Scaling Up Quality Improvement for Surgical Teams
| ISRCTN | ISRCTN11085475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11085475 |
| Secondary identifying numbers | 1.6 |
- 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
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. 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
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 |
| alison.booth@york.ac.uk |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| 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 hypothesis | 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 |
| Condition | 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 | 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 |
| Secondary outcome measures | 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. |
| Overall study start date | 19/10/2017 |
| Overall study end date | 31/07/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 40 Acute NHS Trusts |
| Total final enrolment | 41 |
| Participant inclusion criteria | 1. NHS Acute Trust 2. Commitment from Trust Executive that consent to participate will be provided if Trust is recruited |
| 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
- England
- United Kingdom
Study participating centres
L9 7AL
United Kingdom
RM7 0AG
United Kingdom
E1 2ES
United Kingdom
SS16 5NL
United Kingdom
BD9 6RJ
United Kingdom
HX3 0PW
United Kingdom
CB2 0QQ
United Kingdom
SW10 9NH
United Kingdom
DE22 3NE
United Kingdom
DN2 5LT
United Kingdom
DT1 2JY
United Kingdom
SG1 4AB
United Kingdom
BB2 3HH
United Kingdom
TN37 7PT
United Kingdom
SM5 1AA
United Kingdom
NE9 6SX
United Kingdom
HG2 7SX
United Kingdom
IP4 5PD
United Kingdom
PO30 5TG
United Kingdom
LS9 7TF
United Kingdom
HA1 3UJ
United Kingdom
M13 9WL
United Kingdom
CW1 4QJ
United Kingdom
WF1 4DG
United Kingdom
MK6 5LD
United Kingdom
CM20 1QX
United Kingdom
PE30 4ET
United Kingdom
SY10 7AG
United Kingdom
NW3 2QG
United Kingdom
L7 8XP
United Kingdom
SP2 8BJ
United Kingdom
TS4 3BW
United Kingdom
SK2 7JE
United Kingdom
RH11 7DH
United Kingdom
OL6 9RW
United Kingdom
LN2 5QY
United Kingdom
SO16 6YD
United Kingdom
WS2 9PS
United Kingdom
IP33 2QZ
United Kingdom
BN11 2DH
United Kingdom
WN1 2NN
United Kingdom
Sponsor information
Hospital/treatment centre
Woodhorn Lane
Ashington
NE63 9JJ
England
United Kingdom
| Website | http://www.northumbria.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01gfeyd95 |
Funders
Funder type
Not defined
No information available
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Vifor Pharma Management Ltd., Vifor Pharma Management AG, Vifor Pharma Management SA, Vifor Pharma Ltd.
- Location
- Switzerland
No information available
Results and Publications
| Intention to publish date | 21/07/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/02/2020 | 02/03/2020 | Yes | No |
| Results article | 12/03/2022 | 14/03/2022 | Yes | No |
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.
