Communicating Risks: Consent for Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Recall of probabilistic risk
研究概览
简要总结
The goal of this randomized control trial is to compare the effect of visual aids on the recall of probabilistic risks in healthy participants. The main questions it aims to answer are:
- Will participants consented using a consent process incorporating visual aids recall the consent process better?
- Will participants consented with a consent process incorporating visual aids have higher acceptability if a hypothetical, simulated complication were to occur?
- Is this method of consent (visual aids) usable, appropriate and acceptable? Participants will be required to watch a brief video containing information on how a lumbar puncture is performed as well as the associated risks.
- Participants in the intervention group will receive information in the form of various visual aids (e.g. anatomical diagrams, paling palettes and paling perspective scales). The audio narration and information provided in both groups is identical.
- Participants will be tested on their knowledge of the procedure
- Participants will be asked to rate their response to a series of procedure specific statements and statements from other validated scales.
Researchers will compare the control and intervention group to see if there is improvement in the recall of information and which consent process is more acceptable, appropriate and usable.
详细描述
Background:
Informed consent is an essential process in clinical decision-making, through which healthcare providers educate patients about the benefits, risks and alternatives of a given procedure or intervention in a descriptive way. An accurate understanding of the numerical information pertaining to risk is important because individuals perceive probability differently while also having different thresholds for what they would consider an unacceptable. This is vital for shared decision making to ensure that patients only undergo procedures or treatments where their understanding of the risks is in line with their personal level of acceptability. Aid tools have been employed to elaborate and communicate probabilistic risk information in areas such as screening (1). To the best of our knowledge there are no studies which evaluate the application of such visual aids on probabilistic information in surgical patients.
Objectives:
Our study aims to explore the effectiveness of visual aids to help communicate statistical information during the informed consent of a common clinical procedure: a lumbar puncture. We compare the effectiveness of this enhanced consent process against a typical consent method without visual aids
Methods:
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 were blind as to which arm participants were allocated to as the randomization and intervention/control exposure occurs after participants open the link to the study questionnaire. The same link would allocate participants to either the control/intervention group.
Outcomes were assessed within the questionnaire without any human input No care providers were present in this study
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
- •Healthy individuals
- •Above 18 years old
- •No underlying cognitive impairment
排除标准
- •Individuals with prior experience receiving, performing or observing a lumbar puncture
- •Lacks capacity
- •Hospitalized individuals
结局指标
主要结局
Recall of probabilistic risk
时间窗: Measured immediately following exposure to control/intervention
Measured by the number of correct answers to our procedure specific questionnaire
次要结局
- Response to procedure specific statements(Measured immediately following exposure to control/intervention)
- Acceptability(Measured immediately following exposure to control/intervention)
- Approrpiateness(Measured immediately following exposure to control/intervention)
- Usability(Measured immediately following exposure to control/intervention)
研究者
Anand S. Pandit
Neurosurgical Specialty Registrar (ST4)
University College London Hospitals