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Trial registered on ANZCTR


Registration number
ACTRN12610000164099
Ethics application status
Approved
Date submitted
12/02/2010
Date registered
19/02/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a specialised multidisciplinary consultation team to improve the outcomes of patients with recent onset spinal cord injury in acute hospital
Scientific title
A randomised controlled trial of a specialised multidisciplinary consultation team to improve the outcomes of patients with recent onset spinal cord injury in acute hospital
Secondary ID [1] 1420 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recent onset spinal cord injury 256813 0
Condition category
Condition code
Neurological 256965 256965 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a specialised multidisciplinary consultation team from the Spinal Rehabilitation Unit (SRU) at Caulfield Hospital (CH), Melbourne, Australia. The team will include a rehabilitation medicine doctor, physiotherapy and occupational therapy personnel with expertise in spinal cord injury (SCI) rehabilitation. The team will function as a mobile unit, assessing and reviewing SCI patients in acute hospitals. The physiotherapist and occupational therapist will see the patient for an initial focused assessment, jointly where practical. They will provide the patient and acute hospital treating team with patient-specific written and verbal advice, as relevant and appropriate, to optimise the patients’ care and outcomes. Self-care equipment and exercise equipment may also be provided to patients (with education on correct use) where indicated. The acute hospital nursing and allied health staff working with the patient will be engaged throughout the intervention process with the members of the specialised multidisciplinary consultation team. These efforts will be directed at trying to help improve patients’ independence and regain their ability to perform activities affected by their SCI, prevent SCI-related complications, and start specialist SCI rehabilitation strategies sooner than would otherwise be possible. It will be suggested that the recommendations made by the specialised multidisciplinary consultation team be incorporated into the patients existing program in the acute hospital.

The patients’ status will be monitored and reviewed by a telephone call to the SCI patients treating acute hospital nursing or allied health team by at least one member of the specialised multidisciplinary consultation team within a week of initial assessment. All patients would have a direct medical review by one of the medical members of the team 7-10 days after the initial medical assessment and an allied health review (by either or both the physiotherapist and occupational therapist) within 7-10 days of the initial allied health review. Further direct reviews will occur 7-10 days after the second visit if clinically indicated and if the patient has not yet been admitted to the SRU.

The duration of the intervention will be over the time after randomisation that the participant is in acute hospital, until admission to the SRU. It is not possible to state exactly what this duration will be, but it is anticipated that the expected duration will be about 1-6 weeks.

For practical purposes, the study will limit inclusion to the 4 closest acute hospitals that refer the majority of SCI patients to the SRU at Caulfield Hospital, as listed above.

The allied health members of the Consultation Team will all be qualified practitioners in their field and employed at Caulfield Hospital. Application for establishment of Honorary appointments will be made to the participating sites where consultation team members are not employed.
Intervention code [1] 256020 0
Rehabilitation
Comparator / control treatment
When patients are referred by acute hospitals for consideration of admission to the SRU at Caulfield Hospital, including the sites chosen for this project, the Unit Head (Principal Investigator) or Rehabilitation Registrar assesses them at the acute hospital, usually within 2 working days. During this consultation, advice and recommendations on a range of SCI-related issues are provided to the patient and acute treating team. Follow-up reviews occur as needed, but are generally infrequent once the patient is accepted as ready for admission to rehabilitation. Due to staffing constraints, only on extremely rare occasions in the past has there been clinical involvement of non-medical members of the SRU (ie. allied health or nursing personnel) with SCI patients in acute hospital.

The Registrars who rotate into the SRU and assess patients in acute hospitals are always doctors who are Registered Medical Practitioners in Victoria and Advanced Trainees with the Australasian Faculty of Rehabilitation Medicine (Royal Australasian College of Physicians). The Registrar is provided with training and mentoring by the Principal Investigator in key aspects of SCI patient management and care to help provide the most appropriate recommendations to the patient and acute hospital team.

Patients in the control group will remain on the waiting list and their status in the project will be blinded to the staff that co-ordinate and manage the waiting list and administrative aspect of the admission of patients to the SRU.

The control group participants will be a waitlist control until they are transferred to the SRU. When they are admitted to the SRU the follow-up assessments will be performed and they will receive the same care as the participants. It will not be possible to give the control group the intervention in a cross-over methodology due to the nature of the project.
Control group
Active

Outcomes
Primary outcome [1] 257846 0
The primary study hypothesis is that patients seen by a specialised multidisciplinary consultation team would have an improved ability to manage everyday tasks typically affected by SCI on admission to rehabilitation, compared with patients in the control group.

