- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02410538
Frequently Asked Questions for ICU Patients' Families (FamiréaXVII)
Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Marseille, Frankrike, 13354
- Hôpital Nord Assistance Publique Hôpitaux de Marseille
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of understanding at day 5 by a method of reformulation questionnaire
Tidsram: 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.
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
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
- RC12_3678
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