ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Public Health

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]

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]

Technical Competence

Timepoint [1]

End of year examination

Secondary outcome [1]

Communication and interpersonal skills

Timepoint [1]

End of year examination

Secondary outcome [2]

Knowledge of pelvic examination technique

Timepoint [2]

End of obstetrics and gynaecology placement

Secondary outcome [3]

Student anxiety

Timepoint [3]

End of obstetrics and gynaecology placement

Secondary outcome [4]

Reflective logbook of pelvic examination procedures

Timepoint [4]

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]

United Kingdom

State/province [1]

London

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Barts and The London Charity

Address [1]

Ground Floor
12 Cock Lane
London
EC1A 9BU

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Queen Mary, University of London Research Ethics Comittee

Ethics committee address [1]

Mile End Rd
London Borough of Tower Hamlets
London 
E1 4NS

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

Approval date [1]

17/10/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr James M N Duffy

Address

Women’s Health Research Unit
Blizard Institute
58 Turner Street
London
E1 2AB

Country

United Kingdom

Phone

+44 79 5011 5547

Fax

+44 20 7882 6047

[email protected]

Contact person for scientific queries

Name

Dr James M N Duffy

Address

Women’s Health Research Unit
Blizard Institute
58 Turner Street
London
E1 2AB

Country

United Kingdom

Phone

+44 79 5011 5547

Fax

+44 20 7882 6047

[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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically