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HandSAFE - Development and Evaluation of a Handover Tool for Doctors and Nurses (HandSAFE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by University of Zurich.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609777
First Posted: June 1, 2012
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose

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?

Condition Intervention
Complications of Medical Care, Nec in ICD9CM_2011 Procedure: SBAR

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: HandSAFE - Development and Evaluation of a Handover Tool for Doctors and Nurses

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: June 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Handover with SBAR
Handover with handover tool.
Procedure: SBAR
situation, background, assessment, recommendation

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Inclusion criteria are: doctors and nurses with a minimum of 12 moths of work experience.

Exclusion criteria:

  • Exclusion criteria: staff members that deny participation or don't meet the inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609777


Contacts
Contact: Bastian Grande, MD bastian.grande@usz.ch

Locations
Switzerland
University Hospital Zurich, Institute of Anaesthesiology Not yet recruiting
Zurich, ZH, Switzerland, 8091
Contact: Bastian Grande, MD       bastian.grande@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Bastian Grande, MD University Hospital Zurich, Institute of Anaesthesiology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01609777     History of Changes
Other Study ID Numbers: HandSAFE
First Submitted: April 11, 2012
First Posted: June 1, 2012
Last Update Posted: June 1, 2012
Last Verified: May 2012