NCT04514601

Brief Summary

This project was intended to observe the handover of trauma and orthopaedic patients at a district general hospital in the UK. Following the implementation of a standard operating protocol, the handover of patient information improved including neck of femur fracture patients significantly. The study can therefore be utilised by other similarly structured departments to improve the handover process, thereby improving patient safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

August 6, 2020

Last Update Submit

August 12, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • To assess the efficacy of the handover of trauma patients going to theatre.

    A calculation was performed of how many patients had information handed over to the day staff. This included if a patient's past medical history, investigation results, plan, consent status, mark status and starvation status was handed over either written or verbally. This was expressed as a percentage.

    Up to 6 weeks.

  • To assess the handover of neck of femur (NOF) fracture patients.

    A calculation was performed of how many patients with NOF fractures had information handed over. This included the patient's age, mechanism of injury, past medical history, investigation results, plan, consent status, mark status, starvation status, scoring system calculation and discussion with next of kin regarding resuscitation status. For each of these domains for each patient, if the information was handed over, this was noted and was expressed as a percentage.

    Up to 6 weeks.

  • To determine if unwell patients were being handed over from the admissions list or patients already on the ward.

    From the handover meetings that were observed, it was noted whether 'unwell' patients from the ward had been handed over. This was expressed as a percentage from all the meetings that were observed.

    Up to 6 weeks.

Study Arms (2)

Pre-Intervention Group

The verbal and written handover of these patients was observed. This included 146 general orthopaedic admissions patients and 43 trauma patients. All patient data was anonymised.

Post-Intervention Group

The verbal and written handover of these patients was observed after the introduction of the intervention. This included 81 general orthopaedic admissions patients and 47 trauma patients. All patient data was anonymised.

Other: Standard Operating Protocol

Interventions

This was a written protocol on how the handover process should be conducted.

Post-Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Trauma and Orthopaedic patients.

You may qualify if:

  • All patients that were handed over were included in the study.

You may not qualify if:

  • Nil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandwell Hospital

West Bromwich, United Kingdom

Location

MeSH Terms

Conditions

Femoral Neck FracturesFractures, BoneMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Collette Samuels

    Audit Co-Ordinator Sandwell Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Foundation Year 2 Doctor

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 17, 2020

Study Start

October 23, 2019

Primary Completion

December 13, 2019

Study Completion

December 13, 2019

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations