Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000517370
Ethics application status
Approved
Date submitted
9/01/2017
Date registered
10/04/2017
Date last updated
10/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a return to work programme for adults living in Waikato receiving a ‘sickness’ benefit.

Scientific title
The REACH Initiative Trial (REACH-IT): A Cluster Randomised Controlled Trial evaluating the effectiveness of a return to work programme for adults living in Waikato receiving a ‘sickness’ benefit.
Secondary ID [1] 290862 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
REACH-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 301550 0
Anxiety 301551 0
Musculoskeletal Disorders 301552 0
Traumatic Head Injury 301553 0
Cardiovascular Conditions 301554 0
All health conditions or disabilities that impact on a client's ability to work 301555 0
Visual and auditory disabilities 301556 0
Condition category
Condition code
Public Health 301270 301270 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is evaluating the Realising Employment through Active Coordinated Healthcare (REACH) service. The service/intervention (REACH) was implemented before this study and was co-designed by the Waikato District Health Board (WDHB) and the Ministry of Social Development (MSD)*. This study aims to evaluate the effectiveness of REACH. The study has not designed the intervention.

The REACH programme is a 12 week, goal orientated programme that consists of Key Workers and Living Well Coaches who work in partnership to support clients to achieve personal goals of returning to wellness and gaining employment.

Key Workers are registered health professionals who include nurses, occupational therapists, social workers and physiotherapists. Key workers all hold annual practicing certificates and meet their professional board requirements with regards to competency and continuing professional development. The team also has regular clinical supervision by a clinical psychologist.

Living Well Coaches work under the direction of the Key Workers. The Living Well coaches work alongside the client and Key Worker to identify the activity each day that the client needs the most support with, whilst at the same time empowering the client to take ownership of the rest of their planned activity. This could include developing the client’s Curriculum Vitae (CV) and interview skills to helping establish health behaviors through eating plans and exercise plans.

The REACH service strongly focuses on a team approach, with the Key Worker actively liaising with the client’s GP and with the Ministry of Social Development case manager. The team supports the clients to work on their identified goals in their journey to be work ready, employing a holisitic approach based on the health model, Te Whare Tapa Wha. The interventions provided are based on a cognitive behavioral therapy intervention approach, motivational interviewing and are delivered in an interdisciplinary model.

The REACH Key Worker meets with clients at least weekly and Living Well Coaches having up to 5 contacts a week with clients over the 12 week period. Collectively the REACH team will visit up to three-times a day for the three-months to deliver health interventions and support the client to return to employment. However, the exact frequency and time will be determined at the discretion of the Key Worker based on the participant's progress. The location of the sessions is determined based on the client’s goals and progress. For example, locations could include the GP practice with the GP, the MSD site for a monthly meeting, the clients home and kitchen to establish an eating plan and healthy cooking strategies, it could also involve utilising local gyms, pools or parks.
At completion of each 4 weeks, the client, Key Worker and Work and Income case manager meet to discuss progress to date and where to for the next 4 weeks in the programme and what supports may be required to enable maximum participation by the client. A progress report is drafted by the keyworker and provided to the case manager and GP at each four-week stage.

If at the end of the 12 weeks the client demonstrates potential for further gains, an extension of the programme is negotiated with Work and Income with clearly defined outcomes to be achieved in the extension period. At the end of the programme a handover meeting occurs with the client, Key Worker and Case Manager with a plan made for next steps for the client and who is responsible to follow up these actions. A copy of this report is also provided to the GP. Follow up of the client following exit from the programme can range from monthly text/phone call to face-to-face meetings to provide individual in-work/in-training supports as the client requests.

The REACH team have access to a clinical psychologist, who coordinates hourly fortnightly group and assists keyworkers to support clients when they come against difficulties with taking the next steps in their journey. A key component of the intervention is a joint visit by Key Worker and client to the client’s GP to discuss their partnership and endorsement of the programme, as well as their ongoing support to the client with their identified goals. Basic routines for sleep, nutrition and exercise are established (as able) with clients to give solid foundations to improve their work readiness. Other interventions include career guidance, CV and cover letter preparation, anxiety and or depression management as applicable and strategies for clients to manage any chronic health conditions or maintain wellness in their lives.
The experience of the Key Workers, Living Well Coaches and MSD Case Managers with the REACH services will be captured and evaluated by the study through conducting Focus Groups.
The experience of clients using the REACH service will be captured through interviews (Basline, will be conducted face-to-face with follow-up phone interviews), this data will be compared to clients in the control group who are receiving usual care.
Intervention code [1] 296810 0
Rehabilitation
Intervention code [2] 297143 0
Treatment: Other
Comparator / control treatment
REACH - IT will review the REACH initiative through an Randomised Control Trial (RCT).
Cluster randomization will be conducted on the GP practices within the Waikato District Health Board region (n=85).

Eligible MSD clients who are receiving the Jobseeker- Health Condition and Disability (JS-HCD) support will either receive the intervention or standard care based on the GP practice that they attend.
JS-HCD Clients attending GP practices that are randomised into the control group will receive existing standard care from MSD services. Standard care consists of support facilitated by the client's MSD Case Manager.

Conversely, JSD-HCD clients attending GP practices that are randomised into the initiative group will be offered the WDHB 12-week REACH service in conjunction with standard care.
Control group
Active

Outcomes
Primary outcome [1] 300685 0
Quality of life (SF-36)
Timepoint [1] 300685 0
12 weeks, six and 12 month follow up post baseline.
Secondary outcome [1] 330600 0
Time till off benefit - outcome will be assessed through face to face and phone interviews.
Timepoint [1] 330600 0
12 weeks, six and 12 month follow up post baseline.
Secondary outcome [2] 330601 0
Cost-benefit analysis - outcome will be assessed using retrospective economic data from both MSD and WDHB.
Timepoint [2] 330601 0
18-24 months post initiative introduction
Secondary outcome [3] 332682 0
Client and staff experience
Timepoint [3] 332682 0
6 & 12 month Focus Groups

Eligibility
Key inclusion criteria
Interview Participants:
The participants are JS-HCD benefit receivers that have been identified through MSD as eligible for the REACH initiative. The inclusion criteria outlined by MSD for REACH clients includes:
*Recipient of JS-HCD for a period of six – 36 months
*Streamed to MSD’s Work Focused Case Management – Health Condition, Injury or Disability (WFCM-HCD) pathway.
*Are not receiving JS-HCD due to having one of the following conditions as their primary health condition:
a. Pregnancy related
b. Bipolar o Schizophrenia, or
c. Other psychiatric conditions.
*Aged between 18 – 64
*Not currently in hospital

Focus Group Participants:
Eligible Participants:
*MSD Case Mangers at Waikato Service Centres
*WDHB REACH service providers (Key Workers and Living-well coaches)
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Based on MSD exclusion criteria, individuals will be excluded from the REACH service by their Case Manager if it is not seen beneficial to them or if they are identified to be:
*Participating in another contracted service, for example the Mental Health Employment Service (MHES) trial, InWork NZ or Workbridge.
*Awaiting medical treatment or surgery that would result in them being unavailable or incapacitated for a lengthily period of time.
*In hospital.
*Child Sex offender (CSO).
*Where there are serious safety concerns.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation was undertaken with computer software. Using block randomisation with a 1:1 ratio, GP practices within the Waikato were randomised into two arms consisting of either the control or the initiative group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/11/2016
Date of last participant enrolment
Anticipated
15/06/2018
Actual
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 8552 0
New Zealand
State/province [1] 8552 0

Funding & Sponsors
Funding source category [1] 295293 0
University
Name [1] 295293 0
University of Auckland
Country [1] 295293 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The School of Nursing
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 294114 0
None
Name [1] 294114 0
Address [1] 294114 0
Country [1] 294114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296627 0
UNIVERSITY OF AUCKLAND HUMAN PARTICIPANTS ETHICS COMMITTEE (UAHPEC)
Ethics committee address [1] 296627 0
The University of Auckland Private Bag 92019 Auckland, New Zealand
Level 10, 49 Symonds Street Telephone: 64 9 373 7599 Extension: 87830 / 83761 Facsimile: 64 9 373 7432
Ethics committee country [1] 296627 0
New Zealand
Date submitted for ethics approval [1] 296627 0
16/09/2016
Approval date [1] 296627 0
31/10/2016
Ethics approval number [1] 296627 0
16-Sep-2016
Ethics committee name [2] 296628 0
Waikato District Health Board
Ethics committee address [2] 296628 0
Waikato District Health Board
Pembroke Street
Private Bag 3200
Hamilton 3240
NEW ZEALAND
Ethics committee country [2] 296628 0
New Zealand
Date submitted for ethics approval [2] 296628 0
08/09/2016
Approval date [2] 296628 0
01/11/2016
Ethics approval number [2] 296628 0
RD016069
Ethics committee name [3] 296629 0
Te Puna Oranga Maori Consultation Research Review Committee
Ethics committee address [3] 296629 0
Waikato District Health Board
Pembroke Street
Private Bag 3200
Hamilton 3240
NEW ZEALAND
Ethics committee country [3] 296629 0
New Zealand
Date submitted for ethics approval [3] 296629 0
01/10/2016
Approval date [3] 296629 0
31/10/2016
Ethics approval number [3] 296629 0
RD016069

Summary
Brief summary
Realising Employment through Active Coordinated Healthcare (REACH) is a new service in the Waikato District Health Board (WDHB) that has been developed in collaboration with the Ministry of Social Development (MSD).

Through a Cluster Randomised Control Trial (RCT) the REACH-Initiative Trial (REACH – IT) aims to review the effectiveness and cost-effectiveness of the REACH service. More specifically, REACH – IT aims to assess the impact that the REACH service has on individual’s quality of life and rehabilitation into employment. Secondly, the study aims to identify if the REACH service reduces the time it takes for clients to gain employment. Lastly, REACH – IT will aim to provide a cost analysis of the REACH service and present the experiences of both clients as well as staff.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70522 0
A/Prof Nicolette Sheridan
Address 70522 0
The University of Auckland
M&HS BUILDING 505 - Bldg 505
Level 2, Room 231B
85 PARK RD
GRAFTON
AUCKLAND 1023
New Zealand
Country 70522 0
New Zealand
Phone 70522 0
+64 9 923 7811
Fax 70522 0
Email 70522 0
n.sheridan@auckland.ac.nz
Contact person for public queries
Name 70523 0
Michelle Cameron
Address 70523 0
The University of Auckland
Waikato Hospital Campus
Older Persons Rehabilitation Unit
B1 Administration
Gate 3 - Pembroke Street  
Hamilton 3240
Country 70523 0
New Zealand
Phone 70523 0
+64273918762
Fax 70523 0
Email 70523 0
michelle.cameron@auckland.ac.nz
Contact person for scientific queries
Name 70524 0
Michelle Cameron
Address 70524 0
The University of Auckland
Waikato Hospital Campus
Older Persons Rehabilitation Unit
B1 Administration
Gate 3 - Pembroke Street
Hamilton 3240
Country 70524 0
New Zealand
Phone 70524 0
+64273918762
Fax 70524 0
Email 70524 0
michelle.cameron@auckland.ac.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

Documents added manually
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