ORaClES: A Trial to Improve Prognostication

NCT ID: NCT03360812

Last Updated: 2020-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2018-08-12

Brief Summary

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

Detailed Description

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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

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Terminal Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Online training resource

Intervention Type OTHER

Please see information included in the description of the intervention group.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Online training resource

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Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brunel University

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Marie Curie Hospice, Belfast

OTHER

Sponsor Role collaborator

Hull York Medical School

UNKNOWN

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Stone, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

UCL

Locations

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Brighton and Sussex Medical School

Brighton, , United Kingdom

Site Status

Hull York Medical School

Hull, , United Kingdom

Site Status

Imperial College London

London, , United Kingdom

Site Status

St George's Medical School

London, , United Kingdom

Site Status

UCL Medical School

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 30833321 (View on PubMed)

White 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.

Reference Type BACKGROUND
PMID: 31722611 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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17/0650

Identifier Type: -

Identifier Source: org_study_id

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