Scaling Up Quality Improvement for Surgical Teams

ISRCTN	ISRCTN11085475
DOI	https://doi.org/10.1186/ISRCTN11085475
Protocol serial number	1.6
Sponsor	Northumbria Healthcare NHS Foundation Trust
Funders	NHS Improvement, Northumbria Acute Care Collaboration Vanguard, Vifor Pharma, Schuelke

Submission date: 15/02/2018
Registration date: 21/02/2018
Last edited: 14/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The Institute for Health Improvement (IHI) Breakthrough Series Collaborative model is a short-term learning system that brings together a large number of teams to seek improvement in a focused topic area and proven intervention. Collaboratives provide a suitable vehicle for delivery of a project at this scale, as they not only aim to maximise local engagement and leadership but are designed to build capacity, enable learning and prepare for sustainability. The key elements of participation in the Breakthrough Series Collaborative training and support for teams from Trusts are:
learning sessions, action periods, and summative congress. The aim of the trial is to assess the effectiveness and cost-effectiveness of the Breakthrough Series Collaborative (BSC) method for improving outcomes in patients undergoing elective total hip and knee replacement surgery.

Who can participate?
NHS Acute Trusts

What does the study involve?
Each participating NHS Trust is treated as a cluster, and are randomised 1:1 using minimisation by number of hip and knee replacement procedures performed and the traffic light indicators in the Learning From Mistakes league table. Trusts in both arms in the trial receive the intervention, i.e. training in the Breakthrough Series Collaborative. Trusts are randomised to receive either training on MSSA to control post-surgery infection (20 hospitals) or training on the anaemia optimisation programme (20 hospitals). None of the participating Trusts will have implemented either protocol prior to acceptance into the trial. Therefore, the control group for the anaemia optimisation quality improvement initiative are the other 20 hospitals who continue with their usual practice for anaemia and vice versa, the control group for MSSA are the other 20 hospitals who continue with their usual practice for MSSA screening. Trusts are given the opportunity to be trained in the quality improvement initiative they have not received after the evaluation period is over.

What are the possible benefits and risks of participating?
The potential benefit for participating Trusts is the prospect of improved care and costs. These are a reduction in anaemia related blood transfusions, critical care, length of hospital stay and readmission rates leading to a potential saving of £160 per patient; and a reduction in surgical site MSSA related infections. Participating trusts are expected to save the NHS £6.3M per year, based on the experience at the Chief Investigator’s own Trust. There are no perceived risks to Trusts or the teams from participating Trusts.

Where is the study run from?
This study is being run by Northumbria Healthcare NHS Foundation Trust (UK) and the sites will be added soon.

When is the study starting and how long is it expected to run for?
October 2017 to July 2020

Who is funding the study?
1. NHS Improvement (UK)
2. Northumbria Acute Care Collaboration Vanguard (UK)
3. Vifor Pharma (Switzerland)
4. Schuelke

Who is the main contact?
Mrs Alison Booth (Scientific)
alison.booth@york.ac.uk

Contact information

Mrs Alison Booth
Scientific

Department of Health Sciences
Lower Ground Floor, ARRC Building
Faculty of Science
University of York
Heslington
York
YO10 5DD
United Kingdom

