Trial record 2 of 1333 for:    gynecology

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Birmingham Women's NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01944592
First received: September 13, 2013
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Female Pelvic Examination
Behavioral: Gynaecology Teaching Associates (GTA's)
Behavioral: Manikin (conventional) training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Gynaecology Teaching Associates Versus Teaching on Manikins: a Randomised Controlled Trial

Further study details as provided by Birmingham Women's NHS Foundation Trust:

Primary Outcome Measures:
  • Student confidence [ Time Frame: At the end of placement (week 5) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Student competence [ Time Frame: At the end of placement (week 5) ] [ Designated as safety issue: No ]
    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.

  • Number of vaginal examinations performed [ Time Frame: At the end of placement (week 5) ] [ Designated as safety issue: No ]
    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.

  • Student rated usefulness of training session [ Time Frame: At the end of placement (week 5). ] [ Designated as safety issue: No ]
    All students will be asked to rate the usefulness of their initial training sessions in pelvic examination.


Estimated Enrollment: 340
Study Start Date: September 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Behavioral: 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.
Active Comparator: Manikin training
Final year (Year 5) medical undergraduates embarking upon their O&G clinical placement trained in pelvic examination on manikins.
Behavioral: 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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Final year medical students
  • Consent

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944592

Contacts
Contact: Thomas J Clark, MBChB MD 00441216074712 justin.clark@bwhct.nhs.uk
Contact: Paul P Smith, MBChB BSci 00441216272702 paul.smith@bwhct.nhs.uk

Locations
United Kingdom
Birmingham Womens Hospital Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TG
Contact: Thomas J Clark, MBChB MD    00441216074712    justin.clark@bwhct.nhs.uk   
Contact: Paul P Smith, MBChB BSci    00441216272702    paul.smith@bwhct.nhs.uk   
Sub-Investigator: Paul P Smith, MBChB         
Sub-Investigator: Justin Chu, MBChB         
Sub-Investigator: Aisha Janjua, MBChB         
Sponsors and Collaborators
Birmingham Women's NHS Foundation Trust
Investigators
Principal Investigator: Thomas J Clark, MBChB MD(hons) Birmingham Women's Hospital
  More Information

Publications:
Responsible Party: Thomas Justin Clark, Consultant Obstetrician and Gynaecologist, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01944592     History of Changes
Other Study ID Numbers: TARGET001
Study First Received: September 13, 2013
Last Updated: October 25, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Birmingham Women's NHS Foundation Trust:
Gynaecology Teaching Associate
Pelvic examination
Students

ClinicalTrials.gov processed this record on August 28, 2014