Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000203752
Ethics application status
Approved
Date submitted
18/02/2013
Date registered
20/02/2013
Date last updated
20/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute Rehabilitation Initiative: A randomised controlled trial in early inpatient rehabilitation for patients hospitalised after road accidents.
Scientific title
Early inpatient rehabilitation for patients hospitalised after road accidents in reducing hospital length of stay
Secondary ID [1] 281977 0
Nil
Universal Trial Number (UTN)
Trial acronym
ARI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients admitted after road accidents 288406 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288754 288754 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 288768 288768 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Involvement of a mobile rehabilitation team consisting of at least physio, occupational therapy and social worker and rehabilitation medicine physician. This team provides early multidipsciplinary assessment, adequate intensity of therapy (1-2 hours per day), and weekly case conferencing. They will provide rehabilitation interventions in parallel care with trauma/surgical team for the duration of the acute hospital stay. Patients are monitored as soon as they are admitted by the research assistant and approached for consent. Once the patient consents, early multidisicplinary rehabilitation assessment will take place within 24 hours (or 3 days if on a weekend) or as soon as he/she is discharged from intensive care.
Intervention code [1] 286548 0
Rehabilitation
Intervention code [2] 286549 0
Early detection / Screening
Comparator / control treatment
Standard care - standard ward allied health interventions
Control group
Active

Outcomes
Primary outcome [1] 288894 0
Decrease in total hospital length of stay (acute and rehabilitation)
Timepoint [1] 288894 0
Discharge from hospital
Secondary outcome [1] 301255 0
Return to work or usual activity
Timepoint [1] 301255 0
3 months after mild/moderate trauma 6 months after severe/critical trauma
Secondary outcome [2] 301302 0
Functional outcome as measured by FIM & Bartel Index
Timepoint [2] 301302 0
3 months after mild/moderate trauma 6 months after severe/critical trauma
Secondary outcome [3] 301303 0
Psychological outcome as measured by DASS 21 and PC-PTSD
Timepoint [3] 301303 0
3 months after mild/moderate trauma 6 months after severe/critical trauma
Secondary outcome [4] 301304 0
Alcohol usage - screened with CAGE questionnaire
Timepoint [4] 301304 0
3 months after mild/moderate trauma 6 months after severe/critical trauma
Secondary outcome [5] 301305 0
QOL as measured by SF-12 v2
Timepoint [5] 301305 0
3 months after mild/moderate trauma 6 months after severe/critical trauma

Eligibility
Key inclusion criteria
People admitted to an Acute Hospital as a result of injuries sustained in a road crash on a NSW public road. This includes all vehicle occupants, motorcyclists, cyclists and pedestrians.
Aged over 18.
Willingness to give written or oral informed consent by the person or the person responsible.
Having been cleared by their treating medical/surgical team as being medically/surgically stable for the purposes of being approached by the research coordinator to obtain consent from either the person or in the event of being in Post Traumatic Amnesia, the person responsible.
LOS 5 days or more.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admitted to palliative care ward
Admitted to an acute psychiatric ward (unable to follow instructions)
Severe deafness and unable to carry out a phone interview
Those without a phone or access to one
Overseas tourists leaving Australia to complete and/or rehabilitation overseas

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)
A multi-site single-blinded stratified randomised controlled trial.
A research assistant screens and consents all eligible patients.
The patient is then allocated by central randomisation by fax.
At each of the 3 sites, patients will be stratified by using the Abbreviated Injury Score (AIS) to obtain the Injury Severity Score into severe or mild/moderate and then randomised to either the intervention or control arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each stratum, randomisation in blocks has been made. The website http://www.graphpad.com/quickcalcs/randomize1.cfm has been used to randomly shuffle numbers from 1 to 30 seven times. This has been repeated twice, once for each stratum. The blocks will ensure even distribution of participants in each of the two arms within the two strata as the proportion of participants in the two stratification is unknown. Odd numbers have been assigned 'intervention' and even numbers 'control'.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286755 0
Government body
Name [1] 286755 0
Motor Accidents Authority NSW
Country [1] 286755 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital
Address
Victoria Rd
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 285535 0
Government body
Name [1] 285535 0
NSW Institute of Trauma and Injury Management
Address [1] 285535 0
Level 4, Sage Building
67 Albert Avenue, Chatswood NSW 2067
Country [1] 285535 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Those randomised to the intervention group will receive the services of a Mobile Rehabilitation team who will deliver rehabilitation services while the participant is admitted to the acute wards. Those randomised to the control group will have usual care. Both groups will be followed up by phone interview at 3 months for those with moderate injury and 6 months for those with severe injury to determine health outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37942 0
A/Prof Steven Faux
Address 37942 0
St. Vincent's Hospital
Department of Rehabilitation
Victoria Rd
Darlinghurst NSW 2010
Country 37942 0
Australia
Phone 37942 0
+61 02 83829516
Fax 37942 0
Email 37942 0
[email protected]
Contact person for public queries
Name 37943 0
Jane Wu
Address 37943 0
St. Vincent's Hospital
Department of Rehabilitation
Victoria Rd
Darlinghurst NSW 2010
Country 37943 0
Australia
Phone 37943 0
+61 02 83829516
Fax 37943 0
Email 37943 0
[email protected]
Contact person for scientific queries
Name 37944 0
Jane Wu
Address 37944 0
St. Vincent's Hospital
Department of Rehabilitation
Victoria Rd
Darlinghurst NSW 2010
Country 37944 0
Australia
Phone 37944 0
+61 02 83829516
Fax 37944 0
Email 37944 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.