Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000069358
Ethics application status
Approved
Date submitted
10/01/2017
Date registered
13/01/2017
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An ethnographic study of the new graduate nurse’s experience when encountering the culture of acute mental health services
Scientific title
An ethnographic study of the new graduate nurse’s experience when encountering the culture of acute mental health services
Secondary ID [1] 290881 0
nil known
Universal Trial Number (UTN)
U1111-1191-4741
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Culture of mental health nursing 301593 0
Condition category
Condition code
Public Health 301300 301300 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an ethnographic study involving the observation of new graduate nurses as they encounter the culture of mental health nursing during their first year of practice..
This study will involve two phases - phase I: non-participant observation of new graduate nurses in the staff-only areas of each acute inpatient unit chosen; and phase II: semi-structured interviews of new graduate nurses as well as a group of recently graduate nurses (nurses who have graduated in the last 5 years).

For phase I - up to 24 new graduate nurses will be invited to participate and will be asked to allow 6 hours of observation (in 2 hour blocks) by the researcher over a period of approximately 7 months. This will occur in staff-only areas of acute mental health inpatient units. No consumers of mental health care will be included in the study. The observation will largely focus on the interactions between new graduate nurses and their colleagues.

For phase II - up to 30 participants will be invited to participate in semi-structured interviews. The primary participants will include the new graduate nurses invited to participate in phase I, and an additional number of recent graduate nurses (those who have graduated in the last five years) to increase the depth of findings.
Participants in phase II will be asked questions around their experiences of transitioning into the culture and practice of mental health nursing.
Intervention code [1] 296828 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300713 0
- Non-participant observation by the primary researcher
- Responses from semi-structured interviews
Timepoint [1] 300713 0
12 month duration to complete phase I and II
Secondary outcome [1] 330682 0
- Non-participant observation by the primary researcher
- Responses from semi-structured interviews
Timepoint [1] 330682 0
12 month duration to complete phase I and II

Eligibility
Key inclusion criteria
New graduate nurse - a nurse who satisfied the requirements to practice as a registered nurse in NSW Health and is currently enrolled in a new graduate nurse program within the field of mental health nursing, within the chosen NSW Health local health district.

Recent graduate nurse - a nurse who has fulfilled has completed a new-graduate nurse program in a mental health setting within the last five years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are neither a recent graduate nurse or a new-graduate nurse.
** For the purposes of this study, phase I involves the observation of new graduate nurses within staff-only areas of each mental health inpatient unit. This may involve the indirect observation of other staff members. Whilst the colleagues of new-graduate nurses are not considered primary participants, their permission to observe will be sought and information about the study will be provided to them.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Ethnography requires the in-depth study of a small population or single unit. However in this study, the study focuses on the new graduate nurses who are not contained within a single site. This requires the researcher to observe this population over multiple sites.
The total number of new graduate nurses recruited to the local health district mental health transition program is 24 new graduates per year. All new graduates will be invited to participate. however it is anticipated that not all participants invited will agree to participate. The data collection will occur until data saturation is reached. In this case, it is possible that not all participants that agree to participate will be observed.

This reasoning is applied to both phase I - non-participant observation, and phase II - semi-structured interviews.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2017
Actual
1/04/2017
Date of last participant enrolment
Anticipated
Actual
1/10/2017
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
26
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 295318 0
University
Name [1] 295318 0
The University of Newcastle
Country [1] 295318 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
The University of Newcastle
University Drive
Callaghan NSW 2308

School of Nursing and Midwifery
Country
Australia
Secondary sponsor category [1] 294140 0
None
Name [1] 294140 0
Address [1] 294140 0
Country [1] 294140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296650 0
Hunter New England Research Ethics committee
Ethics committee address [1] 296650 0
Ethics committee country [1] 296650 0
Australia
Date submitted for ethics approval [1] 296650 0
16/09/2016
Approval date [1] 296650 0
01/11/2016
Ethics approval number [1] 296650 0
16/09/21/4.07

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

Contacts
Principal investigator
Name 71626 0
Ms Mary-Ellen Hooper
Address 71626 0
The University of Newcastle
School of Nursing and Midwifery
University Drive
Callaghan NSW 2308
Country 71626 0
Australia
Phone 71626 0
+61 0433 400 943
Fax 71626 0
Email 71626 0
[email protected]
Contact person for public queries
Name 71627 0
Mary-Ellen Hooper
Address 71627 0
The University of Newcastle
School of Nursing and Midwifery
University Drive
Callaghan NSW 2308
Country 71627 0
Australia
Phone 71627 0
+61433400943
Fax 71627 0
Email 71627 0
[email protected]
Contact person for scientific queries
Name 71628 0
Mary-Ellen Hooper
Address 71628 0
The University of Newcastle
School of Nursing and Midwifery
University Drive
Callaghan NSW 2308
Country 71628 0
Australia
Phone 71628 0
+61433400943
Fax 71628 0
Email 71628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.