Condition category
Cancer
Date applied
16/08/2018
Date assigned
05/09/2018
Last edited
04/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Breast cancer is the most common cancer discovered in women globally. Although great strides in detecting and treating patients with breast cancer have been made, these developments have not reached women in low and middle-income countries (LMICs), such as Rwanda. Simulation training is one solution, where screening and diagnostic techniques can be taught to healthcare providers. Simulation training involves teaching and practising techniques on models prior to performing skills on live patients.
We developed a simulation-based training program for health care providers in clinical breast examination (CBE). This study aims to look at whether low cost, locally available models, which are less realistic (low fidelity) are as effective for CBE teaching as high fidelity models. High fidelity models are made of realistic materials that look and feel similar to patients and anatomic structures, whereas low fidelity models sacrifice realism for increased affordability and availability. Low fidelity models can be especially important in LMICs, where resources and costs are strained.

Who can participate?
Adult medical students or residents rotating at CHUK hospital in Kigali, Rwanda

What does the study involve?
All participants will receive clinical breast examination (CBE) training, which will involve lectures and hands-on training, along with 4 examinations of these skills throughout the training day. Participants will be randomly allocated to perform this on either a high fidelity or low fidelity model. The examinations will be recorded on video for evaluation; however, their faces will not be recorded.

What are the possible benefits and risks of participating?
The possible benefit to participants taking part in this study is that they will learn the skills required for effective clinical breast examination. There are no known risks to participants taking part in this study.

Where is the study run from?
CHUK Hospital Kigali (Rwanda)

When is the study starting and how long is it expected to run for?
May 2014 to May 2017

Who is funding the study?
Center for Surgery and Public Health - Brigham and Women's Hospital (USA)

Who is the main contact?
1. Dr Shilpa Murthy (shilpamurthy83@gmail.com)
2. Dr Robert Riviello (robertriviello@gmail.com)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shilpa Murthy

ORCID ID

Contact details

205 Race Street Apt 9I
philadelphia
46204
United States of America

Type

Scientific

Additional contact

Dr Robert Riviello

ORCID ID

Contact details

1620 Tremont St
Boston
02120
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Clinical breast exam skill acquisition using high fidelity versus low fidelity simulation models in Rwanda: a randomised crossover trial

Acronym

Study hypothesis

We used a randomized cross-over trial study design focused on clinical breast exam skill acquisition using high fidelity versus low fidelity models to determine whether training on low fidelity models confers similar skill acquisition as training on high fidelity models.

Ethics approval

Rwanda National Health Research Committee, 10/09/2014, NHRC/2014/PROT/0182
CHUK Ethics Committee, 08/08/2014, EC/CHUK/2014/14

Study design

Interventional single-centre randomised crossover trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Breast cancer

Intervention

Participants were randomised using a computerised random number generator in blocks of two. For every two participants, one was randomised to the high fidelity simulation (HF) group and one to the low fidelity simulation (LF) group. Participants received their fidelity group in a sealed envelope. Participants were not blinded to the models, as both types of models were present in the classroom. The video recordings were coded with unique identifiers so that the video rater was blinded to the level of trainee (medical student versus resident), and the exam attempt (exam 1, 2, 3, versus 4).
A one day four-hour simulation-based session designed to teach clinical breast examination (CBE) was implemented for both groups. This educational course was developed using standardized materials and lesson plans adapted for Rwanda based off primary literature, medical textbooks, the American College of Surgeons (ACS) student simulation-based surgical skills curriculum, surgical council on resident education (SCORE), and breast objective structured clinical exam (OSCE). Participants performed a baseline CBE on the model they were randomised to prior to any teaching sessions. Following this pre-test (Exam 1), participants engaged in a two-hour didactic lecture series on breast anatomy, breast pathology, and CBE. Didactic teaching sessions between HF and LF groups were identical. All lectures were taught by investigator Murthy, SS, with the exception of breast anatomy lecture, which was taught by investigator Ingabire, A when his clinical duties permitted. Following the lectures, students performed a clinical breast examination on the model they were randomised to (Exam 2). After this second exam, students had 90 minutes of hands-on training and practice with the simulator model by investigator (Murthy, SS). Trainees had the opportunity to undergo repeated practice of CBE with immediate feedback from study investigator (Murthy, SS). After lectures, hands-on simulation teaching and practice, participants took a third CBE exam (Exam 3), and then participated in a fourth CBE exam (Exam 4) where they crossed over to the other model they were not originally randomised to. A video analysis technique was used to evaluate the CBE technical skills of participants at each point of the exam. The participants had their entire attempt anonymously recorded using a video recording device. In order to maintain confidentiality, the individual’s face was not recorded, and a unique study number was used in all videos.
Consent was obtained from all participants in the study.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Our primary outcome was to determine mean difference in CBE exam scores between HF and LF groups. The evaluation tool used to score clinical breast exams was published in a study by Schubart et. al and we obtained permission from the authors to use their tool. We expanded and adapted the tool to fit it to the Rwandan cultural context with a similar scoring system as the original research paper.
This was assessed at exams 1-4 and 1 month after the intervention.

Secondary outcome measures

The following are assessed at exams 1-4 and 1 month after the intervention:
1. Overall improvement in CBE exam scores after the education intervention was implemented
2. Whether addition of simulation to lectures improved the mean difference in CBE exam scores
3. Provider level traits that may affect the mean difference in exam scores

Overall trial start date

01/05/2014

Overall trial end date

01/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Consenting medical students or residents rotating at CHUK hospital in Kigali, Rwanda
2. Aged 18 years or older

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

N/A

Recruitment start date

01/07/2014

Recruitment end date

31/03/2015

Locations

Countries of recruitment

Rwanda

Trial participating centre

University Teaching Hospital Kigali
KN 4 Ave
Kigali
N/A
Rwanda

Trial participating centre

Center For Surgery and Public Health
1620 Tremont St
Boston
02120
United States of America

Sponsor information

Organisation

Center for Surgery and Public Health, Brigham and Women's Hospital

Sponsor details

1620 Tremont St
Boston
02120
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Center for Surgery and Public Health, Brigham and Women's Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are hoping to publish the results by 2020.

IPD sharing statement:
Datasets will not be available unless we get permission from our Rwandan co-investigators, as this is a collaborative multi-institutional international study

Intention to publish date

31/12/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/04/2019: The intention to publish date was changed from 31/10/2018 to 31/12/2020.