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Trial registered on ANZCTR


Registration number
ACTRN12615000686505
Ethics application status
Approved
Date submitted
3/06/2015
Date registered
1/07/2015
Date last updated
18/01/2019
Date data sharing statement initially provided
18/01/2019
Date results information initially provided
18/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Standardised patient scenarios versus peer-role play to develop physiotherapy student safety skills in readiness for clinical placement: a pilot non-randomised controlled trial.
Scientific title
Developing physiotherapy student safety skills in readiness for clinical placement using standardised patients compared with peer-role play: a pilot non-randomised controlled trial.

Reason for title update is to reflect the pilot nature of the trial.
Secondary ID [1] 286854 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiotherapy student safety skills 295248 0
Condition category
Condition code
Public Health 295493 295493 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two versions of three hour practical sessions incorporating standardised patient scenarios, (a) with and (b) without student review of video feedback, in assessment and mobilisation of patients in a 2nd year physiotherapy subject (PS200).
The three hour practical sessions are administered in small groups (35-40) of students, working in groups of four. Each group of four students is facilitated by a physiotherapy clinical educator.
The standardised patient scenario activity involves two 30 minute patient interactions, with students working in pairs. One pair of students work in the roles of lead therapist / assistant and the other pair of students in the roles of observers. After 15 minutes, the student pairs switch roles. The students acting a lead therapist / assistant are required to plan and prepare the physical environment, assess the patients capacity to for safe transfer, explain the planned mobility task to the patient and assistant, reassure the patient and complete a safe and effective assited patient mobility task (sitting on edge of bed, standing / walking, sitting out of bed). The students acting in the role of observers are required to complete a peer feedback checklist.

Prior to the first standardised patient scenario activity, all student are provided with a 30 minutes of preparatory time facilitated by physiotherapy clinical educator, where they are provided with a description of the patient (patient vignette) a picture of the attachments that the patient will have, and instructions regarding their task for the session and their roles as either lead therapist / assistant or observer. The task the students are given is to mobilise the patient and guidance regarding how to proceed is provided- eg a brief assessment of the patient to ensure that the patient has the capacity to mobilise and then to mobilise the patient to sit out of bed and the timetable for the session.
At the completion of each standardised patient scenario activity, students move into a separate room to debrief about their session. The debrief sessions, facilitated by physiotherapy clinical educator focus on self-reflection of their performance and the opportunity for peer feedback and review of video feedback is provided.

For the video feedback, the interaction of the lead therapist / assistant and the patient is recorded on an ipad by a student in the observer role. The video feedback, comprises a replay of each of the patient scenarios and is administered in the debrief session which follows immediately from the patient interaction. At the completion of the debrief session, all video footage is deleted.

Over the course of the 3 hour practical session, each group has two 30 minute patient interactions, and two, 30 minute debrief sessions immediately following their patient interactions.
Intervention code [1] 292021 0
Other interventions
Comparator / control treatment
The three hour practical sessions are administered in small groups (35-40) of students, working in groups of four overseen by a total of three physiotherapy clinical educators. Each group of students are provided with a brief, detailed patient scenario and a mobility task for the scenario (e.g. to sit patient out of bed). Over the three hour practical session, the students work through 3-4 different patient scenarios, rotating through the roles of ‘patient’, ‘lead therapist’, ‘assistant’ and ‘observer’. At the completion of each patient scenario, a group debrief is conducted incorporating peer and facilitator feedback and the opportunity for reflection by the students.
Control group
Active

