Advance DirectivesCoPRADANCT05817500
Post-ICU Consultation : a Time to Discuss Advance Directives (CoPRADA)
An observational study of Advance Directives and Post Intensive Care Syndrome, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of this study is to assess the possibility of discussing advance directives during post-intensive care consultation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Directives, Post Intensive Care Syndrome, Advance Care Planning
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2021to 9 Dec 2022
- 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: 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
Who may be able to join
- Patients with 48 hours of mechanical ventilation
- Patients with a 5 days stay in ICU
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Intensive Care, Advance directives, Post Intensive Care syndrome, Post Intensive Care consultation
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients with > 48h mechanical ventilation and/or > 5 days stay in ICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients willing to discuss AD after an ICU stay
Number of patient willing to discussion AD after ICU stay will be observed
Measured: 1 year
Secondary outcomes (4)
Number of patients knowing about AD before their ICU stay
Number of patient knowing before AD before ICU stay will be observed
Measured: 1 year
Factors influencing the writing of AD after an ICU stay
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
Measured: 1 year
Evaluation of the privileged interlocutor to discuss AD
The privileged interlocutor to discuss AD will be observed
Measured: 1 year
Evaluation of the privileged interlocutor to complete AD
The privileged interlocutor to complete AD will be observed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start9 Dec 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advance DirectivesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817500
- Sponsor's protocol ID
- 29BRC21.0335 - CoPRADA
- Acronym
- CoPRADA
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33731201Andreu 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.
PubMed 28826983Lone 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.
PubMed 22837381
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-ICU Consultation : a Time to Discuss Advance Directives
- ClinicalTrials.gov ID
- NCT05817500
- Acronym / sponsor ID
- CoPRADA / 29BRC21.0335 - CoPRADA
- Keywords
- Intensive Care, Advance directives, Post Intensive Care syndrome, Post Intensive Care consultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 18 Apr 2023 (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 aim of this study is to assess the possibility of discussing advance directives during post-intensive care consultation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients with > 48h mechanical ventilation and/or > 5 days stay in ICU | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with 48 hours of mechanical ventilation
- Patients with a 5 days stay in ICU
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Number of patients knowing about AD before their ICU stay
Time frame: 1 year
Factors influencing the writing of AD after an ICU stay
Time frame: 1 year
Evaluation of the privileged interlocutor to discuss AD
Time frame: 1 year
Evaluation of the privileged interlocutor to complete AD
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 33731201Rousseau 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.
- Background: PubMed 28826983Andreu 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.
- Background: PubMed 22837381Lone 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Advance Directives and Post Intensive Care Syndrome, run by University Hospital, Brest 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients willing to discuss AD after an ICU stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817500, which also lists 3 linked publications.
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 18 Apr 2023.