Hybrid Simulation in Teaching Clinical Breast Examination (HS-CBE)

June 22, 2015 updated by: Rana Sharara, American University of Beirut Medical Center

The Use of Hybrid Simulation (HS) of the Breast in Teaching Clinical Breast Examination (CBE) to Medical Students.

The purpose of this study is to determine whether the use of hybrid simulation of the breast are more effective in teaching CBE technique and culturally sensitive doctor-patient communication skills to medical students than the traditional method.

Study Overview

Detailed Description

Breast cancer is a Lebanese national problem. Campaigns for mammography screening are effective but recommendations on breast examinations screening for breast tumors are lacking. On one hand, the Lebanese population is culturally diverse, with women's beliefs ranging from liberal to extremely conservative. On the other hand, Clinical Breast Examination (CBE) is traditionally taught to medicine III students in a lecture, followed by practice on a low-fidelity breast model. The opportunity to clinically practice CBE depends on patient availability and her willingness to be examined by students. This is further limited by some Lebanese women's cultural and religious beliefs. Little is known about the effect of patient cultural practices on the efficacy of CBE.

In this project, we focus on the need for an effective educational tool for teaching CBE to physicians-in-training. The proposed teaching method in this study is hybrid simulation: breast model jacket (simulator) worn by a trained actress (standardized patient, SP). In this study, we compare this standardized educational tool to the traditional teaching method which consists of a lecture and training on a low-fidelity (unrealistic) breast model on a desk (no SP).

We hypothesize that the use of this hybrid simulation tool, as compared to the traditional teaching method, will result in a more complete CBE, better lesion detection and improved culturally sensitive communication skills in terms of awareness of, and ability to deal with, cultural differences related to breast examination.

In order to do so, we will evaluate medical students' performance and examine their attitudes and cultural competencies when they perform CBEs on 3 culturally different standardized patients using hybrid simulation scenarios. Through an experimental design that minimizes biases related to selection of students (randomized controlled), we will compare hybrid simulation (intervention) with low-fidelity simulation (control) in teaching CBE.

Medicine-III students rotating in the Obstetrics and Gynecology department at the American University of Beirut Medical Center (AUBMC) will be asked to participate; they are free to refuse without any effect on their grades in the rotation. The students will be assessed in an Objective Structured Clinical Examination (OSCE) setting similar to their usual oral clinical exams but not contributory to their academic evaluation in the Faculty of Medicine. The OSCE setting will include encounters with 3 culturally different Standardized Patients (1 "outgoing" woman, 1 with "chador", and 1 moderately conservative woman). The assessment tools are questionnaires that are either objective (filled by SP) or self-reporting (filled by students) about (1) met learning objectives, (2) student's attitude, and (3) clinical cultural competency.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beirut, Lebanon
        • American University of Beirut Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Third year medical students (Med III) at the American University of Beirut
  • Rotating in the Obstetrics and Gynecology department at the American University of Beirut Medical Center

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-Fidelity Simulation
Teaching using traditional method
Students in the "control" group will receive the regular lecture given at the American University of Beirut and will attend the usual simulation lab teaching activities (single breast silicone model without any actors). The only new introduction to the curriculum is an educational video on the technique of CBE.
Other Names:
  • Lecture with low-fidelity breast model
Experimental: Hybrid Simulation
Teaching using Hybrid Simulation of breast examination
Students in the "intervention/experimental" group will receive the regular lecture given at the American University of Beirut and will attend a screening of an educational video on the technique of CBE, in addition to the hybrid simulation teaching activities in the simulation lab (standardized patient wearing breast examination simulator jackets)
Other Names:
  • Standardized Patient wearing breast jacket

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBE completeness (in OSCE)
Time Frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
SPs will be objectively grading the students on a scoring sheet
Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Student's attitude about the teaching activity
Time Frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
Self-reported questionnaires
Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
Cultural communication skills (in OSCE)
Time Frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
SPs will be objectively grading the students on a scoring sheet
Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
Student's attitude about the assessment activity (OSCE)
Time Frame: On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity)
Self-reported questionnaires
On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Abdul Karim Sleiman, MD, American University of Beirut Medical Center
  • Principal Investigator: Rana Sharara-Chami, MD, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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