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.

Study Overview

• Status: Completed
• Conditions: Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery
• Intervention / Treatment: Other: Standard informed consent; Other: Anatomy diagrams

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1E 6BT
    • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard informed consent; Video with audio narration containing information provided in the standard informed consent process for a lumbar puncture	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
EXPERIMENTAL: Visual aid group; 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: 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; 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 Names: Paling diagrams; Paling scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of probabilistic risk	Measured by the number of correct answers to our procedure specific questionnaire	Measured immediately following exposure to control/intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to procedure specific statements	Measured using 5-point likert scale responses	Measured immediately following exposure to control/intervention
Acceptability	Measured by the Acceptability of Intervention Measure (AIM) scale	Measured immediately following exposure to control/intervention
Approrpiateness	Measured by the Intervention Appropriateness Measure (IAM) scale	Measured immediately following exposure to control/intervention
Usability	Measured by the System Usability Scale (SUS)	Measured immediately following exposure to control/intervention

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Collaborators: University College, London
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2022
• Primary Completion (ACTUAL): May 26, 2022
• Study Completion (ACTUAL): May 26, 2022

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 28, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Health Literacy; Risk; Spinal Puncture
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 21837.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No