SepsisDiAlSQualNCT05741801
Digital Alerts for Sepsis: a Qualitative Study
An observational study of Sepsis, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Sepsis is a serious disease, most often caused by a bacterial infection, and can be treated with antibiotics. Identifying patients with sepsis as early as possible means treatment with antibiotics can be started earlier. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- interviews
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2022to 17 Jul 2023
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Participants will include hospital healthcare professionals and ex-patients/family members in the UK. The sample size will depend on saturation, i.e. no new themes are identified in data from later interviews/focus groups, however it is estimated that around 30 healthcare professionals and 20 patients/family members will participate. Analysis of data from the interviews and the focus groups will occur concurrently to data collection, where possible, to inform future sampling and data collection.
Who may be able to join
- Healthcare Professionals
- Participant is willing and able to give informed consent for participation in the study.
- Any gender aged 18 years or above (no upper age limit).
- Fluent in English (or able to participate in an interview with other measures in place, e.g. interpreter).
- Currently working as a healthcare professional (e.g. doctor, nurse) in an NHS hospital trust.
- Ex-Patients and Family Member
Show all 10Show fewer
- Participant is willing and able to give informed consent for participation in the study.
- Any gender aged 18 years or above (no upper age limit).
- Fluent in English (or able to participate in an interview with other measures in place, e.g. interpreter).
- Member of the public who has previously been diagnosed with sepsis and treated in hospital or family member/carer of someone who has previously had sepsis.
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Healthcare professional has less than 3 months experience working in relevant role. This is estimated to be a reasonable amount of time for them to have good experience of identifying patients with sepsis and/or using sepsis alert systems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Alerting to Improve Sepsis Detection and Patient Outcomes in NHS Trusts. A Qualitative Study (DiAlS Qual).
Sepsis is a serious disease, most often caused by a bacterial infection, and can be treated with antibiotics. Identifying patients with sepsis as early as possible means treatment with antibiotics can be started earlier. To identify patients who may have sepsis, measurements such as high or low temperature and fast breathing rate are used to create a score showing the possibility of sepsis. Electronic Health Records (EHRs) in hospitals contain the information needed to create a score and can alert a doctor or nurse that a patient may have sepsis. Research has shown that more patients get antibiotics earlier because of hospitals using this type of digital alert. Different hospitals have used different methods to create a score and use different types of digital alerts. This research wants to find out what hospital doctors and nurses think about digital alerts for sepsis and how they use them. The investigators also want to find out what patients who have had sepsis think about hospitals using these digital alerts. Understanding how these digital alerts are used and how they affect patient care can help see how they could be used better so patients can benefit.
Read the detailed description
Sepsis is a common cause of serious illness and death with an estimated 123,000 cases and 46,000 deaths in the UK each year. Similarly, high levels of sepsis have been reported internationally, and sepsis is recognised by the World Health Organisation as a global health priority. Many countries have nationwide sepsis action plans and all UK hospitals have set targets to rapidly diagnose and treat patients with sepsis. Timely appropriately targeted intravenous antibiotics have been shown to be effective in improving outcomes for patients, with a 4% increase in odds of mortality for every hour's delay in administration of intravenous antibiotics.
The need for rapid treatment has led to the development of clinical criteria and 'screening tools' have been proposed to identify patients with sepsis. These include Sequential (Sepsis related) Organ Failure Assessment (Sofa), Systemic Inflammatory Response Syndrome (SIRS) criteria and in England the National Early Warning Score (NEWS), which was developed by the UK Royal College of Physicians. In December 2017, an updated version of NEWS, NEWS2 was published, which is recommended by NICE and the Royal College of Physicians as the most effective screening tool for sepsis in the UK. Available tools are based on current observations which clinicians are able to take and quickly calculate a score, but there is a paucity of evidence as to which tool to use and their effect on patient outcomes.
Potential pathways for the effectiveness of alerts when clinical deterioration is due to sepsis are likely to include an increase in the proportion of patients receiving intravenous antibiotics in one hour, and other 'sepsis six' measures. Improved communication and changes in dialogue between healthcare teams has been suggested as an important pathway for improvements in clinical outcomes. In addition, the introduction of sepsis alerts is often accompanied by treatment plans as well as education and training activities. Little is known about the contribution of these and other potential mediators on the effectiveness of alerts.
Previous qualitative research with healthcare professionals has highlighted problems in identification and management of sepsis including limits in professionals' capacity to identify sepsis, difficulties in handover of patients and errors in communication. These studies highlight both the requirement for healthcare professionals to feel confident in their assessment of patients and for clinical and organisations structures to work efficiently to provide optimal patient care. Previous qualitative research with patients has reported on patients' decisions to seek help with symptoms, experiences of hospitalisation and how patients have managed life after surviving sepsis. Additional studies with caregivers have described the burden on those caring for sepsis survivors and their role in advocating for their loved ones. Another study has looked at the words patients and call handlers use to describe symptoms of sepsis when patients seek help. These topics can help inform how patients and clinicians could use and potentially benefit from the use of digital alerts in hospitals.
This study is part of a wider programme of work seeking to determine the effectiveness of the introduction of digital alerts to improve outcomes of patients with sepsis. This component of the work seeks to explore healthcare professionals' and patients'/family members' views and experiences of deteriorating patient/sepsis alert systems in hospitals. This work will be undertaken within at least some of the NHS Trusts involved in the wider programme of work (Royal Berkshire NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Chelsea and Westminster Hospital NHS Foundation Trust and Cardiff \& Vale University Health Board) and potentially additional Trusts if required.
This is a qualitative study which includes three methods of data collection; observation of healthcare professionals working in hospitals, one-to-one interviews with healthcare professionals and interviews/focus groups with patients/family members.
Healthcare professionals will include doctors, nurses and other professionals who use, or help implement, deteriorating patient/sepsis alerts in NHS hospital Trusts. Patients/family members will include patients recruited from NHS trusts and community settings, who have previously had sepsis or are family members of patients who have had sepsis.
Interviews and focus groups will include topics which may be upsetting for some patients/family members or healthcare professionals. All participants will be made aware of sources of support available to them through the NHS and other relevant organisations. Patients and family members will have the option of taking part in a focus group or an individual interview depending on what they feel comfortable with.
- Conditions
- Sepsis
- Being tested
- interviews
- Keywords
- digital alerts, NHS England hospitals, emergency departments, electronic patients records, outreach teams, decision support systems, patient deterioration scores, antibiotics administration
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewsOther
Also called focus groups, observations
observations of healthcare professionals working in hospitals (outreach/sepsis team), one-on-one interviews with healthcare professionals, and focus groups or interviews with ex-patients/family members.
| Study group | Role | What they receive |
|---|---|---|
| health care professionals | Hospital healthcare professionals who use, or help implement, deteriorating patient/sepsis alerts in NHS trusts. Receives: Other: interviews | |
| ex-patients/survivors and family members/carers | Ex-patients recruited from NHS trusts and other charities, who have previously had sepsis or family members of patients who have had sepsis. Receives: Other: interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-depth, one-to-one, semi-structured interviews [or focus groups] on views and experience on sepsis digital alerts
The views and experiences of healthcare professionals and patients/family members on sepsis/deteriorating patient alert systems in hospitals is analysed, as well as on general identification and management of sepsis.
Measured: June 2023
Secondary outcomes (1)
Observations on use on sepsis digital alerts within the hospital digital system
- To understand how healthcare professionals use sepsis alerts and how alerts influence their decision making.
- To observe healthcare professionals use of sepsis alerts during routine hospital shifts.
- To identify barriers and facilitators to the implementation and use of digital sepsis alerts in NHS hospital settings.
Measured: June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start4 Nov 2022
- Primary completion17 Jul 2023
- Study completion17 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741801
- Sponsor's protocol ID
- 16347
- Acronym
- DiAlSQual
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lazzarino R, Borek AJ, Brent AJ, Welch J, Honeyford K, Daniels R, Kinderlerer A, Cooke G, Patil S, Gordon A, Goodman P, Glampson B, Ghazal P, Costelloe C, Tonkin-Crine S. The sepsis journey and where digital alerts can help: a qualitative, interview study with survivors and family members in England. Front Public Health. 2025 Mar 26;13:1521761. doi: 10.3389/fpubh.2025.1521761. eCollection 2025.
