- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05772195
Central London Patient Safety Research Collaboration
Safer Services, Organisations, and Innovation: The Central London Patient Safety Research Collaboration
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.
Study Overview
Status
Conditions
Detailed 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:
- 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.
- 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.
- 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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London, United Kingdom
- University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- as determined by clinical audits
Exclusion Criteria:
- missing key data items/ or linkage
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Before major system reorganisation
Theme 1 - elective recovery plan 2017/18-2019/20
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Before major system reorganisation - intra-pandemic
Theme 1 - elective recovery plan 2020/21-2021/22
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Post system reorganisation
Theme 1 - elective recovery plan 2023/24 and 2024/25
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total number of elective operations performed within the NHS
Time Frame: 8 years (2017/18 - 2024/25) as per cohort definitions
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Process and outcomes following major system change (Theme 1): To be presented and analysed
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
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Incidence/prevalence of postoperative complications
Time Frame: Pre 2023
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Process and outcomes following major system change (Theme 1): Postoperative complications.
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Pre 2023
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Incidence/prevalence of postoperative complications stratified by socioeconomic and ethnic descriptors
Time Frame: Pre 2023
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Theme 3 safer innovations: Postoperative complications.
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Pre 2023
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean/median postoperative length of stay (days)
Time Frame: 8 years (2017/18 - 2024/25) as per cohort definitions
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Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan
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8 years (2017/18 - 2024/25) as per cohort definitions
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Mean/Median postoperative critical care length of stay (days)
Time Frame: 8 years (2017/18 - 2024/25) as per cohort definitions
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Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan
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8 years (2017/18 - 2024/25) as per cohort definitions
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NIHR204297
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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