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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000165189
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
5/02/2019
Date last updated
1/07/2021
Date data sharing statement initially provided
5/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Allied health use of integrating Science and Practice (iSAP) for case-based learning: Effectiveness for student learning outcomes, staffing and resource efficiency.
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Scientific title
Allied health use of integrating Science and Practice (iSAP) for case-based learning: Effectiveness for student learning outcomes, staffing and resource efficiency.
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Secondary ID [1]
297020
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Nil known
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Universal Trial Number (UTN)
U1111-1226-4319
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neurological conditions
311228
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Cardiac conditions
311229
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Condition category
Condition code
Neurological
309652
309652
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0
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Other neurological disorders
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Cardiovascular
309653
309653
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention of this study is using iSAP cases in Occupational Therapy (OT) and Physiotherapy (PT) curriculum within two selected units in 2nd year, one in undergraduate OT program and one in PT program.
iSAP is a online, case based learning framework that incorporates elements of learning through practice, collaboration and discussion by presenting students with multimedia case studies that simulate real-world practice issues. Participants in group A (groups of 8) will complete two clinical case scenarios specifically designed for units OCC2014 and PTHY2031 delivered through online iSAP module on campus, 2 x 2.5 hours over 1 week for per iSAP case; 2 cases over two weeks. Students will provided with "trigger" that includes brief medical and social history and health status. Students will work on cases in groups on campus to identify clinical issues, research on evidence based practice, select assessment/ intervention, review expert report after completion of tasks and reflect on own performances.
Participants will then attend class as usual for 1 -2 weeks, then completed another two cases delivered through traditional Case-based learning (CBL)/Scenario-based learning (SBL) tutorials on campus. Student will work on cases in groups to identify clinical issues, research on evidence based practice, select assessment/ intervention face to face with tutors facilitating discussion and reflection. Tutors are qualified occupational therapist or physiotherapist with teaching and clinical experiences. Tutors cannot be blinded to the intervention administered but will be blinded to students consent to participate in the study.
The case scenarios delivered via iSAP or traditional CBL/SBL are largely the same. The mode and sequence of delivery are different. Students will be facilitated by tutor in CBL/SBL tutorials but will not be facilitated by tutors when completing iSAP cases online.
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Intervention code [1]
313301
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Other interventions
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Comparator / control treatment
Participants group B will complete the same clinical scenarios as group A, these cases are specifically designed for units OCC2014 and PTHY2031. However, the first two case scenarios will be delivered via traditional CBL/SBL tutorials on campus and the later two cases will be delivered through iSAP, online, on campus. the timeline for intervention is the same for both groups.
Students will completed two cases delivered through traditional Case-based learning (CBL)/Scenario-based learning (SBL) tutorials. Students will complete each case over 2 x 2.5 hours tutorials over 1 week in groups of 8. Student will work on cases in groups to identify clinical issues, research on evidence based practice, select assessment/ intervention face to face with tutors facilitating discussion and reflection. Tutors are qualified occupational therapist or physiotherapist with teaching and clinical experiences. Tutors cannot be blinded to the intervention administered but will be blinded to students consent to participate in the study.
Students then attend class as usual for 1 -2 weeks, then completed another two cases delivered online via iSAP module, 2 x 2.5 hours over 1 week in groups of 8. Students will provided with "trigger" that includes brief medical and social history and health status. Students will work on cases in groups on campus to identify clinical issues, research on evidence based practice, select assessment/ intervention, review expert report after completion of tasks and reflect on own performances. Students are expected to complete tasks related to each case in 5 hours, one case per week.
The case scenarios delivered via iSAP or traditional CBL/SBL are largely the same. The mode and sequence of delivery are different. Students will be facilitated by tutor in CBL/SBL tutorials but will not be facilitated by tutors when completing iSAP cases online.
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Control group
Active
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Outcomes
Primary outcome [1]
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Knowledge tests in form of online multiple choice quizzes developed by academics specifically for the teaching units for this study to assess content knowledge related to all selected case studies.
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Assessment method [1]
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Timepoint [1]
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Knowledge test post completion of each case study (iSAP or CBL/SBL) at week 2,3 5,6 and end of semester (Week 10) knowledge test .
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Primary outcome [2]
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Open ended and close ended questions specifically designed for this study will be use in focus groups and online survey to collect qualitative data on composite primary outcome: students' perception on challenges and benefits of completing iSAP compared to case /scenario based learning.
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Assessment method [2]
318616
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Timepoint [2]
318616
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We will administer online survey pre-intervention, at midway, 1 week post participants completed the first two cases, and post intervention at week 8 or 9. We will conduct focus group within 2 weeks post completion of all iSAP and CBL/SBL cases., between week 9 and 10 of the semester.
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Primary outcome [3]
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Cost of developing and implementing iSAP based teaching are collected as composite secondary outcome. A purposefully designed cost data recording spreadsheet will be used to collect data on time, material and facilitates used in relation to development and implementation of the case studies.
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Assessment method [3]
318617
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Timepoint [3]
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Collection of data for cost evaluation from beginning of preparation of iSAP resources to completion of delivery of iSAP and CBL/SBL cases.
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Secondary outcome [1]
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The Self Assessment of Clinical Reflection and Reasoning, a validated assessment tool will be used to evaluate student's clinical reasoning skills.
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Assessment method [1]
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Timepoint [1]
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Assessments will be administered pre-intervention ( within two weeks), mid-way ( after students completed first two iSAP or CBL/SBL cases) and post intervention ( after students completed another two iSAP or CBL/SBL cases).
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Eligibility
Key inclusion criteria
Occupational therapy students and physiotherapy students in 2nd year undergraduate program who enrol in the teaching units selected for the study: OCC2014 and PTHY2031
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria: Master entry level students, students below 18 years old and above 60 years old.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated into intervention groups using computer generated random sequence by research assistants who do not involve in coordinating, teaching or marking in the selected units. Teaching staff involved in teaching into these units are blinded to the participation of students.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using the Seal Envelope program (https://sealedenvelope.com)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Quantitative analysis
All quantitative data will be cleaned and assess for missing data. SPSS 24.0 will be used to calculate descriptive and inferential statistics. Demographic data will be summarised descriptively and displayed to illustrate distribution of participants characteristics at baseline. Independent variables, where important differences observed, will be included as covariates in primary outcome analysis.
To establish whether 2nd years OT and PT students who experience iSAP achieve equal or better learning outcomes compared to students who attended CBL/SBL, scores between intervention groups post intervention condition 1 and 2 of individual items of SACRR, scores on a ordinal scale will be compared using Mann-Whitney U test. Scores between intervention groups on knowledge test post intervention condition 1 and 2 both scored on 0-100 continuous scale will be analysed using Analysis of Covariance (ANOVA). A p – value <0.05 indicates significant difference between groups. Covariate analysis will include any demographic variance and students international / domestic status.
To evaluate changes in clinical reasoning and critical thinking skills, within group pre and post intervention scores of individual items of SACRR for intervention condition 1 and 2 will be compared using Mann-Whitney U test respectively. A p – value <0.05 indicates significant difference between groups.
Qualitative data analysis
Thematic analysis, will be used to analyse the focus groups and identify common themes within and across the qualitative data set. Data analysis will involve six phases, including:
Data familiarisation by reading and rereading focus group transcripts;
generating initial codes with a summary phrase or word recorded to capture the key idea for each sentence or statement within the transcripts;
searching for themes involves defining codes and grouping similar codes together to form categories and associated sub-categories;
reviewing themes by refining categories and associated sub-categories developed in relation to the coded data extracts and whole data set;
define and name themes, and associated subthemes, by refining each theme, and the relationship between subthemes; and
writing the report provides a final opportunity for analysis as the relationship between a theme, and its associated categories and sub-categories, are drawn.
Content analysis of students’ identified learning objectives will be used to analyse students’ self-identified learning gaps and potential differences between groups that completed iSAP versus CBL/SBL.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
25/02/2019
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Actual
20/02/2019
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Date of last participant enrolment
Anticipated
10/07/2021
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Actual
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Date of last data collection
Anticipated
30/09/2021
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Actual
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Sample size
Target
190
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Accrual to date
20
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
25328
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3199 - Frankston
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Funding & Sponsors
Funding source category [1]
301588
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University
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Name [1]
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Monash University
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Address [1]
301588
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School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G
47 - 49 Moorooduc Highway Frankston, VIC 3199.
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Country [1]
301588
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Australia
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Primary sponsor type
Individual
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Name
Eli Mang Yee Chu
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Address
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,409
47 - 49 Moorooduc Highway Frankston , VIC 3199.
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Country
Australia
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Secondary sponsor category [1]
301286
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Individual
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Name [1]
301286
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Alana Hewitt
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Address [1]
301286
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Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, VIC 3199.
