Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001720202
Ethics application status
Approved
Date submitted
25/09/2018
Date registered
18/10/2018
Date last updated
18/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Advance directives for people using mental health services
Scientific title
Pilot study to evaluate implementation and outcomes of advance directives in mental health services.
Secondary ID [1] 291814 0
Nil known
Universal Trial Number (UTN)
U1111-1196-1503
Trial acronym
MAP study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 303054 0
Condition category
Condition code
Mental Health 302511 302511 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will investigate the use of advance directives (AD) in mental health services. An advance directive protocol will be developed, by members of the research team. These are: a consumer advisor, a registered nurse who is also a doctorally qualified researcher, a research fellow with a legal qualification, a doctorally qualified researcher, a professor of psychiatry, a professor of law, and a registered nurse who is a professional advisor. The focus of the development of the protocol will be the preferred content of the advance directive instrument, for example preferences for medication, community or inpatient care, notification of nominated support people and care of personal property. Development of the protocol will involve an online survey and focus groups. Development will take 6 months from the commencement of data collection. The protocol will be reviewed by members of the research team and by staff of the mental health service during training workshops. The protocol will then implemented in selected inpatient and community mental health services at Southern DHB, New Zealand. Clinical staff will receive training in use of the AD protocol by the research team described above. Training will involve workshops of approximately one hour in which the concept of an advance directive will be outlined and the protocol explained, with an opportunity for feedback and suggestions. Adherence to the protocol will be assessed by a planned evaluation of the implementation of advance directives in the second stage of the study. Service users will then be invited to complete an advance directive, with the support of a nominated person of their preference. Evaluation will be undertaken by review of completed AD protocols, and focus groups of service users, family members and clinicians. Requirements of ADs will be compared with care as documented in clinical notes.
Intervention code [1] 297926 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301925 0
Implementation of the AD protocol will be assessed by numbers of AD documents completed and the content of the complete protocol
Timepoint [1] 301925 0
15 months post commencement of the study.
Primary outcome [2] 307751 0
Adherence to the AD protocol will be assessed by auditing clinical records for evidence of AD statements being adhered to, for example nominated contact persons being contacted, medication preferences being acknowledged. This is a composite outcome. The audit will be completed by members of the research team listed at stage 3.
Timepoint [2] 307751 0
15 months post commencement of the study.
Secondary outcome [1] 334285 0
Clinician experience with ADs. Clinician experience with ADs will be assessed by one on one individual interviews with clinicians. Interviews will follow a series of key questions and prompts developed by the research team, with an additional opportunity for open ended responses.
Timepoint [1] 334285 0
15 months post commencement of the study.
Secondary outcome [2] 352784 0
Service user experience with ADs. Service user experience with ADs will be assessed by one on one individual interviews with clinicians. Interviews will follow a series of key questions and prompts developed by the research team, with an additional opportunity for open ended responses.
Timepoint [2] 352784 0
15 months post commencement of the study.

Eligibility
Key inclusion criteria
Service users: Aged 18 - 65 years, currently enrolled with Southern District Health Board (SDHB) mental health service, have capacity to engage in creating an AD; have experience in creating an AD.
Family members: Be identified by service users as being a family member of a service user currently enrolled in SDHB.
Clinicians. Be a registered health professional employed by SDHB; have been involved in creating ADs.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lacking capacity to complete AD; capacity may fluctuate, therefore a service user lacking capacity at one point may be eligible for the study at a later point.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no allocation concealment. This is an open label trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable. All eligible participants will be enrolled.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/01/2018
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
31/05/2019
Actual
Sample size
Target
100
Accrual to date
60
Final
Recruitment outside Australia
Country [1] 8858 0
New Zealand
State/province [1] 8858 0

Funding & Sponsors
Funding source category [1] 296317 0
Charities/Societies/Foundations
Name [1] 296317 0
James Hume Fund
Country [1] 296317 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
New Zealand 1142
Country
New Zealand
Secondary sponsor category [1] 295243 0
None
Name [1] 295243 0
Address [1] 295243 0
Country [1] 295243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297546 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 297546 0
Private Bag 92019, Auckland 1142
Ethics committee country [1] 297546 0
New Zealand
Date submitted for ethics approval [1] 297546 0
30/06/2017
Approval date [1] 297546 0
31/10/2017
Ethics approval number [1] 297546 0

Summary
Brief summary
The overall aim is to see if ADs increase service users’ involvement in planning their mental health care, especially in crisis situations. There are three parts to the study. The first part involves the development of an AD instrument and associated policies and processes for its implementation. The second part will trial the AD instrument in selected Southern DHB mental health services, and evaluate the feasibility of a service wide implementation of ADs. The third part involves evaluation of clinicians' and service users' experiences of use of advance directives.
Trial website
na
Trial related presentations / publications
Lenagh-Glue, J. O’Brien A. J., Dawson, J., Thom, K. Potiki, J. & Casey H. (2018) A MAP to mental health: the process of creating a collaborative advance preferences instrument. New Zealand Zealand Medical Journal (forthcoming). NZMJ-2018-254
Public notes

Contacts
Principal investigator
Name 74398 0
Dr Anthony O'Brien
Address 74398 0
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Building 505, Room 237
85 Park Road,
Grafton,
Auckland.
Private Bag 92019
Auckland 1142
Country 74398 0
New Zealand
Phone 74398 0
+ 64 27 277 0269
Fax 74398 0
64 9 367 7158
Email 74398 0
a.obrien@auckland.ac.nz
Contact person for public queries
Name 74399 0
Dr Anthony O'Brien
Address 74399 0
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Building 505, Room 237
85 Park Road,
Grafton,
Auckland.
Private Bag 92019
Auckland 1142
Country 74399 0
New Zealand
Phone 74399 0
+ 64 27 277 0269
Fax 74399 0
+64 9 367 7158
Email 74399 0
a.obrien@auckland.ac.nz
Contact person for scientific queries
Name 74400 0
Dr Anthony O'Brien
Address 74400 0
School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Building 505, Room 237
85 Park Road,
Grafton,
Auckland.
Private Bag 92019
Auckland 1142
Country 74400 0
New Zealand
Phone 74400 0
+64 9 373 7599 extn 85693
Fax 74400 0
64 9 367 7158
Email 74400 0
a.obrien@auckland.ac.nz

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
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