- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01449734
Family Satisfaction (FS) in the Intensive Care Unit
Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU
Study Overview
Status
Conditions
Detailed Description
Family members who visit patients on the ICU (intensive care unit) are not just onlookers. They experience the process of care along with their loved ones. Increasingly, the satisfaction of family members with ICU care, decision-making and information, and their empowerment to contribute towards patient care as near relatives, is being perceived as an important aspect of the general quality of ICU care.
Family satisfaction is assessed using the 34-item FS-ICU questionnaire which was recently validated for German-speaking participants.
The aim of this pilot survey is to identify opportunities for improvement of family satisfaction.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Thuringia
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Jena, Thuringia, Germany, D-07743
- Intensive Care Units of the University Hospital Jena
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all visiting family members who consent to participate
Exclusion Criteria:
- no more than two family members per patient;
- prior participation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score
Time Frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making.
After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).
|
From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Severity of Illness
Time Frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
Patient Length of Stay on the ICU
Time Frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
Patient Mortality
Time Frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christiane S Hartog, MD, Jena University Hospital, Dpt. of Anesthesiology and Intensive Care Medicine
Publications and helpful links
General Publications
- Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.
- Heyland DK, Rocker GM, Dodek PM, Kutsogiannis DJ, Konopad E, Cook DJ, Peters S, Tranmer JE, O'Callaghan CJ. Family satisfaction with care in the intensive care unit: results of a multiple center study. Crit Care Med. 2002 Jul;30(7):1413-8. doi: 10.1097/00003246-200207000-00002.
- 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.
- Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Med. 2013 Jun;39(6):1071-9. doi: 10.1007/s00134-013-2862-7. Epub 2013 Feb 16.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jena FS-ICU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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