease of use.
35 weeks
Reduction in length of stay
Time Frame: Admission length (1-7 days)
Evaluation of differences in length of stay for patients admitted during the intervention and control arms respectively.
Admission length (1-7 days)
Monitoring load effect
Time Frame: Admission 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.
Admission length (1-7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital
Hospital of South Western Jutland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2018

Primary Completion (Actual)

April 8, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 20, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDWS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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