ORaClES: A Trial to Improve Prognostication

Terminal Illness Clinical Trial

— ORaClES  

Official title:

Online Randomised Controlled Trial to Improve Clinical Estimates of Survival (ORaClES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360812
• Other study ID #: 17/0650
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: August 12, 2018

Study information

• Verified date: April 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates whether an online training resource can improve the performance of medical students in recognising imminently dying palliative care patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 12, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Over 18 years of age

2. Enrolled on a registered medical course within the United Kingdom

3. In the penultimate or final year of medical school

4. Sufficient English language proficiency

5. Willing and able to provide consent as indicated by taking part in the online survey

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Terminal Illness

Intervention

Other:
• Online training resource
Please see information included in the description of the intervention group.

Locations

Country	Name	City	State
United Kingdom	Brighton and Sussex Medical School	Brighton
United Kingdom	Hull York Medical School	Hull
United Kingdom	Imperial College London	London
United Kingdom	St George's Medical School	London
United Kingdom	UCL Medical School	London

Sponsors (5)

Lead Sponsor	Collaborator
University College, London	Brunel University, Hull York Medical School, Imperial College London, Marie Curie Hospice, Belfast

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

White N, Oostendorp LJ, Tomlinson C, Yardley S, Ricciardi F, Gökalp 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	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	Survival estimates - follow-up	Survival estimates provided from the students at the two week follow-up; ranging from 0-100%.	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.
Secondary	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".	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.
Secondary	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.	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.