Complications of Medical Care, Nec in ICD9CM_2011HandSAFENCT01609777
HandSAFE - Development and Evaluation of a Handover Tool for Doctors and Nurses
A study testing SBAR in people with Complications of Medical Care, Nec in ICD9CM_2011, run by University of Zurich at 1 site in Switzerland.
Trial summary
A handover Tool for doctors and nurses improves the quality of handovers compared to handovers that are being conducted without a tool. In the present study the investigators will develop and evaluate a handover Tool for doctors and nurses. The investigators seek to answer the following research questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Complications of Medical Care, Nec in ICD9CM_2011
- What is being tested?
- SBAR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Jan 2013
- Phase
- Interventional
- 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 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria are: doctors and nurses with a minimum of 12 moths of work experience.
Who cannot join
- Exclusion criteria: staff members that deny participation or don't meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Bastian Grande, MD contact
Switzerland1 site
University Hospital Zurich, Institute of Anaesthesiology
Zurich, Canton of Zurich, 8091
Bastian Grande, MD, bastian.grande@usz.ch
About this study
A handover Tool for doctors and nurses improves the quality of handovers compared to handovers that are being conducted without a tool.
In the present study the investigators will develop and evaluate a handover Tool for doctors and nurses. The investigators seek to answer the following research questions:
- Does the tool improve quality (i.e. efficiency and accuracy)?
- Does the tool improve safety relevant attitude an perceived team collaboration?
Read the detailed description
Medical transfers in the ICU are a critical part of patient care. Ensuring consistency of information that is passed on within the intensive care unit i.e. from shift to shift or between different functional areas (eg ICU to surgery) is ensured. Incorrect, incomplete or incomprehensible information in this context can have severe consequences and jeopardize patient safety. Research on handovers from other high risk organizations that are associated with a high risk of error, such as space flight control centers has shown potential consequences that result from incomplete handovers. Apart from a flawed mental model about the state of the system, the respective recipient of the handover are not able to anticipate possible future events and respond accordingly. The main barriers to implement effective handover in the medical setting are the following factors: The medical and clinical context (constant background noise and lack of privacy); the organizational hierarchy and status differences, which may lead the submitter to stress, as well as linguistic and cultural barriers that may impede further communication.
To counter these barriers, a variety of memory aids (tools) have been designed to structure the handover along defined cornerstones. Examples of such handover tools are LAURS(Listen, Accept, Utilize, Reframe, Suggest) and SBAR (Situation, Background, Assessment, Recommendation). These memory aids facilitate a problem-centered and consistent delivery of information.
This however neglect a crucial fact: from a psychological perspective, the intensive care unit presents a multi-team system. This means that different functional groups (Senior doctors, assistant doctors and nurses) work together towards a common goal, ie the treatment of a patient. However handovers occur mostly parallel with different functional areas, which hampers the consistent exchange of information between the groups. This in turn may reduce team effectiveness and lead to errors in the treatment of a patient.
For this reason, a handover tool not only supports the information flow within a function group, but also between the various functional groups. The previous research on communication between physicians and nurses suggests that the perceived psychological safety is an important prerequisite for overcoming the perceived status differences, and thus for effective and efficient teamwork. Another crucial variable for the joint achievement of a goal is the degree of perceived team collaboration i.e. cooperation between doctors and nurses. If these two parameters - psychological safety and team collaboration - are not met or are insufficient, this may lead not only to lack of information, but also to reactance against the other group. This in turn can lead to inefficient or faulty handovers and thus fatally compromise patient safety.
The aim of the proposed study, therefore, is the development and evaluation is a tool - handSAFE - designed to increase the problem-centered structure of handovers.
- Being tested
- SBAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBARProcedure or surgery
situation, background, assessment, recommendation
| Study group | Role | What they receive |
|---|---|---|
| Handover with SBAR | Other | Handover with handover tool. Receives: Procedure: SBAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement time 4: training of the newly developed handover Tool in the patient simulator
Outcome measured by video-assisted analysis of the handovers and questionnaires pre- and post interventional.
Measured: 6 months
Duration of handovers
Measurement of the handover duration before and after the intervention.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of Medical Care, Nec in ICD9CM_2011Studies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bastian Grande, MD, Principal investigator, University Hospital Zurich, Institute of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609777
- Sponsor's protocol ID
- HandSAFE
- Acronym
- HandSAFE
- Status last verified
- May 2012
- First submitted
- 11 Apr 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HandSAFE - Development and Evaluation of a Handover Tool for Doctors and Nurses
- ClinicalTrials.gov ID
- NCT01609777
- Acronym / sponsor ID
- HandSAFE / HandSAFE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 1 Jun 2012 (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.
A handover Tool for doctors and nurses improves the quality of handovers compared to handovers that are being conducted without a tool.
In the present study the investigators will develop and evaluate a handover Tool for doctors and nurses. The investigators seek to answer the following research questions:
- Does the tool improve quality (i.e. efficiency and accuracy)?
- Does the tool improve safety relevant attitude an perceived team collaboration?
Detailed description
Medical transfers in the ICU are a critical part of patient care. Ensuring consistency of information that is passed on within the intensive care unit i.e. from shift to shift or between different functional areas (eg ICU to surgery) is ensured. Incorrect, incomplete or incomprehensible information in this context can have severe consequences and jeopardize patient safety. Research on handovers from other high risk organizations that are associated with a high risk of error, such as space flight control centers has shown potential consequences that result from incomplete handovers. Apart from a flawed mental model about the state of the system, the respective recipient of the handover are not able to anticipate possible future events and respond accordingly. The main barriers to implement effective handover in the medical setting are the following factors: The medical and clinical context (constant background noise and lack of privacy); the organizational hierarchy and status differences, which may lead the submitter to stress, as well as linguistic and cultural barriers that may impede further communication.
To counter these barriers, a variety of memory aids (tools) have been designed to structure the handover along defined cornerstones. Examples of such handover tools are LAURS(Listen, Accept, Utilize, Reframe, Suggest) and SBAR (Situation, Background, Assessment, Recommendation). These memory aids facilitate a problem-centered and consistent delivery of information.
This however neglect a crucial fact: from a psychological perspective, the intensive care unit presents a multi-team system. This means that different functional groups (Senior doctors, assistant doctors and nurses) work together towards a common goal, ie the treatment of a patient. However handovers occur mostly parallel with different functional areas, which hampers the consistent exchange of information between the groups. This in turn may reduce team effectiveness and lead to errors in the treatment of a patient.
For this reason, a handover tool not only supports the information flow within a function group, but also between the various functional groups. The previous research on communication between physicians and nurses suggests that the perceived psychological safety is an important prerequisite for overcoming the perceived status differences, and thus for effective and efficient teamwork. Another crucial variable for the joint achievement of a goal is the degree of perceived team collaboration i.e. cooperation between doctors and nurses. If these two parameters - psychological safety and team collaboration - are not met or are insufficient, this may lead not only to lack of information, but also to reactance against the other group. This in turn can lead to inefficient or faulty handovers and thus fatally compromise patient safety.
The aim of the proposed study, therefore, is the development and evaluation is a tool - handSAFE - designed to increase the problem-centered structure of handovers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Handover with SBAR | Other | Procedure: SBARHandover with handover tool. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria are: doctors and nurses with a minimum of 12 moths of work experience.
Key exclusion criteria (1 listed)
- Exclusion criteria: staff members that deny participation or don't meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBARsituation, background, assessment, recommendation | Procedure or surgery | Handover with SBAR |
Primary outcome
Measurement time 4: training of the newly developed handover Tool in the patient simulator
Time frame: 6 months
Outcome measured by video-assisted analysis of the handovers and questionnaires pre- and post interventional.
Duration of handovers
Time frame: 6 Month
Measurement of the handover duration before and after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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.
Bastian Grande, MD contact
Bastian Grande, MD principal investigator
University Hospital Zurich, Institute of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBAR in people with Complications of Medical Care, Nec in ICD9CM_2011, run by University of Zurich at 1 site in Switzerland.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2012. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bastian Grande, MD (bastian.grande@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement time 4: training of the newly developed handover Tool in the patient simulator (time frame: 6 months). The study lists 2 primary outcomes in all. 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 1 Jun 2012.