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Completed

NCT Number: NCT02410538

Frequently Asked Questions for 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Nord Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

  • person unable to read French

Treatment and study plan

list of "FAQ"

Other

Primary outcomes

  1. Evaluation of understanding at day 5 by a method of reformulation questionnaire

    Time frame: 5th day after inclusion

    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.

  2. Scale of satisfaction out of intensive care.

    Time frame: 3 months and at one yearfter inclusion

    HADS scores and IES-R at day 5 to day 10.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: FamiréaXVII

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2015
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.