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Completed

NCT Number: NCT05917639

CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

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.

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Key information

Conditions

Knowledge, Attitudes, Practice Behavior Communication Confidence, Self Literacy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Precision Psychiatry Lab (OxPPL)

Oxford, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18 and 65 years (inclusive)

Treatment and study plan

Vitruvian plot

Device

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

Kilim plot

Device

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

Summary of findings table

Device

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

Primary outcomes

  1. Decisional Conflict Scale, low literacy version

    Time frame: through study completion, an average of 20 minutes

    Higher scores indicate worse outcomes (min = 0; max = 100).

Secondary outcomes

  1. Decision Self-Efficacy scale

    Time frame: through study completion, an average of 20 minutes

    Higher scores indicate better outcomes (min = 0; max = 100).

  2. Preparation for Decision Making scale

    Time frame: through study completion, an average of 20 minutes

    Higher scores indicate better outcomes (min = 0; max = 100).

  3. Information comprehension (proportion of participants providing a correct answer)

    Time frame: 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.

Other outcomes

  1. Number of minutes to complete the questionnaire

    Time frame: through study completion, an average of 20 minutes

    Automated 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).

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Acronym: CICERO

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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