Comparison of Criteria for the Designation of a Contact Person in ICU Patients and Close Friends and Relatives (REPERE II/III)

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.

Study Overview

• Status: Unknown
• Conditions: Patients Hospitalised in a Medical ICU
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jean-Pierre QUENOT; Phone Number: +33 03.80.29.36.85; Email: jean-pierre.quenot@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • Recruiting
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between scores measured (relatives/patients) on the scales for the principal criteria for the designation of a contact person	at baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (ACTUAL): August 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: QUENOT 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No