NCT01449734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 11, 2013

Completed
Last Updated

November 11, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

September 30, 2011

Results QC Date

February 26, 2013

Last Update Submit

September 4, 2013

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Patient Severity of Illness

    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

    From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months

  • Patient Mortality

    From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Visiting family members of patients being treated in the ICU

You may qualify if:

  • all visiting family members who consent to participate

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Units of the University Hospital Jena

Jena, Thuringia, D-07743, Germany

Location

Related Publications (4)

  • 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.

    PMID: 17133189BACKGROUND

  • 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.

    PMID: 12130954BACKGROUND

  • 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.

    PMID: 19730813BACKGROUND

  • 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.

    PMID: 23417207DERIVED

Related Links

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christiane Hartog, MD
Organization
CSCC Germany, Jena University Hospital
christiane.hartog@med.uni-jena.de
+49 3641 9323171

Study Officials

  • Christiane S Hartog, MD

    Jena University Hospital, Dpt. of Anesthesiology and Intensive Care Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 10, 2011

Study Start

April 1, 2011

Primary Completion

February 1, 2012

Study Completion

November 1, 2012

Last Updated

November 11, 2013

Results First Posted

November 11, 2013

Record last verified: 2013-09

Locations

DE(1)