Family Satisfaction (FS) in the Intensive Care Unit

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Christiane Hartog, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier:
NCT01449734
First received: September 30, 2011
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU

Further study details as provided by Center for Sepsis Control and Care, Germany:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Patient Mortality [ Time Frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: April 2011
Study Completion Date: November 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449734

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christiane Hartog, Principal investigator, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier: NCT01449734     History of Changes
Other Study ID Numbers: Jena FS-ICU
Study First Received: September 30, 2011
Results First Received: February 26, 2013
Last Updated: September 4, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014