The patients ability to manage everyday tasks typically affected by SCI, as measured using the Functional Independence Measure (FIM).

Assuming P=0.05, the study needs a sample size of 72 to have a power of 80% where the standard deviation is 15, to detect a 10 point difference in the ability of patients measured on the motor subscale of the FIM, on admission to the SRU for patients seen by the consultation team, compared to those in the control group. The FIM raw scores in the motor subscales will be converted by Rasch analysis using a previously reported method to a linear score on a 100-point scale with equal intervals, so that assessment of change using parametric analysis could be performed.
Timepoint [1] 257846 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [1] 263275 0
quality of life measured using the 0 - 10 Visual Analogue Scale from the European Quality of life-5D instrument
Timepoint [1] 263275 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [2] 263276 0
Anxiety or depression measured using the Hospital Anxiety and Depression Scale
Timepoint [2] 263276 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [3] 263277 0
The patients perception of their ability of to deal with the consequences of their SCI measured using a 0 - 10 Visual analogue scale
Timepoint [3] 263277 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [4] 263278 0
Tthe patients ability to manage everyday tasks typically affected by SCI, as measured using the Spinal Cord Independence Measure (SCIM)
Timepoint [4] 263278 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [5] 263279 0
Quality of life measured using the World Health Organization Quality of Life Assessment Instrument (WHOQOL)-Bref.
Timepoint [5] 263279 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [6] 263280 0
pain intensity measured using a 0 -10 Visual Analogue Scale
Timepoint [6] 263280 0
At baseline and admission to the Spinal Rehabilitation Unit
Secondary outcome [7] 263281 0
The occuarance of a pelvic region pressure ulcer.
Timepoint [7] 263281 0
At baseline and admission to the Spinal Rehabilitation Unit

Eligibility
Key inclusion criteria
Only patients with a recent onset SCI will be eligible for inclusion. The onset of the SCI could occur either as a result of illness or trauma that led to hospitalisation, or developed during a hospital admission of another condition. Patients with either non-traumatic spinal cord injury or traumatic spinal cord injury will be included.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if either of the following apply, they:
Have an established SCI that existed before presentation at hospital or
Have an acquired brain injury, either pre-existing or related to their SCI, or other cognitive problems such as dementia that may impact upon their ability to learn complex information and provide informed consent.
Are unable to provide informed consent and read the patient-specific information due to their level of English comprehension.
Have an established pelvic region pressure ulcer at time of enrolment (as this will limit the ability of the patient to participate fully in the interventions offered by the team and assessed by the primary outcome measure)
Have a complete tetraplegia at the eighth cervical spinal cord level or above

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following the usual assessment and consultation by the assessing rehabilitation doctor, when a patient who meets the inclusion criteria is deemed appropriate for admission to the SRU, and they are medically stable, they will be invited to participate in the trial. If the patient indicates interest in participation, they will be given a copy of information about the trial by the assessing doctor. Within 6 days of the patient being accepted as ready for admission to the SRU, a research assistant will visit the patient. After the project has been fully explained and any questions have been answered, participants will be asked to provide written consent. Patients who agree to participate will then complete the baseline measures.

After consenting patients have been waiting for admission to the SRU at Caulfield Hospital for 6 days or more they will be randomly allocated to either the intervention or control group. This is to target the intervention towards patients with the perceived greatest likelihood of benefit, which are those who wait in an acute hospital for a rehabilitation bed for a longer period of time. It is acknowledged that data will be collected on patients who will not be enrolled in the trial. Due to resource constraints this is a necessary compromise. It is envisaged that this information will be used for a separate outcomes research report.

