Surgery-ComplicationsNCT05772195
Central London Patient Safety Research Collaboration
An observational study of Surgery-Complications and Safety Issues, run by University College London Hospitals at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery-Complications, Safety Issues
- How many people
- 500,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2023to Apr 2026
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Major surgery Critical care admission
Who may be able to join
- as determined by clinical audits
Who cannot join
- missing key data items/ or linkage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery-Complications, Safety Issues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before major system reorganisation | Theme 1 - elective recovery plan 2017/18-2019/20 | |
| Before major system reorganisation - intra-pandemic | Theme 1 - elective recovery plan 2020/21-2021/22 | |
| Post system reorganisation | Theme 1 - elective recovery plan 2023/24 and 2024/25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/)
Measured: 8 years (2017/18 - 2024/25) as per cohort definitions
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
Measured: Pre 2023
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
Measured: Pre 2023
Secondary outcomes (2)
Mean/median postoperative length of stay (days)
Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan
Measured: 8 years (2017/18 - 2024/25) as per cohort definitions
Mean/Median postoperative critical care length of stay (days)
Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan
Measured: 8 years (2017/18 - 2024/25) as per cohort definitions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start3 Apr 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Matthew Oliver, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772195
- Sponsor's protocol ID
- NIHR204297
- Status last verified
- May 2023
- First submitted
- 5 Jan 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Services, Organisations, and Innovation: The Central London Patient Safety Research Collaboration
- ClinicalTrials.gov ID
- NCT05772195
- Acronym / sponsor ID
- NIHR204297
- Conditions
- Surgery-Complications, Safety Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500,000 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Mar 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before major system reorganisation | – | –Theme 1 - elective recovery plan 2017/18-2019/20 |
| Before major system reorganisation - intra-pandemic | – | –Theme 1 - elective recovery plan 2020/21-2021/22 |
| Post system reorganisation | – | –Theme 1 - elective recovery plan 2023/24 and 2024/25 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major surgery Critical care admission
Key inclusion criteria (1 listed)
- as determined by clinical audits
Key exclusion criteria (1 listed)
- missing key data items/ or linkage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of elective operations performed within the NHS
Time frame: 8 years (2017/18 - 2024/25) as per cohort definitions
Process and outcomes following major system change (Theme 1): To be presented and analysed 1. nationally, 2. regionally and 3. 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/)
Incidence/prevalence of postoperative complications
Time frame: Pre 2023
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
Incidence/prevalence of postoperative complications stratified by socioeconomic and ethnic descriptors
Time frame: Pre 2023
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
2 secondary outcomes
Mean/median postoperative length of stay (days)
Time frame: 8 years (2017/18 - 2024/25) as per cohort definitions
Mean/Median postoperative critical care length of stay (days)
Time frame: 8 years (2017/18 - 2024/25) as per cohort definitions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery-Complications and Safety Issues, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 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?
Results are not available in the source record.
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?
Total number of elective operations performed within the NHS (time frame: 8 years (2017/18 - 2024/25) as per cohort definitions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.