- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697213
The Surprise Study
An Online International Comparison of Thresholds for Triggering a Negative Response to the "Surprise Question"
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Antwerp, Belgium
- University of Antwerp
-
-
-
-
-
Mainz, Germany
- University of Mainz
-
-
-
-
-
Bologna, Italy
- University of Bologna
-
-
-
-
-
Nijmegen, Netherlands
- Radboud University Medical Centre
-
-
-
-
-
Bern, Switzerland
- University Hospital of Bern
-
-
-
-
-
London, United Kingdom, W1W 7EJ
- Marie Curie Palliative Care Research Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
General Practitioners
Registered General Practitioners in one of the six participating countries.
|
20 hypothetical patient summaries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%).
|
Participants will have up to 8 months (until the study closes) to provide an estimate for each vignette (n=20)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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 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)
|
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)
|
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
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick Stone, MA, MD, FRCP, University College, London
Publications and helpful links
General Publications
- White N, Oostendorp LJ, Vickerstaff V, Gerlach C, Engels Y, Maessen M, Tomlinson C, Wens J, Leysen B, Biasco G, Zambrano S, Eychmuller S, Avgerinou C, Chattat R, Ottoboni G, Veldhoven C, Stone P. An online international comparison of palliative care identification in primary care using the Surprise Question. Palliat Med. 2022 Jan;36(1):142-151. doi: 10.1177/02692163211048340. Epub 2021 Oct 1.
- White N, Oostendorp L, Vickerstaff V, Gerlach C, Engels Y, Maessen M, Tomlinson C, Wens J, Leysen B, Biasco G, Zambrano S, Eychmuller S, Avgerinou C, Chattat R, Ottoboni G, Veldhoven C, Stone P. An online international comparison of thresholds for triggering a negative response to the "Surprise Question": a study protocol. BMC Palliat Care. 2019 Apr 9;18(1):36. doi: 10.1186/s12904-019-0413-x. Erratum In: BMC Palliat Care. 2020 Jan 27;19(1):15.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18/0253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Palliative Care
-
Azienda Usl di BolognaIRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedPalliative Care | Palliative Medicine | Hospice and Palliative Care NursingItaly
-
Mayo ClinicCompletedPalliative Care | Transitional CareUnited States
-
University of NottinghamCompletedPalliative Care | Long-Term CareUnited Kingdom
-
Ankara Yildirim Beyazıt UniversityRecruiting
-
University Hospital, CaenRecruitingPalliative CareFrance
-
University of PennsylvaniaNational Institute on Aging (NIA)Enrolling by invitationPalliative CareUnited States
-
Technische Universität DresdenUniversity Hospital DresdenCompletedPalliative CareGermany
-
Bispebjerg HospitalOdense University Hospital; Rigshospitalet, Denmark; Danish Cancer Society; Nordsjaellands... and other collaboratorsCompletedPalliative CareDenmark
-
University of GuadalajaraCompleted
Clinical Trials on Online study
-
Central Hospital, Nancy, FranceCompleted
-
British Columbia Cancer AgencyUniversity of British Columbia; McMaster University; University of Calgary; Tom... and other collaboratorsUnknown
-
University Hospital, GrenobleUnknown
-
University of MichiganNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedOccupational Health | Hazardous Material Handling
-
King's College LondonBritish Dietetic AssociationCompleted
-
University of ManitobaCanadian Paediatric Society; Manitoba Health, Seniors and Active LivingCompletedSudden Infant DeathCanada
-
Rush University Medical CenterCompleted
-
LUNGevity FoundationBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Novartis; T... and other collaboratorsRecruitingCaregivers | Lung Cancer PatientsUnited States
-
University of California, San FranciscoCompleted
-
University of California, San FranciscoCompletedPhysical InactivityUnited States