Informed Consent, Health Literacy, Risk, Spinal Puncture, NeurosurgeryNCT05717465
Communicating Risks: Consent for Lumbar Puncture
A study testing Anatomy diagrams and Standard informed consent in people with Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery, run by University College London Hospitals at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery
- What is being tested?
- Anatomy diagrams and Standard informed consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2022to 26 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
- Above 18 years old
- No underlying cognitive impairment
Who cannot join
- Individuals with prior experience receiving, performing or observing a lumbar puncture
- Lacks capacity
- Hospitalized individuals
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Anatomy diagrams, Standard informed consent
- Keywords
- Health Literacy, Risk, Spinal Puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomy diagramsOther
Also called Paling diagrams, Paling scale
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
Standard informed consentOther
Audio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form
| Study group | Role | What they receive |
|---|---|---|
| Standard informed consent | Active comparator | Video with audio narration containing information provided in the standard informed consent process for a lumbar puncture Receives: 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 Receives: Other: Anatomy diagrams; Other: Standard informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall of probabilistic risk
Measured by the number of correct answers to our procedure specific questionnaire
Measured: Measured immediately following exposure to control/intervention
Secondary outcomes (4)
Response to procedure specific statements
Measured using 5-point likert scale responses
Measured: Measured immediately following exposure to control/intervention
Acceptability
Measured by the Acceptability of Intervention Measure (AIM) scale
Measured: Measured immediately following exposure to control/intervention
Approrpiateness
Measured by the Intervention Appropriateness Measure (IAM) scale
Measured: Measured immediately following exposure to control/intervention
Usability
Measured by the System Usability Scale (SUS)
Measured: Measured immediately following exposure to control/intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start27 Mar 2022
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Informed Consent, Health Literacy, Risk, Spinal Puncture, NeurosurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Anand S. Pandit, University College London Hospitals
- Investigators
- Anand S Pandit, PhD MRCS, Principal investigator, University College London/University College London HospitalHani J Marcus, PhD FRCS (SN), Principal investigator, University College London/University College London Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717465
- Sponsor's protocol ID
- 21837.001
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33196663
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communicating Risks: Consent for Lumbar Puncture
- ClinicalTrials.gov ID
- NCT05717465
- Acronym / sponsor ID
- 21837.001
- Keywords
- Health Literacy, Risk, Spinal Puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard informed consent | Active comparator | Other: Standard informed consentVideo with audio narration containing information provided in the standard informed consent process for a lumbar puncture |
| Visual aid group | Experimental | Other: Anatomy diagrams, Other: Standard informed consentVideo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy individuals
- Above 18 years old
- No underlying cognitive impairment
Key exclusion criteria (3 listed)
- Individuals with prior experience receiving, performing or observing a lumbar puncture
- Lacks capacity
- Hospitalized individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomy diagramsAlso: Paling diagrams, Paling scaleThe 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 | Visual aid group |
| Standard informed consentAudio narration of a video containing text information relating to the lumbar puncture procedure (including risks) and an image of a consent form | Other | Standard informed consent, Visual aid group |
Primary outcome
Recall of probabilistic risk
Time frame: Measured immediately following exposure to control/intervention
Measured by the number of correct answers to our procedure specific questionnaire
4 secondary outcomes
Response to procedure specific statements
Time frame: Measured immediately following exposure to control/intervention
Acceptability
Time frame: Measured immediately following exposure to control/intervention
Approrpiateness
Time frame: Measured immediately following exposure to control/intervention
Usability
Time frame: Measured immediately following exposure to control/intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 33196663Coyle 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand S Pandit, PhD MRCS principal investigator
University College London/University College London Hospital
Hani J Marcus, PhD FRCS (SN) principal investigator
University College London/University College London Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomy diagrams and Standard informed consent in people with Informed Consent, Health Literacy, Risk, Spinal Puncture, Neurosurgery, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall of probabilistic risk (time frame: Measured immediately following exposure to control/intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.