Neck of Femur FractureNCT04514601
A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
An observational study of Neck of Femur Fracture and Fractures, Bone, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neck of Femur Fracture, Fractures, Bone, Orthopedic Disorder
- What is being tested?
- Standard Operating Protocol
- How many people
- 317 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2019to 13 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Trauma and Orthopaedic patients.
Who may be able to join
- All patients that were handed over were included in the study.
Who cannot join
- Nil.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Poor handover and inadequate transmission of clinical information between shifts can result in patient harm. This study was designed to evaluate the impact of implementing a handover protocol on the quality of information exchanged in the trauma handover meetings in a UK hospital.
A prospective single centre observational study was performed at an acute NHS trust, using the Plan-Do-Study-Act (PDSA) methodology. Ten consecutive weekday trauma meetings, involving 43 patients, were observed to identify poor practices in handover. This data was used in conjunction with the Royal College of Surgeon's recommendations for effective handover (2007) to create a standard operating protocol (SOP). Following the implementation of the SOP, a further 8 consecutive weekday trauma meetings, involving a further 47 patients, were observed. The data collection was performed by 5 trained independent observers. The data was analysed using t test for quantitative variables and chi-square or Fisher's exact tests for categorical variables.
- Conditions
- Neck of Femur Fracture, Fractures, Bone, Orthopedic Disorder
- Being tested
- Standard Operating Protocol
- Medical subject headings
- Femoral Neck Fractures, Fractures, Bone, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Operating ProtocolOther
This was a written protocol on how the handover process should be conducted.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard Operating Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start23 Oct 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck of Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salman Sadiq, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Collette Samuels, Study director, Audit Co-Ordinator Sandwell Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514601
- Sponsor's protocol ID
- QIP Trauma Meetings Sandwell
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
- ClinicalTrials.gov ID
- NCT04514601
- Acronym / sponsor ID
- QIP Trauma Meetings Sandwell
- Conditions
- Neck of Femur Fracture, Fractures, Bone, Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Poor handover and inadequate transmission of clinical information between shifts can result in patient harm. This study was designed to evaluate the impact of implementing a handover protocol on the quality of information exchanged in the trauma handover meetings in a UK hospital.
A prospective single centre observational study was performed at an acute NHS trust, using the Plan-Do-Study-Act (PDSA) methodology. Ten consecutive weekday trauma meetings, involving 43 patients, were observed to identify poor practices in handover. This data was used in conjunction with the Royal College of Surgeon's recommendations for effective handover (2007) to create a standard operating protocol (SOP). Following the implementation of the SOP, a further 8 consecutive weekday trauma meetings, involving a further 47 patients, were observed. The data collection was performed by 5 trained independent observers. The data was analysed using t test for quantitative variables and chi-square or Fisher's exact tests for categorical variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Standard Operating ProtocolThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Trauma and Orthopaedic patients.
Key inclusion criteria (1 listed)
- All patients that were handed over were included in the study.
Key exclusion criteria (1 listed)
- Nil.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Operating ProtocolThis was a written protocol on how the handover process should be conducted. | Other | Post-Intervention Group |
Primary outcome
To assess the efficacy of the handover of trauma patients going to theatre.
Time frame: Up to 6 weeks.
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.
To assess the handover of neck of femur (NOF) fracture patients.
Time frame: Up to 6 weeks.
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.
To determine if unwell patients were being handed over from the admissions list or patients already on the ward.
Time frame: Up to 6 weeks.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collette Samuels study director
Audit Co-Ordinator Sandwell Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck of Femur Fracture and Fractures, Bone, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of the handover of trauma patients going to theatre. (time frame: Up to 6 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.