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CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05917639
Acronym
CICERO
Enrollment
2178
Registered
2023-06-26
Start date
2023-05-31
Completion date
2023-11-27
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Confidence, Self, Knowledge, Attitudes, Practice, Literacy

Keywords

shared decision-making

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.

Interventions

DEVICEVitruvian plot

Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool

DEVICEKilim plot

Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool

DEVICESummary of findings table

Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* aged between 18 and 65 years (inclusive)

Design outcomes

Primary

MeasureTime frameDescription
Decisional Conflict Scale, low literacy versionthrough study completion, an average of 20 minutesHigher scores indicate worse outcomes (min = 0; max = 100).

Secondary

MeasureTime frameDescription
Decision Self-Efficacy scalethrough study completion, an average of 20 minutesHigher scores indicate better outcomes (min = 0; max = 100).
Preparation for Decision Making scalethrough study completion, an average of 20 minutesHigher scores indicate better outcomes (min = 0; max = 100).
Information comprehension (proportion of participants providing a correct answer)through study completion, an average of 20 minutesParticipants 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.

Other

MeasureTime frameDescription
Number of minutes to complete the questionnairethrough study completion, an average of 20 minutesAutomated measurement from the first access to the online questionnaire (first input) to its completion (last input), assessed up to the end of the study (continuous outcome).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026