Communicating Risks: Consent for Lumbar Puncture

Study Overview
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Brief Summary
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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
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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.

Official Title
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Communicating Risks: Consent for Lumbar Puncture

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

Intervention / Treatment
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* Other: Anatomy diagrams
* Other: Standard informed consent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard informed consent<br>Video with audio narration containing information provided in the standard informed consent process for a lumbar puncture | Other: Standard informed consent<br>* Audio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form<br>|
| Experimental: Visual aid group<br>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<br>* 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<br>* Other names: Paling scale;Other: Standard informed consent<br>* Audio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Literacy, Risk, Spinal Puncture