ORCID ID	0000-0001-7138-6295
Phone	+44 1904 321107
Email	alison.booth@york.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Scaling Up Quality Improvement for Surgical Teams: avoiding surgical site infection and anaemia at the time of surgery a randomised controlled trial
Study acronym	QIST
Study objectives	Current study hypothesis as of 01/07/2019: This cluster randomised controlled trial aims to assess whether Breakthrough Series Collaborative is able to deliver fast meaningful change with complex interventions across the UK NHS. Previous study hypothesis: This cluster randomised controlled trial aims to assess whether Institute for Health Improvement (IHI) Breakthrough Series Collaboratives are able to deliver fast meaningful change with complex interventions across the UK NHS.
Ethics approval(s)	This study does not require research ethics approval as it does not involve patients or access to identifiable patient data. This has been confirmed with the Health Research Authority, their Confidential Advisory Group and the University of York Department of Health Sciences Research Governance Group. ref: SRGC/2018/256/D
Health condition(s) or problem(s) studied	Healthcare service delivery
Intervention	Current interventions as of 01/07/2019: The study intervention is a Breakthrough Series Collaborative model. A Collaborative is a short-term learning system that brings together a large number of teams to seek improvement in a focused topic area and proven intervention. Collaboratives provide a suitable vehicle for delivery of a project at this scale, as they not only aim to maximise local engagement and leadership but are designed to build capacity, enable learning and prepare for sustainability. Each participating NHS Trust is treated as a cluster, and are randomised 1:1 using minimisation by number of hip and knee replacement procedures performed and the traffic light indicators in the Learning From Mistakes league table. Trusts in both arms in the trial receive the intervention, i.e. training in the Collaborative. Trusts are randomised to receive either training on MSSA to control post-surgery infection (20 hospitals) or training on the anaemia optimisation programme (20 hospitals). None of the participating Trusts will have implemented either protocol prior to acceptance into the trial. Therefore, the control group for the anaemia optimisation quality improvement initiative are the other 20 hospitals who continue with their usual practice for anaemia and vice versa, the control group for MSSA are the other 20 hospitals who will continue with their usual practice for MSSA screening. Hospitals are given the opportunity to be trained in the quality improvement initiative they have not received after the evaluation period is over. The Trusts are involved in the training programme from May 2018 to October 2019, a total of 18 months. The evaluation period extends to April 2020. Previous interventions: The study intervention is the Institute for Health Improvement (IHI) Breakthrough Series Collaborative model. A Breakthrough Series Collaborative is a short-term learning system that brings together a large number of teams to seek improvement in a focused topic area and proven intervention. Collaboratives provide a suitable vehicle for delivery of a project at this scale, as they not only aim to maximise local engagement and leadership but are designed to build capacity, enable learning and prepare for sustainability. Each participating NHS Trust is treated as a cluster, and are randomised 1:1 using minimisation by number of hip and knee replacement procedures performed and the traffic light indicators in the Learning From Mistakes league table. Trusts in both arms in the trial receive the intervention, i.e. training in the Breakthrough Series Collaborative. Trusts are randomised to receive either training on MSSA to control post-surgery infection (20 hospitals) or training on the anaemia optimisation programme (20 hospitals). None of the participating Trusts will have implemented either protocol prior to acceptance into the trial. Therefore, the control group for the anaemia optimisation quality improvement initiative are the other 20 hospitals who continue with their usual practice for anaemia and vice versa, the control group for MSSA are the other 20 hospitals who will continue with their usual practice for MSSA screening. Hospitals are given the opportunity to be trained in the quality improvement initiative they have not received after the evaluation period is over. The Trusts are involved in the training programme from May 2018 to October 2019, a total of 18 months. The evaluation period extends to January 2020.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measures as of 01/07/2019: 1. Anaemia is measured using the Blood transfusion within 7 days following surgery 2. Deep infection is measured using the Public Health England and Centre for Disease Control and Prevention definition, both at 90 days post-surgery. Previous primary outcome measures: 1. Anaemia is measured using the Blood transfusion within 7 days following surgery 2. Deep infection is measured using Centre for Disease Control and Prevention definition at 90 days post-surgery
Key secondary outcome measure(s)	Current secondary outcome measures as of 01/07/2019: 1. Patient-level outcomes are measured using: 1.1. Superficial infection up to 30 days post-surgery, and name of pathogen (if known) 1.2. Length of hospital stay in days (number of midnights spent in hospital) 1.3. Re-admission within 30 days of discharge 1.4. Critical care admission within 30 days of surgery (regardless of previous discharge) 1.5. Number of days spent in critical care within 30 days of surgery (number of midnights spent in the unit) 2. Process measured for QIST infection are: 2.1. Date patient screened for MSSA 2.2. Results 2.3. Date decolonising pack dispensed 2.4. Confirmation used by the patient: Yes/No/Not recorded 3. Process measures for QIST Anaemia are 3.1. Date patient screened for anaemia 3.2. Date pre-op treatment for anaemia given 3.3. Pre-operative blood results: 3.3.1. Hb <11.5 3.3.2. Ferritin >50 3.4. Was iron indicated: Yes/No/Not recorded 3.5. Was iron given to the patient: Yes/No/Not recorded Aggregated baseline data will be extracted for the 12 months prior to the commencement of the trial. Individual patient data will be extracted monthly from one month after commencement of the trial to feed into the delivery of the intervention. Final data collection point will be one year and four months after start of data collection. Previous secondary outcome measures: 1. Patient-level outcomes are measured using: 1.1. Superficial infection up to 90 days post-surgery, and name of pathogen (if known) 1.2. Length of hospital stay in days (number of midnights spent in hospital) 1.3. Re-admission within 30 days of discharge 1.4. Critical care admission within 30 days of surgery (regardless of previous discharge) 1.5. Number of days spent in critical care within 30 days of surgery (number of midnights spent in the unit) 2. Process measured for QIST infection are: 2.1. Date patient screened for MSSA 2.2. Results 2.3. Date decolonising pack dispensed 2.4. Confirmation used by the patient: Yes/No/Not recorded 3. Process measures for QIST Anaemia are measured: 3.1. Date patient screened for anaemia 3.2. Date pre-op treatment for anaemia given 3.3. Pre-operative blood results: 3.3.1. Hb <11.5 3.3.2. Ferritin >50 3.4. Was iron indicated: Yes/No/Not recorded 3.5. Was iron given to the patient: Yes/No/Not recorded Aggregated baseline data will be extracted for the 12 months prior to the commencement of the trial. Individual patient data will be extracted monthly from one month after commencement of the trial to feed into the delivery of the intervention. Final data collection point will be three months after completion of the training.
Completion date	31/07/2020

Eligibility

Participant type(s)	Other
Age group	Other
Sex	All
Target sample size at registration	40
Total final enrolment	41
Key inclusion criteria	1. NHS Acute Trust 2. Commitment from Trust Executive that consent to participate will be provided if Trust is recruited
Key exclusion criteria	1. Quality improvement initiative for screening and pre-operative treatment of anaemia and/or screening for and decolonisation of MSSA already in routine practice for orthopaedic surgical patients.
Date of first enrolment	06/03/2018
Date of final enrolment	08/05/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Aintree University Hospitals NHS Foundation Trust

Liverpool
L9 7AL
United Kingdom

Barking, Havering & Redbridge University Hospitals NHS Trust

Romford
RM7 0AG
United Kingdom

Barts Health NHS Trust

London
E1 2ES
United Kingdom

Basildon and Thurrock Hospitals NHS Foundation Trust

Basildon
SS16 5NL
United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford
BD9 6RJ
United Kingdom

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield
HX3 0PW
United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge
CB2 0QQ
United Kingdom

Chelsea & Westminster Hospitals NHS Foundation Trust

London
SW10 9NH
United Kingdom

Derby Teaching Hospitals NHS Foundation Trust

Derby
DE22 3NE
United Kingdom

Doncaster & Bassetlaw Hospitals NHS Trust

Doncaster
DN2 5LT
United Kingdom

Dorset County Hospital NHS Foundation Trust

Dorchester
DT1 2JY
United Kingdom

East and North Hertfordshire NHS Trust

Stevenage
SG1 4AB
United Kingdom

East Lancashire NHS Trust, Blackburn Hospital

Blackburn
BB2 3HH
United Kingdom

East Sussex Healthcare NHS Trust

St. Leonards-on-Sea
TN37 7PT
United Kingdom

Epsom & St Helier University Hospitals NHS Trust

Carshalton
SM5 1AA
United Kingdom

Gateshead Health NHS Foundation Trust

Gateshead
NE9 6SX
United Kingdom

Harrogate and District NHS Foundation Trust

Harrogate
HG2 7SX
United Kingdom

Ipswich Hospital NHS Trust

Ipswich
IP4 5PD
United Kingdom

Isle of Wight NHS Trust

Newport
PO30 5TG
United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds
LS9 7TF
United Kingdom

London North West Healthcare NHS Trust

Harrow
HA1 3UJ
United Kingdom

Manchester University NHS Foundation Trust

Manchester
M13 9WL
United Kingdom

Mid Cheshire Hospitals NHS Foundation Trust

Crewe
CW1 4QJ
United Kingdom

Mid Yorkshire Hospitals NHS Trust

Wakefield
WF1 4DG
United Kingdom

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes
MK6 5LD
United Kingdom

Princess Alexandra Hospital

Harlow
CM20 1QX
United Kingdom

Queen Elizabeth Hospital, King’s Lynn NHS Foundation Trust

King's Lynn
PE30 4ET
United Kingdom

Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Trust

Oswestry
SY10 7AG
United Kingdom

Royal Free London NHS Foundation Trust

London
NW3 2QG
United Kingdom

Royal Liverpool & Broadgreen University Hospitals NHS Trust

Liverpool
L7 8XP
United Kingdom

Salisbury NHS Foundation Trust

Salisbury
SP2 8BJ
United Kingdom

South Tees Hospitals NHS Foundation Trust

Middlesbrough
TS4 3BW
United Kingdom

Stockport NHS Foundation Trust

Stockport
SK2 7JE
United Kingdom

Surrey & Sussex Healthcare NHS Trust

Crawley
RH11 7DH
United Kingdom

Tameside & Glossop Integrated Care NHS Foundation Trust

Ashton-under-Lyne
OL6 9RW
United Kingdom

United Lincolnshire Hospitals NHS Trust

Lincoln
LN2 5QY
United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton
SO16 6YD
United Kingdom

Walsall Healthcare NHS Trust

Walsall
WS2 9PS
United Kingdom

West Suffolk NHS Foundation Trust

Bury Saint Edmunds
IP33 2QZ
United Kingdom

Western Sussex Hospitals NHS Foundation Trust

Worthing
BN11 2DH
United Kingdom

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan
WN1 2NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Requests for trial data for the purposes of secondary analysis should be submitted to the CI Mike Reed at mike.reed@nhs.uk and will be considered on a case by case basis by the Trial Management Group. Only anonymised data will be provided and will only be available after publication of the main results.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		12/03/2022	14/03/2022	Yes	No
Protocol article	protocol	28/02/2020	02/03/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/03/2022: Publication reference added.
14/09/2020: IPD sharing statement added.
04/09/2020: Total final enrolment number added.
02/03/2020: Publication reference added.
01/07/2019: The following changes were made:
1. The study protocol number was updated from 1.0 to 1.6.
2. The study hypothesis was updated.
3. The interventions were updated.
4. The primary and secondary outcomes were updated.
5. The trial participating centres were updated.