Clinical trial NCT01449734: Family Satisfaction (FS) in the Intensive Care Unit
Official title: Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Center for Sepsis Control and Care, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2011-10-10
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Visiting family members of patients being treated in the ICU

Brief summary: There is increasing awareness that high-quality care in the intensive care unit also includes care of visiting family members according to their needs. The investigators therefore want to assess family satisfaction using a questionnaire that was specially developed for this setting and recently validated for German-speaking participants.

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.

Eligibility criteria: Inclusion Criteria:

* all visiting family members who consent to participate

Exclusion Criteria:

* no more than two family members per patient;
* prior participation

Primary outcomes:
measure: Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score
timeFrame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
Secondary outcomes:
measure: Patient Severity of Illness
timeFrame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
measure: Patient Length of Stay on the ICU
timeFrame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
measure: Patient Mortality
timeFrame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Intensive Care Units of the University Hospital Jena
state: Thuringia
Study officials:
affiliation: Jena University Hospital, Dpt. of Anesthesiology and Intensive Care Medicine
name: Christiane S Hartog, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.