- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Description détaillée
-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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Paris, France, 75014
- Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Doctor and nurse
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Doctor without nurse
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Family satisfaction assessed by qualitative approach
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Healthcaregivers' satifaction assessed by qualitative approach
Délai: End of the study (up to 2 years)
|
End of the study (up to 2 years)
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Family PTSD
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CPP/107-11
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