Trial Title:
Building Capacity for Screening & Early Diagnosis of Colorectal Cancer Through a Comprehensive Colonoscopy Training Program in Nigeria
NCT ID:
NCT05686499
Condition:
Colon Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Trainees will be selected from among resident doctors and consultants working in teaching
hospitals and federal medical centres that have facilities for colonoscopy. These will be
randomized into two arms - high fidelity (HF) and low fidelity (LF) arms. Baseline test
will then be carried out by the trainees after which they will be exposed to colonoscopy
lectures and demonstrations using respective fidelity type to which they are randomized.
Simulation examination will then be carried out after which trainees will be cross-overed
to alternate arms for further simulation on different fidelity types. They will then all
have opportunity to perform colonoscopy on live patients which will be supervised and
accessed by trainers.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Didactic Lectures and demonstrations
Description:
1. Trainees will receive 4-6 hours of didactic colonscopy lecture sessions 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 adapted to Nigeria context.
2. Trainees will have the opportunity to practice colonoscopy on HF or LF simulators
(depending on the arm) with immediate feedback from instructors.
Arm group label:
High Fidelity (HF) Arm
Arm group label:
Low Fidelity (LF) Arm
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age >18
- Health care professionals will include consultants and registrars in medicine,
surgery, and gastroenterology
Exclusion Criteria:
- Participants under the age of 18
- Participants unwilling to sign consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals
Address:
City:
Ile Ife
Zip:
220005
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Olusegun I Alatise, FWACS
Phone:
2348033859387
Email:
segunalatishe@gmail.com
Facility:
Name:
Obafemi Awolowo University Teaching Hospitals Complex
Address:
City:
Ile-Ife
Zip:
220005
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Olusegun I. Alatise, MD
Phone:
+2348033859387
Email:
segunalatishe@gmail.com
Contact backup:
Last name:
Funmilola O. Wuraola, MD
Phone:
+2348032287556
Email:
wuraie@yahoo.com
Investigator:
Last name:
Shilpa S. Murthy, MD
Email:
Sub-Investigator
Start date:
March 9, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Obafemi Awolowo University Teaching Hospital
Agency class:
Other
Collaborator:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Obafemi Awolowo University Teaching Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05686499
