- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Detaljeret beskrivelse
-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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Paris, Frankrig, 75014
- Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Doctor and nurse
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Doctor without nurse
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Family satisfaction assessed by qualitative approach
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Healthcaregivers' satifaction assessed by qualitative approach
Tidsramme: End of the study (up to 2 years)
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End of the study (up to 2 years)
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Family PTSD
Tidsramme: 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)
|
|
Family HADS
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CPP/107-11
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