- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01609777
HandSAFE - Development and Evaluation of a Handover Tool for Doctors and Nurses (HandSAFE)
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?
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bastian Grande, MD
- Email: bastian.grande@usz.ch
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Institute of Anaesthesiology
-
Contact:
- Bastian Grande, MD
- Email: bastian.grande@usz.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Handover with SBAR
Handover with handover tool.
|
situation, background, assessment, recommendation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Duration of handovers
Time Frame: 6 Month
|
Measurement of the handover duration before and after the intervention.
|
6 Month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bastian Grande, MD, University Hospital Zurich, Institute of Anaesthesiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HandSAFE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complications of Medical Care, Nec in ICD9CM_2011
-
Henry Ford Health SystemCompleted
-
University of Social Welfare and Rehabilitation...CompletedComplications of Surgical Procedures or Medical CareIran, Islamic Republic of
-
University of DundeeUniversity of Strathclyde; Chief Scientist Office of the Scottish Government; Information Services Division, NHS ScotlandCompletedComplications of Surgical and Medical Care: General TermsUnited Kingdom
-
Azienda Ospedaliera San PaoloCompletedComplications of Surgical and Medical Care: General Terms
-
University Hospital, Clermont-FerrandUnknownMen in Relation | Couple Whose Taken Care in Medical Assisted to ReproductionFrance
-
Shangkun Liu (200966)CompletedPostoperative Complications | Complication of Medical Care
-
Haukeland University HospitalCompletedPostoperative Complications | Complications of Surgical Procedures or Medical CareNorway
-
Rhode Island HospitalCompleted
-
Prof. Dr. med. Arno FriggRecruitingComplication of Surgical or Medical CareSwitzerland
-
BSN Medical Ltd. UKTerminatedWound - in Medical CareUnited Kingdom
Clinical Trials on SBAR
-
Universitat de GironaCompleted
-
Centre Hospitalier Universitaire de la RéunionNot yet recruiting
-
University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); QualidigmCompleted