Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001102066
Ethics application status
Approved
Date submitted
13/12/2010
Date registered
16/12/2010
Date last updated
16/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the introduction of a Modified Early Warning Score Observation Chart and associated escalation of medical care protocol on morbidity and mortality rates in the Royal Darwin Hospital
Scientific title
Effect of the introduction of a Modified Early Warning Score Observation Chart and associated escalation of medical care protocol on morbidity and mortality rates in the Royal Darwin Hospital
Secondary ID [1] 253283 0
Nil
Universal Trial Number (UTN)
Not obtained yet
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of the deteriorating patient on a hospital surgical ward 258808 0
Condition category
Condition code
Other 258958 258958 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Public Health 258976 258976 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation of a modified early warning score (MEWS) observation chart on intervention wards preceded by a period of education using the COMPASS program.

(A) Modified Early Warning Score Observation Chart is a new ward observation chart where respiratory rate, oxygen saturation, temperature, blood pressure, heart rate, sedation and urine output are all documented. The observations form the y-axis and time forms the x-axis. These observations are represented graphically and numerically on a discrete area of on the y-axis, except for blood pressure and heart rate which are on the same scale. Each observation done corresponds to MEWS value (0-3) which is colour coded and documented on the chart. At the bottom of the MEWS chart is an area for total MEWS score which adds up the individual MEWS scores for all 7 vital signs. The total MEWS score then corresponds to an escalation protocol.

(B/C/D) The Education session for the COMPASS program involves the following: (1) An interactive CD ROM containing information on the basic physiological principles underlying vital signs, example observation charts of deteriorating patients and questions related to abnormal observations. (2) A 100 page education manual: Containing a comprehensive package on physiological principles underlying vital signs, “ABC” and deteriorating patients, the use of Modified Early Warning Scores and communication strategies and enhancement of team work. (3) Assessment using a multiple choice quiz. The CD and quiz is to be done in each staff member's own time, however a cut off date to have the quiz completed is established on each ward by the nurse in charge. (4) A 2-3 hour face-to-face teaching session where practical instructions on the use of modified early warning score and practical instructions of communication strategy are taught. Multiple sessions are held leading up to the implementation of MEWS charts on each ward, and each staff member must attend one session.

(E) The duration of the intervention period in which I am auditing is one month, however MEWS charts are being rolled out throughout the Royal Darwin Hospital on a permanent basis.
Intervention code [1] 257737 0
Early detection / Screening
Intervention code [2] 257753 0
Treatment: Other
Comparator / control treatment
Retrospective look at the intervention wards one year earlier when the standard hospital observation charts were being used
Control group
Historical

Outcomes
Primary outcome [1] 259811 0
Primary outcome 1. frequency of number of observations documented. ie how many times per day a patients vital signs are measured. These vital signs include: oxygen saturation, blood pressure, heart rate, respiratory rate, temperature, urine output, sedation. This is assessed by looking at patients observations charts and documenting what vitals signs were recorded, the times at which they were recorded, and the duration of stay on that particular ward during the intervention or control period.
Timepoint [1] 259811 0
Timepoint 1: Measured continuously throughout the control and intervention period. I will document every set of observations made during the control and intervention period for 25% of patients admitted to the intervention wards that meet inclusion criteria. During the intervention period I will be looking at and updating MEWS chart documentation weekly. For the control period, I will look at the observations charts retrospectively as often as is needed to complete the audit.
Primary outcome [2] 259812 0
Primary outcome 2: time from which a patient deteriorates, as measured as an increasing modified early warning score, to the time an appropriate medical practitioner reviews the patient
Timepoint [2] 259812 0
Timepoint 2: During the intervention and control period I will be looking at and updating MEWS chart documentation regularly. If I come across any MEWS score that trigger the escalation protocol, I will then document the time to an appropriate medical practitioner review according to the patient notes.
Primary outcome [3] 259813 0
Primary outcome 3: improvement in the rate of code blue activation
Timepoint [3] 259813 0
Timepoint 3: Code blue activation will be checked at the end of both the intervention and control period.
Secondary outcome [1] 268614 0
Primary outcome 4: reduction in unplanned intensive care admissions
Timepoint [1] 268614 0
Timepoint 4: rate of unplanned intensive care admissions will be checked at the end of both the intervention and control period.
Secondary outcome [2] 268666 0
Primary outcome 5: reduction in the unexpected hospital deaths
Timepoint [2] 268666 0
Timepoint 5: rate of unexpected hospital deaths will be checked at the end of both the intervention and control period.

Eligibility
Key inclusion criteria
All patients over 18 years of age admitted to the two intervention wards
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative Care patients

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258202 0
Self funded/Unfunded
Name [1] 258202 0
Country [1] 258202 0
Primary sponsor type
Hospital
Name
Royal Darwin Hospital
Address
Rocklands Drive
Tiwi, NT 0810
Country
Australia
Secondary sponsor category [1] 257375 0
None
Name [1] 257375 0
Address [1] 257375 0
Country [1] 257375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260186 0
Human Resource Ethics Committee of NT dept of Health and Families and Menzies School of Health Research
Ethics committee address [1] 260186 0
Ethics committee country [1] 260186 0
Australia
Date submitted for ethics approval [1] 260186 0
29/09/2010
Approval date [1] 260186 0
08/11/2010
Ethics approval number [1] 260186 0
1/10/1471

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32008 0
Address 32008 0
Country 32008 0
Phone 32008 0
Fax 32008 0
Email 32008 0
Contact person for public queries
Name 15255 0
Kathleen Thomas
Address 15255 0
Royal Darwin Hospital
Rocklands Drive
Tiwi, NT 0810
Country 15255 0
Australia
Phone 15255 0
+61 8 8922 8888
Fax 15255 0
Email 15255 0
[email protected]
Contact person for scientific queries
Name 6183 0
Kathleen Thomas
Address 6183 0
Royal Darwin Hospital
Rocklands Drive
Tiwi, NT 0810
Country 6183 0
Australia
Phone 6183 0
+61 8 8922 8888
Fax 6183 0
Email 6183 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.