Health WorkforceWHOsNCT04374812
Workforce Hospital Outcomes (in English Acute Hospitals)
An observational study of Health Workforce, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Background: The NHS is facing significant challenges in recruiting and retaining staff, particularly registered nurses (RNs). Recruiting unregistered staff is often adopted as a solution to the RN shortage; however recent research found a negative effect of low RN staffing levels on mortality with no evidence that… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Workforce
- What is being tested?
- Exposure to registered nurses and Exposure to nursing assistants
- How many people
- 1,706,388 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2020to 30 Jun 2022
- 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: Patients staying on inpatient wards in acute hospital Trusts in England
Eligibility criteria for hospitals:
- acute hospital Trust in England
- willingness and ability to provide anonymised patient data and the ability to provide electronic roster data for a minimum period of 1 year prior to the commencement of the study.
Eligibility criteria for patients:
- stayed on at least one acute inpatient ward / admissions unit (including High Dependency Unit and Intensive Care Unit) during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences, Costs and Cost-effectiveness of Different Workforce Configurations in English Acute Hospitals: a Longitudinal Retrospective Study Using Routinely Collected Data
Background: The NHS is facing significant challenges in recruiting and retaining staff, particularly registered nurses (RNs). Recruiting unregistered staff is often adopted as a solution to the RN shortage; however recent research found a negative effect of low RN staffing levels on mortality with no evidence that high levels of assistant staff could mitigate the increased risk. Economic modelling suggested that increases in skill mix were potentially cost-effective, but these findings derive from a single NHS hospital Trust with limited cost and outcome data.
Aims and objectives: This project aims to estimate the consequences, costs and cost effectiveness of variation in the size and composition of the staff on hospital wards in England. In order to provide estimates that are more likely to apply across the NHS, this study will include at least four hospitals and consider a wider range of outcomes and sources of costs, including death within 30 days of admission, adverse events such as infections, length of hospital stay, readmissions and rates of staff sickness.
Methods: This retrospective longitudinal observational study will use routinely collected data on ward and shift level nurse staffing, and patient outcomes. Data will be derived from the E-Roster systems, used by hospitals to record all planned and worked shifts. The investigators will consider all rostered direct care staff. These data will be linked to patient data derived from the hospital patient administration system (PAS); and other clinical systems and databases of adverse events (e.g. datix). Relationships between RN and assistant staffing levels and outcomes will be explored using survival models incorporating mixed effects. The investigators will use the results of these analyses to model the costs and consequences of different staffing configurations and to estimate the incremental cost-effectiveness associated with change. Our study will provide evidence to inform staffing levels and skill mix planning in the NHS, highlighting potential cost savings, and offering improved patient safety and reduced adverse staff outcomes.
Read the detailed description
Note that for this study, "Study start" means the date the first hospital Trust was recruited. "Primary completion" is the date by which the investigators anticipate data analysis for the primary outcomes will be complete. "Study completion" is the data by which investigators anticipate data analysis for secondary outcomes will be complete.
The investigators cannot name the hospital Trusts participating because the investigators do not have their consent and this would breach GDPR.
- Conditions
- Health Workforce
- Being tested
- Exposure to registered nurses, Exposure to nursing assistants
- Keywords
- health workforce, outcome measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to registered nursesOther
Also called RN staffing level
Change in outcomes associated with a one hour per patient day increase in exposure to registered nurses
Exposure to nursing assistantsOther
Also called HCA or NA staffing levels
Change in outcomes associated with a one hour per patient day increase in exposure to nursing assistants
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient deaths
Adjusted hazard ratio for death from all causes within 30 days of hospital admission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start21 Sep 2020
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health WorkforceStudies 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
- 1,706,388 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Griffiths, Principal investigator, The University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374812
- Sponsor's protocol ID
- NIHR128056
- Other IDs
- 52957.A1
- Acronym
- WHOs
- Status last verified
- May 2023
- First submitted
- 20 Apr 2020
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffiths P, Saville C, Ball J, Culliford D, Jones J, Lambert F, Meredith P, Rubbo B, Turner L, Dall'Ora C. Consequences, costs and cost-effectiveness of workforce configurations in English acute hospitals. Health Soc Care Deliv Res. 2025 Jul;13(25):1-107. doi: 10.3310/ZBAR9152.
PubMed 40622683Meredith P, Turner L, Saville C, Griffiths P. Nurse understaffing associated with adverse outcomes for surgical admissions. Br J Surg. 2024 Aug 30;111(9):znae215. doi: 10.1093/bjs/znae215.
