Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001638426
Ethics application status
Approved
Date submitted
16/11/2016
Date registered
25/11/2016
Date last updated
9/11/2020
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial about the effectiveness of a supported employment linkage intervention for people with schizophrenia admitted to an adult mental health unit who want to work.
Scientific title
A single blind randomised controlled clinical trial comparing a supported employment linkage intervention to treatment as usual on work and clinical outcomes in chronic schizophrenia.
Secondary ID [1] 290528 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 300949 0
Condition category
Condition code
Mental Health 300746 300746 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two study arms in this clinical trial. Arm 1: Supported Employment Linkage Intervention (SEL) and Treatment As Usual (TAU). Arm 2: Treatment As Usual (TAU). SEL involves mental health nurse clinicians, with outreach capacity, working on the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU), who will deliver the intervention. The intervention starts during the inpatient admission., The patient is linked to an employment agency, called Edge, which is for people with mental and physical disabilities . Edge has good fidelity to the Individual Placement and Support (IPS) model of supported employment as measured by the IPS fidelity scale.
The mental health nurse clinician forms a therapeutic relationship with the patient as soon as they complete their comprehensive medical assessment by their treating team on the SCGH MHU and it is deemed during this assessment the patient has schizophrenia and wants to work in competitive employment. The patient is given a blank Treating Doctor’s Report (TDR) and a Verification of Medical Condition(s) form (VMC) in an Edge Information Pack (EIP) by the nurse to be filled out by the patient’s general practitioner validating capability for at least 8 hours competitive work per week. The TDR and VMC are required to state the patient’s diagnosis, symptoms and an overview of their current medical conditions. The nurse supports and empowers the patient to find and attend a general practitioner to fill out the TDR and VMC while still on the SCGH MHU wherever possible. However this step can occur after discharge. If the patient’s team are supporting a disability pension application this process and the required forms are completed by the treating Team first.
The nurse empowers the patient to make and attend an appointment with Edge during the admission or after discharge. The wait list is 1 week at the most. At the initial and subsequent Edge interviews a family member is welcome to attend. During this initial Edge interview the reality of the patient’s career aspirations is determined and their medical condition disclosed. Regional work in the mining industry is explained as a non-option through Edge.
The patient plus or minus a family member and Edge worker, request and keep an appointment with Centrelink, the pension agency, for a job capacity assessment (JCA) and an Employment Services Assessment (ESAT) by a job capacity assessor. This appointment could occur whilst an inpatient on the SCGH MHU but may occur after discharge. The patient brings their completed VMC and TDR to this appointment. Based on a 15-30 minute interview and the VMC and TDR the assessor determines the genuineness of the disability and the capacity for at least 8 hours per week work whilst on the disability pension or 15 hours per week if not on the disability pension. The patient has to specify that they want Edge for help with job searching and ongoing job support. Centrelink then make a registration appointment with Edge via an on-line diary for the patient plus or minus a family member. Once Edge receives the Centrelink job capacity assessor’s on-line report and appointment they contact the patient to come in for this registration appointment. This usually takes 1-2 weeks. The patient can go into Edge to see how this is progressing if they are anxious. At the registration appointment with Edge the work capacity is checked as correct. The work goals and aspirations are again determined as reality based and an employment specialist is allocated. Financial counselling, if required, is offered by a financial counsellor.
After discharge from the SCGH MHU the designated mental health nurse contacts the patient weekly by telephone to empower them to be able to work through the steps required to become embedded in the employment agency, Edge, and trust and work with its support. The nurse provides weekly telephone contact for up to 6 months from the date of recruitment and the frequency is individually tailored. The ending of this contact is patient determined in collaboration with the nurse .
Edge will provide support with job search to find an employer who wants to make a place for a sensitive stigmatised individual with schizophrenia in their workplace as well as ongoing job support. Edge requires mandatory 2 weekly appointments with the Edge employment specialist and the patient. Additional support is individually tailored by Edge. The employment specialist helps with resumes, job finding, interviews, and on and off job support.
For patients who don’t attend appointments Edge will provide a telephone call, one letter and a wait of 6 months before deregistering the patient. However, the SCGH MHU nurse still has the capacity to make telephone contact with the patient on a weekly basis for up to 6 months following recruitment at the SCGH MHU. These linkage attempts will stop or restart by patient request. If no open competitive employment is found within 2 years the patient is discharged from Edge. The patient can go through the Edge admission process again at any time. The patient can transfer to another employment agency. The nurse will contact Edge 2 monthly to check on the patient’s progress and provide help with any issues. A successful supported employment linkage intervention is achieving at least a 6 month block of registration with Edge in the 2 year period post recruitment.
Intervention code [1] 296378 0
Other interventions
Comparator / control treatment
TAU starts at the time of recruitment when the patient is at the SCGH MHU . TAU involves medication plus at least one medical check-up over 12 months with a doctor and a minimum of one other treatment program attendance from the following list: Psychiatrist visit/visits in addition to the one medical check-up over 12 months with a doctor already mentioned; General practitioner visit/visits; Regular pickup of Webster medication packs at pharmacy; Hospital in the Home twice daily nurse visits for 2 weeks; Mental health nurse outreach support; Generic case manager outreach support; Supportive inpatient milieu as required; Inpatient or outpatient occupational therapy program; Community rehabilitation program; Inpatient alcohol and drug program; Inpatient alcohol and drug brief information pack; Community alcohol and drug rehabilitation program; Nicotine addiction treatment; Drop in centre support; Sheltered work; Supported employment; Volunteer work; Education pathway with support; Education pathway without support; Family meetings; Other type of therapy; Non-government organisation outreach support; Non-government organisation social integration via recreational activities; Recreational group/s; Spiritual group; Regular exercise; Supported accommodation-Psychiatric hostel, group home, supported rental alone or shared, family home, aged care facility.
Control group
Active

Outcomes
Primary outcome [1] 300162 0
Yes or no to a competitive job. Yes to a competitive job means the participant has worked at least 30 minutes on at least 1 day in a job in an integrated situation in the community where they have done the same tasks as a non- disabled person for the same minimum or higher wage. No means the latter has not been achieved. Yes or No to a competitive job will be self reported using the Job Acquisition Questionnaire. It will be confirmed by also interviewing the employment specialist at Edge Employment agency. Type of job, start time, finish time, hours per week and wages will also be self reported and confirmed by Employment specialist at Edge.
Timepoint [1] 300162 0
In the last month at baseline and in last 6 months following recruitment at 6, 12,18 and 24 months.
Secondary outcome [1] 329218 0
Digit Span Test (Wechsler Adult Intelligence Scale - Revised)
Timepoint [1] 329218 0
baseline and 6 and 12 months post recruitment.
Secondary outcome [2] 329219 0
Trail Making test part A & B
Timepoint [2] 329219 0
baseline and 6 and 12 months post recruitment.
Secondary outcome [3] 329220 0
Brief Psychiatric rating Scale
Timepoint [3] 329220 0
baseline and 6 and 12 months post recruitment.
Secondary outcome [4] 329333 0
This is not being used as an outcome measure
Timepoint [4] 329333 0
not being measured
Secondary outcome [5] 329337 0
Adult Hope Scale
Timepoint [5] 329337 0
baseline and 6 and 12 months post recruitment.
Secondary outcome [6] 329339 0
Activity and Participation Questionnaire (APQ-6)
Timepoint [6] 329339 0
baseline and 6 and 12 months post recruitment.

Eligibility
Key inclusion criteria
Diagnosis of schizophrenia defined by DSM-V and want to work; not previously received or currently receiving the supported employment linkage intervention; voluntary and involuntary residents of SCGH MHU Tanami ward; plans to reside in Australia for the duration of follow-ups; available for follow-up for 2 years; able to comply with requirements of the protocol; able and willing to understand and provide written informed consent; aged between 18 and 65 years of age.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Highly dependent on medical care; significant communication barrier.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
The trial design is a randomised single blind clinical trial comparing 2 treatments groups: Supported Employment Linkage Intervention plus Treatment As Usual and Treatment As Usual.
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
Sample size and power calculations
For a moderate effect size for the primary outcome measure in job acquisition which will be either yes or no to a job over the 2 year period post recruitment and an expected power of 0.8 we will need 36 for each group. There will be an expected dropout rate of 10 to 20 in each group so we will canvas 56 patients for each group.

Data Analysis
A mixed model repeat measures ANOVA (suitable given multiple time points of data collection) will be conducted using SPSSv21 to test the hypotheses that the SEL+TAU group will have significantly higher scores of yes to a job over the 2 year period post recruitment compared to the TAU group at 4 varying time points. In clinical work we use multiple measures of outcome. No power has been calculated for these other secondary outcome measures.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We will have adequate 6 month outcome measures with the final collection date on the 30/09/2020 to have a meaningful statistical analysis.
Date of first participant enrolment
Anticipated
19/12/2016
Actual
19/06/2017
Date of last participant enrolment
Anticipated
19/06/2020
Actual
25/03/2020
Date of last data collection
Anticipated
23/09/2020
Actual
23/09/2020
Sample size
Target
112
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294975 0
Government body
Name [1] 294975 0
North Metropolitan Health - Mental Health
Country [1] 294975 0
Australia
Primary sponsor type
Government body
Name
North Metropolitan Health Service -Adult Mental Health
Address
Private Bag 1 PO box Claremont, Western Australia. 6910
Country
Australia
Secondary sponsor category [1] 293796 0
None
Name [1] 293796 0
None
Address [1] 293796 0
None
Country [1] 293796 0
Other collaborator category [1] 279306 0
University
Name [1] 279306 0
Universitiy of Western Australia School of Psychiatry
Address [1] 279306 0
Sir Charles Gairdner Hospital. D Block. Verdun Street. Nedlands. Western Australia. 6009.
Country [1] 279306 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296337 0
North Metropolitan Health Service - Mental health Human Research Ethics Committee
Ethics committee address [1] 296337 0
Gascoyne House Graylands campus Locked bag No 1 PO Claremont Western Australia 6910
Ethics committee country [1] 296337 0
Australia
Date submitted for ethics approval [1] 296337 0
06/10/2016
Approval date [1] 296337 0
23/11/2016
Ethics approval number [1] 296337 0
18_2016

Summary
Brief summary
Aim: This is a single blind randomised controlled clinical trial comparing a new therapeutic intervention in addition to Treatment As Usual (TAU) with TAU for patients with schizophrenia at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU) who want to work. The new therapeutic intervention is called the Supported Employment Linkage Intervention (SEL).The primary hypothesis tested is the addition of SEL to TAU will improve engagement, by patient choice, with a local employment agency called EDGE and procurement of a competitive job. EDGE has good fidelity to the Individual Placement and Support Approach to Supported Employment. We will also see if psychiatric symptoms, cognition, hope and social inclusion will be improved with the addition of SEL to TAU significantly more than with TAU alone. Method: The outcomes measured will be change in: The Engagement with Edge Questionnaire (EEQ), Job Acquisition Questionnaire (JAQ), Brief Psychiatric Rating Scale (BPRS), Trail Making Test A+B, Digit Span Test (Wechsler Adult Intelligence Scale – Revised),, Adult Hope Scale, and the Activity and Participation Questionnaire (APQ-6). Measures will be collected at baseline by the research mental health nurse clinicians and 6 months and 12 months post recruitment by a blinded research officer unfamiliar with the site.

Expected Outcomes: We expect successful engagement with an employment agency called Edge, as measured by the Engagement with Edge Questionnaire (EEQ), to equal a 6 month block of registration with Edge during the 12 month period post recruitment and to be significantly better with SEL + TAU compared to TAU over 12 months post recruitment. We expect yes to a competitive job, as measured by the Job Acquisition Questionnaire (JAQ), to be significantly greater with SEL + TAU compared to TAU at 4 varying time points over 2 years post recruitment. Hope, and social inclusion are anticipated to be significantly improved with SEL + TAU compared to TAU as measured the Adult Hope Scale and the Activity and Participation Questionnaire (APQ-6) respectively at 6 and 12, months post recruitment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70422 0
Dr Ann Solar
Address 70422 0
Sir Charles Gairdner Hospital Mental health Unit
Verdun Street Nedlands Western Australia 6009
Country 70422 0
Australia
Phone 70422 0
+61 8 63831000
Fax 70422 0
Email 70422 0
Ann.Solar@health.wa.gov.au
Contact person for public queries
Name 70423 0
Dr Ann Solar
Address 70423 0
Sir Charles Gairdner Hospital Mental Health Unit
Verdun Street Nedlands Western Australia 6009
Country 70423 0
Australia
Phone 70423 0
+61 8 63831000
Fax 70423 0
Email 70423 0
Ann.Solar@health.wa.gov.au
Contact person for scientific queries
Name 70424 0
Dr Ann Solar
Address 70424 0
Sir Charles Gairdner hospital mental Health Unit
Verdun Street Nedlands Western Australia 6009
Country 70424 0
Australia
Phone 70424 0
+61 8 6383 1000
Fax 70424 0
Email 70424 0
Ann.Solar@health.wa.gov.au

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.