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Female Pelvic ExaminationTARGETNCT01944592

Teaching Associates Randomised to Evaluate the Effectiveness of Gynaecological Pelvic Examination Versus Traditional Teaching Using Manikins

A study testing Gynaecology Teaching Associates (GTA's) and Manikin (conventional) training in people with Female Pelvic Examination, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Physical examination of the pelvis is an important core skill that medical students need to acquire. However, due to its intimate nature some students are graduating unable to perform competent pelvic examinations. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Female Pelvic Examination
What is being tested?
Gynaecology Teaching Associates (GTA's) and Manikin (conventional) training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
492 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Final year medical students
  • Consent

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Birmingham Womens Hospital

    Birmingham, West Midlands, B15 2TG

Other trials in United Kingdom

About this study

Official title: Gynaecology Teaching Associates Versus Teaching on Manikins: a Randomised Controlled Trial

Physical examination of the pelvis is an important core skill that medical students need to acquire. However, due to its intimate nature some students are graduating unable to perform competent pelvic examinations. Gynaecological Teaching Associates (GTA's) are women who have been trained to be examined and give valuable feedback to the students. In North America GTA's are quite commonly used in the medical curriculum and they have also been used in Canada, Australia and Scandinavia. In the UK pelvic examination is mainly taught using a combination of clinic patients, pelvic models and patients anaesthetised for surgery. In Birmingham we have already started using GTA's and like other Universities such as Oxford the students have given positive feedback.

GTA's are paid professionals and hence introducing this method of teaching has financial implications for Universities. Unless it is proven to be worthwhile it is unlikely that academic institutions will introduce and maintain GTA programs. One UK study did show that those who had been trained with a GTA's and pelvic models were significantly better than those who had been trained with pelvic models alone. However, in this study the GTA training was supplementary to the normal curriculum so the amount of teaching rather than the style of teaching may have acted as a confounding factor. Therefore, a large randomised trial of trainees on the Obstetrics and Gynaecology (O\&G) programme comparing those given an initial teaching session on a pelvic model and those taught by GTA's is needed to assess the effectiveness of GTA's on confidence and competence of the students by the end of the training programme is needed.

Read the detailed description

Introduction Physical examination of the pelvis is an important core skill that medical students need to acquire. However, the experience of undergraduates to vaginal examination is becoming increasingly limited such that medical students in Birmingham can qualify without ever performing a vaginal examination in an outpatient setting (personal communication, Raut N). It is well recognised that the intimate nature of the examination poses additional challenges to medical students and their teachers in gaining consent for supervised training. However, other factors may now be affecting student experience. These include competing pressures on contemporary undergraduate medical curricula resulting in traditional clinical placements, such as obstetrics and gynaecology (O\&G), becoming shortened in many academic medical institutions. Empowerment of patients combined with changes in their expectations of interactions with medical professionals may have further restricted access to clinical cases. Changes in attitudes to teaching gynaecological examination may not be restricted to patients; medical educationalists may also have become more conservative or less experienced such that they find teaching vaginal examination an increasing challenge.

Whatever the reasons underlying the diminishing exposure of medical students to gynaecological examination are, the current status quo is unacceptable. Teaching innovations are urgently required to enhance teaching of a skill which is fundamental to both gynaecological and general medical practice. A strategy becoming increasingly popular is the use of "gynaecological teaching associates" or GTA's for short. These women are 'expert patients' who have been trained to undergo and teach gynaecological examination, giving valuable and immediate feedback to the students. In North America GTA's are quite commonly used in the medical curriculum and they have also been used in Canada, Australia and Scandinavia. In the UK pelvic examination is still mainly taught through simulation on pelvic models (manikins) combined with experience gained from supervised teaching on women attending outpatient clinics and those anaesthetised for surgery within clinical attachments. However, the length of these placements varies in length throughout UK medical schools and the quality of experience is likely to be inconsistent even within medical schools. In 2011 at the Birmingham Women's Hospital (BWH), we instituted a GTA teaching programme. Final year medical students from the University of Birmingham Medical School allocated clinical placements in O\&G at the BWH undergo GTA teaching within the first week of their five week attachment. To date, in keeping with other Universities with GTA programmes experience, such as Oxford University and Kings College, London (1), our students have given universally positive feedback (Clark TJ, Personal Communication).

