Central London Patient Safety Research Collaboration

Safety Issues Clinical Trial

Official title:

Safer Services, Organisations, and Innovation: The Central London Patient Safety Research Collaboration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05772195
• Other study ID #: NIHR204297
• Status: Active, not recruiting
• Start date: April 3, 2023
• Est. completion date: April 2026

Study information

• Verified date: May 2023
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patient safety is a priority for healthcare systems. In safe systems, patients would be saved from avoidable harm, both from their own conditions, and from the care and treatments provided to them. Amongst the highest risk clinical settings are Surgical, Perioperative, Acute and Critical carE services (SPACE).

The Central London Patient Safety Research Collaborative is funded to deliver world-class research into improving the safety of SPACE services, within which the investigators will evaluate major service reorganisation, compare and investigate organisational safety and quality, and investigate the disparity in postoperative complications associated with socioeconomic factors.

Description:

Patient safety is a priority for healthcare systems. In safe systems, patients would be saved from avoidable harm, both from their own conditions, and from the care and treatments provided to them.

International estimates suggest that of 421 million hospitalisations worldwide annually, there are 42.7 million adverse events or unsafe experiences, making avoidable harm the 14th leading cause of death and serious illness. Amongst the highest risk clinical settings are Surgical, Perioperative, Acute and Critical carE services (SPACE), treating >25 million NHS patients annually. Patient safety risks are particularly likely in these environments, both because of what clinicians are required to do (the trauma of surgery and anaesthesia, the need for rapid recognition and decision-making in acute illness) and the patient's condition (because acute illness and surgery compound the risks from long-term conditions such as diabetes and heart disease).

The Central London Patient Safety Research Collaborative will be funded by the NIHR to deliver world-class research into improving the safety of Surgical, Perioperative, Acute and Critical carE services (SPACE) services. Three themes, using existing patient data, are included in this application:

1. Safer services The investigators will evaluate the safety of SPACE-related interventions of the NHS' post-pandemic Elective Recovery Plan. The investigators will use NHS administrative datasets to identify and explore changes in safety and quality over the implementation timeframe using advanced statistical methods.

2. Safer organisations From linked clinical and administrative datasets, The investigators will identify and seek to contextualise high- and low-performing units and hospitals across SPACE services using advanced statistical methods. This work will be followed by qualitative research, exploring why differences exist.

3. Safer innovations The investigators will identify the timeframe over which patients from deprived backgrounds develop worse postoperative outcomes (as has previously been demonstrated). These novel findings could pave the way for interventions to reduce inequality.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500000
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• as determined by clinical audits

Exclusion Criteria:

• missing key data items/ or linkage

Related Conditions & MeSH terms

• Safety Issues

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of elective operations performed within the NHS	Process and outcomes following major system change (Theme 1): To be presented and analysed; nationally,; regionally and; at hospital Trust- level; To assess the effectiveness of the NHS Elective recovery plan (https://www.england.nhs.uk/2022/02/nhs-publishes-electives-recovery-plan-to-boost-capacity-and-give-power-to-patients/)	8 years (2017/18 - 2024/25) as per cohort definitions
Primary	Incidence/prevalence of postoperative complications	Process and outcomes following major system change (Theme 1): Postoperative complications.; Occurring whilst inpatient, following the index surgical procedure.; Classified using the Clavien-Dindo and Postoperative Morbidity Survey systems; We will gather and link data from national audit and registry datasets.; We will compare patient outcomes within and between organisations to investigate safety and quality	Pre 2023
Primary	Incidence/prevalence of postoperative complications stratified by socioeconomic and ethnic descriptors	Theme 3 safer innovations: Postoperative complications.; Occurring whilst inpatient, following the index surgical procedure.; Classified using the Clavien-Dindo and Postoperative Morbidity Survey systems; We will gather and link data from national audit and registry datasets.; We will investigate divergences in patient outcomes, stratified by socioeconomic and ethnic descriptors	Pre 2023
Secondary	Mean/median postoperative length of stay (days)	Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan	8 years (2017/18 - 2024/25) as per cohort definitions
Secondary	Mean/Median postoperative critical care length of stay (days)	Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan	8 years (2017/18 - 2024/25) as per cohort definitions