Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000859088
Ethics application status
Approved
Date submitted
12/08/2010
Date registered
14/10/2010
Date last updated
5/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy and acceptability of independent and peer-assisted models of clinical education for undergraduate physiotherapy students and physiotherapy clinical educators; a step toward national best practice.
Scientific title
The efficacy and acceptability of independent and peer-assisted models of clinical education for undergraduate physiotherapy students and physiotherapy clinical educators; a step toward national best practice.
Secondary ID [1] 252431 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical education 257943 0
Public Health 258188 0
Health promotion/education 258189 0
Condition category
Condition code
Other 258110 258110 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Peer-assisted Learning:
Students will complete learning activities in pairs, including assessment and management of patients, reflective processes and supervised sessions.
Learning will take place in the clinical environment, 31 hours per week for 5 weeks.
Each student will undertake 1 intervention for 5 weeks then cross over to the alternate intervention for another 5 weeks. There will be a 3 day washout period between the two interventions.
Intervention code [1] 256998 0
Behaviour
Comparator / control treatment
Independent Learning:
Students will complete all learning activities as individuals, including assessment and management of patients, reflective processes and supervised sessions.
Learning will take place in the clinical environment, 31 hours per week for 5 weeks.
Each student will undertake 1 intervention for 5 weeks then cross over to the alternate intervention for another 5 weeks. There will be a 3 day washout period between the two interventions.
Control group
Active

Outcomes
Primary outcome [1] 258974 0
Clinical Grades
Timepoint [1] 258974 0
End of Placement (week 5)
Secondary outcome [1] 265159 0
Student satisfaction measured by a questionnaire.
Timepoint [1] 265159 0
End of placement (week 5)
Secondary outcome [2] 265160 0
Clinical educator satisfaction measured by a questionnaire.
Timepoint [2] 265160 0
End of placement (week 5)
Secondary outcome [3] 265161 0
Efficiency (number of patients seen) using statistics from the healthcare service.
Timepoint [3] 265161 0
End of placement (week 5)
Secondary outcome [4] 265163 0
Incidence of student request for University learning assistance and wellbeing support using University department records.
Timepoint [4] 265163 0
end of placement (week 5)

Eligibility
Key inclusion criteria
year 3 Monash University undergraduate physiotherapy students on placement at Southern Health, and their clinical educators
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
students from other year levels
students allocated to other clinical placement networks
students who do not consent

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)
The person allocating students to their clinical school and this enrolling them in the trial is unaware of the research aims and group allocations. The actual allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Students who are allocated to the Southern Physiotherapy Clinical-School will be enrolled in the study. Each subject will receive five weeks of clinical education in the intervention phase, five weeks of clinical education in the control phase and a further five weeks which is not involved in the study. All the participants receive both interventions in different sequences. Students will be randomly allocated to pairs by a computer system at the University which matches students to their site preferences for clinical education. Pairs will be randomly allocated to starting positions using computer generated randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Students and educators cannot be blinded to the intervention. Blinded assessors will be used in addition to educator grades.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
6/06/2011
Date of last participant enrolment
Anticipated
30/09/2011
Actual
30/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2401 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 2402 0
Dandenong Hospital - Dandenong
Recruitment hospital [3] 2403 0
Kingston Centre - Cheltenham
Recruitment hospital [4] 2404 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 3136 0
3168

Funding & Sponsors
Funding source category [1] 257448 0
Self funded/Unfunded
Name [1] 257448 0
Country [1] 257448 0
Primary sponsor type
Hospital
Name
Southern Health
Address
246 Clayton Rd
Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 256678 0
University
Name [1] 256678 0
Monash University
Address [1] 256678 0
Peninsula Campus
McMahons Rd
Frankston, Victoria 3199
Country [1] 256678 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259475 0
Southern Health HREC
Ethics committee address [1] 259475 0
Ethics committee country [1] 259475 0
Date submitted for ethics approval [1] 259475 0
02/03/2011
Approval date [1] 259475 0
04/04/2011
Ethics approval number [1] 259475 0

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

Contacts
Principal investigator
Name 31514 0
Mrs Samantha Sevenhuysen
Address 31514 0
Casey Hospital
Locked Bag 3000
Hallam Victoria 3803
Country 31514 0
Australia
Phone 31514 0
+61417050815
Fax 31514 0
Email 31514 0
sam.sevenhuysen@monashhealth.org
Contact person for public queries
Name 14761 0
Samantha Sevenhuysen
Address 14761 0
Southern Health
Casey Hospital
Allied Health
Locked Bag 3000
Hallam, Victoria 3803
Country 14761 0
Australia
Phone 14761 0
+61404041653
Fax 14761 0
Email 14761 0
Sam.Sevenhuysen@southernhealth.org.au
Contact person for scientific queries
Name 5689 0
Samantha Sevenhuysen
Address 5689 0
Southern Health
Casey Hospital
Allied Health
Locked Bag 3000
Hallam, Victoria 3803
Country 5689 0
Australia
Phone 5689 0
+614404041653
Fax 5689 0
Email 5689 0
Sam.Sevenhuysen@southernhealth.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.