Palliative CareNCT03697213
The Surprise Study
An observational study of Palliative Care and Terminal Illness, run by University College, London at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Terminal Illness
- What is being tested?
- Online study
- How many people
- 250 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 25 Mar 2019to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United Kingdom1 site
Marie Curie Palliative Care Research Department
London, W1W 7EJ
About this study
Official title: An Online International Comparison of Thresholds for Triggering a Negative Response to the "Surprise Question"
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.
Read the 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.
- Conditions
- Palliative Care, Terminal Illness
- Being tested
- Online study
- Keywords
- Surprise Question, Prognostication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online studyOther
20 hypothetical patient summaries
| Study group | Role | What they receive |
|---|---|---|
| General Practitioners | Registered General Practitioners in one of the six participating countries. Receives: Other: Online study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability estimate
The continuous estimate of probability of dying within the next 12 months for the SQ (0-100%).
Measured: Participants will have up to 8 months (until the study closes) to provide an estimate for each vignette (n=20)
Secondary outcomes (3)
The Surprise Question
Dichotomous response to the SQ (Yes/No)
Measured: 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
Dichotomous response to the alternative SQ (Yes/No)
Measured: 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
The options for the course of action selected by the participants in each vignette
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start25 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, Radboud University Medical Center, University of Bern, Imperial College London, Universiteit Antwerpen, University of Bologna
- Responsible party
- Sponsor
- Investigators
- Patrick Stone, MA, MD, FRCP, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697213
- Sponsor's protocol ID
- 18/0253
- Status last verified
- Mar 2020
- First submitted
- 25 Sep 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34596445White 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.
PubMed 30979361
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online International Comparison of Thresholds for Triggering a Negative Response to the "Surprise Question"
- ClinicalTrials.gov ID
- NCT03697213
- Acronym / sponsor ID
- 18/0253
- Conditions
- Palliative Care, Terminal Illness
- Keywords
- Surprise Question, Prognostication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, Radboud University Medical Center, University of Bern, Imperial College London, Universiteit Antwerpen, University of Bologna
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Practitioners | – | Other: Online studyRegistered General Practitioners in one of the six participating countries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online study20 hypothetical patient summaries | Other | General Practitioners |
Primary outcome
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%).
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 34596445White 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.
- Derived from this study: PubMed 30979361White 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.
- The Study ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Stone, MA, MD, FRCP principal investigator
University College, London
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care and Terminal Illness, run by University College, London at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Germany, Italy, Netherlands, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability estimate (time frame: Participants will have up to 8 months (until the study closes) to provide an estimate for each vignette (n=20)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.