Terminal IllnessADJUSTNCT04568629
ADJUST: A Study on MDT Prognostication
A study testing Advice from the PiPS-B14 prognostic tool and Advice from another clinician in people with Terminal Illness, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Terminal Illness
- What is being tested?
- Advice from the PiPS-B14 prognostic tool and Advice from another clinician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2020to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinicians working in an adult palliative care service
- Willing and able to provide written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Terminal Illness
- Being tested
- Advice from the PiPS-B14 prognostic tool, Advice from another clinician
- Keywords
- Prognostication, Multidisciplinary teams, Judge-Advisor System, Palliative Care, End-of-life
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Algorithm Arm | Experimental | Participants received prognostic advice from a prognostic algorihm. Receives: Other: Advice from the PiPS-B14 prognostic tool |
| Clinician arm | Experimental | Participants recieved prognostic advice from another clinician. Receives: Other: Advice from another clinician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of survival estimate
Clinicians' estimates of the probability of a patient surviving for two weeks (0-100%)
Measured: 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' responses to demographic questions
Measured: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Participants' weighting policies (the advice itself)
Strength of the prognostic advice provided by the advisor (0-100%)
Measured: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start15 Oct 2020
- Primary completion13 Apr 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Terminal IllnessStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two study arms and received advice reportedly from either a prognostic algorithm, or another clinician.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Stone, MA MD FRCP, Principal investigator, UCL (University College London)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568629
- Sponsor's protocol ID
- 17031/001
- Acronym
- ADJUST
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data (suitably anonymised) may be shared with other research groups if a reasonable request is submitted to and agreed by the CI
Publications
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.
PubMed 36444695
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Advice and Decision-making on Prognosis Using the Judge-advisor System Within Multi-disciplinary Teams (ADJUST)
- ClinicalTrials.gov ID
- NCT04568629
- Acronym / sponsor ID
- ADJUST / 17031/001
- Conditions
- Terminal Illness
- Keywords
- Prognostication, Multidisciplinary teams, Judge-Advisor System, Palliative Care, End-of-life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two study arms and received advice reportedly from either a prognostic algorithm, or another clinician.
| Arm | Type | Receives |
|---|---|---|
| Algorithm Arm | Experimental | Other: Advice from the PiPS-B14 prognostic toolParticipants received prognostic advice from a prognostic algorihm. |
| Clinician arm | Experimental | Other: Advice from another clinicianParticipants recieved prognostic advice from another clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinicians working in an adult palliative care service
- Willing and able to provide written informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advice from the PiPS-B14 prognostic toolParticipants 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. | Other | Algorithm Arm |
| Advice from another clinicianParticipants 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. | Other | Clinician arm |
Primary outcome
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%)
2 secondary outcomes
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' 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 36444695Bruun 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.
- Individual participant dataSharing planned: Yes. Data (suitably anonymised) may be shared with other research groups if a reasonable request is submitted to and agreed by the CI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Stone, MA MD FRCP principal investigator
UCL (University College London)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice from the PiPS-B14 prognostic tool and Advice from another clinician in people with Terminal Illness, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of survival estimate (time frame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.