NCT04568629

Brief Summary

This study investigates how clinicians form intuitive judgements about the prognoses of palliative care patients after receiving advice perceived as coming from either a team member or an algorithm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2021

Completed
Last Updated

January 10, 2022

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 23, 2020

Last Update Submit

December 16, 2021

Conditions

Terminal Illness

Keywords

PrognosticationMultidisciplinary teamsJudge-Advisor SystemPalliative CareEnd-of-life

Outcome Measures

Primary Outcomes (1)

  • Probability of survival estimate

    Clinicians' estimates of the probability of a patient surviving for two weeks (0-100%)

    Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette

Secondary Outcomes (2)

  • Participants' weighting policies (characteristics of the participants)

    Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette

  • Participants' weighting policies (the advice itself)

    Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette

Study Arms (2)

Algorithm Arm

EXPERIMENTAL

Participants received prognostic advice from a prognostic algorihm.

Other: Advice from the PiPS-B14 prognostic tool

Clinician arm

EXPERIMENTAL

Participants recieved prognostic advice from another clinician.

Other: Advice from another clinician

Interventions

Advice from the PiPS-B14 prognostic toolOTHER

Participants were informed that prognostic advice came from the PiPS-B14 prognostic tool. PiPS-B14 is a validated prognostic algorithm that has been shown to be as accurate as an agreed multi-professional survival estimate. Participants were further informed that in a previous study the PiPS-B14 risk categories for predicting two-week survival were as accurate as a doctor's or a nurse's prediction.

Algorithm Arm
Advice from another clinicianOTHER

Participants were informed that prognostic advice came from another clinician. Doctors were told that advice was from a nurse, whereas nurses or other types of HCPs were told that advice was from a doctor.

Clinician arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinicians working in an adult palliative care service
  • Willing and able to provide written informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Related Publications (1)

  • Bruun A, White N, Oostendorp L, Vickerstaff V, Harris AJL, Tomlinson C, Bloch S, Stone P. An online randomised controlled trial of prognosticating imminent death in advanced cancer patients: Clinicians give greater weight to advice from a prognostic algorithm than from another clinician with a different profession. Cancer Med. 2023 Mar;12(6):7519-7528. doi: 10.1002/cam4.5485. Epub 2022 Nov 29.

    PMID: 36444695DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Stone, MA MD FRCP

    UCL (University College London)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The research team and participants were blind to intervention allocation, whilst the database specialist was not blinded to allocation. Group allocation was only revealed once the database had been locked and analyses had been completed.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to one of two study arms and received advice reportedly from either a prognostic algorithm, or another clinician.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 29, 2020

Study Start

October 15, 2020

Primary Completion

April 13, 2021

Study Completion

April 13, 2021

Last Updated

January 10, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
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 study
Access Criteria
The data will be shared upon reasonable request

Locations

GB(1)