Clinical trial NCT03261258: Comparison of Criteria for the Designation of a Contact Person in ICU Patients and Close Friends and Relatives
Official title: ICU and Contact Person: Comparison of Criteria for Designation in Patients and Close Friends and Relatives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Hospitalised in a Medical ICU
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the medical ICU of Dijon CHU Burgundy and their relatives/friends.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: