Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05686499 |
| Other study ID # |
ERC/2022/07/03 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2024 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Obafemi Awolowo University Teaching Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This protocol seeks to develop a colonoscopy training program in Nigeria in order to increase
the number of health care providers proficient in colonoscopy. The goal is to improve
capacity for screening and early diagnosis of colorectal cancer (CRC) by training and
expanding the healthcare workforce that is competent in endoscopy techniques. The project has
three components, a needs assessment, simulation training, and training on live patients.
The first part of this project determines the number of providers and endoscopy procedures
currently performed in Nigeria, as well as patient access to facilities that have colonoscopy
capabilities, through a mixed methods approach. Surveys, focus in-depth interviews with key
stakeholders, and use geographic information system (GIS) modeling technology will be
employed to perform a needs assessment. The second component of this project investigates
whether a locally developed low fidelity (LF) simulation colonoscopy training model is an
effective teaching, training, and assessment tool for skill acquisition and confidence
compared to a high-fidelity (HF) colonoscopy model. The third component of this project is
training healthcare providers on real patients who have an indication for colonoscopy. This
project seeks to build capacity for endoscopy services in order to increase capacity for
screening and early diagnosis of CRC. At the end of the project, it is expected the number of
providers trained to perform colonoscopy in a resource limited setting like Nigeria will
increase.
Description:
The goal of this project is to build capacity for early diagnosis of CRC by developing a
comprehensive colonoscopy training program that could in the future lead to credentialing and
accreditation of a trainee. The first aspect of the project focuses on needs assessment
analysis as it determines the quantity of providers and access to facilities that perform
colonoscopy through surveys, focus in-depth interviews, and GIS technology. The second
component investigates whether a locally developed LF simulation colonoscopy training tool is
an effective teaching, training, and assessment tool for skill acquisition and confidence
compared to a HF colonoscopy model in a resource limited setting. The third component of the
project will assess whether training on a low or high-fidelity simulator then translates to
improved performance of colonoscopy on live patients. At the end of the project, it is
expected the number of providers trained to perform colonoscopy in a resource limited setting
like Nigeria will increase.
OVERVIEW OF STUDY DESIGN/INTERVENTION A mixed methods survey was developed that determines
the baseline number of endoscopists, nurses, anaesthetists, ancillary staff, costs, and the
number of procedures performed per year in endoscopy centers in the country of Nigeria. This
survey will be developed with qualitative specialists at the Obafemi Awolowo University (OAU)
and the Memorial Sloan Kettering Cancer Center (MSKCC). Healthcare professionals who are part
of Nigerian medical societies will be invited to participate in the survey through paper,
electronic, or social media platforms. Focused in-depth interviews with key stakeholders will
be conducted to further understand the barriers to endoscopy care in Nigeria.
Prior to participating in this survey study, the purpose of the study will be explained to
potential participants. They will be provided information about the research study in written
form and a consent form will be provided. Consent will be obtained in written form in
English, since this is the national language medium used for medical professionals in
Nigeria.
Results from this survey and collaborations with medical societies in Nigeria, will provide
information needed to identify which healthcare facilities perform endoscopy in Nigeria. GIS
technology will be utilized to analyze patient access to these facilities based on locations
of facilities to neighborhoods where patients may reside. Qualitative surveys and focus
interviews with key stakeholders will also provide information on barriers to accessing and
providing care to patients who need colonoscopy.
For the simulation training portion of the study, following initial recruitment, an equal
number of consented participants will be randomized to learn colonoscopy on high or low
fidelity models. The HF simulator will be Limbs and Things Colonoscopy Training Model product
KKM40. The LF simulator will be made in Nigeria, based on low fidelity models that have been
published in the literature. Prior to beginning the course, the participants will be given
instructions, a prior experience and confidence survey, and then will be asked to perform
colonoscopy. This first assessment will serve as a baseline measure of colonoscopy skills.
The LF group will perform a pretest on LF models, and the HF group will perform the pre-test
on HF models. Participants will be evaluated utilizing the Mayo colonoscopy skills assessment
tool and the Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) tools that have
been validated and published in the literature previously.
Following this pre-test, study participants will partake in didactic teaching sessions. The
colonoscopy lecture curriculum will be adapted for the Nigerian context and standardized
utilizing content based on the American Board of Surgery Flexible Endoscopy curriculum for
general surgery residents, general surgery resident curriculum (SCORE) endoscopy module, and
the Joint Advisory group on GI Endoscopy program. Teaching sessions between high and low
fidelity groups will be identical except for the type of simulation models used to
demonstrate and practice colonoscopy. Trainees will have the opportunity to practice
colonoscopy on simulators with immediate feedback from instructors.
After this 4-6-hour teaching session, participants will take a post-test identical to the
colonoscopy pre-test. The next day participants will perform colonoscopy procedures on live
patients and be evaluated on live patients utilizing the GAGES and mayo colonoscopy skills
assessment tools. Additionally, at the end of the study, participants will be asked to fill
out a confidence survey During the live patient sessions, the study will involve patients who
were scheduled to undergo a clinically indicated colonoscopy. The patients will sign a
consent form to be part of the study which allows trainees to perform colonoscopy under the
direct supervision by trained colonoscopy physician. The trainee will be the primary
endoscopist under the supervision of a faculty endoscopy evaluator. The evaluator will allow
the study participants independence while ensuring patient safety. The instructor can provide
verbal instruction if necessary. If the instructors feel the study participant is not making
progress or if patient safety is of concern, the instructors are permitted to take control of
the colonoscopy and navigate through difficult portions of the colon or takeover the
procedure completely. The maximum time that will be allotted for the trainee to complete the
colonoscopy will be 30 minutes. A critical flaw point will be given to the trainee
participant if complete takeover occurs, although they will be given the opportunity to try
again on a different patient if feasible.
Trainees will also be evaluated based on total procedure time, time to rectosigmoid junction,
splenic flexure, hepatic flexure and cecal intubation, % of successful cecal intubation, % of
time for which the view of the lumen was lost, % of times TI intubation successful, and
withdrawal time of colonoscopy from cecum, avoidance of bowel perforation and median depth of
maximal insertion based on the following scale: 1 = rectum, 2 = sigmoid, 3 = descending
colon, 4 = splenic flexure, 5 = transverse colon, 6 = hepatic flexure, 7 = ascending colon, 8
= cecum. Additionally, at the end of the study, participants will be asked to fill out course
satisfaction and confidence surveys.
PRIMARY AND SECONDARY OUTCOMES Primary Outcome: To determine whether learning colonoscopy on
a LF simulation model confers similar skill acquisition and confidence as training on a HF
model Secondary Outcomes: Determine access to endoscopists and endoscopy facilities barriers
to endoscopy, and costs of endoscopy in Nigeria. Assess whether training on a low or
high-fidelity simulator improves colonoscopy performance on real patients. To evaluate the
overall improvement in technical skills of trainees before and after delivery of a
simulation-based colonoscopy training program designed to teach colonoscopy in a resource
limited setting. Investigators will also determine costs of implementing a colonoscopy
training program as well as costs of endoscopy at each of the facilities.
