Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000685011
Ethics application status
Approved
Date submitted
18/08/2010
Date registered
19/08/2010
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of using a modelled role-play to teach student health professionals how to incorporate evidence into their communication with patients
Scientific title
Does the use of a modelled role-play improve student health professionals' ability to incorporate evidence into their communication with patients
Secondary ID [1] 252492 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health professional communication skills 257986 0
Condition category
Condition code
Other 258151 258151 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Public Health 258167 258167 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Students will attend one 1-hour tutorial on the principles of communicating evidence to patients, watch a role-play that models effective communication of evidence, and participate in a faciliated group discussion about the observed role-play.

As per students in the control group, intervention group students will also receive the usual teaching methods for this course and be directed to read a relevant chapter in the course textbook.
Intervention code [1] 257038 0
Other interventions
Comparator / control treatment
Usual teaching methods for this course (2 hour lecture once per week for 10 weeks) and directed to read a relevant chapter in course textbook.
Control group
Active

Outcomes
Primary outcome [1] 259013 0
Extent of shared decision making - measured using the Observing Patient Involvement (OPTION) scale
Timepoint [1] 259013 0
2 weeks after the intervention
Primary outcome [2] 259014 0
Relevant susbcales of the Assessing Communication About Evidence and Preferences (ACEP) Coding Scheme
Timepoint [2] 259014 0
2 weeks after the intervention
Secondary outcome [1] 265248 0
Student confidence in communicating with patients about evidence. Measured using custom-developed visual analogue scales
Timepoint [1] 265248 0
2 weeks after the intervention
Secondary outcome [2] 265249 0
Patient-Practitioner Orientation Scale
Timepoint [2] 265249 0
2 weeks after the intervention

Eligibility
Key inclusion criteria
Student health professional (occupational therapy, physiotherapy, or medicine) enrolled in a course that teaches the principles of evidence-based practice
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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 allocated to study group by an independent person at a central administration facilitiy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257484 0
Self funded/Unfunded
Name [1] 257484 0
Country [1] 257484 0
Primary sponsor type
Individual
Name
Tammy Hoffmann
Address
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane Qld 4072
Country
Australia
Secondary sponsor category [1] 256720 0
Individual
Name [1] 256720 0
Sally Bennett
Address [1] 256720 0
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane Qld 4072
Country [1] 256720 0
Australia
Secondary sponsor category [2] 256721 0
Individual
Name [2] 256721 0
Chris Del Mar
Address [2] 256721 0
Faculty of Health Sciences and Medicine
Bond Univeristy
Gold Coast Qld 4229
Country [2] 256721 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259512 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 259512 0
Ethics Committee
University of Queensland
Brisbane 4072
Ethics committee country [1] 259512 0
Australia
Date submitted for ethics approval [1] 259512 0
Approval date [1] 259512 0
19/03/2010
Ethics approval number [1] 259512 0

Summary
Brief summary
The aim of this study is to evaluate the effect of providing health professional students with the opportunity to observe and discuss a modelled role-play that demonstrates how to communicate evidence to patients and faciliate shared decision making. It is hypothesised that the intervention will be effective at improving students' ability to incorporate evidence into their communication and facilitate shared decision making with patients, and improve their confidence and attitude towards doing so.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31538 0
Address 31538 0
Country 31538 0
Phone 31538 0
Fax 31538 0
Email 31538 0
Contact person for public queries
Name 14785 0
Dr Tammy Hoffmann
Address 14785 0
School of Health and Rehabilitation Sciences
University of Queensland
Brisbane 4072
Country 14785 0
Australia
Phone 14785 0
+61 7 5595 5522
Fax 14785 0
Email 14785 0
[email protected]
Contact person for scientific queries
Name 5713 0
Dr Tammy Hoffmann
Address 5713 0
School of Health and Rehabilitation Sciences
University of Queensland
Brisbane 4072
Country 5713 0
Australia
Phone 5713 0
+61 7 5595 5522
Fax 5713 0
Email 5713 0
[email protected]

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.