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CompletedNCT03465839Updated Apr 16, 2019

Bedside Nursing Handovers in the Surgical Context

An interventional study of Education for improving handovers quality and Education for improving bedside handovers in General Surgery, sponsored by University of Eastern Piedmont. Completed at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by University of Eastern Piedmont · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • General Surgery
03

In context

Lead sponsor

University of Eastern Piedmont is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Surgical patients
  • All nurses working with surgical patients who attended the educational intervention

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    Bedside handover

    Education for improving handovers quality + Education for improving bedside handovers

    Behavioral: Education for improving handovers quality · Behavioral: Education for improving bedside handovers

  • Active comparator
    Control

    Education for improving handovers quality

    Behavioral: Education for improving handovers quality

Interventions

  • BehavioralEducation 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.

  • BehavioralEducation for improving bedside handovers

    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.

06

What researchers measure

Primary outcomes

  1. Change in handover quality

    Handoff CEX (Clinical Examination) \[3-9 overall on 6 items about setting, organisation, communication, content, judgment, professionalism; 3 worst - 9 best\]

    Time frame: Baseline, at 1 month after intervention, at 6 months after intervention

Secondary outcomes

  1. Handover length

    Time x handover

    Time frame: Baseline, at 1 month after intervention

  2. Missed care / procedures / diagnostic tests

    Number of missed care / procedures / diagnostic tests

    Time frame: Baseline, at 1 month after intervention, at 6 months after intervention

  3. Patients satisfaction

    Visual Analogic Scale for satisfaction \[0-10; 0 worst - 10 best\]

    Time frame: Baseline, at 1 month after intervention, at 6 months after intervention

07

Study locations

1 site
  • Valuduce Hospital
    Como, 22100, Italy
08

References and documents

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. PubMed 24957503 ↗
  • 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. PubMed 23703824 ↗
  • 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. PubMed 17038108 ↗
  • 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. PubMed 19287252 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2018 to primary completion in Nov 2018, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2018
First posted
Mar 14, 2018
StartActual
Jul 26, 2018
Primary completionActual
Nov 1, 2018
CompletionActual
Jan 31, 2019
Last update
Apr 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03465839
Lead sponsor
University of Eastern Piedmont
Collaborators
Valduce Hospital
Responsible party
Marco Clari (Adjunct professor, University of Eastern Piedmont) — Principal investigator
First posted
Mar 14, 2018
Start date
Jul 26, 2018
Primary completion
Nov 1, 2018
Completion
Jan 31, 2019
Last update
Apr 16, 2019

Study contacts

Marco Clari, RN, PhD s
principal investigator · University of Eastern Piedmont

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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