Helsinki Declaration on Patient Safety | NCT01246544

Studies
Helsinki Declaration on Patient Safety

NCT01246544

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Sep 8, 2011Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Patient Safety

Interventions

Not provided

Countries

Germany

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

Sep 2011

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

Nov 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Nov 22, 2010

First Submission Date that Met QC Criteria

Nov 22, 2010

First Posted Date

Nov 23, 2010Estimated

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

Sep 7, 2011

Last Update Posted Date

Sep 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the investigators would like to ask medical colleagues in the region to participate in an anonymous German online survey on patient safety.

The investigators want to investigate the implementation and establishment of measures on patient safety, that anaesthesiologists utilize to fulfill their obligations.

Detailed Description

The Declaration builds on earlier statements about safety and quality of care. It represents a shared European opinion of what currently is both worth doing and practical to improve patient safety in anaesthesiology in 2010. The Declaration recommends practical steps that all anaesthesiologists who are not already using them should include in their own practice. These are relatively straightforward and where they are currently being used have a track record of improving patient safety. All European anaesthesiology institutions are expected to support the World Health Organization(WHO) 'Safe Surgery Saves Lives' initiative including the "Safe Surgery Checklist". The Declaration was endorsed by European Board of Anaesthesiology (EBA) and the European Society of Anaesthesiology (ESA). It was officially launched at the Euroanaesthesia congress in Helsinki in June 2010 and was subsequently signed by several representatives of European anaesthesiology and different additional stakeholders (WHO, World Federation of Societies of Anaesthesiologists (WFSA), European Patients Federation (EPF)).

The investigators want to investigate the implementation and establishment of measures on patient safety, that anaesthesiologists utilize to fulfill their obligations under the perspective of the Declaration.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Data collection group: physicians		Online survey for physicians/members of the innovation alliance Berlin-Brandenburg (INABBRA)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Actual level on patient safety in Berlin-Brandenburg	Actual level on patient safety in Berlin-Brandenburg; comparing this to the recommendations of the Helsinki Declaration on Patient Safety	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Members of the innovation alliance Berlin-Brandenburg (INABBRA)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Members of the innovation alliance Berlin-Brandenburg (INABBRA)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin		Berlin	State of Berlin	13353/10117	Germany