search
Back to results

Evaluation of the Patient Deterioration Warning System (PDWS)

Primary Purpose

Patient Transfer to Intensive Care Unit (Procedure), Respiratory Arrest (Disorder), Cardiac Arrest (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PDWS Intervension
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patient Transfer to Intensive Care Unit (Procedure) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital
  • Hospital of South Western Jutland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Reduction in length of stay
Evaluation of differences in length of stay for patients admitted during the intervention and control arms respectively.
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.

Full Information

First Posted
October 6, 2017
Last Updated
February 20, 2021
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Hospital of South Western Jutland
search

1. Study Identification

Unique Protocol Identification Number
NCT03375658
Brief Title
Evaluation of the Patient Deterioration Warning System
Acronym
PDWS
Official Title
Cluster Randomized Trial of the Patient Deterioration Warning System in Emergency Departments
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
April 8, 2019 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital, Hospital of South Western Jutland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Transfer to Intensive Care Unit (Procedure), Respiratory Arrest (Disorder), Cardiac Arrest (Disorder), Patient Died in Hospital (Finding)
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
PDWS Intervension
Intervention Description
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
Primary Outcome Measure Information:
Title
In-hospital deterioration
Description
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)
Secondary Outcome Measure Information:
Title
Economic effect of PDWS
Description
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
Title
Acceptance of novel patient monitoring system
Description
Technology Acceptance Model based evaluation of the clinicians' perception of the novel system's usefulness and ease of use.
Time Frame
35 weeks
Title
Reduction in length of stay
Description
Evaluation of differences in length of stay for patients admitted during the intervention and control arms respectively.
Time Frame
Admission length (1-7 days)
Title
Monitoring load effect
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hospital of South Western Jutland
City
Esbjerg
State/Province
Jylland
ZIP/Postal Code
6700
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24718637
Citation
Henriksen DP, Brabrand M, Lassen AT. Prognosis and risk factors for deterioration in patients admitted to a medical emergency department. PLoS One. 2014 Apr 9;9(4):e94649. doi: 10.1371/journal.pone.0094649. eCollection 2014.
Results Reference
background
PubMed Identifier
21767755
Citation
Kellett J, Emmanuel A, Deane B. Who will be sicker in the morning? Changes in the Simple Clinical Score the day after admission and the subsequent outcomes of acutely ill unselected medical patients. Eur J Intern Med. 2011 Aug;22(4):375-81. doi: 10.1016/j.ejim.2011.03.005. Epub 2011 Apr 8.
Results Reference
background
PubMed Identifier
19033493
Citation
Armstrong B, Walthall H, Clancy M, Mullee M, Simpson H. Recording of vital signs in a district general hospital emergency department. Emerg Med J. 2008 Dec;25(12):799-802. doi: 10.1136/emj.2007.052951.
Results Reference
background
PubMed Identifier
25236182
Citation
Brier J, Carolyn M, Haverly M, Januario ME, Padula C, Tal A, Triosh H. Knowing 'something is not right' is beyond intuition: development of a clinical algorithm to enhance surveillance and assist nurses to organise and communicate clinical findings. J Clin Nurs. 2015 Mar;24(5-6):832-43. doi: 10.1111/jocn.12670. Epub 2014 Sep 19.
Results Reference
background
PubMed Identifier
25019354
Citation
Brabrand M, Hallas J, Knudsen T. Nurses and physicians in a medical admission unit can accurately predict mortality of acutely admitted patients: a prospective cohort study. PLoS One. 2014 Jul 14;9(7):e101739. doi: 10.1371/journal.pone.0101739. eCollection 2014.
Results Reference
background
PubMed Identifier
27067076
Citation
Schmidt T, Bech CN, Brabrand M, Wiil UK, Lassen A. Factors related to monitoring during admission of acute patients. J Clin Monit Comput. 2017 Jun;31(3):641-649. doi: 10.1007/s10877-016-9876-y. Epub 2016 Apr 12.
Results Reference
background
PubMed Identifier
21204323
Citation
Acutely Ill Patients in Hospital: Recognition of and Response to Acute Illness in Adults in Hospital [Internet]. London: National Institute for Health and Clinical Excellence (NICE); 2007 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK45947/
Results Reference
background
PubMed Identifier
25055312
Citation
Clifton DA, Wong D, Clifton L, Wilson S, Way R, Pullinger R, Tarassenko L. A large-scale clinical validation of an integrated monitoring system in the emergency department. IEEE J Biomed Health Inform. 2013 Jul;17(4):835-42. doi: 10.1109/JBHI.2012.2234130.
Results Reference
background
PubMed Identifier
18342422
Citation
Fuhrmann L, Lippert A, Perner A, Ostergaard D. Incidence, staff awareness and mortality of patients at risk on general wards. Resuscitation. 2008 Jun;77(3):325-30. doi: 10.1016/j.resuscitation.2008.01.009. Epub 2008 Mar 14.
Results Reference
background
PubMed Identifier
24361459
Citation
Murray A, Kellett J, Huang W, Woodworth S, Wang F. Trajectories of the averaged abbreviated Vitalpac early warning score (AbEWS) and clinical course of 44,531 consecutive admissions hospitalized for acute medical illness. Resuscitation. 2014 Apr;85(4):544-8. doi: 10.1016/j.resuscitation.2013.12.015. Epub 2013 Dec 21.
Results Reference
background
PubMed Identifier
16945465
Citation
Smith GB, Prytherch DR, Schmidt P, Featherstone PI, Knight D, Clements G, Mohammed MA. Hospital-wide physiological surveillance-a new approach to the early identification and management of the sick patient. Resuscitation. 2006 Oct;71(1):19-28. doi: 10.1016/j.resuscitation.2006.03.008. Epub 2006 Aug 30.
Results Reference
background
PubMed Identifier
18064532
Citation
Gorges M, Staggers N. Evaluations of physiological monitoring displays: a systematic review. J Clin Monit Comput. 2008 Feb;22(1):45-66. doi: 10.1007/s10877-007-9106-8. Epub 2007 Dec 7.
Results Reference
background
PubMed Identifier
22617736
Citation
Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
Results Reference
background

Learn more about this trial

Evaluation of the Patient Deterioration Warning System

We'll reach out to this number within 24 hrs