Intensive Care Unit StayTEAMICNCT03162146
Team Elements Associated With Mortality in Intensive Care
An observational study of Intensive Care Unit Stay and Death, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Stay, Death
- What is being tested?
- Deaths in intensive care unit
- How many people
- 43,378 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2017to Sep 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient admitted to intensive care unit
Who may be able to join
- All patients who were admitted to 9 French intensive care units from January 1st 2011 to December 31st 2016
Who cannot join
- Patients admitted in pediatrics intensive care units and in specialized burns units
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation médicale, Hôpital de la Croix Rousse
Lyon, 69317
Claude GUERIN, MD, PhD, 04 26 10 94 18 ext. +33, claude.guerin@chu-lyon.fr
Antoine DUCLOS, MD, PhD, 04 72 11 51 66 ext. +33, antoine.duclos@chu-lyon.fr
About this study
Official title: Influence of Medical and Nursing Teams Composition on Patient Mortality in Intensive Care
The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.
- Conditions
- Intensive Care Unit Stay, Death
- Being tested
- Deaths in intensive care unit
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deaths in intensive care unitOther
Assessment of the influence of team familiarity among the members of medical and nursing staffs on risk of patient death
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted to intensive care unit | All patients requiring intensive care unit stay Receives: Other: Deaths in intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient mortality
Mortality with stratification on patients for whom a forego life-sustaining therapy decision was made
Measured: At the time of intensive care unit discharge up to a maximum of 6 years since admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startJul 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit StayStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 43,378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162146
- Sponsor's protocol ID
- 69HCL17_0031
- Acronym
- TEAMIC
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medical and Nursing Teams Composition on Patient Mortality in Intensive Care
- ClinicalTrials.gov ID
- NCT03162146
- Acronym / sponsor ID
- TEAMIC / 69HCL17_0031
- Conditions
- Intensive Care Unit Stay, Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43,378 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 22 May 2017 (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.
The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient admitted to intensive care unit | – | Other: Deaths in intensive care unitAll patients requiring intensive care unit stay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to intensive care unit
Key inclusion criteria (1 listed)
- All patients who were admitted to 9 French intensive care units from January 1st 2011 to December 31st 2016
Key exclusion criteria (1 listed)
- Patients admitted in pediatrics intensive care units and in specialized burns units
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 |
|---|---|---|
| Deaths in intensive care unitAssessment of the influence of team familiarity among the members of medical and nursing staffs on risk of patient death | Other | Patient admitted to intensive care unit |
Primary outcome
Patient mortality
Time frame: At the time of intensive care unit discharge up to a maximum of 6 years since admission
Mortality with stratification on patients for whom a forego life-sustaining therapy decision was made
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: No
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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.
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 Intensive Care Unit Stay and Death, run by Hospices Civils de Lyon at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 22 May 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claude GUERIN, MD, PhD (04 26 10 94 18 ext. +33, claude.guerin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient mortality (time frame: At the time of intensive care unit discharge up to a maximum of 6 years since admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2017.