Terminal IllnessORaClESNCT03360812
ORaClES: A Trial to Improve Prognostication
A study testing Online training resource in people with Terminal Illness, run by University College, London at 5 sites in United Kingdom.
Trial summary
This study evaluates whether an online training resource can improve the performance of medical students in recognising imminently dying palliative care patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Terminal Illness
- What is being tested?
- Online training resource
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 5 Apr 2018to 12 Aug 2018
- Phase
- Interventional
- 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
Who may be able to join
- Over 18 years of age
- Enrolled on a registered medical course within the United Kingdom
- In the penultimate or final year of medical school
- Sufficient English language proficiency
- Willing and able to provide consent as indicated by taking part in the online survey
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Brighton and Sussex Medical School
Brighton
Hull York Medical School
Hull
Imperial College London
London
St George's Medical School
London
UCL Medical School
London
About this study
Official title: Online Randomised Controlled Trial to Improve Clinical Estimates of Survival (ORaClES)
This study evaluates whether an online training resource can improve the performance of medical students in recognising imminently dying palliative care patients.
Read the detailed description
Clinicians are routinely asked to provide survival estimates for palliative care patients, but recognition of imminent death (last 72 hours of life) is often inaccurate. We developed an online training resource, based on a previous study that identified the symptoms or signs that were most influential in forming expert palliative care doctors' prognostic decisions about imminent death.
This double-blind randomised controlled trial will evaluate the effectiveness of this online training resource in improving the performance of medical students in recognising imminently dying palliative care patients.
Participants are asked to visit the study website and review three series of vignettes describing patients referred to palliative care. For each vignette, participants are asked to provide an estimate (0-100%) about the probability that the patient will die in the next 72 hours. After the first series of vignettes, students randomised to the intervention arm are given access to an online training resource showing how experts weighted the relative importance of symptoms and signs. All participants are asked to complete a second series of vignettes. After two weeks, all participants are asked to return to the website and complete a third series of vignettes to assess if any effect has been maintained.
- Conditions
- Terminal Illness
- Being tested
- Online training resource
- Keywords
- Medical Students, Education, Prognosis, Online training resource
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online training resourceOther
Please see information included in the description of the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention is an online training resource to improve the recognition of imminent death in palliative care patients. The intervention should take approximately 15 minutes to complete. During this time, the participants who are in the intervention arm will be shown the results of a previous study which identified how expert palliative care doctors recognise imminently dying palliative care patients. The intervention will be implemented via the website, immediately after participants have completed the first set of vignettes. Receives: Other: Online training resource |
| Control group | No intervention | The participants assigned to the control group will not receive this additional information and will simply be informed that they are approximately half way through the task and will be asked to continue on to the next set of vignettes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival estimates - immediate effect
The primary outcome will be a continuous survival estimate provided from the students for the second series of vignettes; ranging from 0-100%.
Measured: Second series of vignettes, taking into account the estimates from the first series. Students can participate at their convenience and will have a four week window to complete the first and second series of vignettes.
Secondary outcomes (3)
Survival estimates - follow-up
Survival estimates provided from the students at the two week follow-up; ranging from 0-100%.
Measured: Third series of vignettes, taking into account the estimates from previous series. Two weeks after completing the first and second series of vignettes, students will be asked to complete a third series of vignettes within a four week window.
Cue weighting
Cue weighting of the individual students as compared to the experts; that is the coefficient of each factor as part of their "judgement policy".
Measured: Change over time including all three series of vignettes. Students are given a four week window to complete the first and second series of vignettes. After two weeks, they will be asked to complete a third series of vignettes within a four week window.
Level of expertise
The level of expertise will be assessed with the Cochran-Weiss-Shanteau (CWS) score. This score details the level of ability to discriminate and the level of consistency.
Measured: Change over time including all three series of vignettes. Students are given a four week window to complete the first and second series of vignettes. After two weeks, they will be asked to complete a third series of vignettes within a four week window.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start5 Apr 2018
- Primary completion27 Jul 2018
- Study completion12 Aug 2018
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 Terminal IllnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Brunel University, Imperial College London, Marie Curie Hospice, Belfast, University of Hull
- Responsible party
- Sponsor
- Investigators
- Patrick Stone, PhD, MD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360812
- Sponsor's protocol ID
- 17/0650
- Acronym
- ORaClES
- Status last verified
- Apr 2020
- First submitted
- 23 Nov 2017
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data (suitably anonymised) may be shared with other research groups if a reasonable request is submitted to and agreed by the Chief Investigator.
Publications
Oostendorp L, White N, Harries P, Yardley S, Tomlinson C, Ricciardi F, Gokalp H, Stone P. Protocol for the ORaClES study: an online randomised controlled trial to improve clinical estimates of survival using a training resource for medical students. BMJ Open. 2019 Mar 3;9(3):e025265. doi: 10.1136/bmjopen-2018-025265.
PubMed 30833321White N, Oostendorp LJ, Tomlinson C, Yardley S, Ricciardi F, Gokalp H, Minton O, Boland JW, Clark B, Harries P, Stone P. Online training improves medical students' ability to recognise when a person is dying: The ORaClES randomised controlled trial. Palliat Med. 2020 Jan;34(1):134-144. doi: 10.1177/0269216319880767. Epub 2019 Nov 14.
PubMed 31722611
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Randomised Controlled Trial to Improve Clinical Estimates of Survival (ORaClES)
- ClinicalTrials.gov ID
- NCT03360812
- Acronym / sponsor ID
- ORaClES / 17/0650
- Conditions
- Terminal Illness
- Keywords
- Medical Students, Education, Prognosis, Online training resource
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Brunel University, Imperial College London, Marie Curie Hospice, Belfast, University of Hull
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 12 Aug 2018 (actual)
- First posted
- 4 Dec 2017 (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 evaluates whether an online training resource can improve the performance of medical students in recognising imminently dying palliative care patients.
Detailed description
Clinicians are routinely asked to provide survival estimates for palliative care patients, but recognition of imminent death (last 72 hours of life) is often inaccurate. We developed an online training resource, based on a previous study that identified the symptoms or signs that were most influential in forming expert palliative care doctors' prognostic decisions about imminent death.
This double-blind randomised controlled trial will evaluate the effectiveness of this online training resource in improving the performance of medical students in recognising imminently dying palliative care patients.
Participants are asked to visit the study website and review three series of vignettes describing patients referred to palliative care. For each vignette, participants are asked to provide an estimate (0-100%) about the probability that the patient will die in the next 72 hours. After the first series of vignettes, students randomised to the intervention arm are given access to an online training resource showing how experts weighted the relative importance of symptoms and signs. All participants are asked to complete a second series of vignettes. After two weeks, all participants are asked to return to the website and complete a third series of vignettes to assess if any effect has been maintained.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Online training resourceThe intervention is an online training resource to improve the recognition of imminent death in palliative care patients. The intervention should take approximately 15 minutes to complete. During this time, the participants who are in the intervention arm will be shown the results of a previous study which identified how expert palliative care doctors recognise imminently dying palliative care patients. The intervention will be implemented via the website, immediately after participants have completed the first set of vignettes. |
| Control group | No intervention | –The participants assigned to the control group will not receive this additional information and will simply be informed that they are approximately half way through the task and will be asked to continue on to the next set of vignettes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years of age
- Enrolled on a registered medical course within the United Kingdom
- In the penultimate or final year of medical school
- Sufficient English language proficiency
- Willing and able to provide consent as indicated by taking part in the online survey
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 training resourcePlease see information included in the description of the intervention group. | Other | Intervention group |
Primary outcome
Survival estimates - immediate effect
Time frame: Second series of vignettes, taking into account the estimates from the first series. Students can participate at their convenience and will have a four week window to complete the first and second series of vignettes.
The primary outcome will be a continuous survival estimate provided from the students for the second series of vignettes; ranging from 0-100%.
3 secondary outcomes
Survival estimates - follow-up
Time frame: Third series of vignettes, taking into account the estimates from previous series. Two weeks after completing the first and second series of vignettes, students will be asked to complete a third series of vignettes within a four week window.
Cue weighting
Time frame: Change over time including all three series of vignettes. Students are given a four week window to complete the first and second series of vignettes. After two weeks, they will be asked to complete a third series of vignettes within a four week window.
Level of expertise
Time frame: Change over time including all three series of vignettes. Students are given a four week window to complete the first and second series of vignettes. After two weeks, they will be asked to complete a third series of vignettes within a four week window.
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 10 Apr 2020.
- Background: PubMed 30833321Oostendorp L, White N, Harries P, Yardley S, Tomlinson C, Ricciardi F, Gokalp H, Stone P. Protocol for the ORaClES study: an online randomised controlled trial to improve clinical estimates of survival using a training resource for medical students. BMJ Open. 2019 Mar 3;9(3):e025265. doi: 10.1136/bmjopen-2018-025265.
- Background: PubMed 31722611White N, Oostendorp LJ, Tomlinson C, Yardley S, Ricciardi F, Gokalp H, Minton O, Boland JW, Clark B, Harries P, Stone P. Online training improves medical students' ability to recognise when a person is dying: The ORaClES randomised controlled trial. Palliat Med. 2020 Jan;34(1):134-144. doi: 10.1177/0269216319880767. Epub 2019 Nov 14.
- Individual participant dataSharing planned: Yes. Data (suitably anonymised) may be shared with other research groups if a reasonable request is submitted to and agreed by the Chief Investigator.
Related trials for Terminal Illness
RecruitingObservational study
β2M Post-HD Rebound Prediction
Renal Disease, End Stage
Active, not recruiting
Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain
Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety
Not yet recruiting
PATH-03 Paraguay Feasibility Study
Kidney Disease, End-Stage
Recruiting
Empowering Monterey Bay Residents for Activated, Collaborative, and Equitable Care
Shared Decision-Making, Quality of Life
Recruiting
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Kidney Disease, End-Stage, End-stage Renal Disease
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, PhD, MD principal investigator
UCL
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online training resource in people with Terminal Illness, run by University College, London at 5 sites in United Kingdom.
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 5 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 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
Survival estimates - immediate effect (time frame: Second series of vignettes, taking into account the estimates from the first series. Students can participate at their convenience and will have a four week window to complete the first and second series of vignettes.). 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 NCT03360812, 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 10 Apr 2020.