NCT05817500

Brief Summary

The aim of this study is to assess the possibility of discussing advance directives during post-intensive care consultation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 9, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 5, 2023

Last Update Submit

April 17, 2023

Conditions

Keywords

Intensive CareAdvance directivesPost Intensive Care syndromePost Intensive Care consultation

Outcome Measures

Primary Outcomes (1)

  • Number of patients willing to discuss AD after an ICU stay

    Number of patient willing to discussion AD after ICU stay will be observed

    1 year

Secondary Outcomes (4)

  • Number of patients knowing about AD before their ICU stay

    1 year

  • Factors influencing the writing of AD after an ICU stay

    1 year

  • Evaluation of the privileged interlocutor to discuss AD

    1 year

  • Evaluation of the privileged interlocutor to complete AD

    1 year

Study Arms (1)

ICU patients with > 48h mechanical ventilation and/or > 5 days stay in ICU

Eligibility Criteria

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

All patients with at least 48 hours of mechanical ventilation and/or a 5 days stay in ICU, and then summoned to post-ICU consultation

You may qualify if:

  • Patients with 48 hours of mechanical ventilation
  • Patients with a 5 days stay in ICU

You may not qualify if:

  • Patients with therapeutic limitation discussed during their ICU stay
  • Geographical remotness to come to the post-ICU consultation
  • Minor patients
  • Patient not affiliated to the social security scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brest

Brest, 29200, France

Location

Related Publications (3)

  • Rousseau AF, Prescott HC, Brett SJ, Weiss B, Azoulay E, Creteur J, Latronico N, Hough CL, Weber-Carstens S, Vincent JL, Preiser JC. Long-term outcomes after critical illness: recent insights. Crit Care. 2021 Mar 17;25(1):108. doi: 10.1186/s13054-021-03535-3.

    PMID: 33731201BACKGROUND
  • Andreu P, Dargent A, Large A, Meunier-Beillard N, Vinault S, Leiva-Rojas U, Ecarnot F, Prin S, Charles PE, Fournel I, Rigaud JP, Quenot JP. Impact of a stay in the intensive care unit on the preparation of Advance Directives: Descriptive, exploratory, qualitative study. Anaesth Crit Care Pain Med. 2018 Apr;37(2):113-119. doi: 10.1016/j.accpm.2017.05.007. Epub 2017 Aug 4.

    PMID: 28826983BACKGROUND
  • Lone NI, Walsh TS. Impact of intensive care unit organ failures on mortality during the five years after a critical illness. Am J Respir Crit Care Med. 2012 Oct 1;186(7):640-7. doi: 10.1164/rccm.201201-0059OC. Epub 2012 Jul 26.

    PMID: 22837381BACKGROUND

MeSH Terms

Conditions

postintensive care syndrome

Study Design

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

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

December 9, 2021

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations