Critical IllnessSwiss-BEANNCT00890513
Family Satisfaction in the Intensive Care Unit - a Multicentre Assessment
An observational study of Critical Illness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The primary aim of the present study is to assess satisfaction in a large sample of next of kin in Swiss-German ICUs. Secondary aims are to test the hypothesis that family satisfaction is related to ICU structure and process and to factors related to patients and next of kin. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 1,200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2007to Dec 2007
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Next of kin of patients cared for in one of the 42 ICU's located in german-speaking Switzerland (ICU recognized by Swiss Society of Intensive Care Medicine).
Who may be able to join
- family members of patients staying for > 48 hours in an ICU
Who cannot join
- lack of consent,
- insufficient knowledge of German language
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intenisve Care Medicine, Inselspital
Bern, Canton of Bern, CH-3010
About this study
The primary aim of the present study is to assess satisfaction in a large sample of next of kin in Swiss-German ICUs.
Secondary aims are to test the hypothesis that family satisfaction is related to ICU structure and process and to factors related to patients and next of kin. Further, the hypothesis will be tested that proxy assessment is possible, i.e. next of kin rate satisfaction with care similar to patients.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess satisfaction in Swiss-German ICUs
Secondary outcomes (1)
To test the hypothesis that family satisfaction is related to ICU structure and process To test the hypothesis that proxy assessment is possible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startApr 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Hans U Rothen, MD PhD, Principal investigator, Bern University Hospital, University of Bern-Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890513
- Sponsor's protocol ID
- KEK_180/06
- Acronym
- Swiss-BEAN
- Status last verified
- Nov 2009
- First submitted
- 27 Apr 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Stricker KH, Kimberger O, Schmidlin K, Zwahlen M, Mohr U, Rothen HU. Family satisfaction in the intensive care unit: what makes the difference? Intensive Care Med. 2009 Dec;35(12):2051-9. doi: 10.1007/s00134-009-1611-4.
PubMed 19730813Stricker KH, Kimberger O, Brunner L, Rothen HU. Patient satisfaction with care in the intensive care unit: can we rely on proxies? Acta Anaesthesiol Scand. 2011 Feb;55(2):149-56. doi: 10.1111/j.1399-6576.2010.02293.x. Epub 2010 Sep 6.
PubMed 20825369
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Satisfaction in the Intensive Care Unit - a Multicentre Assessment
- ClinicalTrials.gov ID
- NCT00890513
- Acronym / sponsor ID
- Swiss-BEAN / KEK_180/06
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Apr 2009 (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 primary aim of the present study is to assess satisfaction in a large sample of next of kin in Swiss-German ICUs.
Secondary aims are to test the hypothesis that family satisfaction is related to ICU structure and process and to factors related to patients and next of kin. Further, the hypothesis will be tested that proxy assessment is possible, i.e. next of kin rate satisfaction with care similar to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Next of kin of patients cared for in one of the 42 ICU's located in german-speaking Switzerland (ICU recognized by Swiss Society of Intensive Care Medicine).
Key inclusion criteria (1 listed)
- family members of patients staying for > 48 hours in an ICU
Key exclusion criteria (2 listed)
- lack of consent,
- insufficient knowledge of German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess satisfaction in Swiss-German ICUs
1 secondary outcome
To test the hypothesis that family satisfaction is related to ICU structure and process To test the hypothesis that proxy assessment is possible
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 20 Nov 2009.
- Results publication: PubMed 19730813Stricker KH, Kimberger O, Schmidlin K, Zwahlen M, Mohr U, Rothen HU. Family satisfaction in the intensive care unit: what makes the difference? Intensive Care Med. 2009 Dec;35(12):2051-9. doi: 10.1007/s00134-009-1611-4.
- Derived from this study: PubMed 20825369Stricker KH, Kimberger O, Brunner L, Rothen HU. Patient satisfaction with care in the intensive care unit: can we rely on proxies? Acta Anaesthesiol Scand. 2011 Feb;55(2):149-56. doi: 10.1111/j.1399-6576.2010.02293.x. Epub 2010 Sep 6.
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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.
Hans U Rothen, MD PhD principal investigator
Bern University Hospital, University of Bern-Switzerland
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 Critical Illness, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 2 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 20 Nov 2009. 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 Switzerland. 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?
To assess satisfaction in Swiss-German ICUs. 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 NCT00890513, which also lists 2 linked publications.
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 20 Nov 2009.