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Country [1]
301286
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Australia
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Secondary sponsor category [2]
301288
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Individual
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Name [2]
301288
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Lisa J Murphy
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Address [2]
301288
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Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, VIC 3199.
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Country [2]
301288
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Australia
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Secondary sponsor category [3]
301289
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Individual
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Name [3]
301289
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Aislinn Lalor
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Address [3]
301289
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Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,409
47 -49 Moorooduc Highway Frankston, Vic 3199.
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Country [3]
301289
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Australia
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Secondary sponsor category [4]
301290
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Individual
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Name [4]
301290
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Annemarie Lee
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Address [4]
301290
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Department of Physiotherapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus
47- 49 Moorooduc Highway Frankston, Vic 3199.
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Country [4]
301290
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Australia
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Secondary sponsor category [5]
301291
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Individual
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Name [5]
301291
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Uschi Bay
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Address [5]
301291
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Department of Social Work
School of Primary and Allied Health,
Monash University,
Peninsula Campus,
47-49 Moorooduc Highway Frankston, Vic 3199.
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Country [5]
301291
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Australia
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Secondary sponsor category [6]
301292
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Individual
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Name [6]
301292
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Linda Barclay
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Address [6]
301292
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Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 -49 Moorooduc Highway Frankston, Vic 3199.
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Country [6]
301292
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Australia
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Secondary sponsor category [7]
301293
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Individual
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Name [7]
301293
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Lisa O'Brien
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Address [7]
301293
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Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building,
47 - 49 Moorooduc Highway Frankston, Vic 3199.
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Country [7]
301293
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Australia
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Secondary sponsor category [8]
301294
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Individual
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Name [8]
301294
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Ellie Fossey
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Address [8]
301294
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Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, Vic 3199.
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Country [8]
301294
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Ethics Committee
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Ethics committee address [1]
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Executive Officer
Monash University Human Research Ethics Committee (MUHREC)
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
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Ethics committee country [1]
302318
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Australia
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Date submitted for ethics approval [1]
302318
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18/01/2019
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Approval date [1]
302318
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25/01/2019
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Ethics approval number [1]
302318
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Summary
Brief summary
Case-based learning (CBL) is widely used in health professional education (Thistlewaite, 2015) about which they engage in problem solving, practical skills development, and independent study. Currently, ‘cases’ or ‘scenarios’ are typically presented in class, using a ‘pen and paper’ format, with learning assessed through written and oral exams, but whether this is the most engaging or effective approach to develop students’ theoretical or professional reasoning is unknown. In comparison, integrating Science and Practice (iSAP) is an online CBL framework that incorporates elements of learning through practice, collaboration and discussion by presenting students with multimedia case studies that simulate real-world practice issues reflective of their future roles as health professionals (Williams, Schliphake, Heinrich & Baird, 2017). This study to compare students’ learning outcomes, clinical reflection and reasoning skills, students’ experience with learning and costs associated with delivering iSAP and CBL/SBL. We aim to evaluate learning outcomes and clinical reflection and reasoning skills using standardised outcomes, academic assessments and surveys. We will use survey with open ended questions and focus groups to explore students’ experience.
We hypothesise that students who complete iSAP will achieve equal or better learning outcomes compare to CBL/SBL.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
89802
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Dr Eli Mang Yee Chu
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Address
89802
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Department of Occupational Therapy
School of Primary and Allied Health
Monash University
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, Vic 3199.
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Country
89802
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Australia
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Phone
89802
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+61 3 99044530
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Fax
89802
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Email
89802
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[email protected]
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Contact person for public queries
Name
89803
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Dr Eli Mang Yee Chu
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Address
89803
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Department of Occupational Therapy
School of Primary and Allied Health
Monash University
Peninsula Campus Building G,
47 49 Moorooduc Highway, Frankston, Vic 3199.
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Country
89803
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Australia
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Phone
89803
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+61 3 99044530
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Fax
89803
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Email
89803
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[email protected]
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Contact person for scientific queries
Name
89804
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Dr Eli Mang Yee Chu
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Address
89804
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Department of Occupational Therapy
School of Primary and Allied Health
Monash University
Peninsula Campus Building G,
47 49 Moorooduc Highway, Frankston, Vic 3199.
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Country
89804
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Australia
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Phone
89804
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+61 3 99044530
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Fax
89804
0
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Email
89804
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD will not be available to public. Resulted will be presented in professional conference or via publication in grouped, non-identifiable format.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
12373
Ethical approval
[email protected]
12374
Study protocol
[email protected]
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.
Download to PDF