CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

NCT05917639 | Completed

• 1 other identifier: R86270/RE001
• Study Type: interventional
• Target: 2,178
• Locations: 1 country
• Sites: 1

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.

Conditions

Knowledge, Attitudes, Practice; Literacy; Confidence, Self

Keywords

shared decision-making

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale, low literacy version

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

  through study completion, an average of 20 minutes

Secondary Outcomes (3)

• Decision Self-Efficacy scale

  through study completion, an average of 20 minutes

• Preparation for Decision Making scale

  through study completion, an average of 20 minutes

• Information comprehension (proportion of participants providing a correct answer)

  through study completion, an average of 20 minutes

Other Outcomes (1)

• Number of minutes to complete the questionnaire

  through study completion, an average of 20 minutes

Study Arms (3)

Vitruvian plot

EXPERIMENTAL

Device: Vitruvian plot

Kilim plot

EXPERIMENTAL

Device: Kilim plot

Summary of findings table

ACTIVE COMPARATOR

Device: Summary of findings table

Interventions

Vitruvian plot DEVICE

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

Vitruvian plot

Kilim plot DEVICE

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

Kilim plot

Summary of findings table DEVICE

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

Summary of findings table

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 65 years (inclusive)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Precision Psychiatry Lab (OxPPL)

Oxford, United Kingdom

Location

Related Links

• CICERO trial

MeSH Terms

Conditions

Behavior; Literacy

Condition Hierarchy (Ancestors)

Communication

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 26, 2023
• Study Start: May 31, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Locations

GB (1)