Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000769886
Ethics application status
Not yet submitted
Date submitted
13/04/2012
Date registered
19/07/2012
Date last updated
19/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Individual Placement and Support (IPS) model of supported employment in primary care to improve health and social outcomes
Scientific title
Employment and health outcomes for Sickness Beneficiaries receiving IPS supported employment versus traditional vocational services: A primary care cohort study
Secondary ID [1] 280320 0
None
Universal Trial Number (UTN)
U1111-1129-9546
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic unemployment 286282 0
Mental illness 286283 0
Substance dependency 286284 0
Condition category
Condition code
Mental Health 286509 286509 0 0
Other mental health disorders
Public Health 286510 286510 0 0
Health service research
Mental Health 286511 286511 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual Placement and Support (IPS) model of supported employment, also known as Evidence-Based Supported Employment (EBSE): individualized intensive employment support services integrated with primary health care services, provided by 2 Employment Consultants to general practice patients seeking Sickness or Invalid's Benefit renewals for work incapacity because of psychiatric or substance dependency problems. The Employment Consultants will see participants on a as-needed basis, depending on their health and vocational needs, for the total duration of the study period (18 months).
Intervention code [1] 284674 0
Rehabilitation
Intervention code [2] 284813 0
Prevention
Intervention code [3] 284814 0
Behaviour
Comparator / control treatment
The comparison group will comprise Dunedin Work and Income clients matched for age, sex, NZDep2006 small area deprivation score, and work incapacity diagnosis to intervention group participants on a 2:1 ratio (control:intervention). This group will use existing employment support services available in the community, that is, "treatment as usual".
Control group
Active

Outcomes
Primary outcome [1] 286944 0
Acquisition of competitive employment (open job market). Employment consultants will keep in regular phone and face-to-face contact with clients during the job search and after employment is attained, as part of the IPS model of service delivery.
Timepoint [1] 286944 0
During study period (18 months). At least monthly but it is likely that support will be more intensive during the job search phase and initially at job acquisition, and will be driven in part by client needs, although an assertive outreach approach may also be used to address the needs of clients who consistently fail to make contact.
Primary outcome [2] 286945 0
Time to first job, duration of longest job tenure. Through contact with the Employment Consultant as described above.
Timepoint [2] 286945 0
During study period (18 months). At least monthly.
Primary outcome [3] 286946 0
Annualised number of weeks worked. Through contact with the Employment Consultant as described above.
Timepoint [3] 286946 0
During study period (18 months). At least monthly.
Secondary outcome [1] 297038 0
Psychological symptoms as assessed by the Kessler 10, Brief Psychiatric Rating Scale, Drug and Alcohol Use Scales
Timepoint [1] 297038 0
During study period (18 months). 3-6 monthly, via questionnaires delivered by 2 researchers who are also clinical staff at the study clinic.
Secondary outcome [2] 297039 0
Emergency department presentations and hospital inpatient admissions. By examination of medical records data (at Dunedin Hospital), by the 2 researchers mentioned above.
Timepoint [2] 297039 0
During study period (18 months), assessed at the end of the study period. Compared with the year prior to study commencement.

Eligibility
Key inclusion criteria
All unemployed working age patients presenting during the 6-month run-in period to their GPs at the free clinic requesting a Sickness or Invalid’s Benefit renewal for predetermined psychiatric and substance dependency diagnoses will be eligible to participate.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are an unwillingness to participate in a vocational rehabilitation programme, and medical conditions (other than those above) judged by the referring GP to preclude working 15 hours or more a week.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The intervention cohort will be recruited from patients at the free clinic (Servants Health Centre) seeking assessment for the Sickness or Invalid’s Benefit because of psychiatric problems or substance dependency. Patients will be referred by their general practitioner, and patients consenting to enter the study will receive IPS delivered by the employment consultants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomization will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Data for comparison with the IPS group will come from the Dunedin Work and Income office. They will identify a group of Sickness and Invalid’s Beneficiaries who live in matched NZDep2006 areas but who do not consult at the study clinic, and provide the research team with data on the employment status of this group. The comparison group will matched by frequency on a 2:1 ratio to IPS participants by age, sex, ethnicity and diagnostic classification. Because the reference intervention is treatment-as-usual, there will be no restriction on what vocational support members of the comparison group receive.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 4258 0
New Zealand
State/province [1] 4258 0
Otago

Funding & Sponsors
Funding source category [1] 285088 0
Government body
Name [1] 285088 0
Ministry of Social Development
Country [1] 285088 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Health Research Council
Address
PO Box 5541, Wellesley Street, Auckland 1141
Country
New Zealand
Secondary sponsor category [1] 283953 0
Government body
Name [1] 283953 0
Southern Primary Health Organisation
Address [1] 283953 0
1 Bond Street Dunedin, 9054
Country [1] 283953 0
New Zealand
Other collaborator category [1] 260731 0
Charities/Societies/Foundations
Name [1] 260731 0
Servants Health Centre
Address [1] 260731 0
100 Princes Street, Dunedin 9016
Country [1] 260731 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287104 0
Lower South Regional Ethics Committee
Ethics committee address [1] 287104 0
c/- Ministry of Health
Level 2, Reception
1-3 The Terrace
Wellington
6011
Ethics committee country [1] 287104 0
New Zealand
Date submitted for ethics approval [1] 287104 0
01/06/2012
Approval date [1] 287104 0
Ethics approval number [1] 287104 0

Summary
Brief summary
Chronic unemployment adversely affects health and increases suicide risk. New Zealand has very high youth unemployment and suicide rates. Unemployment is common in people with mental illness, and mental illness is the most frequent reason for work incapacity on the Sickness Benefit (SB). Unemployment, mental illness, and being on the SB are more common in Maori. The Individual Placement and Support (IPS) model of supported employment has proven effectiveness in specialist psychiatric care for helping people with mental illness find open employment. IPS is yet untested in primary care, where most SB medical assessments occur. Two employment consultants will be appointed and trained to deliver IPS to Sickness Beneficiaries with mental illness and/or substance dependence at Dunedin’s free GP clinic. A cohort study is proposed comparing employment outcomes between Sickness Beneficiaries receiving IPS at the free clinic and beneficiaries receiving existing employment support at Work and Income. Participants’ mental health symptoms and use of hospital services will also be monitored. Realistic Evaluation will be used to identify factors promoting the implementation and uptake of the IPS programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34061 0
Address 34061 0
Country 34061 0
Phone 34061 0
Fax 34061 0
Email 34061 0
Contact person for public queries
Name 17308 0
Lik Wei Loh
Address 17308 0
Department of General Practice & Rural Health, Dunedin School of Medicine, University of Otago, P O Box 913, Dunedin 9054
Country 17308 0
New Zealand
Phone 17308 0
+64 21 650126
Fax 17308 0
+64 3 4797431
Email 17308 0
[email protected]
Contact person for scientific queries
Name 8236 0
Lik Wei Loh
Address 8236 0
Department of General Practice & Rural Health, Dunedin School of Medicine, University of Otago, P O Box 913, Dunedin 9054
Country 8236 0
New Zealand
Phone 8236 0
+64 21 650126
Fax 8236 0
+64 3 4797431
Email 8236 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
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