Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05772195
Other study ID # NIHR204297
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - as determined by clinical audits Exclusion Criteria: - missing key data items/ or linkage

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04485481 - Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers Phase 1
Completed NCT03473236 - Phase 1A Safety Trial of Inhaled PK10571 (GB002) Phase 1
Not yet recruiting NCT03683953 - The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells Phase 1
Recruiting NCT05546567 - NOPARK Open Label Extension Study N/A
Recruiting NCT05413226 - Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility N/A
Recruiting NCT05112159 - Study of IPG1094 in Healthy Participants Phase 1
Completed NCT04689035 - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144 Phase 1
Completed NCT04335045 - Phase I Study of PH100 (Ecklonia Cava Phlorotannins) Phase 1
Completed NCT05037227 - Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Recruiting NCT05517291 - DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease N/A
Enrolling by invitation NCT06446778 - Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
Recruiting NCT04573049 - The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement Phase 4
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Completed NCT04188821 - Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander N/A
Completed NCT03667430 - Safety Evaluation of Porous Silica in Men N/A
Completed NCT04499482 - Safety and Tolerability of Soy Fiber N/A
Completed NCT03141905 - Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease N/A
Completed NCT05244161 - A Quasi-experimental Evaluation of the Malezi Program in Tanzania N/A
Recruiting NCT03791372 - Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy Phase 1
Withdrawn NCT04759066 - The HEALiX™ Intubated Patient (IP) Pilot Study N/A