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Trial registered on ANZCTR


Registration number
ACTRN12609000843257
Ethics application status
Approved
Date submitted
14/09/2009
Date registered
29/09/2009
Date last updated
8/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Self Management Increase The Effectiveness Of Vocational Rehabilitation For Chronic Compensated Musculoskeletal Disorders?
Scientific title
Does Self Management for Chronic Compensated Musculoskeletal Disorders increase the effectiveness of Vocational Rehabilitation outcomes?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Compensated Musculoskeletal Disorders 243829 0
Condition category
Condition code
Musculoskeletal 240003 240003 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study introduces a vocational rehabilitation intervention (self management) to the vocational rehabilitation sector. The model will add self-management training to usual care for injured workers with subacute or chronic compensated musculoskeletal conditions.
Self-management is a process that involves engaging individuals in activities and practices that sustain and promote health and well-being. It has been shown to be effective in chronic illness care through improving self-efficacy and wellness behaviours. The well-established Lorig self-management program (developed by the Stanford University in the USA) shall be used as the intervention in this study, but it has been adapted to cater more specifically for our study population. That is, modules concerned with ‘managing return-to-work’ and ‘navigating the compensation systems’ have been developed and will be added to the existing six module training program.
Thus, the intervention being evaluated consists of eight 2-hour self-management training sessions. The sessions will be held weekly, over consecutive eight-week periods. The program will be delivered by health professionals and lay leaders who have been trained to conduct the sessions.
Intervention code [1] 241267 0
Rehabilitation
Comparator / control treatment
The control group will recieve usual care. Usual care in the context of Vocational Rehabilitation refers to any task which may assist a client return to employment. Tasks may include; retraining (up skilling), resume writing, job seeking, pain management, counselling, physiotherapy treatment, case management, functional capacity evaluation. Duration can vary greatly, from 4 weeks through to 12 months+.
Control group
Active

Outcomes
Primary outcome [1] 240905 0
Primary health outcome: Readiness for return-to-work will be evaluated with the Readiness for Return-to-Work (RRTW) scale.
Timepoint [1] 240905 0
Measured at four time points: pre-intervention; immediately post intervention; 6 months post intervention; 12 months post-intervention.
Secondary outcome [1] 257601 0
Secondary health outcomes:
(i) The Health Education Impact Questionnaire (heiQ) is a reliable measure of the impact of health education and self-management programs.
Timepoint [1] 257601 0
Measured at four time points: pre-intervention; immediately post intervention; 6 months post intervention; 12 months post-intervention.
Secondary outcome [2] 257602 0
(ii) Return-to-work (RTW) status will also be employed as a health outcome measure. This will be defined in relation to Australian Government standards.
Timepoint [2] 257602 0
Measured at four time points: pre-intervention; immediately post intervention; 6 months post intervention; 12 months post-intervention.
Secondary outcome [3] 257603 0
(iii) Service and medication use will be collected (including vocational rehabilitation, healthcare, commonwealth services). Service and medication use data will be collected via telephone interview using a specially developed tool.
Timepoint [3] 257603 0
Measured at four time points: pre-intervention; immediately post intervention; 6 months post intervention; 12 months post-intervention.
Secondary outcome [4] 257604 0
(iv) A cost-effectiveness analysis will be conducted which involves measuring and comparing the costs and outcomes for the two study groups. Cost data will be estimated in relation to each participant's use of various health and vocational rehabilitation services, and any informal care/services they may receive during the study period. This will involve estimating costs to the clients, family members/carers, funders and the Government from their use of the various services and in relation to the time they spent attending the services. Outcomes measures to be used include health efficacy and return-to-work measures.

In addition, a partial cost-benefit analysis will be conducted. This will not involve valuing the intervention in terms of the participant's 'willingness to pay' for it, but rather the benefits of the intervention will be measured and valued in terms of 'return-to-work' outcomes. That is, wage rates will be used to value the quantity of paid (and unpaid) work time produced the study groups. This allows the dollar value of the cost of the program to be compared with the dollar value of one aspect of the benefits of the intervention.
Timepoint [4] 257604 0
Measured at four time points: pre-intervention; immediately post intervention; 6 months post intervention; 12 months post-intervention.

Eligibility
Key inclusion criteria
Participants will comprise 366 clients of the participating clinics of Work Solutions, part of the Health Services Australia Group, an industry partner. All participants will have a musculoskeletal disorder. Participants will have been referred to Work Solutions via their private insurer or a government provider.
Inclusion criteria:
(1) A musculoskeletal disorder diagnosed by a medical practitioner of 3 months or more in duration, causing the client too be off work
(2) Referred to Work Solutions for vocational or occupational rehabilitation
(3) Agreement (in writing) by the payer (private insurer, government provider) for clients (participants) to participate in the research
(4) Note clients must have been working at the time of the injury to be eligible for the study
(5) Clients have to be new referrals to Work Solutions to be eligible
(6) It is anticipated that clients will be 3 to 6 months post injury but can be up to 2 years post injury
(7) English language skills adequate to complete the Self Management course
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
(i) Clients will be excluded if they demonstrate signs and symptoms suggestive of a red flag condition (eg tumor, systemic illness, inflammatory disease or infection screened using the criteria outlined in the Evidence based management of acute musculoskeletal pain (Australian Acute Musculoskeletal Pain Guidelines Group).
(ii) Clients whose primary condition is psychiatric
Note: co-morbid psychiatric conditions are not grounds for exclusion

