Family Satisfaction in the Intensive Care Unit - a Multic... | NCT00890513

Studies
Family Satisfaction in the Intensive Care Unit - a Multicentre Assessment

NCT00890513

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Nov 20, 2009Estimated

Enrollment

1,200Actual

Phase

Not provided

Conditions

Critical Illness

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 27, 2009

First Posted Date

Apr 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2009

Last Update Posted Date

Nov 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary aim of the present study is to assess satisfaction in a large sample of next of kin in Swiss-German ICUs.

Secondary aims are to test the hypothesis that family satisfaction is related to ICU structure and process and to factors related to patients and next of kin. Further, the hypothesis will be tested that proxy assessment is possible, i.e. next of kin rate satisfaction with care similar to patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess satisfaction in Swiss-German ICUs

Secondary Outcomes

Measure	Description	Time Frame
To test the hypothesis that family satisfaction is related to ICU structure and process To test the hypothesis that proxy assessment is possible

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

family members of patients staying for > 48 hours in an ICU

Exclusion Criteria:

lack of consent,
insufficient knowledge of German language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Next of kin of patients cared for in one of the 42 ICU's located in german-speaking Switzerland (ICU recognized by Swiss Society of Intensive Care Medicine).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans U Rothen, MD PhD	Bern University Hospital, University of Bern-Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Intenisve Care Medicine, Inselspital		Bern	Canton of Bern	CH-3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19730813	Result	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.
20825369	Derived	Stricker KH, Kimberger O, Brunner L, Rothen HU. Patient satisfaction with care in the intensive care unit: can we rely on proxies? Acta Anaesthesiol Scand. 2011 Feb;55(2):149-56. doi: 10.1111/j.1399-6576.2010.02293.x. Epub 2010 Sep 6.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms