NCT04374812

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,706,388

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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

First Submitted

Initial submission to the registry

April 20, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

April 20, 2020

Last Update Submit

May 30, 2023

Conditions

Keywords

health workforceoutcome measures

Outcome Measures

Primary Outcomes (1)

  • Patient deaths

    Adjusted hazard ratio for death from all causes within 30 days of hospital admission

    30 days

Interventions

Change in outcomes associated with a one hour per patient day increase in exposure to registered nurses

Also known as: RN staffing level

Change in outcomes associated with a one hour per patient day increase in exposure to nursing assistants

Also known as: HCA or NA staffing levels

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hospital Trust A

London, United Kingdom

Location

Related Publications (3)

  • 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.

  • Meredith 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.

  • Rubbo 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.

Study Officials

  • Peter Griffiths

    The University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 5, 2020

Study Start

September 21, 2020

Primary Completion

April 30, 2022

Study Completion

June 30, 2022

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations