CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

Conditions
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Knowledge, Attitudes, Practice, Literacy, Confidence, Self

Intervention / Treatment
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* Device: Vitruvian plot
* Device: Kilim plot
* Device: Summary of findings table


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 65 years (inclusive)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitruvian plot<br> | Device: Vitruvian plot<br>* Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool<br>|
| Experimental: Kilim plot<br> | Device: Kilim plot<br>* Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool<br>|
| Active Comparator: Summary of findings table<br> | Device: Summary of findings table<br>* Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale, low literacy version | Higher scores indicate worse outcomes (min = 0; max = 100). | through study completion, an average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Self-Efficacy scale | Higher scores indicate better outcomes (min = 0; max = 100). | through study completion, an average of 20 minutes | 
| Preparation for Decision Making scale | Higher scores indicate better outcomes (min = 0; max = 100). | 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. | through study completion, an average of 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision-making