Knowledge, Attitudes, PracticeCICERONCT05917639
CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial
A study testing Vitruvian plot, Kilim plot and Summary of findings table in people with Knowledge, Attitudes, Practice and Literacy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
How health-related information is communicated affects what is understood and might influence how people make decisions and how confident they feel in participating in clinical shared decision-making. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge, Attitudes, Practice, Literacy, Confidence, Self
- What is being tested?
- Vitruvian plot, Kilim plot and Summary of findings table
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,178 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2023to 27 Nov 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged between 18 and 65 years (inclusive)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
How health-related information is communicated affects what is understood and might influence how people make decisions and how confident they feel in participating in clinical shared decision-making.
The CICERO trial will compare three different communication tools providing information on fictional interventions for a common medical problem (i.e. social anxiety disorder) both in terms of how well interventions work (benefit) and also possible harms associated (risk). The three communication tools ("Summary of Findings table", "Kilim plot", and "Vitruvian plot") differ in how they present information: exclusively written, primarily written and partially graphical, or mixed written and visual. Each participant will be asked to go through one clinical scenario.
Read more
The investigators will ask participants to familiarise themselves with the tool they have been allocated to (either a plot or a table) and then answer some validated questionnaires to measure how useful and efficient the communication strategy was.
The entire study occurs online in a single study session (about 20 minutes).
The results of the CICERO trial will inform how to communicate research findings to the general population, facilitating their implementation in clinical shared decision-making.
- Conditions
- Knowledge, Attitudes, Practice, Literacy, Confidence, Self
- Being tested
- Vitruvian plot, Kilim plot, Summary of findings table
- Keywords
- shared decision-making
- Medical subject headings
- Behavior, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitruvian plotDevice
Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
Kilim plotDevice
Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
Summary of findings tableDevice
Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool
| Study group | Role | What they receive |
|---|---|---|
| Vitruvian plot | Experimental | Not described Receives: Device: Vitruvian plot |
| Kilim plot | Experimental | Not described Receives: Device: Kilim plot |
| Summary of findings table | Active comparator | Not described Receives: Device: Summary of findings table |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale, low literacy version
Higher scores indicate worse outcomes (min = 0; max = 100).
Measured: through study completion, an average of 20 minutes
Secondary outcomes (3)
Decision Self-Efficacy scale
Higher scores indicate better outcomes (min = 0; max = 100).
Measured: through study completion, an average of 20 minutes
Preparation for Decision Making scale
Higher scores indicate better outcomes (min = 0; max = 100).
Measured: through study completion, an average of 20 minutes
Information comprehension (proportion of participants providing a correct answer)
Participants will be asked to choose one of multiple (fictional) medical interventions based on their characteristics as part of the clinical scenario. The question related to the clinical scenario allows only one correct answer.
Measured: through study completion, an average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start31 May 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
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 Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917639
- Sponsor's protocol ID
- R86270/RE001
- Acronym
- CICERO
- Status last verified
- Dec 2023
- First submitted
- 5 Jun 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ostinelli EG, Efthimiou O, Agunbiade A, Naci H, Cipriani A. Communication of information on benefits and harms of multiple competing medical interventions: three-group, open-label, randomised controlled trial. Br J Psychiatry. 2026 Mar 25:1-11. doi: 10.1192/bjp.2026.10555. Online ahead of print.
PubMed 41877317
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05917639
- Acronym / sponsor ID
- CICERO / R86270/RE001
- Conditions
- Knowledge, Attitudes, Practice, Literacy, Confidence, Self
- Keywords
- shared decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,178 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 26 Jun 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.
How health-related information is communicated affects what is understood and might influence how people make decisions and how confident they feel in participating in clinical shared decision-making.
The CICERO trial will compare three different communication tools providing information on fictional interventions for a common medical problem (i.e. social anxiety disorder) both in terms of how well interventions work (benefit) and also possible harms associated (risk). The three communication tools ("Summary of Findings table", "Kilim plot", and "Vitruvian plot") differ in how they present information: exclusively written, primarily written and partially graphical, or mixed written and visual. Each participant will be asked to go through one clinical scenario.
The investigators will ask participants to familiarise themselves with the tool they have been allocated to (either a plot or a table) and then answer some validated questionnaires to measure how useful and efficient the communication strategy was.
The entire study occurs online in a single study session (about 20 minutes).
The results of the CICERO trial will inform how to communicate research findings to the general population, facilitating their implementation in clinical shared decision-making.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitruvian plot | Experimental | Device: Vitruvian plot |
| Kilim plot | Experimental | Device: Kilim plot |
| Summary of findings table | Active comparator | Device: Summary of findings table |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 18 and 65 years (inclusive)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vitruvian plotVisual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool | Device | Vitruvian plot |
| Kilim plotVisual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool | Device | Kilim plot |
| Summary of findings tableWritten (magnitude, uncertainty) communication tool / interventional decision-making aid tool | Device | Summary of findings table |
Primary outcome
Decisional Conflict Scale, low literacy version
Time frame: through study completion, an average of 20 minutes
Higher scores indicate worse outcomes (min = 0; max = 100).
3 secondary outcomes
Decision Self-Efficacy scale
Time frame: through study completion, an average of 20 minutes
Preparation for Decision Making scale
Time frame: through study completion, an average of 20 minutes
Information comprehension (proportion of participants providing a correct answer)
Time frame: through study completion, an average of 20 minutes
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 18 Dec 2023.
- Derived from this study: PubMed 41877317Ostinelli EG, Efthimiou O, Agunbiade A, Naci H, Cipriani A. Communication of information on benefits and harms of multiple competing medical interventions: three-group, open-label, randomised controlled trial. Br J Psychiatry. 2026 Mar 25:1-11. doi: 10.1192/bjp.2026.10555. Online ahead of print.
- CICERO trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitruvian plot, Kilim plot and Summary of findings table in people with Knowledge, Attitudes, Practice and Literacy, run by University of Oxford 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 1 inclusion and 0 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 18 Dec 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?
Decisional Conflict Scale, low literacy version (time frame: through study completion, an average of 20 minutes). 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 NCT05917639, 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 18 Dec 2023.