Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001469303
Ethics application status
Approved
Date submitted
11/09/2017
Date registered
17/10/2017
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Acute Mental Health Facility Design Study: the NZ experience (2017-2020)
Scientific title
Acute Mental Health Facility Design: perspectives and experiences of NZ stakeholders
Secondary ID [1] 292848 0
NIL
Universal Trial Number (UTN)
None
Trial acronym
AMHFDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Design of psychiatric facility. Perspectives and experiences 304689 0
mental health 304690 0
well being 304691 0
public health 304785 0
Health service research 304786 0
mental health 304787 0
Condition category
Condition code
Public Health 304000 304000 0 0
Health service research
Mental Health 304093 304093 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
The conditions being observed are the acute mental health ward users' perspectives and experiences of the ward environment (not any specific health outcome).

The exposure is the physical building and interior of the acute mental health ward.

The planned period of observation will be the 8 weeks in which the data are collected by the researchers (interview data and focus groups).

There are three main components to this observational study:
1. Face-to-face interviews with 3 groups will be conducted to find out ward users perspectives and expereinces of the design of the ward environment, asking about specific architectural features and related issues. The three groups to be interviewed are: Service users residing in the acute mental health ward, staff working in the ward, and a family member who visits the ward (and who is nominated by the service user interviewed).

2. Stakeholder specific walking focus groups: Stakeholder focus groups led by the architect on this project and the PI will include consenting individuals from five key stakeholder groups. Each stakeholder group will be led around the ward with the architect and the PI and will be asked what the spaces are used for and how they function for these purposes. The building is used as a prompt for discussion. The five stakeholder groups will be:
-Mental health service users resident in the ward
-Nursing and other staff
-Visiting health and allied professionals (social workers, Chaplains, consumer advocates, psychologists and psychiatrists)
-Policy makers/planners, district inspectors, and DHB managers and designers
-Maori stakeholders

3. Architectural analysis of plans and consultation documents.
Data sources: Architects’ plans, building specifications and photographs. Method: Plans will be requested by PI from the appropriate personnel in participating DHBs. Photographs will be taken by the PI and architect of the inside and outside of the facility. Inside will include photographs of rooms and corridors (to show room color, layout and furnishings) and key physical features (fixtures and fittings). Photographs will be taken at a time convenient to ward users and care will be taken to ensure no-one is captured in the photographs.

Photographs of private sleeping quarters will only be taken either a) when the rooms are unoccupied - vacant of people and possessions or b) with written prior consent of the mental health service user. Photographs of bedrooms with personal belongings are important for showing the degree of personalisation and choice enjoyed by the occupants.

Analysis: Plans and photographs will be analysed using a 215 item validated check-list designed in accordance with normalisation theory. Data gleaned will include ward location, size, internal layout and allocation of space (public, private, intimate), room function and purpose, interior decoration, security and other architectural qualities.
Intervention code [1] 299093 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303331 0
Acute mental health ward users experiences and perspectives of the the acute mental health ward environment as measured by a structured face to face interview.
Timepoint [1] 303331 0
Ward users will be interviewed and focus groups conducted in a 6-8 week window of the data collection at each of the three casse study sites. Exact timing will be negotiated with each DHB so as to minimise disruption to patient care.
Primary outcome [2] 303410 0
Acute mental health ward users experiences and perspectives of the the acute mental health ward environment as measured by a walking focus group interview arounde the ward.
Timepoint [2] 303410 0
Ward users will be interviewed and focus groups conducted in a 6-8 week window of the data collection at each of the three casse study sites. Exact timing will be negotiated with each DHB so as to minimise disruption to patient care.
Secondary outcome [1] 338661 0
nil
Timepoint [1] 338661 0
nil

Eligibility
Key inclusion criteria
Interviews

Mental health service users resident in the ward - all adult acute mental health service users who are competent to consent (competence will be assessed by the lead clinician) to participate. are eligible. As there is no restriction on the length of time they have been in the ward, those who have only just arrived will be eligible.

Nominated family member - any familiy member nominated by a consenting mental health service user, who agrees to participate is eligible for inclusion in the study.

Staff - all staff members who work in the ward will be eligible to participate in the study.