PubMed 39313222Rubbo B, Saville C, Dall'Ora C, Turner L, Jones J, Ball J, Culliford D, Griffiths P. Staffing levels and hospital mortality in England: a national panel study using routinely collected data. BMJ Open. 2023 May 17;13(5):e066702. doi: 10.1136/bmjopen-2022-066702.
PubMed 37197808
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences, Costs and Cost-effectiveness of Different Workforce Configurations in English Acute Hospitals: a Longitudinal Retrospective Study Using Routinely Collected Data
- ClinicalTrials.gov ID
- NCT04374812
- Acronym / sponsor ID
- WHOs / NIHR128056
- Conditions
- Health Workforce
- Keywords
- health workforce, outcome measures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,706,388 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 May 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.
Background: The NHS is facing significant challenges in recruiting and retaining staff, particularly registered nurses (RNs). Recruiting unregistered staff is often adopted as a solution to the RN shortage; however recent research found a negative effect of low RN staffing levels on mortality with no evidence that high levels of assistant staff could mitigate the increased risk. Economic modelling suggested that increases in skill mix were potentially cost-effective, but these findings derive from a single NHS hospital Trust with limited cost and outcome data.
Aims and objectives: This project aims to estimate the consequences, costs and cost effectiveness of variation in the size and composition of the staff on hospital wards in England. In order to provide estimates that are more likely to apply across the NHS, this study will include at least four hospitals and consider a wider range of outcomes and sources of costs, including death within 30 days of admission, adverse events such as infections, length of hospital stay, readmissions and rates of staff sickness.
Methods: This retrospective longitudinal observational study will use routinely collected data on ward and shift level nurse staffing, and patient outcomes. Data will be derived from the E-Roster systems, used by hospitals to record all planned and worked shifts. The investigators will consider all rostered direct care staff. These data will be linked to patient data derived from the hospital patient administration system (PAS); and other clinical systems and databases of adverse events (e.g. datix). Relationships between RN and assistant staffing levels and outcomes will be explored using survival models incorporating mixed effects. The investigators will use the results of these analyses to model the costs and consequences of different staffing configurations and to estimate the incremental cost-effectiveness associated with change. Our study will provide evidence to inform staffing levels and skill mix planning in the NHS, highlighting potential cost savings, and offering improved patient safety and reduced adverse staff outcomes.
Detailed description
Note that for this study, "Study start" means the date the first hospital Trust was recruited. "Primary completion" is the date by which the investigators anticipate data analysis for the primary outcomes will be complete. "Study completion" is the data by which investigators anticipate data analysis for secondary outcomes will be complete.
The investigators cannot name the hospital Trusts participating because the investigators do not have their consent and this would breach GDPR.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients staying on inpatient wards in acute hospital Trusts in England
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 |
|---|---|---|
| Exposure to registered nursesAlso: RN staffing levelChange in outcomes associated with a one hour per patient day increase in exposure to registered nurses | Other | – |
| Exposure to nursing assistantsAlso: HCA or NA staffing levelsChange in outcomes associated with a one hour per patient day increase in exposure to nursing assistants | Other | – |
Primary outcome
Patient deaths
Time frame: 30 days
Adjusted hazard ratio for death from all causes within 30 days of hospital admission
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 31 May 2023.
- Derived from this study: PubMed 40622683Griffiths P, Saville C, Ball J, Culliford D, Jones J, Lambert F, Meredith P, Rubbo B, Turner L, Dall'Ora C. Consequences, costs and cost-effectiveness of workforce configurations in English acute hospitals. Health Soc Care Deliv Res. 2025 Jul;13(25):1-107. doi: 10.3310/ZBAR9152.
- Derived from this study: PubMed 39313222Meredith P, Turner L, Saville C, Griffiths P. Nurse understaffing associated with adverse outcomes for surgical admissions. Br J Surg. 2024 Aug 30;111(9):znae215. doi: 10.1093/bjs/znae215.
- Derived from this study: PubMed 37197808Rubbo B, Saville C, Dall'Ora C, Turner L, Jones J, Ball J, Culliford D, Griffiths P. Staffing levels and hospital mortality in England: a national panel study using routinely collected data. BMJ Open. 2023 May 17;13(5):e066702. doi: 10.1136/bmjopen-2022-066702.
- 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.
Peter Griffiths principal investigator
The University of Southampton
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 Health Workforce, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 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?
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?
Patient deaths (time frame: 30 days). 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 NCT04374812, which also lists 3 linked publications.
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 31 May 2023.