Central London Patient Safety Research Collaboration

May 19, 2023 updated by: Charles Matthew Oliver, University College London Hospitals

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

Active, not recruiting

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:

  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.

Study Type

Observational

Enrollment (Anticipated)

500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Major surgery Critical care admission

Description

Inclusion Criteria:

  • as determined by clinical audits

Exclusion Criteria:

  • missing key data items/ or linkage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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/)

8 years (2017/18 - 2024/25) as per cohort definitions
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
Pre 2023
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
Pre 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean/median postoperative length of stay (days)
Time Frame: 8 years (2017/18 - 2024/25) as per cohort definitions
Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan
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
Theme 1: Health economic assessment of the implementation of the NHS Elective recovery plan
8 years (2017/18 - 2024/25) as per cohort definitions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

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

No

Studies a U.S. FDA-regulated device product

No

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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