CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial (CICERO)

University of Oxford

Status: Completed

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

Treatments: Device: Kilim plot; Device: Vitruvian plot; Device: Summary of findings table

Study type: Interventional

Funder types: Other

Identifiers

NCT05917639

R86270/RE001

Details and patient eligibility

About

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.

Enrollment: 2,178 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• aged between 18 and 65 years (inclusive)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,178 participants in 3 patient groups

Vitruvian plot

Experimental group

Treatment:

Device: Vitruvian plot

Kilim plot

Experimental group

Treatment:

Device: Kilim plot

Summary of findings table

Active Comparator group

Treatment:

Device: Summary of findings table