Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001116415
Ethics application status
Approved
Date submitted
28/03/2025
Date registered
13/10/2025
Date last updated
13/10/2025
Date data sharing statement initially provided
13/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Early intervention pathway for major trauma patients at risk of developing persistent pain
Scientific title
To determine if a multidisciplinary early intervention for major trauma leads to a change in health-related quality-of-life at 12-months (assessed using EQ-5D5L) when compared to usual care for major trauma patients at risk of developing persistent pain
Secondary ID [1] 310986 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major trauma 332088 0
Chronic pain 336835 0
Injury 336836 0
Condition category
Condition code
Injuries and Accidents 328811 328811 0 0
Fractures
Injuries and Accidents 328812 328812 0 0
Other injuries and accidents
Anaesthesiology 328813 328813 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Structure of interventions
Inpatient education comprising of a short message about recovery from trauma delivered by a healthcare professional in audio format. It will introduce themes outlined below.
Four x 1 hour 1:1 consultations with a psychologist with specialist pain medicine physician support and review that occur every other week for four sessions (6 weeks total)
Inpatient education will address:
• Basic pain physiology, including pain as danger detector / protector
• Difference between acute and persistent pain and structural and non-structural pain
• Danger/Safety framework and role of attentional system
• Drivers of danger include – unclear diagnosis, fear about pain and its trajectory, compensation stress, perceptions of injustice, hx of trauma
• Drivers of safety include – understanding of pain and diagnosis, feeling supported, recovery pathway including optimisation and facilitation of claim
• Introduction/rationale for understanding pain, activity pacing, gentle movement, relaxation and mindfulness
• Introduction to strategies to manage pain including opioids, anti-inflammatories and nerve modulating medications
5-10-minute video outlining practical aspects of injury/trauma recovery:
• Role of pain medicine, rehabilitation medicine, co-ordinating GP
• What to expect re health processes: specialist appointments, need for certificates
• Compensable systems including Transport Accident Commission (TAC), Worksafe (WCA) claim processes, contacts, supports, troubleshooting
Interventional content – in person or telehealth
Session 1 - Psychology or Physiotherapy lead
• Assessment session (physiotherapy or psychology lead) with brief medical review including diagnosis, stage of recovery, consolidation and ensuring shared understanding of presenting issues and treatment rationale
• Ascertain key targets for intervention and SMART goals
Session 2 - Psychology lead
• Review TAC claim process/coordination of care
• Introduction to Window of Tolerance – for understanding mind/body stress response and emotional regulation
• Noticing and responding to catastrophic /fear cognitions
• Skill building: somatic-tracking + grounding i.e. tuning into / tolerating unpleasant sensations
• Homework practice: Mindfulness exercise: “when pain grabs your attention”
Session 3 - Physiotherapy lead
• Mindful movement – encouraging safety in the body
• Activity pacing
• Homework practice: Completing valued activity applying mindfulness and pacing principles
Session 4 – Psychology or Physiotherapy lead
• Review of progress and sessions to date
• Review of claims process
• Post-discharge medical/nursing summary, goal setting w community links, follow-up plans
• Relapse prevention/planning

- Adherence will be monitored through patient attendance to sessions
- Adherence may also be monitored through recollection of themes checked by psychologist at beginning of each session
- Adherence may also be monitored through web-portal analytics for engagement in disseminated communication and filling in PROMs in a timely fashion if able to do so.
Intervention code [1] 327428 0
Prevention
Intervention code [2] 327429 0
Treatment: Other
Intervention code [3] 327430 0
Rehabilitation
Comparator / control treatment
Control arm:
The control arm will receive usual care which comprises:
Referral to pain medicine:
Following recruitment, referral to pain medicine happens on an ad hoc basis from current referral sources including; acute pain, trauma or other specialist services (e.g., orthopaedics, neurosurgery, plastic surgery). Patients are then triaged by the acute pain service clinical nurse consultant with pain medicine physician input prior to being offered an appointment that may occur between 4-52 weeks. Participants will then be assessed and managed by a pain medicine clinician from either a medical or allied health background in an interdisciplinary clinic with follow up dictated by perceived clinical need and clinic waiting times.
Control group
Active

Outcomes
Primary outcome [1] 340895 0
To determine if a multidisciplinary early intervention for major trauma leads to any change in health-related quality-of-life at 12-months (assessed using EQ-5D5L) when compared to usual care.
Timepoint [1] 340895 0
Pre-morbid, Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks post randomisation. Primary timepoint is 52 weeks post-randomisation.
Secondary outcome [1] 445370 0
To determine if a multidisciplinary early intervention for major trauma leads to a change in Pain catastrophising scale at 12 months
Timepoint [1] 445370 0
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary outcome [2] 445371 0
Acceptability and feasibility of intervention to participants measured as a composite measure
Timepoint [2] 445371 0
6-12 months post randomisation
Secondary outcome [3] 449442 0
To determine if a multidisciplinary early intervention for major trauma leads to any change in pain as assessed by the brief pain inventory at 12 months
Timepoint [3] 449442 0
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks post randomisation.
Secondary outcome [4] 449443 0
To determine if a multidisciplinary early intervention for major trauma leads to any change in neuropathic pain symptoms at 12 months
Timepoint [4] 449443 0
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks post randomisation.
Secondary outcome [5] 450990 0
To determine if a multidisciplinary early intervention for major trauma leads to any change in PROMIS-29 outcomes at 12 months
Timepoint [5] 450990 0
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks post randomisation.
Secondary outcome [6] 450991 0
To determine if a multidisciplinary early intervention for major trauma leads to any change in injustice experience at 12 months
Timepoint [6] 450991 0
Baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks post randomisation.

Eligibility
Key inclusion criteria
Patients:
Any trauma patient at RMH aged 18-65 years old receiving consult services from either the trauma unit and/or the acute pain service who has a high pain report. The patients must have an injury severity score (ISS) >15 (definitive for major trauma) to qualify.

Clinicians:
All clinicians taking part in the project (both intervention and control arms) will be eligible to participate in the qualitative component.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major head injury: Failure of post traumatic amnesia testing for >3 days.
Active psychosis: noted to be psychotic at admission or referral to consultation liaison psychiatry for assessment and management of suspected psychosis.
High-risk ongoing suicidality.
Active or uncontrolled substance use disorder.
Patients unable to converse fluently in English will be excluded, as effective communication is essential for participation. However, individuals who speak English as a second language but are fluent are eligible.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule for the RCT (effectiveness component) will be prepared by the study biostatistician (permuted random block sizes) with stratification by sex (male/female) and compensable status (TAC/not TAC). The schedule will be stored on a password-protected website (REDCapTM) at RMH and maintained by a researcher not involved in either participant recruitment or administration of outcome measures. Group allocation will be revealed to the participant and treating clinician(s) by this same researcher after baseline assessment.

Due to the nature of the intervention, participants will not be blinded to their own group allocation. However, we will use limited disclosure to blind participants to the research questions. Participants will be simply told that the trial is evaluating effectiveness of different pain management programs, but without disclosing the components of each. As most primary and secondary outcomes are participant-reported, by default the assessors of these outcomes are not blinded. The treating clinicians will not be blinded. The Statistical Analysis Plan will be written while the trial biostatisticians are blinded to intervention allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2025
Actual
Date of last participant enrolment
Anticipated
22/09/2026
Actual
Date of last data collection
Anticipated
29/07/2027
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28331 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 44544 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 315247 0
Government body
Name [1] 315247 0
Transport accident commission
Country [1] 315247 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 320977 0
None
Name [1] 320977 0
Address [1] 320977 0
Country [1] 320977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314167 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314167 0
Ethics committee country [1] 314167 0
Australia
Date submitted for ethics approval [1] 314167 0
26/03/2025
Approval date [1] 314167 0
04/07/2025
Ethics approval number [1] 314167 0

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

Contacts
Principal investigator
Name 130654 0
Dr Paul Emery
Address 130654 0
Dept. of Anaesthesia 3 North, Royal Melbourne Hospital, 300 grattan street, Parkville, Vic, 3052
Country 130654 0
Australia
Phone 130654 0
+61 0435888511
Fax 130654 0
Email 130654 0
[email protected]
Contact person for public queries
Name 130655 0
Paul Emery
Address 130655 0
Dept. of Anaesthesia 3 North, Royal Melbourne Hospital, 300 grattan street, Parkville, Vic, 3052
Country 130655 0
Australia
Phone 130655 0
+61 0393427000
Fax 130655 0
Email 130655 0
[email protected]
Contact person for scientific queries
Name 130656 0
Paul Emery
Address 130656 0
Dept. of Anaesthesia 3 North, Royal Melbourne Hospital, 300 grattan street, Parkville, Vic, 3052
Country 130656 0
Australia
Phone 130656 0
+61 0393427000
Fax 130656 0
Email 130656 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: We will delete all data after five years.



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
No additional documents have been identified.