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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
Scientific title
The association between nursing skill mix and outcomes for patients in mental health setting: a feasibility study
Secondary ID [1] 298227 0
Nil known
Universal Trial Number (UTN)
U1111-1233-3724
Trial acronym
MH_SKILLMIX
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Mental health disorders 312827 0
Condition category
Condition code
Mental Health 311331 311331 0 0
Schizophrenia
Mental Health 311332 311332 0 0
Psychosis and personality disorders
Mental Health 311333 311333 0 0
Depression
Mental Health 311334 311334 0 0
Psychosis and personality disorders
Mental Health 311335 311335 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 314476 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320061 0
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.
Timepoint [1] 320061 0
12 months post-discharge from a psychiatric inpatient unit.
Secondary outcome [1] 370401 0
Length of inpatient admission (in days). Data will be extracted from the electronic medical record.
Timepoint [1] 370401 0
From the admission date to the discharge date. The average period is 12 days.
Secondary outcome [2] 375326 0
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).
Timepoint [2] 375326 0
From admission date to the discharge date.
Secondary outcome [3] 375327 0
Time in seclusion (in minutes). Data will be extracted from the hospital incident reporting system (RiskMan).
Timepoint [3] 375327 0
From the admission date to the discharge date.

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.All patients aged below 18 years.

2. All patients not diagnosed with mental disorder

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2019
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13737 0
Latrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 26484 0
3844 - Traralgon

Funding & Sponsors
Funding source category [1] 302767 0
University
Name [1] 302767 0
La Trobe
Country [1] 302767 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Bundoora, Victoria 3086, Australia.
Country
Australia
Secondary sponsor category [1] 303963 0
None
Name [1] 303963 0
Address [1] 303963 0
Country [1] 303963 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303364 0
LaTrobe Regional Hospital’s Human Research Ethics Committee
Ethics committee address [1] 303364 0
Ethics committee country [1] 303364 0
Australia
Date submitted for ethics approval [1] 303364 0
28/10/2019
Approval date [1] 303364 0
Ethics approval number [1] 303364 0
Ethics committee name [2] 303369 0
La Trobe University Human Research Ethics Committee
Ethics committee address [2] 303369 0
Ethics committee country [2] 303369 0
Australia
Date submitted for ethics approval [2] 303369 0
28/10/2019
Approval date [2] 303369 0
Ethics approval number [2] 303369 0

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

Contacts
Principal investigator
Name 93414 0
Mr Nompilo Moyo
Address 93414 0
La Trobe University, Bundoora, Victoria 3086, Australia
Country 93414 0
Australia
Phone 93414 0
+61 410058750
Fax 93414 0
Email 93414 0
n.moyo@latrobe.edu.au
Contact person for public queries
Name 93415 0
Nompilo Moyo
Address 93415 0
La Trobe University, Bundoora, Victoria 3086, Australia
Country 93415 0
Australia
Phone 93415 0
+61 410058750
Fax 93415 0
Email 93415 0
n.moyo@latrobe.edu.au
Contact person for scientific queries
Name 93416 0
Nompilo Moyo
Address 93416 0
La Trobe University, Bundoora, Victoria 3086, Australia
Country 93416 0
Australia
Phone 93416 0
+61 410058750
Fax 93416 0
Email 93416 0
n.moyo@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5161Study protocol  N.Moyo@latrobe.edu.au
5162Statistical analysis plan  N.Moyo@latrobe.edu.au
5163Ethical approval  N.Moyo@latrobe.edu.au



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.