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The Surprise Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697213
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : March 27, 2020
Sponsor:
Collaborators:
Johannes Gutenberg University Mainz
Radboud University Medical Center
University of Bern
Imperial College London
Universiteit Antwerpen
University of Bologna
Information provided by (Responsible Party):
University College, London

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Palliative Care Terminal Illness Other: Online study

Detailed 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.

Study Design
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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An Online International Comparison of Thresholds for Triggering a Negative Response to the "Surprise Question"
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
General Practitioners
Registered General Practitioners in one of the six participating countries.
 Other: Online study
20 hypothetical patient summaries


Outcome Measures
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Primary Outcome Measures :
  1. Probability estimate [ Time Frame: Participants will have up to 8 months (until the study closes) to provide an estimate for each vignette (n=20) ]
    The continuous estimate of probability of dying within the next 12 months for the SQ (0-100%).


Secondary Outcome Measures :
  1. The Surprise Question [ Time Frame: 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) ]
    Dichotomous response to the SQ (Yes/No)

  2. The alternative Surprise Question [ Time Frame: 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) ]
    Dichotomous response to the alternative SQ (Yes/No)

  3. Treatment options [ Time Frame: 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) ]
    The options for the course of action selected by the participants in each vignette


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A convenience sample of registered General Practitioners (GPs) with a variety of years of experience and seniority across six European countries will be approached to participate
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697213


Locations
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Belgium
University of Antwerp
Antwerp, Belgium
Germany
University of Mainz
Mainz, Germany
Italy
University of Bologna
Bologna, Italy
Netherlands
Radboud University Medical Centre
Nijmegen, Netherlands
Switzerland
University Hospital of Bern
Bern, Switzerland
United Kingdom
Marie Curie Palliative Care Research Department
London, United Kingdom, W1W 7EJ
Sponsors and Collaborators
University College, London
Johannes Gutenberg University Mainz
Radboud University Medical Center
University of Bern
Imperial College London
Universiteit Antwerpen
University of Bologna
Investigators
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Principal Investigator: Patrick Stone, MA, MD, FRCP University College, London
  Study Documents (Full-Text)

Documents provided by University College, London:
Study Protocol  [PDF] April 9, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03697213    
Other Study ID Numbers: 18/0253
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Surprise Question
Prognostication