Title: The development and evaluation of enhanced audit and feedback interventions to increase the uptake of evidence-based transfusion practice
Funder: Department of Health and Social Care

Abstract: Aim. To design and evaluate enhanced feedback interventions within a national blood transfusion audit programme, promote the uptake of evidence-based guidelines and reduce the unnecessary use of blood components. Background. Audit and feedback (A&F) is widely used and embedded within the NHS, and represents the most common means of quality improvement, used locally, regionally and nationally. It is widely accepted that current A&F delivers variable and modest, but worthwhile, effects in a range of clinical areas. There is considerable scope to compare different ways of providing feedback and to understand their mechanisms of change to enhance the effects of A&F. Blood components for transfusion are produced from donations of blood by donors and are costly resources that support many areas of hospital practice. National audits of transfusion provide baseline information on compliance with standards. Despite evidence supporting restrictive use of blood components and recommendations in national guidelines, unnecessary over-transfusion practices persist, with wide variation between hospitals. Our preliminary work has identified consistent patterns of influences on transfusion practice, supporting the rationale for the development, application and evaluation of enhanced feedback interventions within A&F, as proposed in this research programme. Workstreams. The programme of research is divided into a sequence of four core workstreams (WSs), as follows: WS1. Development, piloting and refinement of two enhanced feedback interventions: enhanced content and enhanced delivery WS2. Cluster-randomised trial to evaluate effectiveness of enhanced feedback interventions compared with usual feedback, with a decision analytic modelling analysis for cost-effectiveness WS3. A parallel process evaluation to investigate fidelity of the interventions as delivered, received and enacted WS4. Development of general recommendations and tools. Research Environment: The existing National Audit programme of blood transfusion, which is undertaken through collaboration between NHS Blood & Transplant and the Royal College of Physicians, is very well supported by NHS Trusts with high rates of participation. The academic groups are based in institutions with excellent track records of applied health research, including the Clinical Trials Research Unit, with expertise in complex interventions, RCTs, intervention fidelity, health economics. Research Plans. WS1: Three subprojects: A) A structured analysis, based on current theories for understanding behaviour change, of the key components of existing usual feedback documents. This will inform: the development of a guidance document and training materials to describe the principles for analysing and writing up enhanced content of feedback interventions; and a protocol for writing an intervention with optimised content. B) Semi-structured interviews to identify the processes of feedback and the organisational levels and types of healthcare professionals who currently receive feedback. This will inform a protocol for an intervention to enhance delivery of feedback to all relevant staff, as well as practical guidance for clinical teams on how to ensure a systematic and evidence-based team-level response to the enhanced feedback delivery. C) A series of interview, observational and questionnaire studies will assess the acceptability and refine the delivery of the enhanced interventions in pilot sites. WS2: A cluster randomised controlled trial (RCT) and allied decision analytic model to test effectiveness and cost-effectiveness, respectively, of enhanced content and/or enhanced feedback, compared to usual processes of national audits. The enhanced interventions will be specifically designed from the framework developed in WS1 and evaluated for two separate targeted transfusion audit topics in sequence. Testing the interventions for two different topics will allow us to produce more robust evidence on effectiveness. All hospital centres participating in the National Comparative Audit programme will be invited to participate. WS3: To ensure the validity of the RCT, a workstream will evaluate the fidelity of the two interventions, and the mechanisms of change, using documentary analysis of the intervention materials and structured interviews. WS4: This will promote the dissemination of the research, highlighting the potential relevance to other audit programmes in secondary care. It will entail structured exchanges with the PPI panel and additional clinical/management leads from other audit programmes. Research Team: An interdisciplinary team including the Director and Manager of the National Comparative Audit programme in Blood Transfusion and those experienced in implementation research, behavioural sciences, statistics, trial design and management and health economics. The main research costs cover staff in the research team and researchers. Patients and Public Involvement will be embedded in programme oversight and operation and our constituted PPI reflects the range of input appropriate for a programme of research targeted at health care professionals. Programme Management: Overall leadership by PI, with individual workstream leads; a programme Steering Group will provide overall oversight, with specific inputs by PPI. Outputs: The core outputs are evidence of the effectiveness and cost-effectiveness of enhanced content and enhanced feedback, to reduce unnecessary transfusions, alongside research to understand the mechanisms of change in a fidelity study. The research will also provide a stronger basis for A&F programmes across the wider NHS.

Lay abstract: Blood for transfusion is a frequently used clinical intervention. The number of all blood components issued by UK transfusion services is 3million/year. Blood for transfusion is a costly and scarce resource. Many transfusions are given to stable and non-bleeding patients where the evidence from clinical studies suggests no clear benefit. In these cases transfusion is unnecessary and it exposes patients to risks such as wrong transfusion or transfusion transmitted infection. National audits of transfusion provide information on compliance with standards and levels of unnecessary transfusions. Findings continue to show unnecessary use of blood outside established national guidelines. For example, the recent national audit (platelet transfusions) identified levels of unnecessary transfusions at 28%. Audit and feedback (A&F) seeks to improve patient care and outcomes through careful review of health care performance against explicit standards. It is widely used across the NHS as a quality improvement method. Ideally, where a discrepancy is detected, changes are implemented at an individual, team, or service level. As currently used, the effects of A&F are small to moderate and variable. Considerable scope exists to improve its impact on patient care. In recent years, we have developed a better understanding of the key processes necessary for designing more effective A&F, and we have completed work to identify the barriers to changing transfusion practice. We can now apply these findings to improve the methods of A&F and to make an impact on patient outcomes. In a first major study of its type, this 5 year programme of work will develop and test two different enhanced feedback interventions: enhanced content and enhanced delivery . The first stage of our research will develop feedback processes that address the barriers to changing practice (enhanced content) and identify who should receive that feedback so that they can plan to act on that feedback (enhanced delivery). We will compare these two methods of enhanced feedback, against the usual method of undertaking A&F. The usual method will be the current national audit programme for blood transfusions, which has a very high participation rate by all NHS hospitals. We plan an economic evaluation because it's important to know whether methods used to improve the quality of care represent good value for money. In parallel we will investigate how these interventions work in clinical practice on the ground and the active ingredients of A&F by structured interviews with hospital staff. We will work to ensure that the findings from this research are made widely available to NHS staff leading other audit programmes, so that any lessons we learn can be adapted and applied to other conditions, in addition to transfusion. We are a multidisciplinary team with experience in audit, behavioural sciences, and large clinical trials.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: GENERIC HEALTH RELEVANCE