Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001055796
Ethics application status
Approved
Date submitted
19/09/2013
Date registered
23/09/2013
Date last updated
23/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Patient Feedback to Improve Medical Student Consultation Skills
Scientific title
Use of additional patient satisfaction scores to improve medical student consultation skills compared to verbal feedback as educational intervention
Secondary ID [1] 283264 0
Nil
Universal Trial Number (UTN)
Trial acronym
Patient Teaching Associate (PTA) Feedback Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
medical consultation skills 290136 0
Condition category
Condition code
Public Health 290523 290523 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is feedback of Medical Interview Satisfaction Scale (MISS-21), a 21-item validated visit based questionnaire for measuring patient satisfaction, with usual verbal feedback after consultation episodes in patients living with chronic illnesses. The scores are given prior to the last consultation during one semester (generally about 6 consultations in total).
Intervention code [1] 287991 0
Other interventions
Comparator / control treatment
Usual verbal feedback alone
Control group
Active

Outcomes
Primary outcome [1] 290546 0
Medical interview satisfaction scale
Timepoint [1] 290546 0
at end of one semester
Secondary outcome [1] 304772 0
Tutors give summative assessments using Rating Instrument of Clinical consultation Skills (RICS), a student performance assessment tool
Timepoint [1] 304772 0
at end of one semester

Eligibility
Key inclusion criteria
Third year medical students in their first clinical year enrolled in Monash University and Deakin University, Australia
Minimum age
18 Years
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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
24/05/2013
Date of last participant enrolment
Anticipated
6/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288002 0
University
Name [1] 288002 0
FMNHS Learning & Teaching Research Grant Scheme (L&T RGS), Monash University
Country [1] 288002 0
Australia
Primary sponsor type
University
Name
Eastern Health Clinical School, Monash University and Deakin University
Address
5 Arnold Street, Box Hill, Victoria 3128
Country
Australia
Secondary sponsor category [1] 286724 0
None
Name [1] 286724 0
Address [1] 286724 0
Country [1] 286724 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study is designed to test if feedback of patient satisfaction score after consultation sessions improves clinical consultation performance among medical students.
We hypothesise that 1) additional feedback of patient satisfaction scores to students improves student performance over usual feedback; and 2) the teaching model increases patient satisfaction scores in student consultation over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43114 0
Dr Michelle Lai
Address 43114 0
Monash University, Eastern Health Clinical School, Level 3, 5 Arnold Street, Box Hill VIC 3128
Country 43114 0
Australia
Phone 43114 0
+61 3 90918830
Fax 43114 0
Email 43114 0
Michelle.Lai@monash.edu
Contact person for public queries
Name 43115 0
Dr Michelle Lai
Address 43115 0
Monash University, Eastern Health Clinical School, Level 3, 5 Arnold Street, Box Hill VIC 3128
Country 43115 0
Australia
Phone 43115 0
+61 3 90918830
Fax 43115 0
Email 43115 0
Michelle.Lai@monash.edu
Contact person for scientific queries
Name 43116 0
Dr Michelle Lai
Address 43116 0
Monash University, Eastern Health Clinical School, Level 3, 5 Arnold Street, Box Hill VIC 3128
Country 43116 0
Australia
Phone 43116 0
+61 3 90918830
Fax 43116 0
Email 43116 0
Michelle.Lai@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23291Informed consent formlocated at the Eastern Health Clinical School  
23292Study protocol2. Lai MM, Roberts N, Martin J. Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial. Trials. 2014;15(1):361.  
23293Statistical analysis plan2. Lai MM, Roberts N, Martin J. Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial. Trials. 2014;15(1):361. 3. Lai MM, Roberts N, Mohebbi M, Martin J. A randomised controlled trial of feedback to improve patient satisfaction and consultation skills in medical students. BMC Medical Education, 2020.   
23294Clinical study report3. Lai MM, Roberts N, Mohebbi M, Martin J. A randomised controlled trial of feedback to improve patient satisfaction and consultation skills in medical students. BMC Medical Education, 2020.  

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3951Plain language summaryNo both groups improved patient-rated rapport, patien... [More Details]
4431Study results articleYes Lai MM, Roberts N, Mohebbi M, Martin J. A randomis... [More Details]
4432Study results articleYes Lai MM, Roberts N, Mohebbi M, Martin J. A randomis... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): Study protocol for a randomized controlled trial.2014https://dx.doi.org/10.1186/1745-6215-15-361
N.B. These documents automatically identified may not have been verified by the study sponsor.