Post-ICU Consultation : a Time to Discuss Advance Directives (CoPRADA) (CoPRADA)

April 17, 2023 updated by: University Hospital, Brest

Post-ICU Consultation : a Time to Discuss Advance Directives

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

Study Overview

Detailed Description

After a stay in intensive care units (ICU), patients can experience physical, psychological and cognitive impairments. To assess this post intensive care syndrom (PICS), post-ICU consultation have been developed.

Since 5 year mortality is higher in ICU survivors, it might be interesting to address those patients' views relating to illness and end of life through a discussion on advance directives (AD), during post-ICU consultation.

However, the development of these consultations being recent, it has not yet been assessed whether this consultations might be a suitable time to discuss AD and the intensivit a suitable interlocutor.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France, 29200
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients willing to discuss AD after an ICU stay
Time Frame: 1 year
Number of patient willing to discussion AD after ICU stay will be observed
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients knowing about AD before their ICU stay
Time Frame: 1 year
Number of patient knowing before AD before ICU stay will be observed
1 year
Factors influencing the writing of AD after an ICU stay
Time Frame: 1 year
Factors such as lenght of stay in ICU, lenght of hospitalisation, duration of mechanical ventilation /sedation and the existence of PTSD (PCLS) or anxiety/ depression (HADS) will be evaluated and their influence on the completion of AD
1 year
Evaluation of the privileged interlocutor to discuss AD
Time Frame: 1 year
The privileged interlocutor to discuss AD will be observed
1 year
Evaluation of the privileged interlocutor to complete AD
Time Frame: 1 year
The privileged interlocutor to complete AD will be observed
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2021

Primary Completion (Actual)

December 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC21.0335 - CoPRADA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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