Teaching Associates Randomised to Evaluate the Effectiveness of Gynaecological Pelvic Examination Versus Traditional Teaching Using Manikins
NCT ID: NCT01944592
Last Updated: 2015-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
492 participants
INTERVENTIONAL
2013-09-30
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preparing Medical Students to Undertake a First Female Pelvic Exam.
NCT01101971
Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women
NCT03241524
Simulation in Teaching Vaginal Examination
NCT02664025
Surgical Operating Room Enhancement Curriculum for Medical Students
NCT07006337
Evaluation of the PelvicSim Simulator for Training in Intrauterine Device Insertions
NCT02220205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gynaecology Training Associates (GTA's)
Final year (Year 5) medical undergraduates embarking upon their O\&G clinical placement trained in pelvic examination with GTA's
Gynaecology Teaching Associates (GTA's)
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 training
Final year (Year 5) medical undergraduates embarking upon their O\&G clinical placement trained in pelvic examination on manikins.
Manikin (conventional) training
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gynaecology Teaching Associates (GTA's)
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) training
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consent
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Birmingham Women's NHS Foundation Trust
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thomas Justin Clark
Consultant Obstetrician and Gynaecologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas J Clark, MBChB MD(hons)
Role: PRINCIPAL_INVESTIGATOR
Birmingham Women's NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham Womens Hospital
Birmingham, West Midlands, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Plauche WC, Baugniet-Nebrija W. Students' and physicians' evaluations of gynecologic teaching associate program. J Med Educ. 1985 Nov;60(11):870-5.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TARGET001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.