- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01745406
Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU. (NEWS)
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
-Randomized trial with two arms: arm 1: information is delivered by a team (physician and nurse) arm 2: information is delivered by the physician alone
-During the different meetings of the study: at day 1, at day 3, weekly and in case of deterioration of the patient condition.
The other days, family information is delivered as usually in both arms.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Paris, Frankrijk, 75014
- Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- patient : adult, 1 relative at minimum, mechanically ventilated at least 48 hours; and
- family : french-speaking, adult;
Exclusion Criteria:
- Conflict, organ donor, refusal to participate.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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Doctor and nurse
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Doctor without nurse
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Family satisfaction assessed by qualitative approach
Tijdsspanne: Patient's ICU discharge day (up to 3 months after Day 1)
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Patient's ICU discharge day (up to 3 months after Day 1)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Healthcaregivers' satifaction assessed by qualitative approach
Tijdsspanne: End of the study (up to 2 years)
|
End of the study (up to 2 years)
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Family PTSD
Tijdsspanne: 3 months after patient's ICU discharge (up to 6 months after Day 1)
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3 months after patient's ICU discharge (up to 6 months after Day 1)
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Family HADS
Tijdsspanne: 3 months after patient's ICU discharge (up to 6 months after Day 1)
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3 months after patient's ICU discharge (up to 6 months after Day 1)
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Family peri-traumatic dissociation
Tijdsspanne: Patient's ICU discharge (up to 3 months after Day 1)
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Patient's ICU discharge (up to 3 months after Day 1)
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CPP/107-11
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