Frequently Asked Questions for ICU Patients' Families

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

— FamiréaXVII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410538
• Other study ID #: RC12_3678
• Status: Completed
• Phase: N/A
• First received: April 2, 2015
• Last updated: October 27, 2016
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: April 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• list of "FAQ"

Locations

Country	Name	City	State
France	Hôpital Nord Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No