University College London
London, WC1E 6BT, United Kingdom
Completed
NCT Number: NCT05717465
Communicating Risks: Consent for Lumbar Puncture
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.
Completed
Looking for future studies?
Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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:
Healthy participants were recruited within our institution and randomized using Qualtrics to complete a questionnaire containing either the control video or intervention video. Both videos contained identical audio narration however the intervention video included additional visual aids.
Status:
Recruitment of participants has been completed and the study has been written-up and submitted for publication and presentations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy individuals
- Above 18 years old
- No underlying cognitive impairment
Exclusion criteria
- Individuals with prior experience receiving, performing or observing a lumbar puncture
- Lacks capacity
- Hospitalized individuals
Treatment and study plan
Anatomy diagrams
OtherThe visual aids used included:
- An anatomical diagram illustrating how a lumbar puncture is carried out
- Paling palette, diagram illustrating the number of individuals affected by a particular condition
- Paling perspective scale, diagram comparing the risk of an event occurring in comparison to other 'everyday' risks
Other names: Paling diagrams, Paling scale
Standard Informed Consent
OtherAudio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form
Primary outcomes
-
Recall of probabilistic risk
Time frame: Measured immediately following exposure to control/intervention
Measured by the number of correct answers to our procedure specific questionnaire
Secondary outcomes
-
Response to procedure specific statements
Time frame: Measured immediately following exposure to control/intervention
Measured using 5-point likert scale responses
-
Acceptability
Time frame: Measured immediately following exposure to control/intervention
Measured by the Acceptability of Intervention Measure (AIM) scale
-
Approrpiateness
Time frame: Measured immediately following exposure to control/intervention
Measured by the Intervention Appropriateness Measure (IAM) scale
-
Usability
Time frame: Measured immediately following exposure to control/intervention
Measured by the System Usability Scale (SUS)
Sponsors and collaborators
Lead sponsor
University College London Hospitals
Other
Collaborators
- University College, London
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Feb 8, 2023
- Registry last updated
- Feb 8, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.