CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

NCT ID: NCT05917639

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-11-27

Brief Summary

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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

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Conditions

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Knowledge, Attitudes, Practice Literacy Confidence, Self

Keywords

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shared decision-making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Kilim plot

Group Type EXPERIMENTAL

Kilim plot

Intervention Type DEVICE

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

Summary of findings table

Group Type ACTIVE_COMPARATOR

Summary of findings table

Intervention Type DEVICE

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

Vitruvian plot

Group Type EXPERIMENTAL

Vitruvian plot

Intervention Type DEVICE

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

Interventions

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Vitruvian plot

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

Intervention Type DEVICE

Kilim plot

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

Intervention Type DEVICE

Summary of findings table

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aged between 18 and 65 years (inclusive)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oxford Precision Psychiatry Lab (OxPPL)

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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R86270/RE001

Identifier Type: -

Identifier Source: org_study_id