PubMed 40231176
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Alerting to Improve Sepsis Detection and Patient Outcomes in NHS Trusts. A Qualitative Study (DiAlS Qual).
- ClinicalTrials.gov ID
- NCT05741801
- Acronym / sponsor ID
- DiAlSQual / 16347
- Conditions
- Sepsis
- Keywords
- digital alerts, NHS England hospitals, emergency departments, electronic patients records, outreach teams, decision support systems, patient deterioration scores, antibiotics administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 17 Jul 2023 (actual)
- First posted
- 23 Feb 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.
Sepsis is a serious disease, most often caused by a bacterial infection, and can be treated with antibiotics. Identifying patients with sepsis as early as possible means treatment with antibiotics can be started earlier. To identify patients who may have sepsis, measurements such as high or low temperature and fast breathing rate are used to create a score showing the possibility of sepsis. Electronic Health Records (EHRs) in hospitals contain the information needed to create a score and can alert a doctor or nurse that a patient may have sepsis. Research has shown that more patients get antibiotics earlier because of hospitals using this type of digital alert. Different hospitals have used different methods to create a score and use different types of digital alerts. This research wants to find out what hospital doctors and nurses think about digital alerts for sepsis and how they use them. The investigators also want to find out what patients who have had sepsis think about hospitals using these digital alerts. Understanding how these digital alerts are used and how they affect patient care can help see how they could be used better so patients can benefit.
Detailed description
Sepsis is a common cause of serious illness and death with an estimated 123,000 cases and 46,000 deaths in the UK each year. Similarly, high levels of sepsis have been reported internationally, and sepsis is recognised by the World Health Organisation as a global health priority. Many countries have nationwide sepsis action plans and all UK hospitals have set targets to rapidly diagnose and treat patients with sepsis. Timely appropriately targeted intravenous antibiotics have been shown to be effective in improving outcomes for patients, with a 4% increase in odds of mortality for every hour's delay in administration of intravenous antibiotics.
The need for rapid treatment has led to the development of clinical criteria and 'screening tools' have been proposed to identify patients with sepsis. These include Sequential (Sepsis related) Organ Failure Assessment (Sofa), Systemic Inflammatory Response Syndrome (SIRS) criteria and in England the National Early Warning Score (NEWS), which was developed by the UK Royal College of Physicians. In December 2017, an updated version of NEWS, NEWS2 was published, which is recommended by NICE and the Royal College of Physicians as the most effective screening tool for sepsis in the UK. Available tools are based on current observations which clinicians are able to take and quickly calculate a score, but there is a paucity of evidence as to which tool to use and their effect on patient outcomes.
Potential pathways for the effectiveness of alerts when clinical deterioration is due to sepsis are likely to include an increase in the proportion of patients receiving intravenous antibiotics in one hour, and other 'sepsis six' measures. Improved communication and changes in dialogue between healthcare teams has been suggested as an important pathway for improvements in clinical outcomes. In addition, the introduction of sepsis alerts is often accompanied by treatment plans as well as education and training activities. Little is known about the contribution of these and other potential mediators on the effectiveness of alerts.
Previous qualitative research with healthcare professionals has highlighted problems in identification and management of sepsis including limits in professionals' capacity to identify sepsis, difficulties in handover of patients and errors in communication. These studies highlight both the requirement for healthcare professionals to feel confident in their assessment of patients and for clinical and organisations structures to work efficiently to provide optimal patient care. Previous qualitative research with patients has reported on patients' decisions to seek help with symptoms, experiences of hospitalisation and how patients have managed life after surviving sepsis. Additional studies with caregivers have described the burden on those caring for sepsis survivors and their role in advocating for their loved ones. Another study has looked at the words patients and call handlers use to describe symptoms of sepsis when patients seek help. These topics can help inform how patients and clinicians could use and potentially benefit from the use of digital alerts in hospitals.
