NCT05772195

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

January 5, 2023

Last Update Submit

May 19, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Total number of elective operations performed within the NHS

    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

    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

    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 Outcomes (2)

  • Mean/median postoperative length of stay (days)

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

  • Mean/Median postoperative critical care length of stay (days)

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

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major surgery Critical care admission

You may qualify if:

  • as determined by clinical audits

You may not qualify if:

  • missing key data items/ or linkage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 5, 2023

First Posted

March 16, 2023

Study Start

April 3, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2026

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations