Patient SafetyPatient SafetyNCT01246544
Helsinki Declaration on Patient Safety
An observational study of Patient Safety, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Safety
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Members of the innovation alliance Berlin-Brandenburg (INABBRA)
Who may be able to join
- Members of the innovation alliance Berlin-Brandenburg (INABBRA)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin
Berlin, State of Berlin, 13353/10117
About this study
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.
Read the 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)).
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 under the perspective of the Declaration.
- Conditions
- Patient Safety
- Keywords
- Patient Safety, The Helsinki Declaration on Patient Safety in Anaesthesiology, Helsinki Declaration on Patient Safety, European Board of Anaesthesiology (EBA), European Society of Anaesthesiology (ESA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Data collection group: physicians | Online survey for physicians/members of the innovation alliance Berlin-Brandenburg (INABBRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246544
- Sponsor's protocol ID
- Patient Safety
- Acronym
- Patient Safety
- Status last verified
- Sep 2011
- First submitted
- 22 Nov 2010
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helsinki Declaration on Patient Safety
- ClinicalTrials.gov ID
- NCT01246544
- Acronym / sponsor ID
- Patient Safety / Patient Safety
- Conditions
- Patient Safety
- Keywords
- Patient Safety, The Helsinki Declaration on Patient Safety in Anaesthesiology, Helsinki Declaration on Patient Safety, European Board of Anaesthesiology (EBA), European Society of Anaesthesiology (ESA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
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 under the perspective of the Declaration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection group: physicians | – | –Online survey for physicians/members of the innovation alliance Berlin-Brandenburg (INABBRA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Members of the innovation alliance Berlin-Brandenburg (INABBRA)
Key inclusion criteria (1 listed)
- Members of the innovation alliance Berlin-Brandenburg (INABBRA)
Key exclusion criteria (0 listed)
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
Actual level on patient safety in Berlin-Brandenburg
Time frame: 3 months
Actual level on patient safety in Berlin-Brandenburg; comparing this to the recommendations of the Helsinki Declaration on Patient Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
- Online SurveyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patient Safety, run by Charite University, Berlin, 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 0 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 8 Sep 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Actual level on patient safety in Berlin-Brandenburg (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2011.