Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000399796
Ethics application status
Approved
Date submitted
5/04/2013
Date registered
11/04/2013
Date last updated
12/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-level Intervention for Suicide Prevention in New Zealand
Scientific title
The effect of multi-level community interventions including training in recognition of suicide risk factors, workshops on mental health issues, community, media and web based interventions, and the distribution of print resources on annual rate per 100, 000 of suicidal behaviour (suicide and intentional self-harm presentations to Emergency Departments) in four District Health Board regions of New Zealand.
Secondary ID [1] 282257 0
NIL
Universal Trial Number (UTN)
U1111-1141-5320
Trial acronym
MISP-NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suicide 288783 0
intentional self-harm 288784 0
Condition category
Condition code
Mental Health 289140 289140 0 0
Suicide
Mental Health 289141 289141 0 0
Other mental health disorders
Mental Health 289142 289142 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Multi-level Intervention for Suicide Prevention in New Zealand study (MISP-NZ) involved five levels of intervention, training in suicide prevention, workshops on mental health issues, community interventions, media interventions and the distribution of print based resources.

The whole study ran for 31 months with a six month baseline period (1 Dec 2009 to 31 May 2010) and a 25 month intervention period (01 June 2010 to 30 June 2012).
Training in recognition of suicide risk factors involved using a local adaptation of the online Question, Persuade, Refer (QPR) training. This training intervention was distributed to individuals in the community.
Workshops on various mental health issues such as depression, alcohol, anxiety, alcohol and drug issues, and self-harm were delivered. The delivery of the workshops varied. In one DHB a MISP established suicide prevention network invited various influential speakers on suicide prevention and mental health-related topics once a month with an attendance of up to 80 people over the study period.
MISP intervention staff were sometimes invited to join mental health forums or similar organized by DHB staff and MISP intervention staff would present alongside DHB staff.
Most other presentations were delivered solely by trained MISP intervention staff who had a backgrounds of nursing, social work and OT; and had received additional suicide prevention training. Group sizes varied with the sizes of organisations. MISP intervention staff aligned their workshops to organizational needs, hence the session times varied from between 20-30 minutes to 3-4 hour sessions.
Presentations were delivered during weekly staff meeting, at yearly training days, at mental health forums, at workplaces and many workshops were specifically organized. Working hours to deliver those workshops ranged from 6 am to 10 pm, with some delivered at weekends. Organisations included businesses, health organisations and the public.
MISP intervention staff provided between 0 and 5 workshops week. The average was estimated to be one workshop per week per DHB (approximately 4 workshops a week all DHBs), varying in length as per requirement of the organization, over the 25 months intervention period.

Community based interventions included information days and information stalls at family days and festivals.

Media based interventions focused on working with local media to support best practice in the reporting of suicide.
Distribution of print and web-based resources such as leaflets and poster from national campaigns, and the Mental Health Foundation and related mental health organisations.
Print and web-based resources were distributed throughout the 25 months intervention period. Distribution occurred concurrently with the delivery of workshop, preliminary engagement and follow up.

To monitor the implementaiotn of the intervnetions, weekly teleconferences, regular clinical supervision of intervention staff and quarterly face to face meetings ensured that interventions in each DHB aligned between DHBs whilst adhering to the purpose of the study.
Follow-up QPR workshops were delivered monthly for six months in order to debrief participants on their training outcome and if and how they had used their QPR skills. Decreasing numbers of workshop participants led to the de-establishment of these QPR sessions and an increased focus on the distribution and delivery of suicide prevention workshops.
Intervention code [1] 286880 0
Prevention
Comparator / control treatment
Practice as Usual. Normal suicide prevention under the existing National level Suicide Prevention Strategy and National Initiatives.
Control group
Active

Outcomes
Primary outcome [1] 289252 0
District Health Board level suicidal behaviour including: the annual rate per 100,000 persons of intentional self-harm and self-inflicted death. Intentional self-harm is assessed using presentations to emergency departments identified from electronic databases and medical records. Self-inflicted death is assessed using coroner's data from the Coronial Services of New Zealand.
Timepoint [1] 289252 0
25 month intervention period from 1st June 2010 to 30 June 2012.
Secondary outcome [1] 302109 0
Suicidal behaviour by the following population subgroups:
Males age 20-60.
Maori.
Maori males 20-60
Suicidal behaviour will include all presentations for Intentional Self-harm (ISH) to Emergency Departments in the 8 DHB regions for attempted suicide and self-harm. ISH will be measured as the number of identified ISH events in the ED data (as the numerator) relative to DHB population sizes (as the person-time denominator). The person-time used in the denominator will be derived from census data for the DHBs in the study. Rates of self-inflicted deaths, which will include all completed (and suspected) suicides (i.e. excluding self-harm which does not result in death) will be requested from the Coronial Services of New Zealand. ISH will be used as the marker of effect on suicidal behaviours because the number of self-inflicted deaths is too small to use as the main outcome measure alone, leading to insufficient power to be confident of detecting a difference.
Timepoint [1] 302109 0
Same. 25 month intervention period.

Eligibility
Key inclusion criteria
All residents in each intervention DHB area.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
DHBs were approached by the Minsitry of Health and assked to particpate in the study. Once written consent was recieived from eight DHB regions, they were matched into pairs based on a variety of factors (e.g. suicide rates in the region, ethncity, population size and the number of GPs per 100,000 population)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following matching of the DHB pairs, DHBs were rendomised to the MISP-NZ intevneiron package or Practics as Usual arms of the study using a random number generator process in SAS 9.1. This was performed independently by a biostatistician from outside the study team.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
MISP-NZ was a cluster randomised controlled trial (cluster RCT) with randomisation to intervention/control arm being applied at the level of the DHB region.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analysis
Initial analysis will compare DHB-level ISH and self-inflicted death rates between intervention and control DHBs using a paired t-test, to formally account for the matching of DHBs. This is a summary-measures approach to dealing with the clustered nature of the data in addition to accounting for the matched component of the study design.

