NCT03261258

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

August 23, 2017

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person

    at baseline

Study Arms (2)

Patients

Patients hospitalised in the ICU of Dijon CHU Burgundy

Other: Questionnaire

Proches

Relatives/close friends of patients hospitalised in the ICU of Dijon CHU Burgundy

Other: Questionnaire

Interventions

PatientsProches

Eligibility Criteria

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

Patients admitted to the medical ICU of Dijon CHU Burgundy and their relatives/friends.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 24, 2017

Study Start

July 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations