跳至主要内容
临床试验/CTRI/2024/05/066591
CTRI/2024/05/066591尚未招募不适用

IMpact of sImulation-based Training of Anaesthesia residenTs on Informed cONsent process (IMITATION study)

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Significant improvement in consent process as defined by 3-point improvement in the consent taking checklist assessed by the research nurse

研究概览

简要总结

Background :

Informed consent is a fundamental principal in the health care context which includes the patient’s capacity to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Hence, the informed consent refers both to the health professional’s obligation of information disclosure to the patient and to the quality of the patient’s understanding and decision making

Informed consent is composed of three components: preconditions, information, and consent.

“Preconditions” in this context means that a patient is competent as well as willing to grant consent for the proposed medical treatment. To exercise this right, the patient should possess the capacity to make such decisions and must be able to decide without being influenced by other individuals, which includes medical personnel.

The second component of informed consent is “information”. As per the World Health Organisation (WHO) resolution on the promotion of patients’ rights, patients have the right to receive full knowledge regarding the status of their health. This includes their current medical condition, information about the suggested medical procedure, any risks and benefits associated with the said procedure, and any possible alternatives to the planned procedure. The patient should also be educated about the possible effects on their health should they refuse to proceed with the proposed treatment. The process of informed consent should also include a definite care plan including the physician’s advice, and it must be ensured that the patient has successfully comprehended the information shared with them.

Taking informed consent is a fundamental skill expected to be mastered by anaesthesia residents during their training period. Informed consent forms a component of the anaesthesia patient care competency within the pre-anaesthetic evaluation, assessment, and preparation. Studies have shown that consent discussions are usually incomplete. These shortcomings of insufficient consent discussion are often responsible for increased litigation.

Aim : To assess the impact of training in the process of consent taking for anaesthesia

Objectives:

  1. Assessment of impact of consent training on practices regarding anaesthesia consent process of the whole study population
  2. Assessment of impact of consent training on practices regarding anaesthesia consent process of the individual study participants
  3. Assessment of existent practices regarding anaesthesia consent process
  4. Correlation between clinical experience and quality of anaesthesia consent process

Correlation between clinical experience and degree of improvement in quality of anaesthesia consent process.

We aim to assess the residents on their baseline level of consent taking for Anaesthesia, train them and evaluate the impact of the training given to them.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • MD Anesthesia Trainees/Senior Residents working and training in the department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Mumbai
  • Research staff willing to be a part of the study.

排除标准

  • Anesthesia Trainees /Senior Residents who refuse to give consent
  • Anesthesia Trainees / Senior Residents whose tenure is likely to end before the completion of all three phases of the study.

结局指标

主要结局

Significant improvement in consent process as defined by 3-point improvement in the consent taking checklist assessed by the research nurse

时间窗: Until 4 weeks post training

次要结局

  • 1. Quantum of checklist score improvement after training(2. Predictors of significant improvement in change as per the baseline demographics)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Reshma Ambulkar

Tata Memorial Centre

研究点 (1)

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