CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

Knowledge, Attitudes, Practice Clinical Trial

— CICERO  

Official title:

CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917639
• Other study ID #: R86270/RE001
• Status: Completed
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: November 27, 2023

Study information

• Verified date: December 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2178
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged between 18 and 65 years (inclusive)

Related Conditions & MeSH terms

• Confidence, Self
• Knowledge, Attitudes, Practice
• Literacy

Intervention

Device:
• Vitruvian plot
Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
• Kilim plot
Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
• Summary of findings table
Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool

Locations

Country	Name	City	State
United Kingdom	Oxford Precision Psychiatry Lab (OxPPL)	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of minutes to complete the questionnaire	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).	through study completion, an average of 20 minutes
Primary	Decisional Conflict Scale, low literacy version	Higher scores indicate worse outcomes (min = 0; max = 100).	through study completion, an average of 20 minutes
Secondary	Decision Self-Efficacy scale	Higher scores indicate better outcomes (min = 0; max = 100).	through study completion, an average of 20 minutes
Secondary	Preparation for Decision Making scale	Higher scores indicate better outcomes (min = 0; max = 100).	through study completion, an average of 20 minutes
Secondary	Information comprehension (proportion of participants providing a correct answer)	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.	through study completion, an average of 20 minutes

External Links

•   CICERO trial