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临床试验/NCT03135080
NCT03135080已完成不适用

The Effect of Long-Term HEAD START Training on Surgical Skill Levels

University of North Carolina, Chapel Hill5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
5
主要终点
Number of participants who feel long-term HEAD START use is beneficial for their surgical practice.

研究概览

简要总结

The research group developed a surgical simulation device, the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery. In most settings, HEAD START is utilized once during training, then surgeons move on to live surgery and typically do not return to the simulator. The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training, since many surgeons operate seasonally, with long periods of downtime between surgical camps and with little field supervision.

Participating surgeons will practice on HEAD START weekly, with monthly feedback from a senior supervisor. Researchers will assess their skill level at the start of HEAD START training and again at the start of the new surgical season in the fall of 2017. Researchers will also administer questionnaires to elicit feedback on the HEAD START training and supervision process.

详细描述

Eliminating blinding trachoma by 2020 is a key goal of the World Health Organization (WHO). Nearly 8 million individuals worldwide are in need of trichiasis surgery to prevent blindness.1 Currently, many trichiasis surgery programs experience poor outcomes in 10-50% of patients.2-11 High-quality surgery with minimal post-operative trichiasis is critical for success of the WHO goals. Typically, non-physician "surgeons" perform the procedure. Historically, they have been provided with one-week of classroom training and then begin live surgery training.

The research group developed a surgical simulation device, the Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma (HEAD START), to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery. Based on this work, the WHO now recommends that all trainees receive training with a surgical simulation device before performing live surgery and that any refresher training should include simulation training as well.

In most settings, HEAD START is utilized once during training, meaning that once individuals are trained on HEAD START, they move on to live surgery and typically do not return to the simulator. In surgical sub-specialties with ready access to simulation devices, regular surgical simulation practice is utilized for skills maintenance and enhancement. The research team is interested in determining whether HEAD START provides benefit for long-term trichiasis surgery training, since many surgeons operate seasonally, with long periods of downtime between surgical camps and with little field supervision.

This project will compare skills of surgical trainees who continued with HEAD START practice and feedback throughout a 6-month break in surgery with those who did not. Study subjects will be selected based on their participation in an ORBIS-sponsored trichiasis surgery training program (either new training or refresher/conversion training). At the end of the standard training, the trainees who successfully complete training are ranked according to their scores on a classroom-based test and the WHO certification/assessment form. All individuals who successfully complete the training session and are scheduled to begin independent trichiasis surgery practice through the National Eye Care Program will be invited to participate in the study until we have reached 30 participants. Fifteen trainees will be invited to participate in long-term HEAD START practice in addition to performing regular live surgery. An additional 15 individuals will be selected for the trainer to assess their skill levels on live surgery at the end of training and again at the start of the surgical season this fall.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

At the end of the rainy season, an independent examiner (not involved in the HEAD START evaluations) will assess the first 1-2 surgeries of the season of all study participants. The assessor will not know whether surgeons had participated in the long-term HEAD START training over the rainy season.

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who have been selected to complete either
  • new trichiasis surgery training through the Orbis Ethiopia of FHF training program OR
  • refresher training for transitioning from bilamellar tarsal rotation surgery to posterior lamellar tarsal rotation surgery.
  • Plans to continue practicing as a trichiasis surgeon throughout 2017.

排除标准

  • Experienced surgeons who are retiring from surgical practice.

结局指标

主要结局

Number of participants who feel long-term HEAD START use is beneficial for their surgical practice.

时间窗: 6 months

All participants and the senior trainers who conducted the monthly evaluations will be asked to complete an end of project questionnaire documenting their experience with HEAD START regarding the usefulness of regular surgical simulation practice, value of the monthly calls, and any recommendations for changes to the approach. Trainee and trainer responses to an end-of-project questionnaire regarding the utility of incorporating regular HEAD START practice will be analyzed to understand the benefit of regular HEAD START practice.

次要结局

  • Change in overall live-surgery training assessment scores between baseline and follow up(6 months)
  • Change in individual criterion scores for live surgery skills(6 months)
  • Change in individual criterion scores for live surgery skills among long-term HEAD START participants, comparing those who were the most highly active surgeons versus those who were the least active(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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