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Trial registered on ANZCTR


Registration number
ACTRN12614000848606
Ethics application status
Approved
Date submitted
21/07/2014
Date registered
7/08/2014
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
"Vigilance with Vital Signs" for early detection of deterioration in hospital wards
Scientific title
Continuous monitoring of vital signs for early detection of deteriorating patients in surgical or medical wards
Secondary ID [1] 285012 0
Nil
Universal Trial Number (UTN)
U1111-1159-4588
Trial acronym
VVS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical deterioration after admission to Respiratory ward 292525 0
Clinical deterioration after admission to Neurosurgery ward 292526 0
Condition category
Condition code
Respiratory 292828 292828 0 0
Other respiratory disorders / diseases
Public Health 292829 292829 0 0
Health service research
Surgery 292937 292937 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A package of activities for early detection of deterioration:
1. Two-hour Theoretical and bedside practical training sessions to ward staff individually or in small groups by an ICU hospital trainer covering interpretation of vital signs trends for earlier identification of deterioration will be delivered over a 4-week period.
2. One-week practical demonstrations by a trained facilitator in the use of a patient-worn mobile device and remote visual display for their introduction on the wards. This will include demonstrations and practice on the technical aspects; troubleshooting; interpretation of data shown on the screen; and application of the mobile device on all consenting newly admitted patients in the target wards following a protocol.
3. Installation of hardware on nurses station for remote visual displays on the wards, and introduction of the mobile devices (recording heart rate, blood pressure, respiratory rate, oxygen saturation, skin temperature and ECG) applied to patient's wrist and chest. Each newly admitted patient to wear the mobile monitor day and night including during sleep for the first three days or until discharge if this occurs earlier. Patient recruitment over 2 years or less if sample size recruited earlier.
4. Technical support, refresher training as required and adherence monitoring by a group trained as super trainers
5. Verbal and written information provided to patients at the time of recruitment on the device purpose, instruction on alerting nurses on alarms and potential benefits of continuous monitoring

Overal duration of intervention: 2-month 5 weeks clinical and technical training followed by two years of monitoring device implementation.
Intervention code [1] 289846 0
Treatment: Devices
Intervention code [2] 289919 0
Early detection / Screening
Comparator / control treatment
Standard care of spot-checks of vital signs (3 times/day) using routine electronic ward equipment as per hospital policy.

Two control groups will be used to compare outcomes with the intervention groups:
1- Patients in same target wards before the intervention (matched by age-sex and ICD chapter for primary diagnosis) 2- Patients in other hospital general wards hospitalised during the study period and matched by age-sex.
Control group
Active

Outcomes
Primary outcome [1] 292717 0
Change in rates of unplanned transfer to intensive care
Timepoint [1] 292717 0
6 months, 12 months and 24 months
Primary outcome [2] 292718 0
Incidence of deterioration (as defined by monthly rates of rapid response team activations) per 100 admissions to target wards
Timepoint [2] 292718 0
6 months, 12 months and 24 months
Primary outcome [3] 292719 0
Change in mean and median length of stay (overall and LOS after rapid response team activation)
Timepoint [3] 292719 0
12 months and 24 months
Secondary outcome [1] 309541 0
Change in length of stay in ICU for those transferred after a rapid response team call
Timepoint [1] 309541 0
12 months and 24 months
Secondary outcome [2] 309542 0
Proportions of patients who have adverse events and had physiological abnormalities present within 8 and 24 hours of the event
Timepoint [2] 309542 0
12 months and 24 months
Secondary outcome [3] 309543 0
Profile of physiological derangement preceding MET calls
Timepoint [3] 309543 0
12 months and 24 months
Secondary outcome [4] 309544 0
Proportions of missed alarms (no alerts in the presence of deterioration) and false alarms (alarms in the absence of deterioration)
Timepoint [4] 309544 0
6 months and 12 months
Secondary outcome [5] 309546 0
Predictive value of different thresholds for single and combined parameters, and correlation with primary outcomes
Timepoint [5] 309546 0
12 months and 24 months

Eligibility
Key inclusion criteria
All consecutive adult patients including low-risk and high risk who are admitted to the target Neurosurgery or Respiratory Medicine wards with any diagnoses, are able to wear the device under investigation for at least the first three days from admission and can communicate in English (with or without an interpreter).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have a Not For Resuscitation order; patients who die within 15 minutes of admission to ward; Patients who cannot communicate in English.

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)
All consecutive patients admitted will be invited. No concealment possible as intervention include the use of new wireless, mobile technology applied to patients.
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
Other
Other design features
Two control groups will be used to compare outcomes with the intervention groups:
1- Patients in same target wards before the intervention (matched by age-sex and ICD chapter for primary diagnosis)

2- Patients in other hospital general wards hospitalised during the study period and matched by age-sex.
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
SAMPLE SIZE ESTIMATES:
Based on 2013 data for the target wards, length of stay is 8-12 days in the target wards and transfers to ICU occur in 14%-21% of patients receiving a rapid response call. A sample of 264 patients in each ward (and corresponding controls from other hospital wards) will give us 80% power at the 0.05 significance level to detect: (a) an absolute reduction of 7% in ICU transfers and (b) a reduction of 2 days in length of stay. If feasible depending on recruitment pace, a larger sample will be recruited to detect smaller impacts.


