Clinical trial NCT02410538: Frequently Asked Questions for ICU Patients' Families
Official title: Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the Family
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of the stay.

Brief summary: The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ

Detailed description: Half of the families of ICU patients do not understand the information provided by doctors and nurses. Receiving clear, loyal and appropriate information is one of their main expectations. We have previously reported that relatives had difficulty asking questions that allow them to improve their understanding regarding ICU issues. In a preliminary study, we developed a list of questions considered as important by families, ICU doctors and nurses.

The aim of this prospective, randomized and controlled trial is to test the effectiveness of a list of frequently asked questions to relatives of ICU patients on their understanding of the provided information.

The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of ICU stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ).

Eligibility criteria: Inclusion Criteria:

The subjects that will be included are relatives of patients. The patients must be

1. Adults
2. Receiving invasive mechanical ventilation
3. Intubated in the first 48 hours of ICU admission
4. For an expected duration of mechanical ventilation \> 48 hours
5. With a life expectancy of at least 5 days and a SAPS 2 at baseline \< 75
6. Who received a visit within 24 hours after intubation. Only one relative will be included.

Exclusion Criteria:

* person unable to read French

Primary outcomes:
measure: Evaluation of understanding at day 5 by a method of reformulation questionnaire
timeFrame: 5th day after inclusion
measure: Scale of satisfaction out of intensive care.
timeFrame: 3 months and at one yearfter inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Nord Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
citation: Azoulay E, Forel JM, Vinatier I, Truillet R, Renault A, Valade S, Jaber S, Durand-Gasselin J, Schwebel C, Georges H, Merceron S, Cariou A, Moussa M, Hraiech S, Argaud L, Leone M, Curtis JR, Kentish-Barnes N, Jouve E, Papazian L. Questions to improve family-staff communication in the ICU: a randomized controlled trial. Intensive Care Med. 2018 Nov;44(11):1879-1887. doi: 10.1007/s00134-018-5423-2. Epub 2018 Oct 21.