CommunICation of bEnefit Risk Information: an Online Randomised Controlled Trial (CICERO)

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.

Study Overview

• Status: Completed
• Conditions: Knowledge, Attitudes, Practice; Literacy; Confidence, Self
• Intervention / Treatment: Device: Vitruvian plot; Device: Kilim plot; Device: Summary of findings table

• Study Type: Interventional
• Enrollment (Actual): 2178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Oxford Precision Psychiatry Lab (OxPPL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• aged between 18 and 65 years (inclusive)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitruvian plot	Device: Vitruvian plot; Visual (magnitude, uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
Experimental: Kilim plot	Device: Kilim plot; Visual (uncertainty) and written (magnitude) communication tool / interventional decision-making aid tool
Active Comparator: Summary of findings table	Device: Summary of findings table; Written (magnitude, uncertainty) communication tool / interventional decision-making aid tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decisional Conflict Scale, low literacy version	Higher scores indicate worse outcomes (min = 0; max = 100).	through study completion, an average of 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision Self-Efficacy scale	Higher scores indicate better outcomes (min = 0; max = 100).	through study completion, an average of 20 minutes
Preparation for Decision Making scale	Higher scores indicate better outcomes (min = 0; max = 100).	through study completion, an average of 20 minutes
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oxford

Publications and helpful links

Helpful Links

• CICERO trial

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: shared decision-making
• Other Study ID Numbers: R86270/RE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No