Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000730303
Ethics application status
Approved
Date submitted
11/05/2017
Date registered
19/05/2017
Date last updated
19/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Wellington Early Intervention in Psychosis Service Follow Up study: The years after discharge.
Scientific title
Health service use of clients after discharge from an Early Intervention in Psychsosis service
Secondary ID [1] 291916 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychosis 303236 0
Condition category
Condition code
Mental Health 302744 302744 0 0
Psychosis and personality disorders
Public Health 302745 302745 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
We aim to collect health service use information together with client demographics for approx. 350 people who have been discharged from the Wellington Early Intervention in Psychosis Service between November 2006 and November 2014. EIS supports people who have had a first episode of psychosis for 2 or 3 years in the community. Clients are discharged to either primary health care or to another community mental health service. All participants will be followed up over the years since discharge. For each participant we will collect at least 2 years worth of health service use data. The primary health care and community mental health services which we are interested in provide health care, (physical as well as mental health care) to people in the community.
Intervention code [1] 298038 0
Not applicable
Comparator / control treatment
One of the analyses we are planning is a comparison of the group of clients who were discharged to their GP and the group of clients who were discharged to a community mental health service.
Control group
Active

Outcomes
Primary outcome [1] 302066 0
Composite outcome 1. The number and duration of hospital admissions assessed by extracting information from CCDHB’s DataMart
Timepoint [1] 302066 0
Data will be collected over the years after discharge from EIS until the end of 2016
Primary outcome [2] 302137 0
Composite outcome 2. The number and duration of referrals to respite care assessed by extracting information from CCDHB’s DataMart
Timepoint [2] 302137 0
Data will be collected over the years after discharge from EIS until the end of 2016
Primary outcome [3] 302161 0
Composite outcome 3. The number referrals across mental and physical health services assessed by extracting information from CCDHB’s DataMart
Timepoint [3] 302161 0
Data will be collected over the years after discharge from EIS until the end of 2016
Secondary outcome [1] 334674 0
Composite outcome 1: Number of Community Mental Health Team contacts assessed by extracting information from CCDHB’s DataMart and Compass Health’s database
Timepoint [1] 334674 0
Data will be collected over the years after discharge from EIS until the end of 2016.
Secondary outcome [2] 334805 0
Composite outcome 2 Number and type of specialist visits assessed by extracting information from CCDHB’s DataMart
Timepoint [2] 334805 0
Data will be collected over the years after discharge from EIS until the end of 2016.
Secondary outcome [3] 334806 0
Composite outcome 3 Number and type of Emergency Department visits assessed by extracting information from CCDHB’s DataMart
Timepoint [3] 334806 0
Data will be collected over the years after discharge from EIS until the end of 2016.
Secondary outcome [4] 334807 0
Composite outcome 4: Number and type of primary health contacts and GP visits assessed by extracting information from Compass Health's data system
Timepoint [4] 334807 0
Data will be collected over the years after discharge from EIS until the end of 2016.
Secondary outcome [5] 334808 0
Composite outcome 5: Number and normality of blood tests assessed by extracting results from CCDHB's DataMart
Timepoint [5] 334808 0
Data will be collected over the years after discharge from EIS until the end of 2016.

Eligibility
Key inclusion criteria
all clients who have been discharged from the Wellington Early Intervention in Psychosis Service between November 2006 and November 2014
Minimum age
15 Years
Maximum age
36 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
excluded will be clients who left the country, the region or who died.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics, correlations, group comparisons (between the group of clients discharged to primary health care and the group pf clients discharged to community mental health care)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
Date of last participant enrolment
Anticipated
1/06/2017
Actual
Date of last data collection
Anticipated
1/06/2017
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment outside Australia
Country [1] 8895 0
New Zealand
State/province [1] 8895 0
Wellington

Funding & Sponsors
Funding source category [1] 296421 0
Government body
Name [1] 296421 0
Capital & Coast District Health Board
Country [1] 296421 0
New Zealand
Primary sponsor type
Government body
Name
Capital & Coast District Health Board, Wellington Early Intervention in Psychosis Service
Address
Wellington Early Intervention in Psychosis Service.
21 Hania Street, Mount Victoria, Wellington 6011
Country
New Zealand
Secondary sponsor category [1] 295371 0
None
Name [1] 295371 0
Address [1] 295371 0
Country [1] 295371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297649 0
Health and Disability Ethics Committees
Ethics committee address [1] 297649 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 297649 0
New Zealand
Date submitted for ethics approval [1] 297649 0
Approval date [1] 297649 0
09/05/2017
Ethics approval number [1] 297649 0
17/STH/56

Summary
Brief summary
Wellington Early Intervention Service Follow Up study: The years after discharge.
The Early Intervention Service supports people in the community after a first episode of psychosis. After discharge (usually after 2 years) our clients are referred to the care of their GP or a Community Mental Health Team, depending on their needs at the time.
We want to find out how our clients fare, what services they access and how their health needs and recovery develop in the years after discharge. In particular we are interested in a comparison between the group discharged to GP and the group discharged to a CMHT team so that we can evaluate our discharge process and criteria.
We propose to collect the following information together with client demographics for approx. 350 people who have been discharged from the EIS between November 2006 and November 2014:
a. Age, ethnicity, gender
b. Duration of time with the Early Intervention Service
c. Date of discharge from EIS
d. Discharged to GP, CMHT or other
e. Number and duration of hospital admissions
f. Number and duration of admissions to respite
g. Number of referrals across mental and physical health services
h. CMHT contacts
i. Specialist visits and assessments
j. ED contacts
k. Primary health contacts
l. GP visits
m. Blood tests, number and normality
The information is available in the CCDHB’s DataMart and Compass Health’s database. So no patient files or notes will have to be accessed.
Compass Health in Wellington are interested in cooperating, and they are waiting to hear how we get on with HDEC as they do not have their own process.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74702 0
Dr Saskia van Stockum
Address 74702 0
Wellington Early Intervention in Psychosis Service
21 Hania street
Mount Victoria
Wellington 6011
Country 74702 0
New Zealand
Phone 74702 0
+64 4 806 0002
Fax 74702 0
Email 74702 0
saskia.stockum@ccdhb.org.nz
Contact person for public queries
Name 74703 0
Dr Saskia van Stockum
Address 74703 0
Wellington Early Intervention in Psychosis Service
21 Hania street
Mount Victoria
Wellington 6011
Country 74703 0
New Zealand
Phone 74703 0
+64 4 806 0002
Fax 74703 0
Email 74703 0
saskia.stockum@ccdhb.org.nz
Contact person for scientific queries
Name 74704 0
Dr Saskia van Stockum
Address 74704 0
Wellington Early Intervention in Psychosis Service
21 Hania street
Mount Victoria
Wellington 6011
Country 74704 0
New Zealand
Phone 74704 0
+64 4 806 0002
Fax 74704 0
Email 74704 0
saskia.stockum@ccdhb.org.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

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Documents added automatically
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