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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

bastian.grande@usz.ch

Switzerland1 site
  • University Hospital Zurich, Institute of Anaesthesiology

    Zurich, Canton of Zurich, 8091

    Bastian Grande, MD, bastian.grande@usz.ch

Other trials in Switzerland

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:

  1. Does the tool improve quality (i.e. efficiency and accuracy)?
  2. 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 groups in NCT01609777
Study groupRoleWhat they receive
Handover with SBAROtherHandover with handover tool.
Receives: Procedure: SBAR

What is being measured

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

  1. 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

  2. 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.

  1. First posted1 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2013 (estimated)
  4. Study completionJan 2013 (estimated)

Resources

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)
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

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.

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