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)
Recruitment and Randomisation: Identification and recruitment will be undertaken by Work Solutions practitioners in the participating clinics. Participation in the study will be voluntary. Volunteers once accepted into the study will be randomised into a treatment group or control group by an independent body, the Qld Clinical Trials Centre, external to the research team and Work Solutions. Randomisation will be within each state (SA and QLD) centre to cater for local conditions of workers compensation schemes and to build groups of 10 for participation in the self-management program. The recruitment period will be over 18 months, a time sufficient, based on the number of clients (participants) cared for in the Work Solutions network, to recruit all subjects for this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2075 0
4000
Recruitment postcode(s) [2] 2076 0
5000

Funding & Sponsors
Funding source category [1] 243733 0
Government body
Name [1] 243733 0
Australia Research Council Linkage Grant
Address [1] 243733 0
PO Box 6022
Parliament House
Canberra ACT 2600
Country [1] 243733 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Health Services Australia Group
Address
GPO Box 9821
Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 237094 0
Commercial sector/Industry
Name [1] 237094 0
The Workers' Compensation Regulatory Authority (Q-COMP)
Address [1] 237094 0
PO Box 10119
Brisbane Adelaide Street
QLD 4001
Country [1] 237094 0
Australia
Secondary sponsor category [2] 237095 0
Commercial sector/Industry
Name [2] 237095 0
Motor Accident Insurance Commission (MAIC)
Address [2] 237095 0
GPO Box 1083
Brisbane QLD 4001
Country [2] 237095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243857 0
Behavioural and Social Sciences Ethical Review Committee, The University of Queensland
Ethics committee address [1] 243857 0
University of Queensland
St Lucia QLD 4067
Ethics committee country [1] 243857 0
Australia
Date submitted for ethics approval [1] 243857 0
Approval date [1] 243857 0
26/05/2009
Ethics approval number [1] 243857 0
2009000597

Summary
Brief summary
In this project a new intervention for the vocational rehabilitation of chronic compensated musculoskeletal disorders will be developed. The intervention will add self-management training to usual care for injured workers who have transitioned from the acute to chronic stage of their musculoskeletal condition. Study participants will be recruited through one of the industry partners, Health Services Australia, a national provider of occupational health services and vocational rehabilitation. The participants who meet the inclusion criteria will be recruited from clinics in Brisbane, Canberra, Melbourne, Tasmania or Adelaide. Participants will be randomised into two study arms: the new model for management or a control group who will receive usual care. Acceptability, effectiveness (job readiness, health efficacy and pain) and the cost-effectiveness and cost-benefit of the new model compared to usual care will be assessed using tools which have been pre-tested with this target group.
Aims:
1. To develop and document, in care protocols, an intervention which adds self-management to vocational rehabilitation for patients with chronic compensated musculoskeletal disorders.
2. To test the acceptability of the intervention to patients, their vocational rehabilitation providers’, policy makers and regulators through qualitative research with representatives from each group.
3. To test the effectiveness of the intervention by comparing readiness to return-to-work, health efficacy and pain in a group of patients who receive the intervention and a control group who receive usual care (single blind randomised controlled trial).
4. To assess the cost-effectiveness, and cost-benefit of the intervention.
Hypotheses:
1. That adding self management to vocational rehabilitation will be acceptable to patients, health-care providers, policy makers and regulators.
2. The proportion of workers who are classified as ready to return-to-work based on a validated scale (the ‘Prepared for action - Self-evaluative or Maintenance-Uncertain or Maintenance-Uncertain category’) will be significantly different for those participating in the self-management program. This will be achieved through an improvement in their health efficacy (as defined by the heiQ questionnaire).
3. Adding self-management to active treatment and vocational rehabilitation will be worthwhile from an efficiency perspective, i.e. the productivity gains from adding the program shall be greater in dollar value than the societal costs of the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30282 0
Address 30282 0
Country 30282 0
Phone 30282 0
Fax 30282 0
Email 30282 0
Contact person for public queries
Name 13529 0
Professor Niki Ellis
Address 13529 0
C/- Alison MacKenzie
Centre for Military and Veterans' Health
University of Queensland
Mayne Medical School
Herston Road, Herston QLD 4006
Country 13529 0
Australia
Phone 13529 0
+ 61 434072118
Fax 13529 0
Email 13529 0
n.ellis@uq.edu.au
Contact person for scientific queries
Name 4457 0
Professor Niki Ellis
Address 4457 0
C/- Alison MacKenzie
Centre for Military and Veterans' Health
University of Queensland
Mayne Medical School
Herston Road, Herston QLD 4006
Country 4457 0
Australia
Phone 4457 0
+ 61 434072118
Fax 4457 0
Email 4457 0
n.ellis@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results