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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.
Scientific title
Allied health use of integrating Science and Practice (iSAP) for case-based learning: Effectiveness for student learning outcomes, staffing and resource efficiency.
Secondary ID [1] 297020 0
Nil known
Universal Trial Number (UTN)
U1111-1226-4319
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurological conditions 311228 0
Cardiac conditions 311229 0
Condition category
Condition code
Neurological 309652 309652 0 0
Other neurological disorders
Cardiovascular 309653 309653 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313301 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 318615 0
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.
Timepoint [1] 318615 0
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 .
Primary outcome [2] 318616 0
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.
Timepoint [2] 318616 0
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.
Primary outcome [3] 318617 0
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.
Timepoint [3] 318617 0
Collection of data for cost evaluation from beginning of preparation of iSAP resources to completion of delivery of iSAP and CBL/SBL cases.
Secondary outcome [1] 365529 0
The Self Assessment of Clinical Reflection and Reasoning, a validated assessment tool will be used to evaluate student's clinical reasoning skills.
Timepoint [1] 365529 0
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).

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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Master entry level students, students below 18 years old and above 60 years old.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using the Seal Envelope program (https://sealedenvelope.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/02/2019
Actual
20/02/2019
Date of last participant enrolment
Anticipated
10/07/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
190
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25328 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 301588 0
University
Name [1] 301588 0
Monash University
Country [1] 301588 0
Australia
Primary sponsor type
Individual
Name
Eli Mang Yee Chu
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.
Country
Australia
Secondary sponsor category [1] 301286 0
Individual
Name [1] 301286 0
Alana Hewitt
Address [1] 301286 0
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, VIC 3199.
Country [1] 301286 0
Australia
Secondary sponsor category [2] 301288 0
Individual
Name [2] 301288 0
Lisa J Murphy
Address [2] 301288 0
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, VIC 3199.
Country [2] 301288 0
Australia
Secondary sponsor category [3] 301289 0
Individual
Name [3] 301289 0
Aislinn Lalor
Address [3] 301289 0
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,409
47 -49 Moorooduc Highway Frankston, Vic 3199.
Country [3] 301289 0
Australia
Secondary sponsor category [4] 301290 0
Individual
Name [4] 301290 0
Annemarie Lee
Address [4] 301290 0
Department of Physiotherapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus
47- 49 Moorooduc Highway Frankston, Vic 3199.
Country [4] 301290 0
Australia
Secondary sponsor category [5] 301291 0
Individual
Name [5] 301291 0
Uschi Bay
Address [5] 301291 0
Department of Social Work
School of Primary and Allied Health,
Monash University,
Peninsula Campus,
47-49 Moorooduc Highway Frankston, Vic 3199.
Country [5] 301291 0
Australia
Secondary sponsor category [6] 301292 0
Individual
Name [6] 301292 0
Linda Barclay
Address [6] 301292 0
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 -49 Moorooduc Highway Frankston, Vic 3199.
Country [6] 301292 0
Australia
Secondary sponsor category [7] 301293 0
Individual
Name [7] 301293 0
Lisa O'Brien
Address [7] 301293 0
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building,
47 - 49 Moorooduc Highway Frankston, Vic 3199.
Country [7] 301293 0
Australia
Secondary sponsor category [8] 301294 0
Individual
Name [8] 301294 0
Ellie Fossey
Address [8] 301294 0
Department of Occupational Therapy
School of Primary and Allied Health,
Monash University,
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, Vic 3199.
Country [8] 301294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302318 0
Monash University Human Ethics Committee
Ethics committee address [1] 302318 0
Ethics committee country [1] 302318 0
Australia
Date submitted for ethics approval [1] 302318 0
18/01/2019
Approval date [1] 302318 0
25/01/2019
Ethics approval number [1] 302318 0

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

Contacts
Principal investigator
Name 89802 0
Dr Eli Mang Yee Chu
Address 89802 0
Department of Occupational Therapy
School of Primary and Allied Health
Monash University
Peninsula Campus Building G,
47 - 49 Moorooduc Highway Frankston, Vic 3199.
Country 89802 0
Australia
Phone 89802 0
+61 3 99044530
Fax 89802 0
Email 89802 0
eli.chu@monash.edu
Contact person for public queries
Name 89803 0
Eli Mang Yee Chu
Address 89803 0
Department of Occupational Therapy
School of Primary and Allied Health
Monash University
Peninsula Campus Building G,
47 49 Moorooduc Highway, Frankston, Vic 3199.
Country 89803 0
Australia
Phone 89803 0
+61 3 99044530
Fax 89803 0
Email 89803 0
eli.chu@monash.edu
Contact person for scientific queries
Name 89804 0
Eli Mang Yee Chu
Address 89804 0
Department of Occupational Therapy
School of Primary and Allied Health
Monash University
Peninsula Campus Building G,
47 49 Moorooduc Highway, Frankston, Vic 3199.
Country 89804 0
Australia
Phone 89804 0
+61 3 99044530
Fax 89804 0
Email 89804 0
eli.chu@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12373Ethical approval  eli.chu@monash.edu
12374Study protocol  eli.chu@monash.edu



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.