Family Satisfaction (FS) in the Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT01449734
• Recruitment Status: Completed
• First Posted: October 10, 2011
• Results First Posted: November 11, 2013
• Last Update Posted: November 11, 2013
• Sponsor: Center for Sepsis Control and Care, Germany
• Collaborator: German Federal Ministry of Education and Research
• Information provided by (Responsible Party): Christiane Hartog, Center for Sepsis Control and Care, Germany

Study Description

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.

Condition or disease
Critical Illness

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 Design

• Study Type: Observational
• Actual Enrollment: 217 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU
• Study Start Date: April 2011
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: November 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. Patient Mortality [ Time Frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Visiting family members of patients being treated in the ICU

Criteria

Inclusion Criteria:

• all visiting family members who consent to participate

Exclusion Criteria:

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

Contacts and Locations

Locations

Germany

Intensive Care Units of the University Hospital Jena

Jena, Thuringia, Germany, D-07743

Sponsors and Collaborators

Center for Sepsis Control and Care, Germany

German Federal Ministry of Education and Research

Investigators

• Principal Investigator: Christiane S Hartog, MD; Jena University Hospital, Dpt. of Anesthesiology and Intensive Care Medicine

More Information

Additional Information:

Publication of study results 

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Günther 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.

• Responsible Party: Christiane Hartog, Principal investigator, Center for Sepsis Control and Care, Germany
• ClinicalTrials.gov Identifier: NCT01449734
• Other Study ID Numbers: Jena FS-ICU
• First Posted: October 10, 2011
• Results First Posted: November 11, 2013
• Last Update Posted: November 11, 2013
• Last Verified: September 2013

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes