CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

Not Applicable

Completed

• Conditions: Confidence, Self; Knowledge, Attitudes, Practice; Literacy
• Interventions: Device: Vitruvian plot; Device: Kilim plot; Device: Summary of findings table

• Registration Number: NCT05917639
• Lead Sponsor: University of Oxford

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-26
• Primary Completion: 2023-11-27
• Study Completion: 2023-11-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2178

Inclusion Criteria

• aged between 18 and 65 years (inclusive)

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitruvian plot	Vitruvian plot	-
Kilim plot	Kilim plot	-
Summary of findings table	Summary of findings table	-

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale, low literacy version	through study completion, an average of 20 minutes	Higher scores indicate worse outcomes (min = 0; max = 100).

Secondary Outcome Measures

Name	Time	Method
Preparation for Decision Making scale	through study completion, an average of 20 minutes	Higher scores indicate better outcomes (min = 0; max = 100).
Decision Self-Efficacy scale	through study completion, an average of 20 minutes	Higher scores indicate better outcomes (min = 0; max = 100).
Information comprehension (proportion of participants providing a correct answer)	through study completion, an average of 20 minutes	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.

Trial Locations

Locations (1)

Oxford Precision Psychiatry Lab (OxPPL); 🇬🇧 Oxford, United Kingdom