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Frequently Asked Questions for ICU Patients' Families

NCT ID: NCT02410538

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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).

Conditions

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Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the Family

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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

list of "FAQ"

Intervention Type OTHER

families that received information as usual

A formal interview is scheduled relatives of ICU patients on D3 inclusion

list of "FAQ"

Intervention Type OTHER

Interventions

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list of "FAQ"

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Hôpital Nord Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 30374690 (View on PubMed)

Other Identifiers

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RC12_3678

Identifier Type: -

Identifier Source: org_study_id