Frequently Asked Questions for ICU Patients' Families (FamiréaXVII)

Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.

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

Study Overview

• Status: Completed
• Conditions: Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the Family
• Intervention / Treatment: Other: 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).

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

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Hôpital Nord Assistance Publique Hôpitaux de Marseille

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

relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of the stay.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
families that received the list of "FAQ"; The intervention consists of the delivery to the relatives of ICU patients a list of "21 key issues" in intensive care during the first 48h period of ICU stay, only for intubated and mechanically ventilated patients A formal interview is scheduled to relatives of ICU patients on D3 of inclusion	Other: list of "FAQ"
families that received information as usual; A formal interview is scheduled relatives of ICU patients on D3 inclusion	Other: list of "FAQ"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of understanding at day 5 by a method of reformulation questionnaire	The physician in charge of the patient provides the diagnosis, the treatment and the prognosis to the investigator prior to meet the relative. After the meeting, the relative gives to the investigator the diagnosis, main treatements and the prognosis as they have undestood them. In a final step, the investigator will indicate whether similar responses are consistent or not consistent.	5th day after inclusion
Scale of satisfaction out of intensive care.	HADS scores and IES-R at day 5 to day 10.	3 months and at one yearfter inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: April 2, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: RC12_3678