The allocation process ensures that both the patient and the research assistant will remain blinded to group allocation at baseline. A research assistant will perform the re-assessment of patients enrolled in the trial on admission to the SRU and will also be blinded to group allocation. Notification to the research assistant will be made by either the Registrar or the Consultant (principal investigator).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomisation design will be used, with stratification by site. The random allocation sequence will be generated by one of the associate investigators (Dr Terry Haines) who will not be involved in any patient contact using a computerised random number generator. Permuted blocks of size 4, 6 and 8 participants will be selected randomly using a random number generator to construct the allocation sequence. This sequence will then be placed into sealed, consecutively numbered, opaque envelopes. These envelopes will be kept in a locked filing cabinet in the office of the physiotherapist who will open the envelopes in order of participant recruitment. The random allocation sequence will not be revealed to research nurses conducting the baseline or follow-up assessments and will only be opened by the research physiotherapists upon notification of completion of the baseline assessment by the research nurses.
Masking / blinding
Blinded (masking 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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
30/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2593 0
3162
Recruitment postcode(s) [2] 2594 0
3168
Recruitment postcode(s) [3] 2595 0
3144
Recruitment postcode(s) [4] 2596 0
3000
Recruitment postcode(s) [5] 2597 0
3181

Funding & Sponsors
Funding source category [1] 256517 0
Hospital
Name [1] 256517 0
Caulfield Hospital
Country [1] 256517 0
Australia
Funding source category [2] 256518 0
Charities/Societies/Foundations
Name [2] 256518 0
Royal Australasian College of Physicians
Country [2] 256518 0
Australia
Primary sponsor type
Individual
Name
Dr Peter New
Address
Head, Spinal Rehabilitation Unit
Caulfield Hospital
260 Kooyong Rd
Caulfield 3161
VICTORIA
Country
Australia
Secondary sponsor category [1] 255826 0
Individual
Name [1] 255826 0
Karen Roberts
Address [1] 255826 0
Caulfield Hospital
260 Kooyong Rd
Caulfield 3161
VICTORIA
Country [1] 255826 0
Australia
Secondary sponsor category [2] 255827 0
Individual
Name [2] 255827 0
Rodney Sturt
Address [2] 255827 0
Caulfield Hospital
260 Kooyong Rd
Caulfield 3161
VICTORIA
Country [2] 255827 0
Australia
Secondary sponsor category [3] 255828 0
Individual
Name [3] 255828 0
Dr Terrance Haines
Address [3] 255828 0
Kingston Centre
Warrigal Rd
Cheltenham 3192
VICTORIA
Country [3] 255828 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258563 0
Alfred Health Human Reserach and Ethics Committee
Ethics committee address [1] 258563 0
Ethics committee country [1] 258563 0
Australia
Date submitted for ethics approval [1] 258563 0
16/11/2009
Approval date [1] 258563 0
22/12/2009
Ethics approval number [1] 258563 0
423/09
Ethics committee name [2] 258564 0
Southern Health Human Research and Ethics Committee
Ethics committee address [2] 258564 0
Ethics committee country [2] 258564 0
Australia
Date submitted for ethics approval [2] 258564 0
16/11/2009
Approval date [2] 258564 0
03/03/2010
Ethics approval number [2] 258564 0
09342B
Ethics committee name [3] 258565 0
Cabrini Human Research Ethics Committee
Ethics committee address [3] 258565 0
Ethics committee country [3] 258565 0
Australia
Date submitted for ethics approval [3] 258565 0
18/11/2009
Approval date [3] 258565 0
07/04/2010
Ethics approval number [3] 258565 0
05-07-12-09
Ethics committee name [4] 258566 0
Royal Melbourne Hospital
Ethics committee address [4] 258566 0
Ethics committee country [4] 258566 0
Australia
Date submitted for ethics approval [4] 258566 0
01/03/2010
Approval date [4] 258566 0
Ethics approval number [4] 258566 0

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

Contacts
Principal investigator
Name 30844 0
Address 30844 0
Country 30844 0
Phone 30844 0
Fax 30844 0
Email 30844 0
Contact person for public queries
Name 14091 0
Dr Peter New
Address 14091 0
Spinal Rehabilitation Unit
Caulfield Hospital
260 Kooyong Rd
Caulfield
VICTORIA 3162
Country 14091 0
Australia
Phone 14091 0
61-03-9076 6000
Fax 14091 0
Email 14091 0
p.new@cgmc.org.au
Contact person for scientific queries
Name 5019 0
Dr Peter New
Address 5019 0
Spinal Rehabilitation Unit
Caulfield Hospital
260 Kooyong Rd
Caulfield
VICTORIA 3162
Country 5019 0
Australia
Phone 5019 0
61-03-9076 6000
Fax 5019 0
Email 5019 0
p.new@cgmc.org.au

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

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