- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02410538
Frequently Asked Questions for ICU Patients' Families (FamiréaXVII)
Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Half of the families of ICU patients do not understand the information provided by doctors and nurses. Receiving clear, loyal and appropriate information is one of their main expectations. We have previously reported that relatives had difficulty asking questions that allow them to improve their understanding regarding ICU issues. In a preliminary study, we developed a list of questions considered as important by families, ICU doctors and nurses.
The aim of this prospective, randomized and controlled trial is to test the effectiveness of a list of frequently asked questions to relatives of ICU patients on their understanding of the provided information.
The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of ICU stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ).
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
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Marseille, Francia, 13354
- Hôpital Nord Assistance Publique Hôpitaux de Marseille
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
The subjects that will be included are relatives of patients. The patients must be
- Adults
- Receiving invasive mechanical ventilation
- Intubated in the first 48 hours of ICU admission
- For an expected duration of mechanical ventilation > 48 hours
- With a life expectancy of at least 5 days and a SAPS 2 at baseline < 75
- Who received a visit within 24 hours after intubation. Only one relative will be included.
Exclusion Criteria:
- person unable to read French
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
families that received the list of "FAQ"
The intervention consists of the delivery to the relatives of ICU patients a list of "21 key issues" in intensive care during the first 48h period of ICU stay, only for intubated and mechanically ventilated patients A formal interview is scheduled to relatives of ICU patients on D3 of inclusion
|
|
|
families that received information as usual
A formal interview is scheduled relatives of ICU patients on D3 inclusion
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of understanding at day 5 by a method of reformulation questionnaire
Lasso di tempo: 5th day after inclusion
|
The physician in charge of the patient provides the diagnosis, the treatment and the prognosis to the investigator prior to meet the relative. After the meeting, the relative gives to the investigator the diagnosis, main treatements and the prognosis as they have undestood them. In a final step, the investigator will indicate whether similar responses are consistent or not consistent. |
5th day after inclusion
|
|
Scale of satisfaction out of intensive care.
Lasso di tempo: 3 months and at one yearfter inclusion
|
HADS scores and IES-R at day 5 to day 10.
|
3 months and at one yearfter inclusion
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RC12_3678
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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-
Western Carolina UniversityReclutamento
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Medical University of ViennaRitiratoTelemedicina | EcocardiografiaAustria
-
Scripps HealthBurl Concepts, Inc.ReclutamentoForame ovale pervio (PFO)Stati Uniti