Clinical trial NCT01944592: Teaching Associates Randomised to Evaluate the Effectiveness of Gynaecological Pelvic Examination Versus Traditional Teaching Using Manikins
Official title: Gynaecology Teaching Associates Versus Teaching on Manikins: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Pelvic Examination
Keywords: Gynaecology Teaching Associate
Pelvic examination
Students
Lead sponsor: Birmingham Women's NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2013-09-17
Enrollment: 492
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

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?

Eligibility criteria: Inclusion Criteria:

* Final year medical students
* Consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Student confidence
timeFrame: At the end of placement (week 5)
Secondary outcomes:
measure: Student competence
timeFrame: At the end of placement (week 5)
measure: Number of vaginal examinations performed
timeFrame: At the end of placement (week 5)
measure: Student rated usefulness of training session
timeFrame: At the end of placement (week 5).
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
state: West Midlands
Study officials:
affiliation: Birmingham Women's NHS Foundation Trust
name: Thomas J Clark, MBChB MD(hons)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Plauche WC, Baugniet-Nebrija W. Students' and physicians' evaluations of gynecologic teaching associate program. J Med Educ. 1985 Nov;60(11):870-5.
citation: 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.