跳至主要内容
临床试验/NCT05686499
NCT05686499招募中不适用

Building Capacity for Screening & Early Diagnosis of Colorectal Cancer Through a Comprehensive Colonoscopy Training Program in Nigeria

Obafemi Awolowo University Teaching Hospital4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
4
主要终点
ratio of low-fidelity simulator trained endoscopists with improved colonoscopy performance on real patients to high-fidelity simulator trained endoscopists with improved performance on real patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Health care professionals will include consultants and registrars in medicine, surgery, and gastroenterology

排除标准

  • Participants under the age of 18
  • Participants unwilling to sign consent

结局指标

主要结局

ratio of low-fidelity simulator trained endoscopists with improved colonoscopy performance on real patients to high-fidelity simulator trained endoscopists with improved performance on real patients

时间窗: 5 days

proportion of LF simulator training who can perform colonoscopy adequately on live patient to proportion of HF simulator training who can perform colonoscopy adequately on live patients

次要结局

未报告次要终点

研究者

发起方
Obafemi Awolowo University Teaching Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olusegun Alatise

professor

Obafemi Awolowo University Teaching Hospital

研究点 (4)

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