This study is part of a wider programme of work seeking to determine the effectiveness of the introduction of digital alerts to improve outcomes of patients with sepsis. This component of the work seeks to explore healthcare professionals' and patients'/family members' views and experiences of deteriorating patient/sepsis alert systems in hospitals. This work will be undertaken within at least some of the NHS Trusts involved in the wider programme of work (Royal Berkshire NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, Imperial College Healthcare NHS Trust, Chelsea and Westminster Hospital NHS Foundation Trust and Cardiff \& Vale University Health Board) and potentially additional Trusts if required.
This is a qualitative study which includes three methods of data collection; observation of healthcare professionals working in hospitals, one-to-one interviews with healthcare professionals and interviews/focus groups with patients/family members.
Healthcare professionals will include doctors, nurses and other professionals who use, or help implement, deteriorating patient/sepsis alerts in NHS hospital Trusts. Patients/family members will include patients recruited from NHS trusts and community settings, who have previously had sepsis or are family members of patients who have had sepsis.
Interviews and focus groups will include topics which may be upsetting for some patients/family members or healthcare professionals. All participants will be made aware of sources of support available to them through the NHS and other relevant organisations. Patients and family members will have the option of taking part in a focus group or an individual interview depending on what they feel comfortable with.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health care professionals | – | Other: interviewsHospital healthcare professionals who use, or help implement, deteriorating patient/sepsis alerts in NHS trusts. |
| ex-patients/survivors and family members/carers | – | Other: interviewsEx-patients recruited from NHS trusts and other charities, who have previously had sepsis or family members of patients who have had sepsis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will include hospital healthcare professionals and ex-patients/family members in the UK. The sample size will depend on saturation, i.e. no new themes are identified in data from later interviews/focus groups, however it is estimated that around 30 healthcare professionals and 20 patients/family members will participate. Analysis of data from the interviews and the focus groups will occur concurrently to data collection, where possible, to inform future sampling and data collection.
Key inclusion criteria (10 listed)
- Healthcare Professionals
- Ex-Patients and Family Member
- Participant is willing and able to give informed consent for participation in the study.
- Any gender aged 18 years or above (no upper age limit).
- Fluent in English (or able to participate in an interview with other measures in place, e.g. interpreter).
Key exclusion criteria (2 listed)
- The participant may not enter the study if ANY of the following apply:
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 |
|---|---|---|
| interviewsAlso: focus groups, observationsobservations of healthcare professionals working in hospitals (outreach/sepsis team), one-on-one interviews with healthcare professionals, and focus groups or interviews with ex-patients/family members. | Other | ex-patients/survivors and family members/carers, health care professionals |
Primary outcome
In-depth, one-to-one, semi-structured interviews [or focus groups] on views and experience on sepsis digital alerts
Time frame: June 2023
The views and experiences of healthcare professionals and patients/family members on sepsis/deteriorating patient alert systems in hospitals is analysed, as well as on general identification and management of sepsis.
1 secondary outcome
Observations on use on sepsis digital alerts within the hospital digital system
Time frame: June 2023
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 28 Aug 2024.
- Derived from this study: PubMed 40231176Lazzarino R, Borek AJ, Brent AJ, Welch J, Honeyford K, Daniels R, Kinderlerer A, Cooke G, Patil S, Gordon A, Goodman P, Glampson B, Ghazal P, Costelloe C, Tonkin-Crine S. The sepsis journey and where digital alerts can help: a qualitative, interview study with survivors and family members in England. Front Public Health. 2025 Mar 26;13:1521761. doi: 10.3389/fpubh.2025.1521761. eCollection 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sepsis, run by University of Oxford 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 10 inclusion and 2 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 28 Aug 2024. 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?
In-depth, one-to-one, semi-structured interviews [or focus groups] on views and experience on sepsis digital alerts (time frame: June 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741801, which also lists 1 linked publication.
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 28 Aug 2024.