Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000847718
Ethics application status
Approved
Date submitted
26/07/2013
Date registered
1/08/2013
Date last updated
23/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Work Injury Screening and Early intervention (WISE) Study
Scientific title
Implementation of an early intervention protocol for workers with soft tissue injuries at high risk of long-term disability compared to usual care
Secondary ID [1] 282650 0
Nil known
Universal Trial Number (UTN)
U1111-1145-3740
Trial acronym
WISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work related soft tissue injuries 289351 0
Condition category
Condition code
Musculoskeletal 289687 289687 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the Intervention hospitals, those workers found to be at significant risk for a long-term disability (who meet the inclusion criteria) will be offered a specified management protocol. High risk cases will be defined according to their score on the modified Orebro Musculoskeletal Pain Screening Questionnaire – short form (OMPSQ-SF) (greater than or equal to 50/100). The OMPSQ-SF is designed to identify known psychosocial risk factors for long-term disability following a musculoskeletal injury. The OMPSQ-SF is to be administered as soon as possible after the worker first reports his/her claim (within 5 working days of the injury). The OMPSQ-SF items will be read out (over the telephone) to each injured worker by a claims manager and that officer will note the score (between 0-10) for each item. But the officer will not determine the total score for a particular case. Instead, this will be completed by the Research Manager (the same day) separately. Subsequently, the Research Manager will notify the Intervention claims manager if a particular case is in the high risk category.

The implementation of the protocol will be the responsibility of the RTW coordinator for the identified worker’s hospital once s/he has been advised by the insurance Claims Manager that a case is in the high risk category. The protocol will include the immediate referral to a nominated clinical psychologist for an assessment of the psychosocial obstacles for early recovery and return to work. The RTW coordinator will then contact the nominated treating doctor (NTD) to explain the research project and to seek his/her cooperation and consent for the referral to the nominated clinical psychologist for up to 6 treatment sessions (i.e. 1 hour sessions at least once per week for up to 6 sessions in total). The RTW coordinator will also request the claims manager to refer the injured worker to a nominated independent medical consultant (IMC) for an early specialist review (< 3 weeks). The IMC will provide a report on his/her findings and recommendations to the NTD, RTW coordinator, and the claims manager. It is also expected that the RTW coordinators will be in close (and early) contact with each injured worker’s workplace supervisor to assist the RTW processes (e.g., identify and resolve any workplace-based RTW obstacles as required) as per usual practice. The protocol will also require a review by an independent physiotherapist if any physiotherapy treatments are continuing beyond 6 weeks. The referral for this review will be made by the claims manager within 2-3 weeks of the initial claim. The intervention protocol is expected to run for 8 weeks.
Intervention code [1] 287316 0
Treatment: Other
Comparator / control treatment
The Control hospitals will continue as per current practice, but with the addition of early use of the screening questionnaire used in the Intervention hospitals.
Control group
Active

Outcomes
Primary outcome [1] 289776 0
1) Reduced costs of workers compensation claims

[The costs will be obtained from EML’s database for each claim. These include all costs incurred by a claim as the insurance agent is responsible for making these payments. They include costs of treatments and time lost from work.]
Timepoint [1] 289776 0
12, 24 and 60 months
Primary outcome [2] 289779 0
2) Earlier sustained RTW in the 12 month follow-up period

[The sustained RTW will be calculated from the number of days the worker is at work in the year after their injury.]
Timepoint [2] 289779 0
12, 24 and 60 months
Secondary outcome [1] 303224 0
1) Musculoskeletal Pain Screening Questionnaire, Short-Form (OMPSQ-SF)
Timepoint [1] 303224 0
Intervention group: end of psychological treatment (2-3 months post-recruitment) and 12 months
Control group: 12 months
Secondary outcome [2] 303225 0
2) Pain Catastrophizing Scale (PCS)
Timepoint [2] 303225 0
Intervention group only: end of psychological treatment (2-3 months post-recruitment) only
Secondary outcome [3] 303226 0
3) Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [3] 303226 0
Intervention group only: end of psychological treatment (2-3 months post-recruitment) only
Secondary outcome [4] 303227 0
4) The Depression Anxiety and Stress Scales (DASS-21 items version)
Timepoint [4] 303227 0
Intervention group only: end of psychological treatment (2-3 months post-recruitment) only
Secondary outcome [5] 304837 0
Brief Pain Inventory (BPI - Interference scale)
Timepoint [5] 304837 0
Intervention group only: end of psychological treatment (2-3 months post recruitment) only

Eligibility
Key inclusion criteria
Health workers (from the participating hospitals) who report soft tissue injuries that are substantially due to their work, make a claim for workers compensation, report their injury to their Nominated Treating Doctor (NTD), and take 7 or more days off work due to their injury will be invited to participate in the research project. The injured worker must be able to read and speak English well-enough to not require an interpreter. The injured worker must provide informed consent to participate (based on the requirements of relevant ethics committee) after having the purpose of the study explained to him/her by the claims manager by telephone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a non-significant injury (i.e., take less than 7 days off work and do not report it to their NTD), a stress claim, or are non-English speaking will be excluded. The presence of a ‘Red Flag condition’ (fractures or neurological damage indicating a need for early surgery) is also an exclusion criterion, as well as being unwilling to participate in the study.

