The Surprise Study

Palliative Care Clinical Trial

Official title:

An Online International Comparison of Thresholds for Triggering a Negative Response to the "Surprise Question"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697213
• Other study ID #: 18/0253
• Status: Completed
• Start date: March 25, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates the use of the Surprise Question [SQ] (would you be surprised if this patient were to die in the next 12 months?) in routine practice. In particular, the study will investigate the consistency of the responses to the SQ and the relationship with the subsequent course of action decided upon.

Description:

Whilst the original use of the Surprise Question was to identify people who might be in the last year of life and benefit from palliative care, the prognostic capability of the Surprise Question has been shown to be variable. What is unclear, is the extent to which a doctor should be "surprised" before a patient is suitable for palliative care, how consistently doctors respond to this question, and how the subsequent treatment decision relates to the SQ response.

The study will recruit 600 General Practitioners (GPs) from 6 participating countries (100 per country; UK, Germany, Switzerland, Italy, Belgium, the Netherlands). Each participant will asked to complete a series of 20 hypothetical patient summaries in an online task.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered General Practitioner in one of the six participating countries

• Able to read and understand the language in which the questionnaire is presented to them

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Palliative Care
• Terminal Illness

Intervention

Other:
• Online study
20 hypothetical patient summaries

Locations

Country	Name	City	State
Belgium	University of Antwerp	Antwerp
Germany	University of Mainz	Mainz
Italy	University of Bologna	Bologna
Netherlands	Radboud University Medical Centre	Nijmegen
Switzerland	University Hospital of Bern	Bern
United Kingdom	Marie Curie Palliative Care Research Department	London

Sponsors (7)

Lead Sponsor	Collaborator
University College, London	Imperial College London, Johannes Gutenberg University Mainz, Radboud University, Universiteit Antwerpen, University of Bern, University of Bologna

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability estimate	The continuous estimate of probability of dying within the next 12 months for the SQ (0-100%).	Participants will have up to 8 months (until the study closes) to provide an estimate for each vignette (n=20)
Secondary	The Surprise Question	Dichotomous response to the SQ (Yes/No)	up to 8 months (until the study closes)Participants will have up to 8 months (until the study closes) to provide a response for each vignette (n=20)
Secondary	The alternative Surprise Question	Dichotomous response to the alternative SQ (Yes/No)	up to 8 months (until the study closes)Participants will have up to 8 months (until the study closes) to provide a response for each vignette (n=20)
Secondary	Treatment options	The options for the course of action selected by the participants in each vignette	up to 8 months (until the study closes)Participants will have up to 8 months (until the study closes) to provide a response for each vignette (n=20)

External Links

•   The Study Protocol