Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12612001247864
Ethics application status
Approved
Date submitted
20/11/2012
Date registered
26/11/2012
Date last updated
26/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Learning from Consumers: Can Gynaecology Teaching Associates Deliver Effective Training for Medical Students?
Scientific title
A Single-Blinded Randomised Controlled Trial Evaluating the Role of Gynaecology Teaching Associates in Pelvic Examination Training of Medical Students - The GTA Trial.
Secondary ID [1] 281551 0
N/A
Universal Trial Number (UTN)
U1111-1137-1509
Trial acronym
The GTA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Examination Training 287830 0
Condition category
Condition code
Reproductive Health and Childbirth 288177 288177 0 0
Other reproductive health and childbirth disorders
Public Health 288226 288226 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gynaecology Teaching Associate Pelvic Examination Training

Single two and half hour session with two fully qualified and trained gynaecological teaching associates teaching pelvic examination. One gynaecological teaching associate as instructor and the second gynaecological teaching associate acting as a patient.
Intervention code [1] 286070 0
Other interventions
Comparator / control treatment
Routine pelvic examination training - lecture (1 hour faclitated by clinician) / access to pelvic examiniation models (self directed learning) / training within clinical settings (4 weeks)
Control group
Active

Outcomes
Primary outcome [1] 288377 0
Technical Competence
Timepoint [1] 288377 0
End of year examination
Secondary outcome [1] 300001 0
Communication and interpersonal skills
Timepoint [1] 300001 0
End of year examination
Secondary outcome [2] 300103 0
Knowledge of pelvic examination technique
Timepoint [2] 300103 0
End of obstetrics and gynaecology placement
Secondary outcome [3] 300104 0
Student anxiety
Timepoint [3] 300104 0
End of obstetrics and gynaecology placement
Secondary outcome [4] 300105 0
Reflective logbook of pelvic examination procedures
Timepoint [4] 300105 0
End of obstetrics and gynaecology placement

Eligibility
Key inclusion criteria
Undergraduate medical student
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Declining participation within the trial

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)
Allocation Concealment
Randomisation communicated within sequential, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Design
Single centre, individually randomised controlled trial.
Intervention and routine undergraduate’s education
or
Routine undergraduate education

Truly randomised, computer generated. Simple randomisation by using a randomisation table created by computer software (i.e., computerised sequence generation).
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
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
101
Accrual to date
Final
Recruitment outside Australia
Country [1] 4683 0
United Kingdom
State/province [1] 4683 0
London

Funding & Sponsors
Funding source category [1] 286350 0
Charities/Societies/Foundations
Name [1] 286350 0
Barts and The London Charity
Country [1] 286350 0
United Kingdom
Primary sponsor type
University
Name
Queen Mary, University of London
Address
Mile End Rd
London Borough of Tower Hamlets
London
E1 4NS
Country
United Kingdom
Secondary sponsor category [1] 285138 0
None
Name [1] 285138 0
Address [1] 285138 0
Country [1] 285138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288433 0
Queen Mary, University of London Research Ethics Comittee
Ethics committee address [1] 288433 0
Mile End Rd
London Borough of Tower Hamlets
London
E1 4NS
Ethics committee country [1] 288433 0
United Kingdom
Date submitted for ethics approval [1] 288433 0
Approval date [1] 288433 0
17/10/2012
Ethics approval number [1] 288433 0
QMREC2012/67

Summary
Brief summary
There are considerable challenges in training undergraduate medical students to perform the pelvic examination. These difficulties are due to several factors including the potential embarrassment to patients, discomfort of medical students and limited opportunities to train in clinical settings because of time constraints and unwilling patients. Traditional training methods have included manikins, videos and patients within clinical settings including anaesthetised patients. Medical students who have learnt by these methods achieve poor training outcomes. As a qualified doctor this lack of confidence results in increased discomfort for women and reduced reliability of the results obtained which ultimately affects patient care. Training utilising manikins only develops technical skills with no emphasis on communication or interpersonal skill development. Training involving ‘real patients’ in clinical settings is associated with high levels of medical student anxiety and discomfort, difficulties in finding willing patients associated with the possibility of patient right infringement and lack of patient feedback on performance. These difficulties have resulted in increasing volumes of training involving anaesthetised patients. Utilising anaesthetised patients presents difficulties in obtaining informed consent, lack of patient feedback with training entirely focused on technical skills with little duplication of the conditions where the majority of pelvic examinations are performed as a doctor.

Gynaecological Teaching Associates (GTAs) have been employed for many years in the Netherlands and USA with the first programme described in 1978. In the United Kingdom many medical schools, notably Kings College London and The University of Birmingham, have developed comprehensive GTA programs to train medical students. GTAs are women trained to teach pelvic examination with themselves being examined. They work in pairs, with one acting as a patient and the other as an instructor. It is anticipated the introduction of GTAs as active teachers could assist medical students in the gaining new clinical skills, improved confidence in counselling, development of complex communication skills with a reduction in anxiety associated with training. In the future it is likely any improvement will have a direct impact on patient care and improved patient outcomes.

GTAs are an established component of undergraduate training in many counties and becoming more widespread in the United Kingdom. Many low quality studies have reported positive outcomes for both GTAs and medical students. Further high quality research is required to objectively assess the positive and negative outcomes for both students and patients.

The study objective is to provide robust evidence to evaluate the GTA program for the delivery of undergraduate pelvic examination training. Evaluation themes include:
1. Competence to perform pelvic examination
Technical skills
Communication skills
Interpersonal skills
Patient experience
2. Student anxiety
3. Student evaluation of program
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 34961 0
Address 34961 0
Country 34961 0
Phone 34961 0
Fax 34961 0
Email 34961 0
Contact person for public queries
Name 18208 0
Dr James M N Duffy
Address 18208 0
Women’s Health Research Unit
Blizard Institute
58 Turner Street
London
E1 2AB
Country 18208 0
United Kingdom
Phone 18208 0
+44 79 5011 5547
Fax 18208 0
+44 20 7882 6047
Email 18208 0
[email protected]
Contact person for scientific queries
Name 9136 0
Dr James M N Duffy
Address 9136 0
Women’s Health Research Unit
Blizard Institute
58 Turner Street
London
E1 2AB
Country 9136 0
United Kingdom
Phone 9136 0
+44 79 5011 5547
Fax 9136 0
+44 20 7882 6047
Email 9136 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.