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)
A controlled, non-randomised, intervention design will be used, where the outcomes of 6 public hospitals will be compared with the outcomes from 4 other public hospitals. This means that workers in each hospital will be assigned to one or other condition (Intervention or Control) according to the predetermined assignment for that hospital (i.e., if the hospital has been assigned to the control condition all high risk workers at that site will be assigned to the control condition).

The assignment of hospitals to Intervention or Control was based on the following reasoning: the types of work (as well as qualifications and salaries) in each hospital are comparable, but hospitals in the Control and Intervention arms should also be comparable in terms of total workforce size and total numbers of work injury claims in the previous year. The hospitals are covered by the same insurance claims agent in order to ensure consistency in claims management. Location of the hospitals is not important as their workers are drawn from a wide area and many travel some distance to work each day. More importantly, in order to ensure both blinding of risk status and adherence to the protocol, the chosen hospitals in the different categories (Intervention and Control) have to be in different Local Health Districts (LHDs) as the Return to Work (RTW) Coordinators in each LHD are responsible for managing the RTW of all injured Health workers in their District. Thus, if one hospital in a given LHD was in the Intervention group and another in the same LHD was in the Control group, the RTW coordinator would be at risk of breaching adherence to the protocol. Accordingly, the 6 Intervention hospitals are in different LHDs to the 4 Control hospitals. We expect to be able to recruit sufficient numbers within one year, but will monitor each claim to closure (Work Certificate finalisation) and for a period of one year beyond that, up to a maximum of five years in total (to assess sustainability of RTW).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The Intervention hospitals will implement a specially designed protocol for the management of each identified high-risk claim. The Control hospitals will continue as per current practice, but with the addition of early use of the screening questionnaire used in the Intervention hospitals. The risk screening will be conducted by the claims agent’s staff (EML) (by specially trained teams) for both conditions. Two teams of claims staff will be selected, one assigned to the Intervention conditions and the other to the Control condition. The two teams will not share information about their cases and the Control claims team will be blind to the results of the screening. The Intervention claims team will be made aware of the identity of the high risk cases, but not their individual scores. The RTW coordinators, NTD and other treatment providers for the Intervention condition will also be notified that a particular case is in the high risk category, but not their actual scores. The RTW coordinators, NTD and other treatment providers for injured workers in the Control condition will be blind as their risk category.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine the sample size needed data obtained from the pilot study conducted in another hospital was used. According to the sample size calculation, we would need 95 cases per group to provide 90% probability of finding a statistically significant difference between the two high risk groups. As some may be lost from the study, we suggest using an additional 15 cases per group (ie. 110 high risk workers per region or 220 in total) to adequately test the aims of the study.
The outcome data will be analysed using an intention-to-treat approach by a statistician who is blinded to group allocation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
Date of last participant enrolment
Anticipated
31/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1102 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 1103 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [3] 1104 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 1110 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 1111 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [6] 1112 0
St George Hospital - Kogarah
Recruitment hospital [7] 1114 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [8] 1115 0
The Sutherland Hospital - Caringbah
Recruitment hospital [9] 1116 0
Westmead Hospital - Westmead
Recruitment hospital [10] 1117 0
Wollongong Hospital - Wollongong

Funding & Sponsors
Funding source category [1] 287431 0
Government body
Name [1] 287431 0
NSW Self Insurance Corporation (SICorp)
Country [1] 287431 0
Australia
Funding source category [2] 287434 0
Government body
Name [2] 287434 0
NSW Ministry of health (NSW Health)
Country [2] 287434 0
Australia
Funding source category [3] 287435 0
Commercial sector/Industry
Name [3] 287435 0
Employers Mutual Ltd
Country [3] 287435 0
Australia
Primary sponsor type
University
Name
Sydney Medical School (Northern) - University of Sydney
Address
The University of Sydney, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 286178 0
None
Name [1] 286178 0
Address [1] 286178 0
Country [1] 286178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289545 0
Sydney Local health District Human Research Ethics Committee - Concord Repatriation General Hospital
Ethics committee address [1] 289545 0
Ethics committee country [1] 289545 0
Australia
Date submitted for ethics approval [1] 289545 0
Approval date [1] 289545 0
17/06/2013
Ethics approval number [1] 289545 0
HREC/13/CRGH/84

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

Contacts
Principal investigator
Name 40654 0
Prof Michael Nicholas
Address 40654 0
The University of Sydney, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country 40654 0
Australia
Phone 40654 0
+61 2 9463 1515
Fax 40654 0
Email 40654 0
[email protected]
Contact person for public queries
Name 40655 0
Garry Pearce
Address 40655 0
Greenwich Hospital
97-115 River Road
Greenwich
NSW 2065
Country 40655 0
Australia
Phone 40655 0
+61 2 9903 8333
Fax 40655 0
Email 40655 0
[email protected]
Contact person for scientific queries
Name 40656 0
Michael Nicholas
Address 40656 0
The University of Sydney, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country 40656 0
Australia
Phone 40656 0
+61 2 9463 1515
Fax 40656 0
Email 40656 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImplementation of Early Intervention Protocol in Australia for 'High Risk' Injured Workers is Associated with Fewer Lost Work Days Over 2 Years Than Usual (Stepped) Care.2020https://dx.doi.org/10.1007/s10926-019-09849-y
N.B. These documents automatically identified may not have been verified by the study sponsor.