Condition category
Not Applicable
Date applied
15/02/2018
Date assigned
21/02/2018
Last edited
20/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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. Hospitals 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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Alison Booth

ORCID ID

http://orcid.org/0000-0001-7138-6295

Contact details

Department of Health Sciences
Lower Ground Floor
ARRC Building
Faculty of Science
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 1904 321107
alison.booth@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Scaling Up Quality Improvement for Surgical Teams: avoiding surgical site infection and anaemia at the time of surgery a randomised controlled trial

Acronym

QIST

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

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

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Healthcare service delivery

Intervention

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

Phase

Drug names

Primary outcome measure

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

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.

Overall trial start date

19/10/2017

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. NHS Acute Trust
2. Commitment from Trust Executive that consent to participate will be provided if Trust is recruited

Participant type

Other

Age group

Other

Gender

Both

Target number of participants

40 Acute NHS Trusts

Participant 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.

Recruitment start date

06/03/2018

Recruitment end date

08/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
Ashington
YO10 5DD
United Kingdom

Sponsor information

Organisation

Northumbria Healthcare NHS Foundation Trust

Sponsor details

Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.northumbria.nhs.uk

Funders

Funder type

Not defined

Funder name

NHS Improvement

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Northumbria Acute Care Collaboration Vanguard

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Vifor Pharma

Alternative name(s)

Vifor Pharma Ltd.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Funder name

Schuelke

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings will be published regardless of the results of the research. The findings will be disseminated to NHS Managers, healthcare professionals and patient groups through:
1. Publication in academic journals
2. Dissemination of a short plain English evidence briefing relevant to participating Trusts, and the groups
3. Presentations at high profile events such as the British Orthopaedic Association Annual Congress and NHS Improvement’s Medical Director’s Conference
4. Feedback to patients locally through relevant patient groups at individual Trusts and nationally through NHS England’s Patient and Public Involvement Network
5. Dissemination of the findings to national policy makers such as NICE
6. Use of social media to highlight publications, events etc

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

21/07/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes