NCT03875521

Brief Summary

This is a prospective, non-randomized, multicenter, observational national study, involving centers with different working shift organizations. Participating centers are 24 French adult intensive care units with different working shift organizations (12-hours shift vs. less than 12-hours shift) in public hospitals. Caregivers (doctors, nurses and assistant nurses) constitute the population of the study. The duration of the study is 13 months. The aim of this study is to evaluate the impact of the working shift organizations on:

  • The intensive care units operation;
  • The use of outside staff;
  • The caregivers' quality of life at work;
  • The caregivers' satisfaction at work;
  • The nursing work environment;
  • Psychosocial and organisational work constraints
  • The performance of the intensive care units;
  • The costs and efficiency of the working shift organizations.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

December 7, 2018

Last Update Submit

July 23, 2019

Conditions

Keywords

Work Schedule ToleranceObservational StudyIntensive Care Units/manpowerJob Satisfaction

Outcome Measures

Primary Outcomes (1)

  • intensive care units operation

    Percentage of hours during which the French standard ratio of 1 nurse for 2.5 patients in intensive care units is not observed or during which intensive care beds are closed

    during 1 year

Secondary Outcomes (9)

  • use of outside staff

    during 1 year

  • caregivers' quality of life at work

    first and eleventh months of the study

  • caregivers' quality of life at work

    first and eleventh months of the study

  • caregivers' quality of life at work

    first and eleventh months of the study

  • caregivers' satisfaction at work

    first and eleventh months of the study

  • +4 more secondary outcomes

Study Arms (2)

12 hours

< 12hours

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

volunteer caregivers: health care staff of 24 intensive care units will be included in the study: doctors, nurses and assistant nurses

You may qualify if:

  • assistant nurses, nurses, doctors
  • working in an hospital intensive care unit

You may not qualify if:

  • \- opposition to use data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

medical-surgical intensive care unit - TENON hospital (AP-HP)

Paris, 75020, France

RECRUITING

Study Officials

  • Pierre-Yves BLANCHARD, RN, MSN

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Yves BLANCHARD, RN, MSN

CONTACT

Muriel FARTOUKH, MD, Prof.

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 7, 2018

First Posted

March 14, 2019

Study Start

June 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations