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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01609777
Other study ID # HandSAFE
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 11, 2012
Last updated May 29, 2012
Start date June 2012
Est. completion date January 2013

Study information

Verified date May 2012
Source University of Zurich
Contact Bastian Grande, MD
Email bastian.grande@usz.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical 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. Does the tool improve quality (i.e. efficiency and accuracy)?

2. Does the tool improve safety relevant attitude an perceived team collaboration?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 68 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms

  • Complications of Medical Care, Nec in ICD9CM_2011

Intervention

Procedure:
SBAR
situation, background, assessment, recommendation

Locations

Country Name City State
Switzerland University Hospital Zurich, Institute of Anaesthesiology Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months Yes
Primary Duration of handovers Measurement of the handover duration before and after the intervention. 6 Month No