The Surprise Study

• Sponsor: University College, London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03697213
• Collaborator: Johannes Gutenberg University Mainz (Other), Radboud University Medical Center (Other), University of Bern (Other), Imperial College London (Other), Universiteit Antwerpen (Other), University of Bologna (Other)
• Enrollment: 250
• Locations: 6
• Actual Duration (Months): 11.2
• Patients Per Site: 41.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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	Phase
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

• 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: Mar 25, 2019
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
General Practitioners Registered General Practitioners in one of the six participating countries.	Other: Online study; 20 hypothetical patient summaries

Outcome Measures

Primary Outcome Measures

1. Probability estimate [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Antwerp	Antwerp		Belgium
2	University of Mainz	Mainz		Germany
3	University of Bologna	Bologna		Italy
4	Radboud University Medical Centre	Nijmegen		Netherlands
5	University Hospital of Bern	Bern		Switzerland
6	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

• Principal Investigator: Patrick Stone, MA, MD, FRCP, University College, London

Study Documents (Full-Text)

• Study Protocol - Apr 9, 2019

More Information

Additional Information:

• The Study Protocol

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT03697213
• Other Study ID Numbers: 18/0253
• First Posted: Oct 5, 2018
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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

Study Results

No Results Posted as of Mar 27, 2020