- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Detaljerad beskrivning
-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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Paris, Frankrike, 75014
- Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
---|
Doctor and nurse
|
Doctor without nurse
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Family satisfaction assessed by qualitative approach
Tidsram: Patient's ICU discharge day (up to 3 months after Day 1)
|
Patient's ICU discharge day (up to 3 months after Day 1)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Healthcaregivers' satifaction assessed by qualitative approach
Tidsram: End of the study (up to 2 years)
|
End of the study (up to 2 years)
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Family PTSD
Tidsram: 3 months after patient's ICU discharge (up to 6 months after Day 1)
|
3 months after patient's ICU discharge (up to 6 months after Day 1)
|
Family HADS
Tidsram: 3 months after patient's ICU discharge (up to 6 months after Day 1)
|
3 months after patient's ICU discharge (up to 6 months after Day 1)
|
Family peri-traumatic dissociation
Tidsram: Patient's ICU discharge (up to 3 months after Day 1)
|
Patient's ICU discharge (up to 3 months after Day 1)
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CPP/107-11
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