Verbal Probability Expressions in Peri-operative Risk

NCT03720834 | Completed

• 1 other identifier: STH20393
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 1

Brief Summary

Before having an operation doctors use expressions such as high risk, or low risk to describe the chance of complications occurring. Complications include things such as strokes and heart attacks and even death. It is thought that using words like this, instead of percentages makes it easier for patients to understand their level of risk. It is also often hard for a doctor to give a patient an exact percentage. It is important that patients have a good understanding about their level of risk associated with an operation so they can make informed decisions about whether to go ahead with it. This is an important part of taking consent before an operation. The aim of this study is to assess whether using expressions such as high risk and low risk to communicate the chance of a complication occurring during an operation is useful. Different patients may assign different meanings to these expressions. If it is found that patients interpret these expressions differently from how the doctor intended it would suggest that the way doctors communicate risk to patients should be reviewed. Patients will be asked if they are willing to participate in the study and after giving consent they will complete a questionnaire. The questionnaire will list various expressions used by doctors to describe the chance of a complication occurring during an operation, such as high risk and low risk. Each participant will be asked to give a percentage for each of the expressions. The questionnaire will be completed by patients who are waiting to have an operation at the Royal Hallamshire Hospital.

Conditions

Surgery--Complications; Risk Reduction

Outcome Measures

Primary Outcomes (1)

• To determine the perceived peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions in patients awaiting surgery.

  Percentage risk assigned to verbal risk descriptors

  Day 0

Secondary Outcomes (3)

• To determine the implied patient peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions that are used by clinicians in the pre-operative setting.

  Day 0

• To determine the level of correlation between clinicians and patient perception of risk when verbal probability expressions are used.

  Day 0

• To investigate the impact of patient sex, surgical speciality, presence of carcinoma, and calculated risk of surgery on patient perception of risk when verbal probability expressions are used.

  Day 0

Study Arms (2)

Patients

Questionnaire on risk perception

Clinicians

Questionnaire on risk perception

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical population

You may qualify if:

• Any patient due to undergo surgery who attends pre-operative assessment clinic

You may not qualify if:

• Inability to speak/read English; inability to provide own consent.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 25, 2018
• Study Start: November 1, 2018
• Primary Completion: July 21, 2019
• Study Completion: July 21, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)