ANALYSIS
The effect of the intervention will be presented as the odds ratio (OR with 95% confidence intervals).

Differences in estimates between hospital wards will use the Mantel-Haenszel test and paired comparisons (before-after) within wards will use the McNemar’s test. The null hypotheses will be evaluated as 2-sided significance level of 0.05. Multivariable random effects logistic regression models will be used for predictor analysis, i.e. the binary outcome variable in model would be unplanned transfer to ICU.

Receiver Operating Characteristics (ROC) curve will be used as a tools to measure the performance of the device by testing several thresholds to select the optimal model and discard suboptimal thresholds for triggering the use of the rapid response team service and for predicting outcomes.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This trial was abandoned by hospital management due to internal issues and TGA approval delays.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2761 0
Liverpool Hospital - Liverpool

Funding & Sponsors
Funding source category [1] 289639 0
Government body
Name [1] 289639 0
National Health & Medical Research Council
Address [1] 289639 0
GPO Box 1421
Canberra, ACT 2601
Country [1] 289639 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
The Simpson Centre for Health Services Research,
Level 1, AGSM Building,
Australian Institute of Health Innovation, UNSW,
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 288327 0
Government body
Name [1] 288327 0
Clinical Excellence Commission
Address [1] 288327 0
Level 13,
227 Elizabeth St, Sydney NSW 2000
Country [1] 288327 0
Australia
Secondary sponsor category [2] 288328 0
Government body
Name [2] 288328 0
HealthShare NSW
Address [2] 288328 0
Tower A, Level 17, Zenith Centre,
821 Pacific Highway
Chatswood NSW 2067
Country [2] 288328 0
Australia
Other collaborator category [1] 278059 0
Hospital
Name [1] 278059 0
Liverpool Hospital
Address [1] 278059 0
Elizabeth St, Liverpool NSW 2170
Country [1] 278059 0
Australia
Other collaborator category [2] 278060 0
Government body
Name [2] 278060 0
South Western Sydney Local Health District
Address [2] 278060 0
Eastern Campus Of Liverpool Hospital
Warwick Farm NSW 2170
Country [2] 278060 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291379 0
South Western Sydney Local Health District (SWSLHD)
Ethics committee address [1] 291379 0
Level 2, Liverpool Hospital/Elizabeth St,
Liverpool NSW 2170
Ethics committee country [1] 291379 0
Australia
Date submitted for ethics approval [1] 291379 0
09/09/2014
Approval date [1] 291379 0
29/01/2014
Ethics approval number [1] 291379 0
EC00136

Summary
Brief summary
The Vigilance with Vital Signs Study aims to establish a system for early identification of high-risk patients through the continuous electronic monitoring of vital signs (respiratory rate, heart rate, blood pressure, skin temperature, ECG and oxygen saturation) to trigger a response and prevent adverse events in general wards. Our hypothesis is that a continuous monitoring system including clinical training, the mobile device and pre-defined alarm thresholds can reduce adverse events,deaths and unplanned admissions to intensive care by detecting earlier deterioration and prompting earlier intervention by ward staff.
Trial website
Trial related presentations / publications
See public notes on publications released before recruitment.
Public notes
Trial-related subprojects published
--Cardona-Morrell M, Prgomet M, Lake R, Nicholson M, Long J, Harrison R, and K H. Vital
signs monitoring and nurse-patient interaction: an observational study of hospital practice.
Int J Nurs Stud 2016;56:9–16
--Prgomet M, Cardona-Morrell M, Nicholson M, Lake R, Long J,Westbrook J, Braithwaite J, and Hillman K. Vital signs monitoring on general wards: clinical staff perceptions of current
practices and the planned introduction of continuous monitoring technology. IJQHC2016;28(4) 515-521.

Contacts
Principal investigator
Name 50046 0
Prof Ken Hillman
Address 50046 0
ICU, Liverpool Hospital
Locked Bag 7103,
Liverpool BC
New South Wales 1870
Country 50046 0
Australia
Phone 50046 0
+61 2 8738 3585
Fax 50046 0
Email 50046 0
k.hillman@unsw.edu.au
Contact person for public queries
Name 50047 0
A/Prof Michael Parr
Address 50047 0
A/Prof Michael Parr
Director
Intensive Care, Liverpool Hospital and South Western Sydney Clinical School, UNSW
Locked Bag 7103,
Liverpool BC
New South Wales 1870
Country 50047 0
Australia
Phone 50047 0
+61 2 8738 3400
Fax 50047 0
Email 50047 0
Michael.Parr@sswahs.nsw.gov.au
Contact person for scientific queries
Name 50048 0
Dr Magnolia Cardona-Morrell
Address 50048 0
Level1, AGS Building,
Australian Institute of Health Innovation
Gate 11, Botany St entrance
The University of NSW
Kensington NSW 2052
Australia
Country 50048 0
Australia
Phone 50048 0
+61 2 8738 9373
Fax 50048 0
Email 50048 0
m.cardonamorrell@unsw.edu.au

No data has been provided for results reporting
Summary results
Not applicable