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Communicating Risks: Consent for Lumbar Puncture

NCT05717465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-02-08

No results posted yet for this study

Summary

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.

Conditions

  • Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery

Interventions

OTHER

Anatomy diagrams

The 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

Standard informed consent

Audio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • University College London Hospitals

    lead OTHER

Principal Investigators

  • Anand S Pandit, PhD MRCS · University College London/University College London Hospital

  • Hani J Marcus, PhD FRCS (SN) · University College London/University College London Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-27
Primary Completion
2022-05-26
Completion
2022-05-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717465 on ClinicalTrials.gov