ENT DiseaseNCT03695666
A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic
An observational study of ENT Disease, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial summary
ENT UK guidelines recommend booking no more than 6 patients during each 4-hour clinic session. Retrospectively, the investigators counted patients booked for each clinic on ourbooking system. The second cycle showed improved compliance with guidelines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ENT Disease
- What is being tested?
- Clerical policy
- How many people
- 333 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 14 Mar 2018
- 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
- Child, Adult, Older adult
Study population: All patients booked into SHO-led ENT casualty clinics
Who may be able to join
- All ENT casualty clinics with patients booked within the study time period
Who cannot join
- All clinics that were not staffed by an SHO
Trial locations and contacts
1 site in 1 country.
About this study
ENT UK guidelines recommend booking no more than 6 patients during each 4-hour clinic session. Retrospectively, the investigators counted patients booked for each clinic on ourbooking system. The second cycle showed improved compliance with guidelines.
Read the detailed description
Background The investigators' centre runs a regular ENT casualty clinic, run by an SHO, for rapid assessment and treatment of simple, acute ENT cases. ENT UK guidelines from 2017 recommend that no more than 6 patients be booked for an SHO to see during a 4-hour clinic session. This study aims to assess whether this centre meets those guidelines.
Method Data was retrospectively collected from MedWay, the centre's networked booking system. The number of patients booked for each ENT casualty clinic was counted over a period of two months. This was repeated two months after intervention to close the loop.
Result In the first cycle, 2 out of 22 clinics (9%) were found to be compliant with guidelines. Our intervention was to inform clinic booking staff of the guidelines. In the second cycle, 20 of 24 clinics were compliant (83%).
Discussion Anecdotally, prior to intervention, SHOs would often struggle to keep up with the casualty clinic caseload, and clinics would overrun. Clinic booking staff were not previously aware of ENT UK guidelines, and the number of clinic slots was set arbitrarily. This was easily and effectively resolved by educating staff. It can be learned that de facto management practice is not always based on guidelines or evidence; and highlights the importance of auditing all aspects of how organisations are run. Further quality improvement studies should focus on what happens to patients who can no longer be fit into existing casualty clinics.
- Conditions
- ENT Disease
- Being tested
- Clerical policy
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clerical policyOther
Clerical policy introduction
| Study group | Role | What they receive |
|---|---|---|
| Cycle 1 | Counted number of patients booked into clinic. No individual patient data collected. | |
| Cycle 2 | Counted number of patients booked into clinic. No individual patient data collected. Receives: Other: Clerical policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospectively counted patients booked
Retrospectively counted patients booked
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Nov 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ENT DiseaseStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sadik Quoraishi, National Health Service, United Kingdom
- Investigators
- Sadik Quoraishi, Principal investigator, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695666
- Sponsor's protocol ID
- w106k6eMBibC
- Status last verified
- Oct 2018
- First submitted
- 1 Oct 2018
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Completed-cycle Local Audit of Patient Load in the SHO-led ENT Casualty Clinic
- ClinicalTrials.gov ID
- NCT03695666
- Acronym / sponsor ID
- w106k6eMBibC
- Conditions
- ENT Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 4 Oct 2018 (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.
ENT UK guidelines recommend booking no more than 6 patients during each 4-hour clinic session. Retrospectively, the investigators counted patients booked for each clinic on ourbooking system. The second cycle showed improved compliance with guidelines.
Detailed description
Background The investigators' centre runs a regular ENT casualty clinic, run by an SHO, for rapid assessment and treatment of simple, acute ENT cases. ENT UK guidelines from 2017 recommend that no more than 6 patients be booked for an SHO to see during a 4-hour clinic session. This study aims to assess whether this centre meets those guidelines.
Method Data was retrospectively collected from MedWay, the centre's networked booking system. The number of patients booked for each ENT casualty clinic was counted over a period of two months. This was repeated two months after intervention to close the loop.
Result In the first cycle, 2 out of 22 clinics (9%) were found to be compliant with guidelines. Our intervention was to inform clinic booking staff of the guidelines. In the second cycle, 20 of 24 clinics were compliant (83%).
Discussion Anecdotally, prior to intervention, SHOs would often struggle to keep up with the casualty clinic caseload, and clinics would overrun. Clinic booking staff were not previously aware of ENT UK guidelines, and the number of clinic slots was set arbitrarily. This was easily and effectively resolved by educating staff. It can be learned that de facto management practice is not always based on guidelines or evidence; and highlights the importance of auditing all aspects of how organisations are run. Further quality improvement studies should focus on what happens to patients who can no longer be fit into existing casualty clinics.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle 1 | – | –Counted number of patients booked into clinic. No individual patient data collected. |
| Cycle 2 | – | Other: Clerical policyCounted number of patients booked into clinic. No individual patient data collected. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients booked into SHO-led ENT casualty clinics
Key inclusion criteria (1 listed)
- All ENT casualty clinics with patients booked within the study time period
Key exclusion criteria (1 listed)
- All clinics that were not staffed by an SHO
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 |
|---|---|---|
| Clerical policyClerical policy introduction | Other | Cycle 2 |
Primary outcome
Retrospectively counted patients booked
Time frame: 2 months
Retrospectively counted patients booked
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 4 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Sadik Quoraishi principal investigator
National Health Service, United Kingdom
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 ENT Disease, run by National Health Service, United Kingdom 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 4 Oct 2018. 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?
Retrospectively counted patients booked (time frame: 2 months). 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 4 Oct 2018.