NCT05917639

CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,178 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Knowledge, Attitudes, Practice
• Literacy
• Confidence, Self

Interventions

Type	Name	Description
DEVICE	Vitruvian plot	Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
DEVICE	Kilim plot	Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
DEVICE	Summary of findings table	Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool

Timeline

• Start date: 2023-05-31
• Primary completion: 2023-11-27
• Completion: 2023-11-27
• First posted: 2023-06-26
• Last updated: 2023-12-18

Locations

1 site across 1 country: United Kingdom