Two cluster randomised controlled trials to evaluate feedback in blood transfusion audits

ISRCTN	ISRCTN15490813
DOI	https://doi.org/10.1186/ISRCTN15490813
Protocol serial number	18531
Sponsor	NHS Blood and Transplant (NHSBT)
Funder	National Institute for Health Research

Submission date: 11/03/2015
Registration date: 11/03/2015
Last edited: 25/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Blood transfusion is a frequently used clinical treatment, but it’s a costly and scarce resource. There are many cases where patients have been given blood transfusions when there has been no clinical need. Such transfusions are unnecessary and can put patients at risk of the wrong type of blood transfusion or infection. National audits of transfusion give information on compliance with standards and the number of unnecessary transfusions. “Audit and feedback” (A&F) seeks to improve patient care by reviewing health care performance against agreed standards. It allows changes to be made in areas where problems with patient care has been found. The aim of this study is to design and test an enhanced A&F intervention in order to promote uptake of evidence-based guidance and reduce the number of unnecessary blood transfusions.

Who can participate?
NHS trusts/health boards participating in the relevant national audit programme.

What does the study involve?
NHS trusts/health boards are randomly allocated to receive different ways of providing feedback following a clinical audit in two linked cluster trials. The data collected is then used as part of the NHS Blood and Transplant National Comparative Audit (NHSBT NCA) to evaluate the feedback. NHSBT NCA is a well-established quality improvement activity which compares current best practice with an agreed standard in blood transfusion practice.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
A number of NHS trusts in the UK

When is the study starting and how long is it expected to run for?
January 2014 to December 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Lauren Moreau

