Physician JudgmentUPSNCT02648828
Understanding Physician Signout Risk Perception
An observational study of Physician Judgment, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of the study is to compare the ability of physicians and a statistical index (the Rothman score) to predict clinical deterioration over the next 24 hours. Clinical deterioration is defined as concern in change in vital signs or patient status requiring a call to the rapid response team, cardiopulmonary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physician Judgment
- What is being tested?
- Clinical deterioration
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Feb 2016
- Phase
- Observational
- 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
Study population: Cohorts will be selected from the teaching teams of the University of Pittsburgh's General Internal Medicine wards.
Who may be able to join
- Interns, residents, attendings in the Department of Medicine, Division of General Internal Medicine, University of Pittsburgh.
- Rotating on the general medical service at the University of Pittsburgh Medical Center - Presbyterian Hospital.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of the study is to compare the ability of physicians and a statistical index (the Rothman score) to predict clinical deterioration over the next 24 hours. Clinical deterioration is defined as concern in change in vital signs or patient status requiring a call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.
Read the detailed description
The proposed study will ask interns, residents, and attending physicians from general internal medicine teaching teams in a large teaching hospital to make predictions about the probability of their patient having a clinical deterioration in the next 24 hours. The investigators will compare these judgments to the Rothman index.
- Conditions
- Physician Judgment
- Being tested
- Clinical deterioration
- Keywords
- Judgment, risk assessment, clinical deterioration, cardiac arrest, Rothman Index
- Medical subject headings
- Clinical Deterioration, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical deteriorationOther
Patients at risk of clinical deterioration
| Study group | Role | What they receive |
|---|---|---|
| Intern | Interns are in their first year of residency. Receives: Other: Clinical deterioration | |
| Residents | Residents are in their 2nd or 3rd year of residency. Receives: Other: Clinical deterioration | |
| Attendings | Attendings are physicians who have completed their residency. Receives: Other: Clinical deterioration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between physician prediction of risk of clinical deterioration and Rothman Index
Physicians will make judgments about the probability of clinical deterioration for each of their patients on a 0 (definitely won't) to 100 (certainly will) scale. Clinical deterioration is defined as rapid response, cardiopulmonary arrest, or ICU transfer in the next 24 hours. The Rothman Index is an index that predicts clinical deterioration. The area under the receiver operating curve (AUROC) will be calculated for physicians and the Rothman Index. The AUROC measures the association between the physician's judgment or Rothman Index and actual clinical deterioration. The AUROC of these two measures will then be statistically compared.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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 Physician JudgmentStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University
- Responsible party
- Principal investigator, Janel Hanmer, University of Pittsburgh
- Investigators
- Janel A Hanmer, M.D., Principal investigator, University of PittsburghDeepika Mohan, MD, Principal investigator, University of PittsburghAlex Davis, PhD, Principal investigator, Carnegie Mellon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648828
- Sponsor's protocol ID
- PRO15040582
- Acronym
- UPS
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2015
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnold J, Davis A, Fischhoff B, Yecies E, Grace J, Klobuka A, Mohan D, Hanmer J. Comparing the predictive ability of a commercial artificial intelligence early warning system with physician judgement for clinical deterioration in hospitalised general internal medicine patients: a prospective observational study. BMJ Open. 2019 Oct 10;9(10):e032187. doi: 10.1136/bmjopen-2019-032187.
PubMed 31601602
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Physician Signout Risk Perception
- ClinicalTrials.gov ID
- NCT02648828
- Acronym / sponsor ID
- UPS / PRO15040582
- Conditions
- Physician Judgment
- Keywords
- Judgment, risk assessment, clinical deterioration, cardiac arrest, Rothman Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Carnegie Mellon University
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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.
The purpose of the study is to compare the ability of physicians and a statistical index (the Rothman score) to predict clinical deterioration over the next 24 hours. Clinical deterioration is defined as concern in change in vital signs or patient status requiring a call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.
Detailed description
The proposed study will ask interns, residents, and attending physicians from general internal medicine teaching teams in a large teaching hospital to make predictions about the probability of their patient having a clinical deterioration in the next 24 hours. The investigators will compare these judgments to the Rothman index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intern | – | Other: Clinical deteriorationInterns are in their first year of residency. |
| Residents | – | Other: Clinical deteriorationResidents are in their 2nd or 3rd year of residency. |
| Attendings | – | Other: Clinical deteriorationAttendings are physicians who have completed their residency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohorts will be selected from the teaching teams of the University of Pittsburgh's General Internal Medicine wards.
Key inclusion criteria (2 listed)
- Interns, residents, attendings in the Department of Medicine, Division of General Internal Medicine, University of Pittsburgh.
- Rotating on the general medical service at the University of Pittsburgh Medical Center - Presbyterian Hospital.
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 |
|---|---|---|
| Clinical deteriorationPatients at risk of clinical deterioration | Other | Attendings, Intern, Residents |
Primary outcome
Difference between physician prediction of risk of clinical deterioration and Rothman Index
Time frame: Six months
Physicians will make judgments about the probability of clinical deterioration for each of their patients on a 0 (definitely won't) to 100 (certainly will) scale. Clinical deterioration is defined as rapid response, cardiopulmonary arrest, or ICU transfer in the next 24 hours. The Rothman Index is an index that predicts clinical deterioration. The area under the receiver operating curve (AUROC) will be calculated for physicians and the Rothman Index. The AUROC measures the association between the physician's judgment or Rothman Index and actual clinical deterioration. The AUROC of these two measures will then be statistically compared.
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 28 Aug 2017.
- Derived from this study: PubMed 31601602Arnold J, Davis A, Fischhoff B, Yecies E, Grace J, Klobuka A, Mohan D, Hanmer J. Comparing the predictive ability of a commercial artificial intelligence early warning system with physician judgement for clinical deterioration in hospitalised general internal medicine patients: a prospective observational study. BMJ Open. 2019 Oct 10;9(10):e032187. doi: 10.1136/bmjopen-2019-032187.
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.
Janel A Hanmer, M.D. principal investigator
University of Pittsburgh
Deepika Mohan, MD principal investigator
University of Pittsburgh
Alex Davis, PhD principal investigator
Carnegie Mellon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physician Judgment, run by University of Pittsburgh at 1 site in United States.
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 28 Aug 2017. 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 States. 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?
Difference between physician prediction of risk of clinical deterioration and Rothman Index (time frame: Six months). 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 NCT02648828, 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 28 Aug 2017.