Condition category
Haematological Disorders
Date applied
11/03/2015
Date assigned
11/03/2015
Last edited
16/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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. Here, we want 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?
Miss Cathryn Tyas

Trial website

Contact information

Type

Scientific

Primary contact

Miss Cathryn Tyas

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18531

Study information

Scientific title

Two linked cluster randomised trials to evaluate feedback interventions embedded within a national audit of blood transfusion practice

Acronym

Study hypothesis

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 we will randomise NHS trusts / health boards to receive different ways of providing feedback following a clinical audit in two linked cluster trials. We will use the data collected 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.

Ethics approval

NRES Committee East Midlands - Leicester, 08/12/2014, ref: 14/EM/1295

Study design

Randomised; Interventional and Observational; Design type: Process of Care, Cross-sectional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/04/2015

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Trust / health board (cluster) inclusion criteria:
1. Participating in the relevant national audit programme
2. Receive NHS permissions
3. Male & Female
4. Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 152; UK Sample Size: 152

Participant 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.

Recruitment start date

01/04/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

NHS Blood and Transplant (NHSBT)

Sponsor details

National R&D Office
500 North Bristol Park
Northway
Bristol
BS34 7QH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination of the findings will be aimed at two main groups of stakeholders:

1. Specific feedback to health care professionals involved in transfusion practice, regionally, nationally and internationally.
2. General feedback to NHS staff involved in current audit and feedback (A&F) programmes, to ensure the lessons learnt from this programme of research can widely considered, for applicability in other health care settings The current regional structures of the Transfusion Liaison Teams for hospitals across England (slightly differently in devolved nations) support regional educational events in transfusion for all hospitals, at which discussion of national audits is one core function. These structures will provide an established means for dissemination of findings (alongside engagement in the research plans).

Our findings will also be described and reported through peer-reviewed journals, in addition to national and international conferences (we benefit from active engagement with Canadian collaborators).

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes