Family Satisfaction (FS) in the Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449734
• Other study ID #: Jena FS-ICU
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: September 4, 2013
• Start date: April 2011
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: Center for Sepsis Control and Care, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: November 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all visiting family members who consent to participate

Exclusion Criteria:

• no more than two family members per patient;

• prior participation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Germany	Intensive Care Units of the University Hospital Jena	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Center for Sepsis Control and Care, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score	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	No
Secondary	Patient Severity of Illness		From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months	No
Secondary	Patient Length of Stay on the ICU		From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months	No
Secondary	Patient Mortality		From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months	No

External Links

•   Publication of study results