ADJUST: A Study on MDT Prognostication (ADJUST)

December 16, 2021 updated by: University College, London

Study of Advice and Decision-making on Prognosis Using the Judge-advisor System Within Multi-disciplinary Teams (ADJUST)

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.

Study Overview

Detailed Description

Using the Judge-Advisor System, the investigators will recruit clinicians working in palliative care for adults. Participants will be asked to complete an online survey and review five patient summaries ("vignettes") based on real cases derived from a previous study. Clinicians will be presented with key prognostic information and will be asked to provide an estimate of the probability that the patient will survive for two weeks (0-100%). After providing this initial estimate, participants will receive prognostic advice. While in reality all participants will receive the same advice, participants will be randomised into two groups and these groups will be informed that the advice is either: (1) provided by an algorithm; or (2) provided by a team colleague. Participants will then be given the opportunity to give a second, possibly revised estimate in the light of the advice received.

Study Type

Interventional

Enrollment (Actual)

323

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

      • London, United Kingdom, WC1E 6BT
        • University College London

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:

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Algorithm Arm
Participants received prognostic advice from a prognostic algorihm.

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.

Experimental: Clinician arm
Participants recieved prognostic advice from another clinician.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probability of survival estimate
Time Frame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' weighting policies (characteristics of the participants)
Time Frame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Participants' responses to demographic questions
Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Participants' weighting policies (the advice itself)
Time Frame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Strength of the prognostic advice provided by the advisor (0-100%)
Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Patrick Stone, MA MD FRCP, UCL (University College London)

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)

October 15, 2020

Primary Completion (Actual)

April 13, 2021

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

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 CI

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 study

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.

Clinical Trials on Terminal Illness

Clinical Trials on Advice from the PiPS-B14 prognostic tool

  • McMaster University
    Completed
    Coronary Artery Disease | Stroke | Multiple Sclerosis | Hypertension | Diabetes | Chronic Obstructive Pulmonary Disease | Osteoarthritis | Rheumatoid Arthritis | Back Pain | Osteoporosis
    Canada
3
Subscribe