Communicating Risks: Consent for Lumbar Puncture

NCT05717465 | Completed

• 1 other identifier: 21837.001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Health Literacy; Risk; Spinal Puncture

Outcome Measures

Primary Outcomes (1)

• Recall of probabilistic risk

  Measured by the number of correct answers to our procedure specific questionnaire

  Measured immediately following exposure to control/intervention

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard informed consent

ACTIVE COMPARATOR

Video with audio narration containing information provided in the standard informed consent process for a lumbar puncture

Other: Standard informed consent

Visual aid group

EXPERIMENTAL

Video with identical audio narration (to the control) containing information provided in the standard informed consent process for a lumbar puncture. The video also received statistical information in the form of visual aids; anatomy diagrams, Paling diagrams and Paling scales

Other: Anatomy diagrams; Other: Standard informed consent

Interventions

Anatomy diagrams OTHER

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

Also known as: Paling diagrams, Paling scale

Visual aid group

Standard informed consent OTHER

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

Standard informed consent; Visual aid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals
• Above 18 years old
• No underlying cognitive impairment

You may not qualify if:

• Individuals with prior experience receiving, performing or observing a lumbar puncture
• Lacks capacity
• Hospitalized individuals

Sponsors & Collaborators

• University College London Hospitals: lead
• University College, London: collaborator

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Related Publications (1)

• Coyle M, Gillies K. A systematic review of risk communication in clinical trials: How does it influence decisions to participate and what are the best methods to improve understanding in a trial context? PLoS One. 2020 Nov 16;15(11):e0242239. doi: 10.1371/journal.pone.0242239. eCollection 2020.

  PMID: 33196663 BACKGROUND

Study Officials

• Anand S Pandit, PhD MRCS

  University College London/University College London Hospital

  PRINCIPAL INVESTIGATOR

• Hani J Marcus, PhD FRCS (SN)

  University College London/University College London Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgical Specialty Registrar (ST4)

Model Details: Upon clicking the link to the study questionnaire, participants were randomized to either receive the control or intervention questionnaire. This was done through Qualtrics (Qualtrics, Provo, UT) built-in randomization.

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: March 27, 2022
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

GB (1)