Outcomes
Primary outcome [1] 295227 0
Student safety skills demonstrated in a practical examination (OSCE)
Timepoint [1] 295227 0
17/06/15
Five weeks post intervention.
Primary outcome [2] 295228 0
Before and after the practical session participants will complete a 10-item survey with statements that cover communication, confidence, preparedness for placement and self-perception of their ability to conduct communicative, practical and reasoning skills. Participants respond to each statement on the survey by marking a visual analogue scale between zero (strongly disagree) and 10 (strongly agree). This survey has previously been used in evaluating simulated learning experiences by students (Mandrusiak et al 2014).
Timepoint [2] 295228 0
13/05/15
This outcome is assessed for each participant on the day of intervention (prior to and immediately following completion of the intervention).
Primary outcome [3] 303369 0
Feasibility, focussing on the process and resource requirements for the workshops. Process requirements include participant recruitment, retention and survey response rates and whether the training for clinical educators and SPs and workshop sessions for SP interactions including the debriefing and feedback (from the SP and video) are able to be delivered as planned. The resource requirements are the total time taken and costs ($AUD) associated with the training for and participation in the workshops for both SPs and clinical educators.
Timepoint [3] 303369 0
13/05/15 following workshop completion.
Secondary outcome [1] 315117 0
Follow of participants into the subsequent years (years 3 and 4) of the physiotherapy program. Review of GPA in 2016 and final grade achieved on acute care placement in 2016 (1 year follow up).
Timepoint [1] 315117 0
1 year follow up December 2016 to review GPA and final grade achieved on acute care placement in 2016.
Secondary outcome [2] 338755 0
Review of GPA in 2017, 2 years post intervention.
Timepoint [2] 338755 0
December 2017, 2 years post intervention.
Secondary outcome [3] 338756 0
Participant satisfaction with the SP scenarios. Participants were asked to rate their satisfaction with the SP scenarios by marking a visual analogue scale between zero (strongly disagree) and 10 (strongly agree).
Timepoint [3] 338756 0
13/05/15 immediately following the SP scenario workshop.

Eligibility
Key inclusion criteria
All second year physiotherapy students enrolled in the course (PS200) will be involved in one of the three learning situations and the practical exam. However, only consenting students will be asked to participate in the pre-post survey of clinical preparedness or have their practical examination data included in this study.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Physiotherapy students who do not provide wrtitten consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The main outcome measures were participant recruitment, retention and survey response rates, whether the training and workshops were delivered as scheduled and costs for SPs and staff training and workshop attendance. Before and after the practical session participants will complete a 10-item survey with statements that cover communication, confidence, preparedness for placement and self-perception of their ability to conduct communicative, practical and reasoning skills. Participants respond to each statement on the survey by marking a visual analogue scale between zero (strongly disagree) and 10 (strongly agree). This survey has previously been used in evaluating simulated learning experiences by students. Student perceived preparedness for placement will be compared for each intervention arm using paired t tests. Descriptive statistics will be used to describe and explore the feasibility measures, participants’ characteristics, survey responses and OSCE scores. Pre-post workshop changes in perceived confidence, perceived preparedness for clinical placement and satisfaction with the use of the SP scenarios were examined within the intervention groups for each of the ten items of the survey using paired t-tests. Averages of OSCE scores and number of fails observed for students in each of the study groups will be reported but due to non-random allocation will not be statistically compared. The software package SPSS v17.0 (SPSS Inc., Chicago, IL, USA) was used for all analyses.
Written comments provided to open ended questions by participants will be de identified, extracted verbatim and collated. Comments will be reviewed and those with common content grouped into major and minor categories. Organisation of extracts into categories will be discussed with a second researcher until consensus is reached and a descriptive summary generated including examples of data excerpts to illustrate the categories.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 291408 0
University
Name [1] 291408 0
University of South Australia, Teaching and Learning Unit.
Address [1] 291408 0
GPO Box 2471
Adelaide South Australia 5001
Country [1] 291408 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide South Australia 5001
Country
Australia
Secondary sponsor category [1] 290082 0
None
Name [1] 290082 0
Address [1] 290082 0
Country [1] 290082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292956 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 292956 0
GPO Box 2471
Adelaide, South Australia 5001
Ethics committee country [1] 292956 0
Australia
Date submitted for ethics approval [1] 292956 0
Approval date [1] 292956 0
05/12/2014
Ethics approval number [1] 292956 0
0000033913

Summary
Brief summary
Using simulated learning environments with standardised patients (SPs) provides a way to scaffold the development of skills for patient safety in a low risk environment. There are no data regarding whether adding SP interactions in early years of physiotherapy training improves safe performance on clinical placement. We aimed to assess the feasibility of recruiting and collecting data from junior physiotherapy students during an SP workshop with a pilot non-randomised trial, also assessing time, cost and scheduling information.

