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临床试验/NCT06010836
NCT06010836已完成不适用

Anesthesiology Counseling, Consent, & Professionalism

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2021年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
257
试验地点
2
主要终点
Number of Participants Who Recall Anesthesia Team Members

研究概览

简要总结

The anesthesia consent form has become a standard before surgery. However, verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion has not been addressed. This study will use preoperative discussions and postoperative patient questionnaires to examine the degree of awareness that the patients and the patients families have regarding what general anesthesia is, the responsibilities of the anesthesiologist, and the specifics of what the participants are agreeing to by signing the consent form.

详细描述

There is a substantial body of work regarding the written anesthesia consent form. As a result, the written anesthesia consent form has become a standard requirement throughout the United States of America. However, there has been little examination of verbal aspects of anesthesia consent and of the value of the preoperative anesthesia discussion that should take place prior to surgery. Non-anesthesia medical studies have indicated that inadequate patient-physician communication and an inadequate patient-physician relationship will result in misunderstanding and an increased malpractice risk. Lack of understanding of the duties and responsibilities of anesthesiologists is also damaging to the professional status of the field of anesthesiology. This study will utilize patient interviews and questionnaires to examine the degree of awareness that the patients and the patients families possess regarding what general anesthesia is, the duties and responsibilities of the anesthesiologist, the role of the anesthesiologist within the operating room and the specifics of what the participants are agreeing to by signing the consent form. If it is determined that a more structured and thorough pre-anesthesia discussion will help patients and the patients families understand what general anesthesia is, understand the specific responsibilities of anesthesiology providers, understand the professional status of anesthesiologists, give the participants a better feeling of autonomy and better understand what the participants are agreeing to by signing the consent form, then there will be substantial ramifications to the priority and importance given to pre-anesthesia discussions nationwide. Secondary benefits include influences on anesthesia residency training and improved patient satisfaction with the anesthesia experience.

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 (Participant)

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

  • Age 18 and up
  • Elective Procedures
  • English-speaking
  • Consenting for general anesthesia

排除标准

  • Obstetric patients
  • Prisoners
  • Emergency cases
  • Patients under age 18
  • Patients don't speak English
  • Not consented for general anesthesia

研究组 & 干预措施

Control

No Intervention

Group getting standard treatment without script guided intervention in the preoperative period

Script guided intervention

Experimental

Group getting script guided intervention during the preoperative conversation

干预措施: Script guided conversation (Behavioral)

结局指标

主要结局

Number of Participants Who Recall Anesthesia Team Members

时间窗: up to 3 days after surgery

Postoperative recall of anesthesia conversation. Recall of team members score 0-100 with higher score indicating better recall of anesthesia team members.

Number of Participants Who Recall Anesthetic Risks

时间窗: up to 3 days after surgery

anesthesia risks, (0) don't remember any risks - (3) remembered 3 or more correctly

Postoperative Understanding of Anesthetic Plan as Assessed by the Questionnaire Developed by the Study Team

时间窗: up to 3 days after surgery

Demonstrate understanding of anesthetic plan; score total 0-100 with a higher score more understanding. Standard deviation is reported.

次要结局

  • Number of Participants Satisfied With Anesthesia Conversation(up to three days after surgery)
  • Preoperative Anxiety as Assessed by Questionnaire Developed by Study Team(up to 3 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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