Contact information

Dr Lauren Moreau
Scientific

University of Leeds
Clinical Trials Research Unit (CTRU)
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised; Interventional and Observational; Design type: Process of Care, Cross-sectional study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Two linked cluster randomised trials to evaluate feedback interventions embedded within a national audit of blood transfusion practice
Study acronym	AFFINITIE
Study objectives	The development and evaluation of enhanced audit and feedback interventions to increase the uptake of evidence-based transfusion practice (AFFINITIE) is a NIHR Programme Grant for Applied Research which aims to develop and evaluate feedback interventions to promote the uptake of evidence-based transfusion guidance to reduce the unnecessary use of blood. In this research NHS trusts/health boards will be randomised to receive different ways of providing feedback following a clinical audit in two linked cluster trials. The data collected as part of the NHS Blood and Transplant National Comparative Audit (NHSBT NCA) will be used to evaluate the feedback. NHSBT NCA is a well-established quality improvement activity which compares current best practice with an agreed standard in blood transfusion practice.
Ethics approval(s)	NRES Committee East Midlands - Leicester, 08/12/2014, ref: 14/EM/1295
Health condition(s) or problem(s) studied	Topic: Haematology; Subtopic: Blood (all Subtopics); Disease: Non-malignant haematology
Intervention	1. Enhanced Documents: Feedback with content written to deliver the relevant behaviour change techniques will be delivered as per usual practice by the NCA programme through written and graphic feedback presented in multiple feedback documents and presentations, once per audit topic. Feedback is provided electronically direct from the NCA to site, generally sent to the transfusion practitioner, audit staff, or junior doctor. Enactment at a site level varies and will be at a sites discretion. 2. Enhanced documents & f/o support: Feedback with content written to deliver the relevant behaviour change techniques will be delivered as per usual practice by the NCA programme through written and graphic feedback presented in multiple feedback documents and presentations, once per audit topic. Feedback is provided electronically direct from the NCA to site, generally sent to the transfusion practitioner, audit staff, or junior doctor. 3. Usual Documents: Feedback will be delivered as per normal practice by the NCA, once per audit topic. Feedback is provided electronically direct from the NCA to site, generally sent to the transfusion practitioner, audit staff, or junior doctor and is typically in the form of a written clinical audit report, a PowerPoint presentation and action plan templates. The content of the written report varies, depending on the audit. Enactment at a site level varies and will be as per standard practice. 4. Usual Feedback & f/o support: Feedback will be delivered as per normal practice by the NCA, once per audit topic. Feedback is provided electronically direct from the NCA to site, generally sent to the transfusion practitioner, audit staff, or junior doctor and is typically in the form of a written clinical audit report, a PowerPoint presentation and action plan templates. The content of the written report varies, depending on the audit.
Intervention type	Other
Primary outcome measure(s)	The primary outcome for each audit topic, measured at the patient level and taken from the NCA follow-up audit, is whether a transfusion is categorised as unnecessary or not (binary). A clinical algorithm is agreed by the NCA BT Audit Group (which is a multidisciplinary team including content experts) alongside reviews of guidelines and the literature prior to finalising each baseline audit tool. For each audit topic, a statistical algorithm will be developed by the CTRU statisticians and piloted and approved by the NCA BT Audit Group prior to the baseline audit. This will minimise the risk of detection bias. The final versions will be included in the Statistical Analysis Plan. For the surgical audit, transfusion may occur pre-operatively, intra-operatively or post-operatively. There may also be multiple transfusion episodes after surgery but prior to discharge. As all patients will have had one or more transfusions over the entire operative period (14 days prior to surgery to 7 days following surgery), the primary outcome is whether any of these transfusions were unnecessary versus all transfusions being necessary (binary). The statistical algorithm given in the Statistical Analysis Plan will specify the statistical process needed to derive the primary outcome from the patient-level NCA audit. No clinical judgement will be required at a patient-level to categorise transfusions.
Key secondary outcome measure(s)	1. To generate data to serve as inputs for an investigation of the relative cost-effectiveness of the two feedback interventions compared to usual NCA feedback in each audit topic from a NHS perspective 2. To investigate whether the two feedback interventions reduce volume of blood products transfused (i) across specialities within NHS trusts and health boards and (ii) for patients treated in specialities targeted by transfusion topics, when compared to usual feedback, up to 12 months following the release of feedback by the NCA 3. To investigate whether two feedback interventions reduce the number of errors reported to SHOT, when compared to usual feedback, up to 12 months following release of feedback by the NCA 4. To explore whether there are differential predictors (or moderators) of the effects of the two feedback interventions when compared to usual feedback (i.e. subgroup effects) 5. To explore the mechanisms by which the two feedback interventions affect outcome (i.e. mediators of the treatment effect) 6. To explore whether the effect of the two enhanced feedback interventions when compared to usual feedback differs according to the transfusion topic
Completion date	18/09/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	152
Total final enrolment	152
Key inclusion criteria	Trust/health board (cluster) inclusion criteria: 1. Participating in the relevant national audit programme 2. Receive NHS permissions 3. Male and female 4. Lower age limit 18 years
Key exclusion criteria	Trust/health board (cluster) exclusion criteria: 1. Independent Hospitals (as clinicians involved in transfusion decisions at the NHS Trusts / Health Boards are also likely to practice at the independent Hospitals leading to potential contamination) 2. The four NHS Trusts that participated in the development of the intervention will still be invited to take part in the national audits but will not be randomised and will receive the enhanced feedback documents with post-feedback support. They will therefore not be included in the evaluation of the feedback of post feedback support. This is to prevent contamination whilst still allowing the site to be included in the NCA programme Reasons for non-participation will be documented and reported in the final trial report. Note that, where at least one hospital site within a cluster is eligible, the cluster will be regarded as eligible. Where multiple hospital sites are eligible within a cluster, the NCA may treat them as separate but they will be regarded as a single cluster for the purposes of randomisation.
Date of first enrolment	01/04/2015
Date of final enrolment	31/05/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Leeds

Clinical Trials Research Unit (CTRU)
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/02/2022	25/02/2022	Yes	No
Results article		01/03/2022	25/04/2023	Yes	No
Protocol article	protocol	12/12/2016		Yes	No
Protocol article	protocol	03/07/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/04/2023: Publication reference added.
25/02/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
06/08/2021: The intention to publish date was changed from 30/08/2021 to 30/11/2021.
10/05/2021: The intention to publish date was changed from 20/11/2020 to 30/08/2021.
20/05/2020: The intention to publish date was changed from 01/11/2019 to 20/11/2020.
29/07/2019: The following changes have been made:
1. The plain English summary has been updated to reflect the current trial contact.
2. The trial acronym has been added.
3. The intention to publish date has been changed from 30/06/2019 to 01/11/2019.
19/02/2019: The following changes were made:
1. The overall end date was changed from 31/05/2016 to 18/09/2017.
2. The intention to publish date was added.
05/07/2017: Publication reference added.
20/12/2016: Publication reference added.