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Trial registered on ANZCTR


Registration number
ACTRN12620000041954
Ethics application status
Approved
Date submitted
2/01/2020
Date registered
21/01/2020
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Matched Care For Australia Post Employees (EMCAP) with work-related injuries and at risk of delayed return to work.
Scientific title
Effect of Early Psychosocial intervention for injured Australia Post workers on duration of time off work.
Secondary ID [1] 300122 0
NONE
Universal Trial Number (UTN)
Trial acronym
EMCAP STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Injury 315653 0
Psychological Wellbeing 315868 0
Condition category
Condition code
Musculoskeletal 313942 313942 0 0
Other muscular and skeletal disorders
Mental Health 314150 314150 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early psychological intervention will be provided to injured Australia Post workers. The workers will be receiving up to 6 sessions of CBT-based care for the identified psychosocial risk factors, in addition to their standard care. Standard care will involve the injured worker being managed by a medical practitioner who can refer as necessary.The early intervention protocol will also involve coordination between the workplace, Workplace Rehabilitation Provider, Employee Assistance Program (EAP) clinician, and medical staff.


1. Brief description of the psychological intervention (a-e)
The early psychological intervention will be provided by the Employee Assistance Program (EAP) workers (Converge) associated with Australia Post. The EAP workers will provide a brief, problem-focussed face-to-face intervention for the injured worker. EAP workers have expertise in providing brief and targeted treatment. Adherence to the intervention will be monitored in the follow up appointment with he injured worker. This intervention will focus on reducing symptoms and facilitating return to work. More specifically, the early intervention will 1) focus on activity and independence, 2) working towards agreed goals, 3) regular review of progress and 4) targeting identified psychosocial obstacles for return to work. The EAP workers will be asked to assess and address any identified obstacles for return to work that they considered within their competence in up to 1 X 1 hour session per week for 6 sessions. No specific therapy or target problem will be specified, but the participating EAP workers will be informed that their intervention should be brief, problem-focussed, consistent with a cognitive-behavioural approach, and have a clear return to work focus. The EAP workers will be expected to maintain contact with both the workplace via the Work Rehabilitation Provider (WRP) and GP at least every 2 weeks to report on progress. They will be required to alert the workplace (WRP) and treating doctor to any issues they thought could affect successful return to work. EAP workers will attend a short, structured training program to ensure they have the necessary skills and knowledge to work in a manner consistent with the protocol. Regular supervision of the EAP workers will be provided by the Research leader and Clinical Psychologist on the Steering Committee.

2. Brief description of the standard care
Standard Care: Focusses on standard management of the injury by a General Practitioner. Injured workers who were screened as high risk receive treatment as usual under the Comcare Guidelines. After the incident, a three point contact would typically be established between the Workplace Rehabilitation Provider (WRP), the GP, the workplace and the insurer. The frequency and duration of GP appointment will be at the discretion of the injured worker and the GP. The GP will case manage the injured worker and refer to other providers, support groups, websites as necessary.

Intervention code [1] 316397 0
Treatment: Other
Comparator / control treatment
The study will be conducted at Australia Post worksites and their associated Employee Assistance Program (EAP) sites across four Australian states: New South Wales, Queensland, Victoria and South Australia. New South Wales and Queensland will act as standard care (control) sites; Victoria and South Australia will receive the risk factor intervention protocol plus standard care. Participants in the control sites will receive the standard care which will involve the injured worker being managed by a medical practitioner who can refer as necessary.
Control group
Active

Outcomes
Primary outcome [1] 322336 0
Duration of time off work which will be assessed via employment records.
Timepoint [1] 322336 0
12 months post commencement of the intervention.
Primary outcome [2] 322537 0
Cost associated with the injury (health related expenses) which will be assessed by the Employment records. It is routine process of Employment Assistance Program at the Australia Post to keep a record of all costs associated with a injured post worker.
Timepoint [2] 322537 0
12 months post commencement of the intervention.
Secondary outcome [1] 378149 0
Change in emotional distress assessed by Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [1] 378149 0
12 months post commencement of the intervention.
Secondary outcome [2] 378871 0
Change in Pain and pain-related disability assessed by the Brief pain Inventory (BPI; Cleeland et al., 1994)
Timepoint [2] 378871 0
12 months post commencement of the intervention.
Secondary outcome [3] 378872 0
Change in self-efficacy due to pain assessed by the Pain Self-Efficacy Questionnaire (PSEQ; Nicholas et al., 2007)
Timepoint [3] 378872 0
12 months post commencement of the intervention.
Secondary outcome [4] 378873 0
Change in self-rated health assessed as 1 (poor) to 5 (excellent) on a 1 to 5 self-report scale
Timepoint [4] 378873 0
12 months post commencement of the intervention.
Secondary outcome [5] 378874 0
Change in psychosocial quality of work assessed by Psychosocial Job Quality Scale (Butterworth et al., 2011).
Timepoint [5] 378874 0
12 months post commencement of the intervention.

Eligibility
Key inclusion criteria
The inclusion criteria are the worker:
• Must be part of the Australia Post Group (Australia Post and Star Track)
• Have a current workers compensation claim
• Have a work-related injury
• Must have sustained the injury within four weeks
• Have a score greater than 48/100 on the Örebro Musculoskeletal Pain Screening Questionnaire - Short Form (*ÖMPSQ-SF).
• Has adequate English to not require an interpreter to complete the survey.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
• Having a primary psychological injury
• Having a catastrophic injury (e.g. spinal cord injury)
• Being a casual, contracted or labour-hire worker who could be job detached (where their contract has expired and/or there is no job to return to)
• Having concurrent claims where the worker already has an open claim when the new injury occurs.
• If the worker’s rehabilitation case is being managed external to Australia Post

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main analysis for this study will compare costs of early intervention protocol versus standard care regarding days to return to work and costs per claim. We will use linear mixed models with bootstrapping to compare total costs, duration before return to work (RTW) and psychosocial outcomes over the 12 months duration of the study, taking into account clustering by state within trial arms. We will also use repeated measures linear mixed models to examine change in cumulative costs over time and how this differs between trial arms. We will be reporting descriptive statistics regarding demographic variables, as well as measures of psychological status, pain, pain-related disability, and medication use for each participant. Data analysis will be conducted by Dr Daniel Costa who is the Pain Management Research Centre’s statistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2020
Actual
Date of last participant enrolment
Anticipated
14/12/2020
Actual
Date of last data collection
Anticipated
14/12/2021
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 304563 0
Charities/Societies/Foundations
Name [1] 304563 0
Pain Foundation Ltd
Country [1] 304563 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Australia Post Group
Address
Level 2, 219-241 Cleveland Street
Strawberry Hills, NSW, 1420
Country
Australia
Secondary sponsor category [1] 304852 0
None
Name [1] 304852 0
Address [1] 304852 0
Country [1] 304852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304989 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 304989 0
Ethics committee country [1] 304989 0
Australia
Date submitted for ethics approval [1] 304989 0
08/11/2019
Approval date [1] 304989 0
19/12/2019
Ethics approval number [1] 304989 0
2019/976

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

Contacts
Principal investigator
Name 98878 0
Prof Michael Nicholas
Address 98878 0
The University of Sydney, Pain Management Research Institute,
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital, St Leonards, Sydney
NSW , 2065
Country 98878 0
Australia
Phone 98878 0
+61 2 9463 1515
Fax 98878 0
Email 98878 0
michael.nicholas@sydney.edu.au
Contact person for public queries
Name 98879 0
Michael Nicholas
Address 98879 0
The University of Sydney, Pain Management Research Institute,
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital, St Leonards, Sydney
NSW , 2065
Country 98879 0
Australia
Phone 98879 0
+61 2 9463 1515
Fax 98879 0
Email 98879 0
michael.nicholas@sydney.edu.au
Contact person for scientific queries
Name 98880 0
Michael Nicholas
Address 98880 0
The University of Sydney, Pain Management Research Institute,
Faculty of Medicine and Health
Ground Floor, Douglas Building
Royal North Shore Hospital, St Leonards, Sydney
NSW , 2065
Country 98880 0
Australia
Phone 98880 0
+61 2 9463 1515
Fax 98880 0
Email 98880 0
michael.nicholas@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As de-identified data will be obtained from Australia Post Group, IPD will not be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6284Ethical approval    378955-(Uploaded-02-01-2020-11-02-34)-Study-related document.pdf



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.