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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619001337167p
Ethics application status
Not yet submitted
Date submitted
14/05/2019
Date registered
30/09/2019
Date last updated
30/09/2019
Date data sharing statement initially provided
30/09/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The association between nursing skill mix and outcomes for patients in mental health setting: a feasibility study
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Scientific title
The association between nursing skill mix and outcomes for patients in mental health setting: a feasibility study
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Secondary ID [1]
298227
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Nil known
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Universal Trial Number (UTN)
U1111-1233-3724
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Trial acronym
MH_SKILLMIX
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Linked study record
None
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Health condition
Health condition(s) or problem(s) studied:
Mental health disorders
312827
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Condition category
Condition code
Mental Health
311331
311331
0
0
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Schizophrenia
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Mental Health
311332
311332
0
0
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Psychosis and personality disorders
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Mental Health
311333
311333
0
0
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Depression
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Mental Health
311334
311334
0
0
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Psychosis and personality disorders
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Mental Health
311335
311335
0
0
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Condition observed: Patients admitted to an acute psychiatric ward experiencing a severe mental disorder e.g. schizophrenia, bipolar disorder, depression, personality disorder.
Exposure: The exposure is a nursing skill mix. In this study, this is defined as the ratio of mental health to registered nurses providing nursing care to included patients.
Duration of observation: One year.
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Intervention code [1]
314476
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Not applicable
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Relapse determined by admission to a psychiatric inpatient unit or referral to mental health crisis care. Data will be extracted from the electronic medical record.
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Assessment method [1]
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Timepoint [1]
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12 months post-discharge from a psychiatric inpatient unit.
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Secondary outcome [1]
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Length of inpatient admission (in days). Data will be extracted from the electronic medical record.
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Assessment method [1]
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Timepoint [1]
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From the admission date to the discharge date. The average period is 12 days.
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Secondary outcome [2]
375326
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The number of untoward incidents (e.g. violence or aggression, inpatient absconsions, applications of physical or mechanical restraint whilst inpatient). Data will be extracted from the hospital incident reporting system (RiskMan).
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Assessment method [2]
375326
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Timepoint [2]
375326
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From admission date to the discharge date.
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Secondary outcome [3]
375327
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Time in seclusion (in minutes). Data will be extracted from the hospital incident reporting system (RiskMan).
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Assessment method [3]
375327
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Timepoint [3]
375327
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From the admission date to the discharge date.
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Eligibility
Key inclusion criteria
1. All patients aged at least18 years, diagnosed with any mental health condition and have been admitted in mental health inpatients units for at least 24 hours from 01 January 2017 to 31 December 2018.
2. All nurses who worked in mental health inpatient units across all shifts (morning, afternoon and night) from 01 January 2017 to 31 December 2017.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1.All patients aged below 18 years.
2. All patients not diagnosed with mental disorder
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Retrospective
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Statistical methods / analysis
Descriptive analysis will be used to describe the characteristics of the participants.
Univariate model, multivariate model and Cox proportional hazards regression models will be conducted to assess the association between variables and calculate odds ratios, 95% confidence intervals and p values.
Kaplan-Meier survival curve will be calculated to examine the effect of nursing care provided by specialist mental health nurses and other nurses on patient outcomes
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/12/2019
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/12/2019
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
13737
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Latrobe Regional Hospital - Traralgon
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Recruitment postcode(s) [1]
26484
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3844 - Traralgon
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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La Trobe
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Address [1]
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La Trobe University Melbourne (Bundoora) Victoria 3086 Australia
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Country [1]
302767
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
La Trobe University, Bundoora, Victoria 3086, Australia.
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Country
Australia
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Secondary sponsor category [1]
303963
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None
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Name [1]
303963
0
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Address [1]
303963
0
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Country [1]
303963
0
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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LaTrobe Regional Hospital’s Human Research Ethics Committee
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Ethics committee address [1]
303364
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10 Village Avenue, Traralgon West, Victoria, 3844
PO Box 424, Traralgon, Victoria,3844
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Ethics committee country [1]
303364
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Australia
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Date submitted for ethics approval [1]
303364
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28/10/2019
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Approval date [1]
303364
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Ethics approval number [1]
303364
0
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Ethics committee name [2]
303369
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La Trobe University Human Research Ethics Committee
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Ethics committee address [2]
303369
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La Trobe University, Bundoora, Victoria 3086, Australia.
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Ethics committee country [2]
303369
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Australia
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Date submitted for ethics approval [2]
303369
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28/10/2019
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Approval date [2]
303369
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Ethics approval number [2]
303369
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Summary
Brief summary
In this study, we are interested in the effects of mental health nursing on patient outcomes. A mental health nurse has had special training in how to care for people who are mentally unwell. Our study aim is to find out if it is possible to use routine health data to test if there is a link between the amount of mental health nurse care patients get and the chance of them have a relapse after they leave the hospital.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Nompilo Moyo
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Address
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La Trobe University, Bundoora, Victoria 3086, Australia
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Country
93414
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Australia
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Phone
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+61 410058750
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Fax
93414
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Email
93414
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[email protected]
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Contact person for public queries
Name
93415
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Mr Nompilo Moyo
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Address
93415
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La Trobe University, Bundoora, Victoria 3086, Australia
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Country
93415
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Australia
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Phone
93415
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+61 410058750
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Fax
93415
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Nompilo Moyo
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Address
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La Trobe University, Bundoora, Victoria 3086, Australia
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Country
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Australia
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Phone
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+61 410058750
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Fax
93416
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The sample is too large to provide IPD. The results of the study will be published and presented in conferences (if accepted).
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5161
Study protocol
[email protected]
5162
Statistical analysis plan
[email protected]
5163
Ethical approval
[email protected]
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.
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