- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465839
Bedside Nursing Handovers in the Surgical Context
The Efficacy of Bedside Nursing Handovers in Improving Information Exchange Quality in Surgical Patients: a Randomised Controlled Trial
Nursing handovers are performed 2-3 times a day for each patient, with an approximate average of 2 million nursing deliveries per year in a hospital of medium size. Nursing handovers are considered essential for the continuity and safety of care. If the relevant clinical information is not shared in a precise and timely manner, it may worsen the patients' outcomes with an increase in adverse events, delays or inappropriate treatment until the omission of procedures.
The modality of nursing delivery presents, therefore, a gap of vulnerability where vital information could not be considered and systematically shared.
Patients should be involved in their care to promote a patient-centred approach. The involvement of patients in handovers is effective compared to other delivery methods.
To date, however, the best mode to deliver handovers was still unclear due to a systematic lack of studies to identify the best practice of nursing handovers. The studies in the literature lack of sound methodologies due to not randomized designs.
Thus an intervention to improve quality of handovers and to implement bedside handovers in surgical wards will be performed.
The following hypotheses were made:
- The introduction of nursing bedside handovers will improve the quality of the information exchanged.
- The educational intervention training intervention will positively modify the nursing handovers.
- There is a relationship between the qualitative level of nursing handovers and working status (expert vs novice) of the nurses.
- There is a relationship between the qualitative level of nursing handovers and the patients' characteristics.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Como, Italy, 22100
- Valuduce Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Surgical patients
- All nurses working with surgical patients who attended the educational intervention
Exclusion Criteria:
- Nurses who did not participate in the educational intervention
- Nursed who did not operate stably in the surgical wards included in the study
- New hired nurses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bedside handover
Education for improving handovers quality + Education for improving bedside handovers
|
Specific education on the importance of handovers quality will be provided.
The educational session will last 4 hours.
The program will be divided into the following sections: 1) a structured survey on the perception of the participants on the handovers importance; 2) Key theoretical concepts on the relevance of handovers with case studies of errors related to this critical moment; 3) showing movie clips of nursing handovers to critically interpret the clips by the participants; 4) presentation of the SBAR method recommended by WHO; 5) general presentation of the nursing delivery assessment project of the Valduce Hospital.
In addition to the education for improving handovers quality, the following intervention will be implemented for nurses assigned to the study department.
The course will be supplemented by a section of the duration of an hour, containing 1) information on the principles underlying bedside handovers; 2) how to handle information in front of the patient and on his / her direct involvement; 3) role-playing of the bedside handover will be performed, assigning the roles of nurse and patient among the participants to bring out impressions linked to the functions.
|
Active Comparator: Control
Education for improving handovers quality
|
Specific education on the importance of handovers quality will be provided.
The educational session will last 4 hours.
The program will be divided into the following sections: 1) a structured survey on the perception of the participants on the handovers importance; 2) Key theoretical concepts on the relevance of handovers with case studies of errors related to this critical moment; 3) showing movie clips of nursing handovers to critically interpret the clips by the participants; 4) presentation of the SBAR method recommended by WHO; 5) general presentation of the nursing delivery assessment project of the Valduce Hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in handover quality
Time Frame: Baseline, at 1 month after intervention, at 6 months after intervention
|
Handoff CEX (Clinical Examination) [3-9 overall on 6 items about setting, organisation, communication, content, judgment, professionalism; 3 worst - 9 best]
|
Baseline, at 1 month after intervention, at 6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handover length
Time Frame: Baseline, at 1 month after intervention
|
Time x handover
|
Baseline, at 1 month after intervention
|
Missed care / procedures / diagnostic tests
Time Frame: Baseline, at 1 month after intervention, at 6 months after intervention
|
Number of missed care / procedures / diagnostic tests
|
Baseline, at 1 month after intervention, at 6 months after intervention
|
Patients satisfaction
Time Frame: Baseline, at 1 month after intervention, at 6 months after intervention
|
Visual Analogic Scale for satisfaction [0-10; 0 worst - 10 best]
|
Baseline, at 1 month after intervention, at 6 months after intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marco Clari, RN, PhD s, University of Eastern Piedmont
Publications and helpful links
General Publications
- Smeulers M, Lucas C, Vermeulen H. Effectiveness of different nursing handover styles for ensuring continuity of information in hospitalised patients. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD009979. doi: 10.1002/14651858.CD009979.pub2.
- Abraham J, Kannampallil T, Patel VL. A systematic review of the literature on the evaluation of handoff tools: implications for research and practice. J Am Med Inform Assoc. 2014 Jan-Feb;21(1):154-62. doi: 10.1136/amiajnl-2012-001351. Epub 2013 May 23.
- Clemow R. Care plans as the main focus of nursing handover: information exchange model. J Clin Nurs. 2006 Nov;15(11):1463-5. doi: 10.1111/j.1365-2702.2006.01524.x. No abstract available.
- Chaboyer W, McMurray A, Johnson J, Hardy L, Wallis M, Sylvia Chu FY. Bedside handover: quality improvement strategy to "transform care at the bedside". J Nurs Care Qual. 2009 Apr-Jun;24(2):136-42. doi: 10.1097/01.NCQ.0000347450.90676.d9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UPO1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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