CIA: Consent in Anaesthesia, Prospective Randomised-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 206
- 主要终点
- Patient satisfaction CSQ-8
研究概览
简要总结
DESIGN: Prospective randomised-controlled trial AIM: To determine whether presenting both techniques of general anaesthesia and regional anaesthesia in an unbiased manner, with video media, aids the anaesthetic consent process, compared to standard verbal consent alone.
OUTCOME MEASURES
Primary outcome:
- Participants' satisfaction regarding the anaesthetic consent process
Secondary outcomes:
- Knowledge, attitudes and practices towards anaesthesia
- Participants' choice of anaesthetic technique POPULATION: General adult population (>18yrs), males and females DURATION: 2 years
详细描述
The main aim of this study is to determine if presenting both anaesthetic techniques of general anaesthesia (GA) and regional anaesthesia (RA) to a participant in an unbiased manner, with video media, affects the participants' satisfaction, knowledge of, and attitudes towards anaesthesia. The investigators hypothesise that using video media will improve participants' satisfaction with the anaesthetic consent process, thereby resulting in better quality informed consent.
Participant's knowledge retention, attitudes and practices towards GA and RA, measured by an knowledge, attitudes and practices (KAP) questionnaire based on the consent process. Participant's stated preference for anaesthetic technique (i.e. General or Regional).
Several studies have shown that video-based patient education have led to better patient comprehension and satisfaction as well as reduced patient anxiety during the consent process compared to verbal consent.
Examples The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial showed that 80.7% of patients preferred portable video media (PVM) and 19.3% preferred standard video consent (SVC). PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process.
Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia, showed that preoperative multimedia information reduces the anxiety of patients undergoing surgery under regional anaesthesia. This type of information is easily delivered and can benefit many patients.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcome assessors are blinded to which arm the participants are allocated when analysing the data.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presenting to pre-operative orthopaedic surgical clinic
- •Informed consent
排除标准
- •Patients <18 years or vulnerable groups
- •Inability to communicate in English or language difficulty that requires an interpreter
- •Severe vision or hearing loss if lack of other communication channels
- •Private patients
- •Prisoners
- •Patients who reside outside the United Kingdom (home address)
- •Opt-out patients on General Practitioner register
结局指标
主要结局
Patient satisfaction CSQ-8
时间窗: 5 -10 minutes
Client Satisfaction Questionnaire is a questionnaire measuring satisfaction. Response options differ from item to item, but all are based on a four-point scale. Examples include: "How satisfied are you with the amount of help you have received?" (which response options: 1 = "Quite dissatisfied", 2 = "Indifferent or mildly dissatisfied", 3 = "Mostly satisfied", 4 = "Very satisfied"; and, "Have the services you received helped you to deal more effectively with your problems?" (Which has the response options: 4 = Yes, they helped a great deal", 3 = "Yes, they helped somewhat", 2 = "No, they didn't help", 1 = "No, they seemed to make things worse". with an overall score is produced by summing all item responses. For the CSQ-8 version, scores range from 8 to 32, with higher values indicating higher satisfaction.
次要结局
- KAP Questionnaire(5 - 10 minutes)
- Anaesthetic choice(1 - 2 minutes)