Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the FamilyFamiréaXVIINCT02410538
Frequently Asked Questions for ICU Patients' Families
An observational study of Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the Family, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the Family
- What is being tested?
- list of "FAQ"
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of the stay.
Who may be able to join
- 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.
Who cannot join
- person unable to read French
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Nord Assistance Publique Hôpitaux de Marseille
Marseille, 13354
About this study
Official title: Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the 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
Read the detailed description
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).
- Being tested
- list of "FAQ"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
list of "FAQ"Other
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: list of "FAQ" | |
| families that received information as usual | A formal interview is scheduled relatives of ICU patients on D3 inclusion Receives: Other: list of "FAQ" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of understanding at day 5 by a method of reformulation questionnaire
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.
Measured: 5th day after inclusion
Scale of satisfaction out of intensive care.
HADS scores and IES-R at day 5 to day 10.
Measured: 3 months and at one yearfter inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the FamilyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410538
- Sponsor's protocol ID
- RC12_3678
- Acronym
- FamiréaXVII
- Status last verified
- Apr 2016
- First submitted
- 2 Apr 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Azoulay E, Forel JM, Vinatier I, Truillet R, Renault A, Valade S, Jaber S, Durand-Gasselin J, Schwebel C, Georges H, Merceron S, Cariou A, Moussa M, Hraiech S, Argaud L, Leone M, Curtis JR, Kentish-Barnes N, Jouve E, Papazian L. Questions to improve family-staff communication in the ICU: a randomized controlled trial. Intensive Care Med. 2018 Nov;44(11):1879-1887. doi: 10.1007/s00134-018-5423-2. Epub 2018 Oct 21.
PubMed 30374690
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
- ClinicalTrials.gov ID
- NCT02410538
- Acronym / sponsor ID
- FamiréaXVII / RC12_3678
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the 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
Detailed description
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| families that received the list of "FAQ" | – | Other: 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 | – | Other: list of "FAQ"A formal interview is scheduled relatives of ICU patients on D3 inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of the stay.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- person unable to read French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| list of "FAQ" | Other | families that received information as usual, families that received the list of "FAQ" |
Primary outcome
Evaluation of understanding at day 5 by a method of reformulation questionnaire
Time frame: 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.
Scale of satisfaction out of intensive care.
Time frame: 3 months and at one yearfter inclusion
HADS scores and IES-R at day 5 to day 10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 30374690Azoulay E, Forel JM, Vinatier I, Truillet R, Renault A, Valade S, Jaber S, Durand-Gasselin J, Schwebel C, Georges H, Merceron S, Cariou A, Moussa M, Hraiech S, Argaud L, Leone M, Curtis JR, Kentish-Barnes N, Jouve E, Papazian L. Questions to improve family-staff communication in the ICU: a randomized controlled trial. Intensive Care Med. 2018 Nov;44(11):1879-1887. doi: 10.1007/s00134-018-5423-2. Epub 2018 Oct 21.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Improve the Understanding of the Diagnosis the Treatment and the Prognosis by One Member of the Family, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of understanding at day 5 by a method of reformulation questionnaire (time frame: 5th day after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.