Second year physiotherapy students were invited to participate and allocated to either the SP workshop in a simulated hospital environment (with and without video feedback) or usual teaching comprising peer role play. The main outcome measures were participant recruitment, retention and survey response rates, whether the training and workshops were delivered as scheduled and costs for SPs and staff training and workshop attendance. Students self-reported confidence, communication, preparedness for clinic and satisfaction was measured using pre-post surveys.
Trial website
Trial related presentations / publications
Electronic poster presentation at the Australasian Simulation Congress, 26 - 29 September 2016, Melbourne Convention and Exhibition Centre, Victoria, Australia.
Presented at World Congress for Physical Therapy (WCPT) in Cape Town South Africa, July 4th 2017.
Published in BMC Medical Education August 2017. Link to open access publication. http://rdcu.be/uUwx
Public notes
Attachments [1] 2053 2053 0 0

Contacts
Principal investigator
Name 57802 0
Dr Anna Phillips
Address 57802 0
University of South Australia
GPO Box 2471
Adelaide South Australia
5001
Country 57802 0
Australia
Phone 57802 0
+61883021278
Fax 57802 0
Email 57802 0
anna.phillips@unisa.edu.au
Contact person for public queries
Name 57803 0
Dr Anna Phillips
Address 57803 0
University of South Australia
GPO Box 2471
Adelaide South Australia
5001
Country 57803 0
Australia
Phone 57803 0
+61883021278
Fax 57803 0
Email 57803 0
anna.phillips@unisa.edu.au
Contact person for scientific queries
Name 57804 0
Dr Anna Phillips
Address 57804 0
University of South Australia
GPO Box 2471
Adelaide South Australia
5001
Country 57804 0
Australia
Phone 57804 0
+61883021278
Fax 57804 0
Email 57804 0
anna.phillips@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The datasets are not publicly available, however the datasets used and analysed during the current study available from the corresponding author on reasonable request
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 975 0
Phillips AC, Mackintosh SF, Bell A, Johnston KJ, ‘Developing physiotherapy student safety skills in readiness for clinical placement using standardised patients compared with peer-role play: a pilot non-randomised controlled trial.’ BMC Medical Education 2017, 17:133.

https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-017-0973-5#Decs/

https://doi.org/10.1186/s12909-017-0973-5
Attachments [1] 975 0
Other publications
Have study results been made publicly available in another format?
Yes
Results – plain English summary
The pilot trial proved to be feasible, with 108 students recruited (100%) and high retention (95%) and survey response rates (85%). The training sessions and workshops were delivered as scheduled, costing $4700AUD.
Physiotherapy students rated their confidence and preparedness for clinical placement significantly higher following the workshop sessions and reported high levels of satisfaction with the interactions with standardised patients.
The impact of participating in the workshops with standardised patients did not affect the physiotherapy students grades achieved on clinical placement in the year following the workshops, nor did it affect the overall grade point average (GPA) for the physiotherapy students with no difference found between physiotherapy students who interacted with standardised patients and those who did not.
This pilot study sample was not randomised and was limited by student enrolment and conducted at a single institution, which limit the interpretation and generalisability of the results.
The survey measure used to report student self-efficacy and preparedness for placement does not have established reliability or validity.
It is likely that the one-off exposure to a workshop experience offered limited opportunity to effect change in the skills in comparison to role-play scenarios.