Clinical trial NCT05717465: Communicating Risks: Consent for Lumbar Puncture
Official title: Communicating Risks: Consent for Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery
Keywords: Health Literacy
Risk
Spinal Puncture
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2023-02-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recall of probabilistic risk
timeFrame: Measured immediately following exposure to control/intervention
Secondary outcomes:
measure: Response to procedure specific statements
timeFrame: Measured immediately following exposure to control/intervention
measure: Acceptability
timeFrame: Measured immediately following exposure to control/intervention
measure: Approrpiateness
timeFrame: Measured immediately following exposure to control/intervention
measure: Usability
timeFrame: Measured immediately following exposure to control/intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College London/University College London Hospital
name: Anand S Pandit, PhD MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London/University College London Hospital
name: Hani J Marcus, PhD FRCS (SN)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.