Stakeholder focus groups:
Stakeholder focus groups led by the architect on this project and the PI will include consenting individuals from these five key stakeholder groups:
-Mental health service users resident in the ward (same eligibility criteria as for interviews above)
-Nursing and other staff (same criteria as for interviews)
-Visiting health and allied professionals (social workers, Chaplains, consumer advocates, psychologists and psychiatrists). - identified by staff members will be eligible to participate in the focus groups.
-Policy makers/planners, district inspectors, and DHB managers and designers identified by staff will be eligible to participate.
-Maori stakeholders - identiifed by staff members and through any additional Maori consultation process for each DHB will be eligible to participate.


Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mental health service users: any service user deemed not competent to consent at the time of the interview or focus group will be excluded (this includes any patient in seclusion at the time).

Family member/family friend - only family members nominated by a service user who has consented to be interviewed will be eligible to participate.

Any stakeholder unavailable at the time of the interview or focus group will be excluded.


Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data from interviews and focus groups will be analysed by thematic analysis.
Data from architectural plans will be analysed using space syntax analysis and healthcare architecture analysis. All data will be triangulated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2018
Actual
Date of last participant enrolment
Anticipated
1/06/2019
Actual
Date of last data collection
Anticipated
1/06/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 9187 0
New Zealand
State/province [1] 9187 0
We are still arranging locality consent with the DHB participants. There will be three DHB regions selected as case studies. We will not be sure which three until we have completed negotiations and locality approval processes.

Funding & Sponsors
Funding source category [1] 297481 0
Charities/Societies/Foundations
Name [1] 297481 0
Royal Society of NZ
Country [1] 297481 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
23a Mein St
Newtown
PO Box 7343
Wellington South 6242
Country
New Zealand
Secondary sponsor category [1] 296555 0
University
Name [1] 296555 0
Otago
Address [1] 296555 0
University of Otago, Wellington
23a Mein St, Newtown
PO Box 7343
Wellington South 6242
Country [1] 296555 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298583 0
Health and Disability Ethics Committee
Ethics committee address [1] 298583 0
Ethics committee country [1] 298583 0
New Zealand
Date submitted for ethics approval [1] 298583 0
03/04/2017
Approval date [1] 298583 0
25/07/2017
Ethics approval number [1] 298583 0
17/CEN/94

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

Contacts
Principal investigator
Name 77554 0
Dr Gabrielle Jenkin
Address 77554 0
Deputy Director
Suicide and mental health research group
University of Otago, Wellington
23a Mein St
Newtown
Wellington 6021
Country 77554 0
New Zealand
Phone 77554 0
+64 212578040
Fax 77554 0
Email 77554 0
[email protected]
Contact person for public queries
Name 77555 0
Gabrielle Jenkin
Address 77555 0
Deputy Director
Suicide and mental health research group
University of Otago, Wellington
23a Mein St
Newtown
Wellington 6021
Country 77555 0
New Zealand
Phone 77555 0
+64 212578040
Fax 77555 0
Email 77555 0
[email protected]
Contact person for scientific queries
Name 77556 0
Gabrielle Jenkin
Address 77556 0
Deputy Director
Suicide and mental health research group
University of Otago, Wellington
23a Mein St
Newtown
Wellington 6021
Country 77556 0
New Zealand
Phone 77556 0
+64 212578040
Fax 77556 0
Email 77556 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
SourceTitleYear of PublicationDOI
EmbaseGender and intersecting vulnerabilities on the mental health unit: Rethinking the dilemma.2022https://dx.doi.org/10.3389/fpsyt.2022.940130
EmbasePlaces of safety? Fear and violence in acute mental health facilities: A large qualitative study of staff and service user perspectives.2022https://dx.doi.org/10.1371/journal.pone.0266935
Dimensions AI‘My Work Matters’: A Qualitative Exploration of Why Staff Love Working in Acute Mental Health2022https://doi.org/10.3390/ijerph192013619
Dimensions AI‘We have to band together’: service user experiences of naturally occurring peer support on the acute mental health unit2022https://doi.org/10.1080/1177083x.2022.2093230
N.B. These documents automatically identified may not have been verified by the study sponsor.