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NEWS
Sponsor study identifier
observational
100
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
October 2014
Actual (reported)When a patient is admitted to the ICU this often happens so suddenly that this can create a significant amount of stress and anxiety for family members for several reasons. Firstly, the family does not have a pre existing relationship with the ICU team. Secondly, the urgency of the situation and the technic it requires is often such that minimal information can be given to family members. And finally, as a result of the unpredictability of each patient's condition, it can be difficult to predict outcome for family members. Together, these factors compound the stress and anxiety of family members. This anxiety is natural and it is important for health caregivers to be able to offer the best support possible. A high quality communication provided by structured information given by physicians and nurses as well could improve support to the families and lead to greater satisfaction. Giving information to families during meetings is crucial at 3 moments: at the first day when the patient is admitted, at day 3, weekly and each time important news is given (surgery, deterioration in condition, end-of-life). The purpose of this project is to evaluate if the involvement of nurses during those meetings could improve quality in communication which is assessed by mixed methods. Families and healthcare workers satisfaction will be assessed by qualitative methodology. Family peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using validated scales. Training of healthcare workers will be done by role play. Information to the families is delivered using a framework for physicians and nurses. All the meetings of the study will be audited by a psychologist.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2012
Actual (reported)December 10, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 2014
Actual (reported)October 2014
Actual (reported)Family satisfaction assessed by qualitative approach
Patient's ICU discharge day (up to 3 months after Day 1)
Healthcaregivers' satifaction assessed by qualitative approach
End of the study (up to 2 years)
Family PTSD
3 months after patient's ICU discharge (up to 6 months after Day 1)
Families of patients hospitalized in ICU.
Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
Paris, 75014, France
100 participants (actual enrollment reported by the registry).
First Submitted
September 28, 2012
First Posted
December 10, 2012
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Family HADS
3 months after patient's ICU discharge (up to 6 months after Day 1)
Family peri-traumatic dissociation
Patient's ICU discharge (up to 3 months after Day 1)
Contact the study team to confirm eligibility.
Primary Completion
June 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
August 7, 2015
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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