Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000257460
Ethics application status
Approved
Date submitted
16/12/2015
Date registered
24/02/2016
Date last updated
24/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised control trial of early rehabilitation and follow up model of care at an Australian major trauma centre
Scientific title
Efficacy of an early rehabilitation post discharge follow-up model for trauma patients at an Australian major trauma centre: A randomised control trial.
Secondary ID [1] 288177 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injury 297079 0
Condition category
Condition code
Public Health 297314 297314 0 0
Health service research
Injuries and Accidents 297480 297480 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in randomised to the intervention arm will be followed up within 2 weeks of hospital discharge using a single visit follow up clinic staffed by the Trauma Clinical Nurse Consultant Physiotherapist, Mental Health Nurse Practitioner and Trauma Surgery Registrar. The clinic will be conducted within the hospital at a designated consultation room within the Emergency Department. The clinic will review patient progress and make referrals to social work, physiotherapists and Mental Health Nurse Practitioners working within ED if required. Referrals to Mental Health services from the trauma follow up clinic will be based on results of screening tests (Kessler-6 scale) which is routinely used by Mental Health Services at RPAH. Patients will also undertake post traumatic amnesia screening tests and be referred to appropriate outpatient services if found to be positive. Patients will undertake these screening surveys in person at the time of follow up clinic appointment.
Intervention code [1] 293475 0
Rehabilitation
Comparator / control treatment
Standard follow up procedures including specialist appointments at the discretion of the treating medical team e.g. fracture clinic or follow up with General Practitioner
Control group
Active

Outcomes
Primary outcome [1] 296882 0
Proportion of patients who have returned to employment or previous occupation at 6 months post discharge from hospital. This will be assessed by telephone interview with the participant conducted by a trained research nurse
Timepoint [1] 296882 0
6 months
Secondary outcome [1] 319619 0
Quality of Life - Mental and physical Summary Scores dreived from SF-12 will be measured at 3 and 6 months telephone follow up calls
Timepoint [1] 319619 0
3 and 6 months post discharge from hospital
Secondary outcome [2] 319742 0
Patient satisfaction assessed using a single item 5 point Likert scale conducted at the time of three month follow up telephone interviews
Timepoint [2] 319742 0
3 months post discharge from hospital
Secondary outcome [3] 319909 0
Unplanned representations to hospital - measured through existing routine trauma data collection and trauma registry
Timepoint [3] 319909 0
3 and 6 months post discharge from hospital
Secondary outcome [4] 319910 0
Use of outpatient health services - through patient self report at 3 and 6 month telephone follow up
Timepoint [4] 319910 0
3 and 6 months post discharge from hospital
Secondary outcome [5] 319911 0
Hospital length of stay - through routine trauma registry records
Timepoint [5] 319911 0
at time of discharge from hospital

Eligibility
Key inclusion criteria
Patient population – Patients will be recruited after trauma team activation in ED who satisfy the following:
1. age between 16 and 65 years of age,
2. Presenting with injuries following road trauma (and motorised vehicle, train, pedestrian, cyclist), fall or work-related injury.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions - Patients excluded will be expectant death within 48 hours of admission, severe head injury, severe multisystem injury, patient identified after 48 hours of admission, penetrating injury, assault, self-inflicted injury, pre-existing mental health illness or cognitive impairment, pre-existing diagnosis of drug and alcohol use disorders, residence in an aged care facility, no fixed abode or contact details lack of adequate English speaking family member present at home. Exclusions are based on previous work at this institution that demonstrated poor telephone follow up rates.

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)
Patients will be randomised to either intervention or standard of care arms using a computer generated number sequence and sealed envelope system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline descriptive statistics for the study population will be presented in tabular form. The primary outcome will be analysed using chi square tests and repeated measures logistic regression. SF12 scores will be converted to Mental and Physical Component scores and normalised using available Australian norms. Repeated measures will be compared using repeated measures mixed modelling. The anticipated sample size during the initial one year study pilot period will be around 250 patients based on the inclusion criteria and current trauma admission characteristics at this hospital. Assuming 200 patients are recruited, this will provide an 80% power of detecting a 20% difference (45% to 65%) in return to work or previous occupation at 6 months. Analysis will be by intention to treat – in the context of this study, control patients who request and receive early rehabilitation assessment independent of this study will still be analysed as a control patient.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/11/2015
Date of last participant enrolment
Anticipated
24/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4982 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 12467 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 292574 0
Hospital
Name [1] 292574 0
Royal Prince Alfred Hospital
Country [1] 292574 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 291296 0
None
Name [1] 291296 0
na
Address [1] 291296 0
na
Country [1] 291296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294054 0
Sydney Local Health District Ethics Committee (RPA zone)
Ethics committee address [1] 294054 0
Ethics committee country [1] 294054 0
Date submitted for ethics approval [1] 294054 0
21/01/2015
Approval date [1] 294054 0
15/04/2015
Ethics approval number [1] 294054 0
PROTOCOL X13-0265 & HREC/13/RPAH/347

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

Contacts
Principal investigator
Name 62254 0
A/Prof Michael Dinh
Address 62254 0
Emergency Department
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 62254 0
Australia
Phone 62254 0
+61 2 9515 6111
Fax 62254 0
Email 62254 0
[email protected]
Contact person for public queries
Name 62255 0
Kevin Cornwall
Address 62255 0
Trauma Unit
Level 10
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 62255 0
Australia
Phone 62255 0
+61 2 9515 6111
Fax 62255 0
Email 62255 0
[email protected]
Contact person for scientific queries
Name 62256 0
Michael Dinh
Address 62256 0
Royal Prince Alfred Hospital
Missenden Road Camperdown NSW 2050
Country 62256 0
Australia
Phone 62256 0
+61 2 9515 6111
Fax 62256 0
Email 62256 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
No additional documents have been identified.