Anecdotal qualitative data from our students is reassuring but whether the GTA programme in its current design is effective and indeed cost-effective in key educational outcomes is unclear. The published data available are generally descriptive studies of the process and institution of GTA programmes into the undergraduate medical curriculum (2-7). Studies addressing student competence and confidence are limited to small, observational series. One non-randomised controlled study from the UK demonstrated that students who had been trained with GTA's were significantly better than those who had been trained with pelvic models alone (1). However, in this study the GTA training was supplementary to the normal curriculum so the amount of teaching rather than the style of teaching may have acted as a confounding factor. Moreover, a valid assessment tool was not used to assess clinical performance. Evaluating the educational benefit of GTAs is also important if we are to allocate scarce undergraduate educational resources efficiently. Gynaecological teaching associates are paid professionals and introducing this method of teaching has financial implications for Universities.

At present, the University of Birmingham has not fully incorporated GTA teaching into its final year O\&G curriculum with 150/400 students placed at the BWH being taught in this way. Thus, with opinion as to the value of GTAs not yet solidified and in the absence of rigorous scientific assessment of the educational and economic benefits of GTAs, we propose a large randomised controlled trial. The RCT will compare the effectiveness and cost-effectiveness of teaching female pelvic examination to medical students using GTAs with traditional teaching using pelvic manikins.

Objectives

The TARGET RCT has been designed to answer the following research questions:

Principal Research Question

  • Do gynaecological teaching associates improve the level of confidence of medical students in performing gynaecological pelvic examination compared to manikin based teaching?

Secondary Research question

  • Do Gynaecological Teaching Associates improve the level of competence of medical students in performing gynaecological pelvic examination compared to manikin based teaching?
  • Do the following factors affect the competence and confidence of medical students in performing gynaecological pelvic examination: student gender; ethnicity; perception of clinical placement; number of supervised vaginal examinations conducted during clinical placement?
  • Are Gynaecological Teaching Associates cost-effective?
Being tested
Gynaecology Teaching Associates (GTA's), Manikin (conventional) training
Keywords
Gynaecology Teaching Associate, Pelvic examination, Students

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gynaecology Teaching Associates (GTA's)Behavioural

    Two GTA's will conduct the session according to the following structure; Students will receive a short anatomy PowerPoint presentation from the GTA's followed by demonstration of a gynaecological examination on a pelvic manikin. Students will then be taken to the out-patient department where one GTA will demonstrate pelvic examination on the other. Each student will then examine one of the GTAs under supervision by the other. The three non-active students will observe each of their colleagues' examinations. The students will then undergo a role play scenario where they will examine one of the GTAs under supervision of the other and feedback will be given by both GTAs.

  • Manikin (conventional) trainingBehavioural

    Clinical Lecturers in Gynaecology (equivalent to Specialist Registrar experience) will conduct the sessions as follows: Students will receive a short anatomy PowerPoint presentation (the same as used in the GTA training). The Clinical Lecturer will then demonstrate pelvic examination on the pelvic manikin. Each student will then perform the pelvic examination twice supervised by the Clinical Lecturer.

Study groups in NCT01944592
Study groupRoleWhat they receive
Gynaecology Training Associates (GTA's)ExperimentalFinal year (Year 5) medical undergraduates embarking upon their O\&G clinical placement trained in pelvic examination with GTA's
Receives: Behavioral: Gynaecology Teaching Associates (GTA's)
Manikin trainingActive comparatorFinal year (Year 5) medical undergraduates embarking upon their O\&G clinical placement trained in pelvic examination on manikins.
Receives: Behavioral: Manikin (conventional) training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Student confidence

    At the start of the placement in O\&G (during week one), the students will be asked to rate their confidence in gynaecological examination. The assessment tool comprises five questions relating to various communication and practical aspects of the procedure as well as a further global assessment of confidence. A 100mm VAS will be used to measure response. The students will be asked to rate their confidence on the same scales at the end of their placement.

    Measured: At the end of placement (week 5)

Secondary outcomes (3)
  1. Student competence

    all participants will be invited to attend an assessment session under standard MB ChB examination conditions. Two senior examiners (post MRCOG specialists in Gynaecology), with an interest in Medical Education and familiarity in OSCE style assessments will assess the students independently using a validated assessment tool (Personal Communication, Clark TJ). The assessment tool comprises six domains including a global assessment with competence measured according to a 100mm visual analogue scale (VAS). The mean score over all domains will form the final student score. Examiners will be blinded to the student's group allocation.

    Measured: At the end of placement (week 5)

  2. Number of vaginal examinations performed

    The students will be asked how many vaginal examinations they have performed (excluding those on GTAs) during their five week placement under supervision on (i) women in the outpatient clinic or ward setting; (ii) women under general anaesthesia prior to operative intervention.

    Measured: At the end of placement (week 5)

  3. Student rated usefulness of training session

    All students will be asked to rate the usefulness of their initial training sessions in pelvic examination.

    Measured: At the end of placement (week 5).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
492 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01944592
Sponsor's protocol ID
TARGET001
Acronym
TARGET
Status last verified
Feb 2015
First submitted
13 Sep 2013
Last updated
5 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Pickard S, Baraitser P, Rymer J, Piper J. Can gynaecology teaching associates provide high quality effective training for medical students in the United Kingdom? Comparative study. BMJ. 2003 Dec 13;327(7428):1389-92. doi: 10.1136/bmj.327.7428.1389.

    PubMed 14670887
  • Wanggren K, Fianu Jonassen A, Andersson S, Pettersson G, Gemzell-Danielsson K. Teaching pelvic examination technique using professional patients: a controlled study evaluating students' skills. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1298-303. doi: 10.3109/00016349.2010.501855.

    PubMed 20846063
  • Wanggren K, Pettersson G, Gemzell-Danielsson K. Medical students learning the pelvic examination: evaluation of a clinical patient model. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1304-9. doi: 10.3109/00016349.2010.513425.

    PubMed 20726831
  • Robertson K, Hegarty K, O'Connor V, Gunn J. Women teaching women's health: issues in the establishment of a clinical teaching associate program for the well woman check. Women Health. 2003;37(4):49-65. doi: 10.1300/J013v37n04_05.

    PubMed 12956214
  • Beckmann CR, Barzansky BM, Sharf BF, Meyers K. Training gynaecological teaching associates. Med Educ. 1988 Mar;22(2):124-31. doi: 10.1111/j.1365-2923.1988.tb00422.x.

    PubMed 3374413
  • Beckmann CR, Sharf BF, Barzansky BM, Spellacy WN. Student response to gynecologic teaching associates. Am J Obstet Gynecol. 1986 Aug;155(2):301-6. doi: 10.1016/0002-9378(86)90814-8.

    PubMed 3740146
  • Plauche WC, Baugniet-Nebrija W. Students' and physicians' evaluations of gynecologic teaching associate program. J Med Educ. 1985 Nov;60(11):870-5.

    PubMed 4057229
  • Janjua A, Roberts T, Okeahialam N, Clark TJ. Cost-effective analysis of teaching pelvic examination skills using Gynaecology Teaching Associates (GTAs) compared with manikin models (The CEAT Study). BMJ Open. 2018 Jun 22;8(6):e015823. doi: 10.1136/bmjopen-2017-015823.

    PubMed 29934378

Questions about this trial

What is this clinical trial studying?

A study testing Gynaecology Teaching Associates (GTA's) and Manikin (conventional) training in people with Female Pelvic Examination, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Student confidence (time frame: At the end of placement (week 5)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01944592, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.

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