Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000377235
Ethics application status
Approved
Date submitted
26/02/2018
Date registered
14/03/2018
Date last updated
1/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a prototype for Individual Placement and Support (IPS) - Waitemata District Health Board (DHB)
Scientific title
Feasibility of an Individual Placement and Support (IPS) prototype developed by Waitemata District Health Board (DHB) for people aged 18-35 with severe mental health conditions
Secondary ID [1] 294155 0
Nil known
Universal Trial Number (UTN)
U1111-1209-8967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe mental health condition 306782 0
schizophrenia 306783 0
schizoaffective disorders 306784 0
bipolar affective disorders 306785 0
Condition category
Condition code
Mental Health 305884 305884 0 0
Schizophrenia
Mental Health 305885 305885 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to pre-test and pilot the fidelity, reach and retention, activities and outcomes, and cutural fit of an Individual Placement and Support (IPS) prototype.
IPS is a well specified integrated supported employment scheme for people with severe mental illness based upon eight principles:
- Competitive employment is the primary goal;
- Everyone who wants it is eligible for employment support;
- Job search is consistent with individual preferences;
- Job search is rapid: beginning within one month;
- Employment specialists and clinical teams work and are located together;
- Employment specialists develop relationships with employers based upon a person’s work preferences;
- Support is time-unlimited and individualised to both the employer and the employee;
- Welfare benefits counselling supports the person through the transition from benefits to work (Becker, Swanson, Reese, Bond, & Mcleman, 2015).
Two employment specialists will work within a mental health team. On average each FTE can provide services to 25 clients at one time or 40-60 over a period of a year. The sessions will be face to face withthe employment specialist and will be tailored to the invidual. The frequency and duration of the individual sessions with the employment consultant will vary depending on the needs of the client, but will continue for up to niine months.
Delivery will acknowledge and consider the situation of each participant and use an approach that is appropriate, individualised and delivered in a manner sensitive to participant needs. The service will be delivered in an environment that is positive and encourages achievement.
Existing Provider care delivery processes will be utilised wherever possible. Employment specialists will have extensive local networks with support services, including counselling and budgeting services, employers, industry groups and training providers. They will source vacancies from their own employer networks or listed Work and Income vacancies.
Activities will include regular face-to-face engagement with the participant, under-taking a work assessment, support with job development/job placement and providing job coaching and follow-along support
Waitemata DHB plan to undertake a 'high fidelity' roll-out of IPS, focusing on people aged 18-35 years with severe mental health conditions who access mental health services at Waitemata DHB. The intervention will provide individual tailored support to people who experience a mental illness to assist them into employment. The approach tries to place people into the open labour market. People are placed quickly in normal work settings where they receive intensive on-the-job support. The theory of change for the IPS initiiative is that having imployment specialists integrated into a treatment setting maximises engagement with the focus on early job search activities. The intervention takes place in an integrated health care setting. The employment specialists and clinical teams work and are located together. Progress on participants will be regularly reviewed and data collected on attendance and participation.
IPS supported employment programs help anyone who expresses the desire to work. All clients interested in working have access to IPS services regardless of job readiness factors, substance abuse, symptoms, history of violent behaviour, cognition impairments, treatment non-adherence, and personal presentation.
Benefits advice, also called work incentives planning, is part of the employment decision-making process and will ensure that people understand the financial implications of employment in relation to their Work and Income benefit.. Employment specialists ensure that people are offered comprehensive and personalized benefits planning, which includes information about how work may affect their benefits and about work incentives in order to make informed decisions about job starts and changes.
Employment specialists help people look for jobs soon after entering the program, instead of requiring extensive pre-employment assessment and training, or intermediate work experiences (for example, prevocational work units, transitional employment, agency-run businesses or sheltered workshops).
Support from the employment specialist, and members of the mental health treatment team, continues as long as clients want assistance upt to a year after commencement. Job supports often occur outside of the work place and can include help from other practitioners, family members, coworkers, and supervisors.
Jobs are seen as transitions. People commonly try several jobs before finding a job they want to keep. Each job is viewed as a positive learning experience. If a job is a bad fit for any reason, an employment specialist offers to help the person find a new job based upon lessons learned.
IPS supported employment follows the philosophy that all choices and decisions about work and support are individualized, based on the person’s preferences, strengths, and experiences. In IPS, everyone is encouraged to carry out the job search and job performance as independently as possible, and employment specialists offer assistance as needed to support people in their working lives.
Assistance with career advancement planning is offered. For some people, career development might focus on a different job that the person anticipates will be more enjoyable. For others, career development could include specific vocational training or education through credit-bearing or certified educational programs.
Intervention code [1] 300448 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304930 0
Fidelity to IPS principles
After 6 months, fidelity will be assessed using the IPS-25 Fidelity Scale (Becker, Swanson, Bond, & Merrens, 2011). This scale assesses adherence to the principles of supported employment. The IPS-25 has adequate inter-rater reliability and predictive validity (Bond et al, 2012; Kim et al., 2015) and is used to monitor quality of implementation of programs in New Zealand and internationally. A recent review provides evidence of moderate, yet important, predictive validity, but indicates that good fidelity may be necessary but not sufficient for good competitive employment outcomes (Locket et al., 2016)
Timepoint [1] 304930 0
One Fidelity Review after 6 months from the start of intervention
Secondary outcome [1] 343630 0
Reach and retention assessed using monitoring data collected in aggregated form:
- Number and percentage of participants leaving the IPS service.
- Reason for leaving the IPS service (e.g. work, education/training, moved out of area, illness, didn’t like the programme, agreed to participate but withdrew before receiving support from the intervention).
Timepoint [1] 343630 0
Data will be collected and reviewed monthly
Secondary outcome [2] 343631 0
Cultural acceptability assessed using:
1. A client satisfaction survey The preamble and items [1]-[3] and [10]-[14] are adapted from the Health Quality and Safety Commission Primary Care Patient Experience Survey (https://www.hqsc.govt.nz/assets/Health-Quality-Evaluation/PR/Patient-experience-survey-Apr-2016.pdf and https://se2.myexperience.health.nz/?u=94c7c637ec294463b782785683976ef5&h=6760&w=1). Items [4]-[5] are adapted from the Parent Satisfaction Survey used in the Early Start study https://www.msd.govt.nz/about-msd-and-our-work/publications-resources/journals-and-magazines/social-policy-journal/spj28/28-client-satisfaction-with-the-early-start-service-p179-196.html. Items [6]-[9] are adapted from the Parent Satisfaction Survey used in the Incredible Years Pilot Study (https://www.msd.govt.nz/about-msd-and-our-work/publications-resources/evaluation/incredible-years-report/index.html).
2. WHOQOL bref questionnaire
Timepoint [2] 343631 0
Client satisfaction survey collected once at 6 months or exit from the service.
WHOQOL conducted at start of service, 3 months and 6 months in service.
Secondary outcome [3] 343775 0
activities and outcomes (movement into work) assessed using team meeting observations,monitoring data collected in aggregated form
- Number and percentage of participants taking steps towards work (e.g. engagement in job search activities; discussions with employers).
- Number and percentage of participants in work for 15 and 30 hours or more per week.
- The average amount of one-on-one support (time) the Employment specialist spends with each participant on a monthly basis
Timepoint [3] 343775 0
Data will be collected and reviewed monthly
Secondary outcome [4] 343995 0
Quality of life measured using the WHOQOL tool
Timepoint [4] 343995 0
WHOQOL conducted at start of service, 3 months and 6 months in service.

Eligibility
Key inclusion criteria
Study subjects are clients aged 18-35 with severe mental health conditions (including schizoaffective disorders, and bipolar effective disorders) who access mental health services at Waitemata DHB who
- say they want to work
- are in receipt of a main benefit or at risk of losing their employment and becoming benefit dependant due to their health condition
- have been identified by the Waitemata District Health Board Mental Health Service clinical team as a suitable participant for the IPS Prototype.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will not be recruited if they are in an acute phase of illness, or are considered by the clinical team to be unable to safely participate in the programme.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Methods of assessment are:
- an IPS Fidelity Review of the prototype with an added focus on gathering client and clinician perspectives on cultural relevance and cultural acceptability
- analysis of de-identified monitoring data and analysis of outcomes for MSD clients accessing the service (based on identified data)
- an anonymous client satisfaction survey that allows satisfaction with the prototype, including its cultural acceptability, to be assessed for clients overall.
IPS Fidelity Review
After 6 months, fidelity will be assessed using the IPS-25 Fidelity Scale (Becker, Swanson, Bond, & Merrens, 2011). This scale assesses adherence to the principles of supported employment. The IPS-25 has adequate inter-rater reliability and predictive validity (Bond et al, 2012; Kim et al., 2015) and is used to monitor quality of implementation of programs in New Zealand and internationally. A recent review provides evidence of moderate, yet important, predictive validity, but indicates that good fidelity may be necessary but not sufficient for good competitive employment outcomes (Locket et al., 2016).
Reviewers follow a set protocol with instructions for preparing sites for the visit and sample interview questions. Fidelity items are rated on a five-point scale based on the degree of implementation ranging from 1 = no implementation to 5 = full implementation. Recommendations for improving fidelity are provided for each item scored lower than 5.
Data collection procedures include:
- team meeting observations: both a mental health treatment team and the vocational unit
- individual interviews: the IPS coordinator, the agency’s clinical director, the executive director, mental health practitioners (i.e., case managers), a medical director or psychiatrist, and employment specialists
- interview with a small group of clients who have received IPS services – participation will be voluntary
- shadowing employment specialists individually while they conduct job development (e.g., contacting employers for community-based job searches)
- Reviewing a small number of client records (Becker, Swanson, Bond, & Merrens, 2011).
A provider with experience in conducting IPS Fidelity Reviews and trained reviewers will be commissioned to conduct the review.
The work commissioned from the Provider will include additional questions that focus on gathering client and clinician perspectives on cultural relevance and cultural acceptability, and assessing the need for adaptations in the full implementation to ensure cultural fit in the New Zealand context.
Reviewers will provide a report to the Waitemata DHB including observations, assessments and recommendations for programme improvement. The report will be sent directly to the DHB within 2 or 3 weeks, so they can make immediate improvements. The report will form part of the evaluation of the prototype.
Monitoring data
Monitoring data will be collected for the evaluation. This will be provided in aggregate form to MSD
In addition, as part of contract monitoring, identifiable information on MSD clients receiving IPS will be required and will be shared by Waitemata DHB with MSD, with the informed consent of clients. This information is limited to name, date of birth, start and end date of accessing IPS services, reason for leaving the service and date of entering into paid employment and the number of hours per week. It does not include any clinical information.
Reporting will be on a monthly basis.
The following provide indicative lists of de-identified monitoring data. The feasibility of some data items will need to be tested with the team selected for the prototype.
Reach:
- Number of people who accept to be enrolled in the IPS Prototype
Activities and short-term outcomes within 1, 3 and 6 months of enrolment:
- Number and percentage of participants taking steps towards work (e.g. engagement in job search activities; discussions with employers)
- Number and percentage of participants in work for 15 and 30 hours or more per week
- The average amount of one-on-one support (time) the Employment specialist spends with each participant on a monthly basis.
Retention within 1, 3 and 6 months of enrolment:
- Number and percentage of participants leaving the IPS service
- Reason for leaving the IPS service (e.g. work, education/training, moved out of area, illness, didn’t like the programme, agreed to participate but withdrew before receiving support from the intervention)
Client satisfaction survey
A brief client satisfaction survey will be administered to clients participating in the IPS service 6 months after the prototype commences. Participation will be voluntary and responses will be anonymous.
While numbers in the prototype will not be large enough to allow significant differences in responses between ethnic groups to be detected, results will be used to assess the acceptability of the prototype to clients overall and for the main ethnic groups, including its cultural acceptability.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
Date of last participant enrolment
Anticipated
1/11/2018
Actual
Date of last data collection
Anticipated
30/05/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 9625 0
New Zealand
State/province [1] 9625 0
Auckland

Funding & Sponsors
Funding source category [1] 298793 0
Government body
Name [1] 298793 0
Ministry of Social Development
Country [1] 298793 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Social Development
Address
PO Box 1556
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 297975 0
Other
Name [1] 297975 0
West Adult Community Mental Health Services
Address [1] 297975 0
Waimarino Building
33 Paramount Drive
Henderson 0610
Auckland
Country [1] 297975 0
New Zealand
Other collaborator category [1] 279961 0
Government body
Name [1] 279961 0
Waitemata District Health Board
Address [1] 279961 0
Private Bag 93-503
Takapuna
Auckland 0740
Country [1] 279961 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299737 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 299737 0
Ethics committee country [1] 299737 0
Date submitted for ethics approval [1] 299737 0
01/03/2018
Approval date [1] 299737 0
30/04/2018
Ethics approval number [1] 299737 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81414 0
Dr Sheryl Jury
Address 81414 0
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country 81414 0
New Zealand
Phone 81414 0
+64 094872231
Fax 81414 0
Email 81414 0
[email protected]
Contact person for public queries
Name 81415 0
Sheryl Jury
Address 81415 0
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country 81415 0
New Zealand
Phone 81415 0
+64 094872231
Fax 81415 0
Email 81415 0
[email protected]
Contact person for scientific queries
Name 81416 0
Sheryl Jury
Address 81416 0
Waitemata DHB
Private Bag 93-503
Takapuna
Auckland 0740
Country 81416 0
New Zealand
Phone 81416 0
+64 094872231
Fax 81416 0
Email 81416 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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