NCT03465839

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

February 27, 2018

Last Update Submit

April 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in handover quality

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

    Baseline, at 1 month after intervention, at 6 months after intervention

Secondary Outcomes (3)

  • Handover length

    Baseline, at 1 month after intervention

  • Missed care / procedures / diagnostic tests

    Baseline, at 1 month after intervention, at 6 months after intervention

  • Patients satisfaction

    Baseline, at 1 month after intervention, at 6 months after intervention

Study Arms (2)

Bedside handover

EXPERIMENTAL

Education for improving handovers quality + Education for improving bedside handovers

Behavioral: Education for improving handovers qualityBehavioral: Education for improving bedside handovers

Control

ACTIVE COMPARATOR

Education for improving handovers quality

Behavioral: Education for improving handovers quality

Interventions

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.

Bedside handoverControl

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.

Bedside handover

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valuduce Hospital

Como, 22100, Italy

Location

Related Publications (4)

  • 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.

    PMID: 24957503BACKGROUND
  • 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.

    PMID: 23703824BACKGROUND
  • 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.

    PMID: 17038108BACKGROUND
  • 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.

    PMID: 19287252BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Marco Clari, RN, PhD s

    University of Eastern Piedmont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct professor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 14, 2018

Study Start

July 26, 2018

Primary Completion

November 1, 2018

Study Completion

January 31, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations