Patients Hospitalised in a Medical ICUREPERE II/IIINCT03261258
Comparison of Criteria for the Designation of a Contact Person in ICU Patients and Close Friends and Relatives
An observational study of Patients Hospitalised in a Medical ICU, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In the vast majority of cases, the person of trust (or contact person) is not designated by the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team thus identifies a person who 1) may not be the person the patient would have designated and 2) may not be the most suitable to take… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Hospitalised in a Medical ICU
- What is being tested?
- Questionnaire
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2016to 31 Dec 2016
- 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: Patients admitted to the medical ICU of Dijon CHU Burgundy and their relatives/friends.
Who may be able to join
- Patients and their friends/relatives who have been given information on the study
- Patients admitted to the ICU according to the criteria defined by decree n° 2002-465 of the law of 5 April 2002 relative to the rights of patients and the quality of the healthcare system;
- Patients unable to designate a person of trust on admission;
- Patients able to designate a person of trust on discharge from the ICU.
Who cannot join
- Refusal to participate;
- Age < 18 years;
- Patient/relative under ward of court;
- Patient/relative presenting a major cognitive disorder ruling out a reliable interview;
- Patient and/or relative who cannot be interviewed or who cannot provide information ;
- Absence of family and/or close friends.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ICU and Contact Person: Comparison of Criteria for Designation in Patients and Close Friends and Relatives
In the vast majority of cases, the person of trust (or contact person) is not designated by the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team thus identifies a person who 1) may not be the person the patient would have designated and 2) may not be the most suitable to take on this responsibility. Though the first point is not easy, the main difficulty for the clinician is to know if he is dealing with the "right person for the job", meaning a person who is able to take on the responsibility of the contact person. This is a heavy responsibility in terms of the information given, of passing on this information to relatives and friends, of consulting the doctors, of help or support in medical decisions, etc. This responsibility may also be difficult for one person alone to take on and it may be helpful to share it between several friends or relatives. In a princeps study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate a contact person was based on criteria such as knowledge of the wishes and values of the patient, the strength of the relationship with the patient, and the person of trust designated before admission to the ICU. However, we do not know what criteria are used by the patients themselves or those used by their close friends and relatives. This study will make it possible to determine and to measure the possible differences between the criteria used by the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those used by close friends and relatives (REPERE II).
In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete questionnaires.
- Conditions
- Patients Hospitalised in a Medical ICU
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients hospitalised in the ICU of Dijon CHU Burgundy Receives: Other: Questionnaire | |
| Proches | Relatives/close friends of patients hospitalised in the ICU of Dijon CHU Burgundy Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Jul 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Hospitalised in a Medical ICUStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261258
- Sponsor's protocol ID
- QUENOT 2016
- Acronym
- REPERE II/III
- Status last verified
- Feb 2026
- First submitted
- 23 Aug 2017
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rigaud JP, Hardy JB, Meunier-Beillard N, Devilliers H, Ecarnot F, Quesnel C, Gelinotte S, Declercq PL, Eraldi JP, Bougerol F, Quenot JP. The concept of a surrogate is ill adapted to intensive care: Criteria for recognizing a reference person. J Crit Care. 2016 Apr;32:89-92. doi: 10.1016/j.jcrc.2015.12.011. Epub 2015 Dec 21.
PubMed 26787167
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU and Contact Person: Comparison of Criteria for Designation in Patients and Close Friends and Relatives
- ClinicalTrials.gov ID
- NCT03261258
- Acronym / sponsor ID
- REPERE II/III / QUENOT 2016
- Conditions
- Patients Hospitalised in a Medical ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 24 Aug 2017 (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.
In the vast majority of cases, the person of trust (or contact person) is not designated by the patient (emergency, severe disease situations, coma, sedation, etc.). The healthcare team thus identifies a person who 1) may not be the person the patient would have designated and 2) may not be the most suitable to take on this responsibility. Though the first point is not easy, the main difficulty for the clinician is to know if he is dealing with the "right person for the job", meaning a person who is able to take on the responsibility of the contact person. This is a heavy responsibility in terms of the information given, of passing on this information to relatives and friends, of consulting the doctors, of help or support in medical decisions, etc. This responsibility may also be difficult for one person alone to take on and it may be helpful to share it between several friends or relatives. In a princeps study (QUENOT, 2015), it was shown that the process used by the healthcare team to designate a contact person was based on criteria such as knowledge of the wishes and values of the patient, the strength of the relationship with the patient, and the person of trust designated before admission to the ICU. However, we do not know what criteria are used by the patients themselves or those used by their close friends and relatives. This study will make it possible to determine and to measure the possible differences between the criteria used by the ICU healthcare team (REPERE I), those used by patients (REPERE III) and finally, those used by close friends and relatives (REPERE II).
In order to do this, 300 persons (150 patients and 150 relatives/friends) will complete questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnairePatients hospitalised in the ICU of Dijon CHU Burgundy |
| Proches | – | Other: QuestionnaireRelatives/close friends of patients hospitalised in the ICU of Dijon CHU Burgundy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the medical ICU of Dijon CHU Burgundy and their relatives/friends.
Key inclusion criteria (4 listed)
- Patients and their friends/relatives who have been given information on the study
- Patients admitted to the ICU according to the criteria defined by decree n° 2002-465 of the law of 5 April 2002 relative to the rights of patients and the quality of the healthcare system;
- Patients unable to designate a person of trust on admission;
- Patients able to designate a person of trust on discharge from the ICU.
Key exclusion criteria (6 listed)
- Refusal to participate;
- Age < 18 years;
- Patient/relative under ward of court;
- Patient/relative presenting a major cognitive disorder ruling out a reliable interview;
- Patient and/or relative who cannot be interviewed or who cannot provide information ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire | Other | Patients, Proches |
Primary outcome
Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person
Time frame: at baseline
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 9 Feb 2026.
- Results publication: PubMed 26787167Rigaud JP, Hardy JB, Meunier-Beillard N, Devilliers H, Ecarnot F, Quesnel C, Gelinotte S, Declercq PL, Eraldi JP, Bougerol F, Quenot JP. The concept of a surrogate is ill adapted to intensive care: Criteria for recognizing a reference person. J Crit Care. 2016 Apr;32:89-92. doi: 10.1016/j.jcrc.2015.12.011. Epub 2015 Dec 21.
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 Patients Hospitalised in a Medical ICU, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 6 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 9 Feb 2026. 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?
Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person (time frame: at baseline). 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 NCT03261258, which also lists 1 linked publication.
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 9 Feb 2026.