NCT05717465

Communicating Risks: Consent for Lumbar Puncture

Completed NA Last updated 8 February 2023

What this trial tests

NA trial testing Anatomy diagrams in Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery in 52 participants. Completed in 26 May 2022.

Timeline

27 March 2022

Primary endpoint
26 May 2022

26 May 2022

Quick facts

Lead sponsor	University College London Hospitals
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	52
Start date	27 March 2022
Primary completion	26 May 2022
Estimated completion	26 May 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Anatomy diagrams
• Standard informed consent

Conditions studied

• Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery — all drugs for Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery →

Sponsor

University College London Hospitals

Who can join

18 and older, any sex, with Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improving risk communication: a proof-of-concept randomised control trial assessing the impact of visual aids for neurosurgical consent
   Chatzopoulou D, Jalal A, Stoyanov D, Marcus H, et al · · 2024