Trial from ANZCTR


Trial ID ACTRN12609000973213
Trial Status: Registered
Date Submitted: 10/11/2009
Date Registered: 11/11/2009
Prospectively registered

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Public title Do additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes?
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Does providing additional allied health services for inpatients receiving rehabilitation result in a reduced lenth of stay without compromising patient outcomes compared with inpatients receiving standard rehabilitation services?
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Secondary ID [1] 262728 0
ID2
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Health conditions will include conditions of patients admitted for rehabilitation. From our pilot data we expect the most common health conditions to be stroke and hip fracture. 252161 0
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Condition category: Condition code:
Physical Medicine / Rehabilitation Physiotherapy
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252363 252363 0 0
Physical Medicine / Rehabilitation Occupational therapy
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252364 252364 0 0
Stroke Ischaemic
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252365 252365 0 0

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Descriptions of intervention(s) / exposure The experimental group will receive standard rehabilitation from Monday to Friday, plus an additional one hour of physiotherapy and one hour of occupational therapy on Saturday, until discharge from hospital.
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Intervention Code:
Rehabilitation 241530 0
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Comparator / control treatment The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday, until discharge from hospital.
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Control group Active
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Primary Outcome: Patient length of stay defined as the number of overnight stays in the rehabilitation unit from the day of admission until the day of discharge from the unit. 253234 0
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Timepoint: At discharge 253234 0
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Primary Outcome: Quality of life assessed with the EuroQol questionnaire 253235 0
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Timepoint: Admission, Discharge, 6 months post discharge, 12 months post discharge 253235 0
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Primary Outcome: Functional status will be assessed with the Functional Independence Measure (FIM) 253236 0
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Timepoint: Admission, Discharge, 6 months post discharge, 12 months post discharge 253236 0
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Primary Outcome: Health service utilisation and costs will be assessed with a health service utilisation questionnaire, and accessing cost data from the rehabilitation facility and Medicare Australia 253237 0
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Timepoint: Admission, Discharge, 6 months post discharge, 12 months post discharge 253237 0
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Primary Outcome: Activity levels will be assessed with the ActivPAL (uniaxial accelerometer based activity monitor) for steps, energy expenditure and time upright on a subgroup of rehabilitation patients admitted with a lower limb orthopaedic diagnosis 269326 0
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Timepoint: Prior to discharge from rehabilitation 269326 0
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Secondary Outcome: Walking speed will be assessed with the 10 metre walk test 262194 0
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Timepoint: Admission, Discharge 262194 0
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Secondary Outcome: Mobility will be assessed with the timed up and go test 262195 0
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Timepoint: Admission, Discharge 262195 0
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Secondary Outcome: Personal Care Participation Assessment and Resource Tool (PC-PART) 262198 0
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Timepoint: Admission, discharge 262198 0
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Secondary Outcome: Movement, arm function, hand function, walking, and sitting balance in patients with a neurological diagnosis will be assessed with The Modified Motor Assessment scale 262199 0
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Timepoint: Admission, discharge 262199 0
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Secondary Outcome: Discharge destination, either home, low level residential care, high level residential care, acute hospital transfer 262200 0
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Timepoint: Discharge 262200 0
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Key inclusion criteria 1. Aged 18 years or older
2. Have been admitted for rehabilitation at The Angliss Hospital or Peter James Centre
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria 1. If admitted for geriatric evaluation and management
2. If they or their next of kin do not give informed consent to participate
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Sequentially numbered opaque envelopes
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Permuted block randomisation stratified for site and casemix (neurological and other) generated by computerised sequence generation.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/05/2010
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Date of first participant enrolment 1/07/2010
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Anticipated date last participant recruited/enrolled 30/12/2011
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Actual date last participant recruited/enrolled 30/06/2011
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Target sample size 712
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Postcode: 3128 2209 0
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Postcode: 3156 2210 0
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Postcode: 3131 2211 0
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Recruitment outside Australia

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Funding Source: Government body 244000 0
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Name: National Health and Medical Research Council 244000 0
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Address: GPO Box 1421
Canberra
ACT
2601
244000 0
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Country: Australia 244000 0
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Primary Sponsor Individual
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Name: Nicholas Taylor
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Address: School of Physiotherapy
La Trobe University
Bundoora
Victoria
3086
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Country: Australia
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Secondary Sponsor: Individual 251352 0
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Name: Natasha Brusco 251352 0
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Address: Angliss Hospital
Albert Street
Upper Ferntree Gully
Victoria
3156
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Country: Australia 251352 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: La Trobe University Human Ethics Committee 244105 0
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Address: Human Ethics Committee
La Trobe University
Bundoora
Victoria
3086
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Country: Australia 244105 0
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Approval Date: 16/06/2010 244105 0
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Submitted Date: 01/12/2009 244105 0
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HREC: FHEC 10/14 244105 0
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Ethics Committee name: Eastern Health Research and Ethics 244106 0
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Address: Level 3/5 Arnold Street
Box Hill
Victoria
3128
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Country: Australia 244106 0
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Approval Date: 08/06/2010 244106 0
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Submitted Date: 23/11/2009 244106 0
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HREC: E58/0910 244106 0
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Brief summary This trial will examine if providing additional therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service.
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Trial website
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Trial related presentations / publications Taylor NF, Brusco NK, Watts JW, Shields N, Peiris C, Sullivan N, Kennedy G, Teo CK, Farley A, Lockwood K, Radia-George C. 2010. A study protocol of a randomised controlled trial incorporating a health economic analysis to investigate if additional allied health services for rehabilitation reduce length of stay without compromising patient outcomes. BMC Health Services Research 10(1): 308.

Peiris CL, Shields N, Brusco NK, Watts JJ, Taylor NF. 2013. Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomized controlled trial. BMC Medicine 11:198.

Peiris CL, Taylor NF, Shields N. 2013. Patients receiving inpatient rehabilitation for lower limb orthopaedic conditions do much less physical activity than recommended in guidelines for healthy older adults: an observational study. Journal of Physiotherapy 59:39-44.

Peiris CL, Taylor NF, Shields N. 2012. Patients value patient-therapist interactions more than the amount or content of therapy during inpatient rehabilitation: a qualitative study. Journal of Physiotherapy 58:261-268.

Peiris CL, Taylor NF, Shields N. 2012. Additional Saturday allied health services increase habitual physical activity among patients receiving inpatient rehabilitation for lower limb orthopedic conditions: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation 93: 1365-1370.

Peiris CL, Taylor NF, Shields N. 2011. Extra physical therapy reduces patient length of stay and improves functional outcomes and quality of life in people with acute or sub-acute conditions: a systematic review. Archives of Physical Medicine and Rehabilitation 92(9): 1490-1500.

(updated 11/12/2013)
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Public Notes
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Principal Investigator
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Name: Nicholas Taylor
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Address: Department of Physiotherapy La Trobe University Bundoora Victoria 3086
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Country: Australia
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Tel: 61 3 9479 5860
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Email: N.Taylor@latrobe.edu.au
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Contact person for public queries
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Name: Nicholas Taylor
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Address: School of Physiotherapy La Trobe University Bundoora Victoria 3086
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Contact person for scientific queries
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Name: Nicholas Taylor
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Address: School of Physiotherapy La Trobe University Bundoora Victoria 3086
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Contact person responsible for updating information
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Name: Nicholas Taylor
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Address: School of Physiotherapy La Trobe University Bundoora Victoria 3086
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Tel: 61 3 94795860
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Email: N.Taylor@latrobe.edu.au
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Addition Cancer fields
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