ORaClES: A Trial to Improve Prognostication (ORaClES)

April 7, 2020 updated by: University College, London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Brighton, United Kingdom
        • Brighton and Sussex Medical School
      • Hull, United Kingdom
        • Hull York Medical School
      • London, United Kingdom
        • Imperial College London
      • London, United Kingdom
        • St George's Medical School
      • London, United Kingdom
        • UCL Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Other: Online training resource
Please see information included in the description of the intervention group.
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

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

Investigators

  • Principal Investigator: Patrick Stone, PhD, MD, UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Actual)

July 27, 2018

Study Completion (Actual)

August 12, 2018

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17/0650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data (suitably anonymised) may be shared with other research groups if a reasonable request is submitted to and agreed by the Chief Investigator.

IPD Sharing Time Frame

The data will become available after the publication of results and will be archived securely by the Chief Investigator for a minimum of 20 years from the declaration of end of trial.

IPD Sharing Access Criteria

The data will be shared upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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