跳至主要内容
临床试验/NCT04438811
NCT04438811已完成不适用

Task-based Credentialing for Medical Officers in Spinal Anesthesia: An Innovative Approach to the Specialist Workforce Crisis in Rural Indian Hospitals Curriculum Training of Medical Officers

Harvard Medical School (HMS and HSDM)5 个研究点 分布在 2 个国家目标入组 486 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
486
试验地点
5
主要终点
Successful delivery of spinal anaesthesia

研究概览

简要总结

Test the safety and effectiveness of training medical officers in the provision of spinal anesthesia in a rural hospital context using a non-inferiority randomized trial.

The safety and effectiveness of the MOs will be evaluated through a non-inferiority trial in which patients are randomized to care by a trained MO or an anesthesiologist. The primary outcomes are safety (adherence to adapted anesthesia safety checklist- see supporting documents "Adapted Anesthesia Safety Checklist") and effectiveness (adequate analgesia) of spinal anesthesia.

详细描述

The vast majority of the world is without access to surgical and anesthesia care, and a severe workforce shortage is a major contributing factor. The Lancet Commission on Global Surgery (LCoGS) demonstrated that Africa and South Asia, home to over a third of the global population, lay claim to just 12% of surgeons, anesthesiologists and obstetricians. This workforce shortage may be particularly severe for anesthesia care given that anesthesiologist make up less than 20% of surgical care providers globally. In a series of qualitative interviews, providers across three continents noted that in rural and under-resourced areas, it was unlikely that there was a surgeon and an anesthesiologist in the same place.

In India, the concerns of under-provision of human resources in the rural area are especially severe. The Lancet commission on Global Surgery estimates that while 68% of Indians live in rural areas, only 22% of the health care workforce does. For specialist services, which are even more urbanized, the disparity is likely greater. The result is that, in South Asia, 95% of people are estimated to lack access to safe, affordable and timely surgical care.

In India, which is home to nearly 400 medical schools, it may be posited that the country is well positioned to close this gap. However, the number of postgraduate training seats - 14,000 countrywide - are entirely insufficient for the 50,000 doctors that graduate each year. With only 1500 postgraduate training seats for anesthesia, a graduate who may otherwise aspire to train in anesthesia instead remains generalist MO or seeks training elsewhere. The World Health Organization suggests that a presence of anesthesiologists in rural India may be so scarce it is "non-existent.". It has also been estimated that 43% of the Indian population lives more than 50km from their nearest health center, 76% of which do not have an anesthesiologist.

The result of these human resource limitations, is that rural Indian surgeons often administer anesthesia for their patient prior to performing necessary surgeries or medical officers with only ad hoc training provide anesthesia care. The de facto standard of care in rural India, ends up being the provision of anesthesia by a surgeon or untrained medical officer. While advocacy towards increasing post-graduate education must continue, it is also clear that interim measures are needed to improve upon current baseline practices.

One such measure suggested by the Disease Control Priorities 3 (DCP3), the LCoGS, and others is the concept of "task-based credentialing." In this model of credentialing, physicians are trained and credentialed in a limited set of procedures. Task sharing - a process by which non-specialists take on whole-sale the tasks typically performed by a specialist - is prevalent in the provision of anesthesia care worldwide. However, a recent meta-analysis evaluated outcomes for task-sharing in anesthesia in 15 LMIC and found that administration of anesthesia by a non-physician was a risk-factor for maternal mortality. To mitigate these concerns, task-based credentialing focuses on the training of non-specialist medical officers in a discrete, well-defined task and includes training to deal with the possible complications. This task-based training would serve as an improvement on the de facto standard of care in rural India by providing specific training in place of ad hoc learning.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for MOs
  • Consent to participate in practical training and clinical trial (consent process will be repeated)
  • Successful completion of the theoretical and simulation training
  • Be deemed safe to continue to practical training by their supervising Anesthesiologist
  • Feel comfortable to proceed to practical training
  • Inclusion criteria for patients
  • Age 18-65
  • Undergoing one of the surgeries noted in supporting document "List of surgeries for patient inclusion criteria" or otherwise deemed appropriate for spinal anesthesia as determined by surgeon and supervising anesthesiologist
  • Willingness to provide informed consent
  • ASA (American Society of Anesthesiology Physical Status Classification System) grades I and II
  • Inclusion criteria for Consultant Anesthetists
  • Anesthetist licensed to practice independently with availability to provide care at one of the selected sites

排除标准

  • Exclusion criteria for MOs
  • Recent suspension from clinical practice
  • Due to change sites or retire before the expected end date of the trial
  • Exclusion criteria for patients
  • Obese (BMI > 35)
  • Refusal of consent to participate in trial

结局指标

主要结局

Successful delivery of spinal anaesthesia

时间窗: Assessed pre-operatively following recruitment and consent (day 0 of the follow up period)

Delivery of spinal anaesthesia into the intrathecal space with three or less attempts and no intra-operative conversion to general anaesthesia due to spinal failure

次要结局

  • Post-operative Complications(Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively)
  • Patient experience measures(Reviewed at two time points - on discharge from healthcare facility or day 3 post-operatively (whichever occurs first) and day 10-14 post-operatively)
  • Intraoperative Complications(Assessed intraoperatively during surgical procedure)

研究者

发起方
Harvard Medical School (HMS and HSDM)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig McClain

Principle Investigator

Harvard Medical School (HMS and HSDM)

研究点 (5)

Loading locations...

相似试验

Task-based Credentialing for Medical Officers in... | 临床试验