Subsequent analysis will use a generalized linear model approach, assuming a Poisson distribution arising from count data, to compare the rates of ISH between the intervention and control DHBs.

Secondary analysis
The Poisson GLM approach discussed in the primary analysis will also be used in secondary analysis to look at changes in rates of ISH and self-inflicted death for those specific sub-populations known to be at high risk of suicide (Maori ethnicity, males aged 20-60). Cumulative person time for the denominators of these rates will be derived for each DHB from census data; classification by ethnicity/age for ISH events will be based on the information available in the ED presentation data.

Sample Size:
A simple paired t-test approach to the power calculation was used to determine the number of DHBs required for the study (Shipley M, Smith P, Dramaix M. Calculation of power for matched pair studies when randomization is by group. International Journal of Epidemiology 1989;18(2):457-461.) This sample size calculation used the following assumptions:

1. 8 DHB regions (4 intervention and 4 control),
2. Difference to detect of a 12% relative reduction in rates of suicidal behaviour in the intervention arm relative to control,
3. Outcomes after two years,
4. Unvaried rate of approximately 150 per 100,000 in the control DHBs (i.e. 300 per 100,000 over 2 years)
5. standard deviation for between DHB variability equal to 40 per 100,000 in the absence of any intervention effect; based on data on hospitalisations for self harm obtained from national Suicide Facts document (Minister of Health. Suicide Facts 2005-2006 data. In: Health Mo, editor: Ministry of Health, 2007.)

This study design provided 85% power to detect a difference of 12% in the primary outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2009
Actual
1/12/2009
Date of last participant enrolment
Anticipated
1/02/2010
Actual
1/02/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
714306
Accrual to date
Final
Recruitment outside Australia
Country [1] 4995 0
New Zealand
State/province [1] 4995 0
Capital and Coast DHB
Country [2] 4996 0
New Zealand
State/province [2] 4996 0
Bay of Plenty DHB
Country [3] 4997 0
New Zealand
State/province [3] 4997 0
Northland DHB
Country [4] 4998 0
New Zealand
State/province [4] 4998 0
Taranaki DHB

Funding & Sponsors
Funding source category [1] 287023 0
Government body
Name [1] 287023 0
Ministry of Health
Country [1] 287023 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
23a Meiin St
Newtown
Wellington South 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285805 0
None
Name [1] 285805 0
Address [1] 285805 0
Country [1] 285805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289061 0
New Zealand Northern Y Ethics Committee
Ethics committee address [1] 289061 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 289061 0
New Zealand
Date submitted for ethics approval [1] 289061 0
Approval date [1] 289061 0
27/11/2009
Ethics approval number [1] 289061 0
NTY/09/10/103

Summary
Brief summary
MISP-NZ is a 25 month Multi-level community Intervention for Suicide Prevention designed for implementation in New Zealand (MISP-NZ). Its design and key components are informed by lessons learned from two similar multi-level suicide prevention studies implemented in Japan and Germany but tailored to the New Zealand context.

Design: MISP-NZ is a cluster randomised controlled trial involving eight District Health Board (hospital) regions, comprising four demographically matched pairs. One DHB region in each pair will be randomised to receive either the intervention or control (practice as usual).

Methods: After conducting a stock-take of existing suicide prevention activities in each region, an intervention package will be designed for implementation in each DHB region. The interventions will include: training in recognition of suicide risk factors; workshops on various mental health issues; community based interventions; media based interventions; and the distribution of print and web-based resources. The key objective of MISP-NZ is to determine whether the MISP-NZ interventions are more effective in reducing rates of suicidal behaviours than current practice. The main outcome is the annual rate per 100,000 of suicidal behaviours (intentional self-harm and self-inflicted deaths) evaluated over the study period.
Discussion: The design of MISP-NZ is based on what is known from the public health and health services literature on complex trial methods overseas to create a robust study for the New Zealand setting. This 25 month multi-level intervention trial will be unique in that the interventions will be tailored to the local context and aligned with the goals of the national suicide prevention strategy. A key challenge will lie in the successful completion of a process evaluation which will enable conclusions to be drawn about the effectiveness of the interventions, their implementation and their overall impact on the primary outcome of intentional self-harm. Successful achievement of this will shed considerable insight into the impact of MISP-NZ on intentional self-harm and the potential generalisability of the findings to other countries and contexts.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39042 0
Prof Sunny Collings
Address 39042 0
University of Otago
23a Mein St
Newtown
Wellington South 6242
Country 39042 0
New Zealand
Phone 39042 0
+64 43855541
Fax 39042 0
Email 39042 0
[email protected]
Contact person for public queries
Name 39043 0
Dr Gabrielle Jenkin
Address 39043 0
University of Otago
23a Mein St
Newtown
Wellington South 6242
Country 39043 0
New Zealand
Phone 39043 0
+64 21 2578040
Fax 39043 0
Email 39043 0
[email protected]
Contact person for scientific queries
Name 39044 0
Prof Sunny Collings
Address 39044 0
University of Otago
23a Mein St
Newtown
Wellington South 6242
Country 39044 0
New Zealand
Phone 39044 0
+64 43855541
Fax 39044 0
Email 39044 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
EmbasePreventing suicidal behaviours with a multilevel intervention: a cluster randomised controlled trial.2018https://dx.doi.org/10.1186/s12889-018-5032-6
N.B. These documents automatically identified may not have been verified by the study sponsor.