Nurse's RoleWAiRDNCT06043986
Would Artificial Intelligence Reduce Delays to Nurse Response Times
An observational study of Nurse's Role, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- novel nurse call system
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 May 2023to 2 Sep 2024
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients admitted to the cardiology ward
Who may be able to join
- All adults 18 years who are admitted to the cardiology admissions ward will be eligible to take part.
- -
- Exclusion Criteria: Any patient who does not wish to participate will have their anonymised data removed from the trial.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Muzahir Tayebjee, 01132066051, muzahir.tayebjee@nhs.net
About this study
Official title: Would Artifical Intelligence Reduce Delays to Nurse Response Times
Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations.
Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.
- Conditions
- Nurse's Role
- Being tested
- novel nurse call system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel nurse call systemDevice
Inavya Ventures Ltd (Inavya) has developed a medical-grade artificial intelligence enabled mobile system (AVATR) to support out-of-hospital healthcare. AVATR is approved as a UK Government official supplier of healthcare technology on the UK Digital Marketplace for cloud-based solutions (G Cloud). AVATR in hospital, will connect to the existing AVATR outpatient service building on existing AVATR technology, which is regulated CE-mark Grade 1 (EU/UK). The research team will create, deploy and test a novel ward-based AI technology innovation to transform current nurse call systems to patient-centred mobile technology assets at bedside, thus reducing the need for unproductive visits by nurses to the bedside, which takes away time and attention where it is otherwise best served.
Having mobile connection to the patients, would improve patient experience and saving nursing staff time, thereby improving quality of care, and saving money.
| Study group | Role | What they receive |
|---|---|---|
| Bed bay A | Time from nurse call system activated by the novel nurse call system to initial response time T1 and time to complete task T2.
Reason for nurse call system activated: Toilet/Pain/Medication/ /Need a nurse/Other Receives: Device: novel nurse call system | |
| Bed bay B | Time from nurse call system activated by standard system to initial response timeT1 and time to complete task T2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
study objective
The primary outcome of this study is the time taken to respond to the alert raised by the novel nurse call system and time taken from call to completion of task.
Measured: 1 year
Secondary outcomes (2)
Nursing time saved
The time taken using the novel system will be measured against the regular method to find the difference in time.
Measured: 1 year
patient acceptability of the novel system
this is a qualitative measure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 May 2023
- Primary completion2 Sep 2024 (estimated)
- Study completion2 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043986
- Sponsor's protocol ID
- CD22/153868
- Acronym
- WAiRD
- Status last verified
- Oct 2023
- First submitted
- 5 Sep 2023
- Last updated
- 27 Oct 2023
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Would Artifical Intelligence Reduce Delays to Nurse Response Times
- ClinicalTrials.gov ID
- NCT06043986
- Acronym / sponsor ID
- WAiRD / CD22/153868
- Conditions
- Nurse's Role
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 2 Sep 2024 (estimated)
- Study completion
- 2 Sep 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations.
Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bed bay A | – | Device: novel nurse call systemTime from nurse call system activated by the novel nurse call system to initial response time T1 and time to complete task T2. Reason for nurse call system activated: Toilet/Pain/Medication/ /Need a nurse/Other |
| Bed bay B | – | –Time from nurse call system activated by standard system to initial response timeT1 and time to complete task T2. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the cardiology ward
Key inclusion criteria (4 listed)
- All adults 18 years who are admitted to the cardiology admissions ward will be eligible to take part.
- -
- Exclusion Criteria: Any patient who does not wish to participate will have their anonymised data removed from the trial.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| novel nurse call systemInavya Ventures Ltd (Inavya) has developed a medical-grade artificial intelligence enabled mobile system (AVATR) to support out-of-hospital healthcare. AVATR is approved as a UK Government official supplier of healthcare technology on the UK Digital Marketplace for cloud-based solutions (G Cloud). AVATR in hospital, will connect to the existing AVATR outpatient service building on existing AVATR technology, which is regulated CE-mark Grade 1 (EU/UK). The research team will create, deploy and test a novel ward-based AI technology innovation to transform current nurse call systems to patient-centred mobile technology assets at bedside, thus reducing the need for unproductive visits by nurses to the bedside, which takes away time and attention where it is otherwise best served. Having mobile connection to the patients, would improve patient experience and saving nursing staff time, thereby improving quality of care, and saving money. | Device | Bed bay A |
Primary outcome
study objective
Time frame: 1 year
The primary outcome of this study is the time taken to respond to the alert raised by the novel nurse call system and time taken from call to completion of task.
2 secondary outcomes
Nursing time saved
Time frame: 1 year
patient acceptability of the novel system
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- 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.
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 Nurse's Role, run by The Leeds Teaching 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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Leese (0113 2065455, l.leese@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study objective (time frame: 1 year). 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 27 Oct 2023.