NCT03162146

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
43,378

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 17, 2017

Last Update Submit

May 19, 2017

Conditions

Intensive Care Unit StayDeath

Outcome Measures

Primary Outcomes (1)

  • Patient mortality

    Mortality with stratification on patients for whom a forego life-sustaining therapy decision was made

    At the time of intensive care unit discharge up to a maximum of 6 years since admission

Study Arms (1)

Patient admitted to intensive care unit

All patients requiring intensive care unit stay

Other: Deaths in intensive care unit

Interventions

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

Patient admitted to intensive care unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient admitted to intensive care unit

You may qualify if:

  • All patients who were admitted to 9 French intensive care units from January 1st 2011 to December 31st 2016

You may not qualify if:

  • Patients admitted in pediatrics intensive care units and in specialized burns units

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation médicale, Hôpital de la Croix Rousse

Lyon, 69317, France

Location

MeSH Terms

Conditions

Death

Interventions

Death DomainIntensive Care Units

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Death Domain SuperfamilyProtein Interaction Domains and MotifsProtein DomainsProtein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical PhenomenaHospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Central Study Contacts

Claude GUERIN, MD, PhD

CONTACT

04 26 10 94 18claude.guerin@chu-lyon.fr

Antoine DUCLOS, MD, PhD

CONTACT

04 72 11 51 66antoine.duclos@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 22, 2017

Study Start

July 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 22, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)