Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000894897
Ethics application status
Approved
Date submitted
27/07/2012
Date registered
22/08/2012
Date last updated
22/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short Multi -disciplinary Acute Rehabilitation Team (SMART) to acute care
Scientific title
Randomized Controlled Trial of a short multi-disciplinary acute rehabilitation team (SMART) to acute care-identifying whether the provision of an acute rehabilitation program to acute care is better in relation to patient and process outcomes than standard care.
Secondary ID [1] 280919 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
functional decline due to injury or illness 287002 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287334 287334 0 0
Other physical medicine / rehabilitation
Public Health 287493 287493 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a multidisciplinary rehabilitation program consisting of rehabilitation medicine, occupational therapy and physiotherapy.
Twice daily therapy with one group therapy session and one individual therapy session as well as three weekly case conferences to discuss the rehabilitation as well as discharge plan.
Rehabilitation medicine component provides coordination and medical review of rehabilitation program for each patient.
Daily group therapy session; duration 45-60 minutes (dependent on the length of time patient takes to perform activities and number of patients in the group); maximum of 7 total sessions per patient. Facilitated by Occupational therapist (OT), Physiotherapist (PT) and allied health assistant (OT and PT are part of investigational team).The execution of the sessions is aided by an allied health assistant, who is not a member of the investigative team.
Daily individual treatment sessions provided by PT in addition to the group session and OT intervention as indicated by individual patient needs. Duration 30minutes with a total 7 sessions per patient.
Occupational Therapy provides assessment and treatment of deficits in activity performance and participation. Treatment is individualized to specific patient needs and may included such things as dressing retraining or energy conservation. Treatment includes an ADL activity practice component in the daily group therapy session.
Physiotherapy provides assessment and treatment of of deficits in activity performance and participation. The treatment is individualized to specific patient needs but will include balance, strengthening and gait retraining during the group session. Individual treatment sessions are comprised of gait retraining, mobility assessment, stair practice and general strengthening. A individual exercise program is provided to each patient to perform independently.
Intervention code [1] 285355 0
Rehabilitation
Comparator / control treatment
Provision of standard care which involves physiotherapy treatment and occupational therapy treatment as directed by the treating team. Patient receive one individual physiotherapy session daily, which may include mobility practice, stair practice or strengthening exercises. Length of session varies from 10-15 minutes (dependent on therapist judgement).
Occupational therapy assessment and treatment is initiated by the treating team and usually involves assessment and discharge planning, equipment prescription and home visits as needed. Length of session will be individualized to patient requirements. Discharge planning by treating team. Most patients will be referred to inpatient subacute rehabilitation. Standard treatment is coordinated by different groups in different wards and patients get various levels of therapy (nil occupational therapy, physiotherapy treatment daily or second daily) waiting for a subacute rehabilitation bed.
Control group
Active

Outcomes
Primary outcome [1] 287607 0
Length of stay in acute care as measured by hospital data system HIE, electronic patient record will be accessed to identify total length of stay for patient in acute ward .
Timepoint [1] 287607 0
discharge from Royal North Shore Hospital acute ward
Secondary outcome [1] 298524 0
Functional Improvement
Timepoint [1] 298524 0
Timed up and go and Functional Independence Measure conducted at admission to study and at 7 days of treatment or at discharge if earlier than 7 days.

Eligibility
Key inclusion criteria
Adult Inpatient in acute ward at RNSH
Patients admitted under the care of a medical or surgical specialty
Medically stable
Having Identified rehab goals
Willing to participate in program
Provision of written informed consent
Assessed to be suitable for discharge from hospital within 7 days
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children
Patients assessed as requiring >7 days of inpatient rehabilitation in sub-acute care
Unwilling to participate in rehabilitation program
Unwilling to provide written informed consent

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)
Rehabilitation Coordinator will receive referrals via email, pager, phone or in ward meetings from allied health, nursing or medical teams. Patients will then be screened by the rehabilitation coordinator or rehab physician as to their suitablility to SMART in acordance to standing SMART inclusion criteria.
Recruitment:
All patients referred to the SMART program will be considered potential participants.Once identified as suitable for SMART the research project officer will be visiting the patient to recruit patients and complete baseline data collection (FIM, TUG, MMSE)

ENROLMENT PROCEDURE
The participant will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The physcian or coordinator enrolling the patient are unaware, when this decision is made, to which group the patient will be allocated. Central Randomization schedule is performed via computer by staff affiliated with the northern sydney clinical school and provided to investagatory team in sealed opaque envelopes at central administration site.
The participant will receive a study enrolment number and this will be documented in the participant’s medical record and on all study documents.
INFORMED CONSENT PROCESS
Written informed consent will be gained from the potential participant during the recruitment process. The research project officer will provide written and verbal information on the study and obtain consent from participant or his/her guardian as appropriate. The patient will be provided with a copy of the signed consent form and the original consent form will be kept in the researchers department.
For participants with an appointed guardian/enduring guardian written informed consent will be obtained from the legally appointed person.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
RANDOMISATION PROCEDURE
Randomization will be computer generated .
The participant will be randomized prior to move to ward 8D after they have met the inclusion criteria and provided consent to study. At that point in time the participant will be randomised to Intervention group or Control group, and receive a Randomisation Number allocated by a computer.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
24/07/2012
Actual
20/07/2012
Date of last participant enrolment
Anticipated
Actual
6/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285703 0
Commercial sector/Industry
Name [1] 285703 0
Ramsay Healthcare allied health research awards
Country [1] 285703 0
Australia
Primary sponsor type
Individual
Name
Anna Butcher
Address
Department of Rehabilitation Medicine Royal North Shore Hospital
Level 4B Clinical Administration
Reserve Road St. Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 284531 0
Individual
Name [1] 284531 0
A/Prof. Stephen Wilson
Address [1] 284531 0
Department of Rehabilitation Medicine Royal North Shore Hospital
Level 4B Clinical Administration
Reserve Road St. Leonards NSW 2065
Country [1] 284531 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287702 0
Northern Sydney coast Human Research ethics Committee (EC00112)
Ethics committee address [1] 287702 0
Ethics committee country [1] 287702 0
Australia
Date submitted for ethics approval [1] 287702 0
Approval date [1] 287702 0
07/06/2012
Ethics approval number [1] 287702 0
1203-100M

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

Contacts
Principal investigator
Name 34491 0
Mrs Anna Butcher
Address 34491 0
Department of Rehabilitation Medicine Royal North Shore Hospital
Level 4B Clinical Administration
Reserve Road St. Leonards NSW 2065
Country 34491 0
Australia
Phone 34491 0
+61 2 9463 2467
Fax 34491 0
+61 2 9463 2041
Email 34491 0
[email protected]
Contact person for public queries
Name 17738 0
Anna Butcher
Address 17738 0
Department of Rehabilitation Medicine Royal North Shore Hospital
Level 4B Clinical Administration
Reserve Road St. Leonards NSW 2065
Country 17738 0
Australia
Phone 17738 0
+61 (02) 9463 2467
Fax 17738 0
+61 (02) 9463 2041
Email 17738 0
[email protected]
Contact person for scientific queries
Name 8666 0
A/Prof. Stephen Wilson
Address 8666 0
Department of Rehabilitation Medicine Royal North Shore Hospital
Level 4B Clinical Administration
Reserve Road St. Leonards NSW 2065
Country 8666 0
Australia
Phone 8666 0
+61 (02) 9463 2466
Fax 8666 0
+61 (02) 9463 2041
Email 8666 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.