Family Satisfaction (FS) in the Intensive Care Unit

An observational study of Critical Illness, run by Center for Sepsis Control and Care, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Critical Illness
How many people: 217 participants
Where: 1 siteGermany
Study dates: Apr 2011to Nov 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Visiting family members of patients being treated in the ICU

Who may be able to join

all visiting family members who consent to participate

Who cannot join

no more than two family members per patient;
prior participation

Trial locations and contacts

1 site in 1 country.

Germany1 site

Intensive Care Units of the University Hospital Jena
Jena, Thuringia, D-07743

Other trials in Germany

About this study

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

Read the 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.

Conditions: Critical Illness
Medical subject headings: Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 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
Measured: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months
Patient Mortality
Measured: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Nov 2012

First posted10 Oct 2011 (estimated)
Study startApr 2011
Primary completionFeb 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Critical IllnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01449734
Sponsor's protocol ID: Jena FS-ICU
Status last verified: Sep 2013
First submitted: 30 Sep 2011
Last updated: 11 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1097/01.CCM.0000251122.15053.50.
PubMed 17133189
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.
PubMed 12130954
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.
PubMed 19730813
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.
PubMed 23417207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

All Critical Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU
ClinicalTrials.gov ID: NCT01449734
Acronym / sponsor ID: Jena FS-ICU
Conditions: Critical Illness
Study type: Observational
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Center for Sepsis Control and Care, GermanyUniversity, hospital or other
Collaborators: German Federal Ministry of Education and Research
Study start: Apr 2011
Primary completion: Feb 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 10 Oct 2011 (estimated)
Results: Posted 11 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Visiting family members of patients being treated in the ICU

Key inclusion criteria (1 listed)

all visiting family members who consent to participate

Key exclusion criteria (2 listed)

no more than two family members per patient;
prior participation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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).

3 secondary outcomes

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
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
Patient Mortality
Time frame: From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months

Results and safety

Results posted to the registry on 11 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family Satisfaction	215	215

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Family Satisfaction n = 215
Value	78.3 (14.3)

Population analysed: By invitation

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: March to November 2011. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Family Satisfaction	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17133189Wall 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.
Background: PubMed 12130954Heyland 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.
Background: PubMed 19730813Stricker 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.
Derived from this study: PubMed 23417207Schwarzkopf 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.
Publication of study resultsLink provided by the sponsor.

Related trials for Critical Illness

RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christiane S Hartog, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness, run by Center for Sepsis Control and Care, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01449734, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.