NCT05741801

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed
Last Updated

August 28, 2024

Status Verified

January 1, 2023

Enrollment Period

9 months

First QC Date

January 31, 2023

Last Update Submit

August 27, 2024

Conditions

Keywords

digital alertsNHS England hospitalsemergency departmentselectronic patients recordsoutreach teamsdecision support systemspatient deterioration scoresantibiotics administration

Outcome Measures

Primary Outcomes (1)

  • 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.

    June 2023

Secondary Outcomes (1)

  • Observations on use on sepsis digital alerts within the hospital digital system

    June 2023

Study Arms (2)

health care professionals

Hospital healthcare professionals who use, or help implement, deteriorating patient/sepsis alerts in NHS trusts.

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.

Other: interviews

Interventions

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.

Also known as: focus groups, observations
ex-patients/survivors and family members/carershealth care professionals

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SepsisEmergencies

Interventions

Interviews as TopicFocus GroupsWatchful Waiting

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthOutcome Assessment, Health CareOutcome and Process Assessment, Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 23, 2023

Study Start

November 4, 2022

Primary Completion

July 17, 2023

Study Completion

July 17, 2023

Last Updated

August 28, 2024

Record last verified: 2023-01

Locations