Bridging the gap between pragmatic intervention design and theory: using behavioural science tools to modify an existing quality improvement programme to implement "Sepsis Six".

BACKGROUND: Sepsis has a mortality rate of 40 %, which can be halved if the evidence-based "Sepsis Six" care bundle is implemented within 1 h. UK audit shows low implementation rates. Interventions to improve this have had minimal effects. Quality improvement programmes could be further developed by using theoretical frameworks (Theoretical Domains Framework (TDF)) to modify existing interventions by identifying influences on clinical behaviour and selecting appropriate content. The aim of this study was to illustrate using this process to modify an intervention designed using plan-do-study-act (P-D-S-A) cycles that had achieved partial success in improving Sepsis Six implementation in one hospital. METHODS: Factors influencing implementation were investigated using the TDF to analyse interviews with 34 health professionals. The nursing team who developed and facilitated the intervention used the data to select modifications using the Behaviour Change Technique (BCT) Taxonomy (v1) and the APEASE criteria: affordability, practicability, effectiveness, acceptability, safety and equity. RESULTS: Five themes were identified as influencing implementation and guided intervention modification. These were:(1) "knowing what to do and why" (TDF domains knowledge, social/professional role and identity); (2) "risks and benefits" (beliefs about consequences), e.g. fear of harming patients through fluid overload acting as a barrier to implementation versus belief in the bundle's effectiveness acting as a lever to implementation; (3) "working together" (social influences, social/professional role and identity), e.g. team collaboration acting as a lever versus doctor/nurse conflict acting as a barrier; (4) "empowerment and support" (beliefs about capabilities, social/professional role and identity, behavioural regulation, social influences), e.g. involving staff in intervention development acting as a lever versus lack of confidence to challenge colleagues' decisions not to implement acting as a barrier; (5) "staffing levels" (environmental context and resources), e.g. shortages of doctors at night preventing implementation. The modified intervention included six new BCTs and consisted of two additional components (Sepsis Six training for the Hospital at Night Co-ordinator; a partnership agreement endorsing engagement of all clinical staff and permitting collegial challenge) and modifications to two existing components (staff education sessions; documents and materials). CONCLUSIONS: This work demonstrates the feasibility of the TDF and BCT Taxonomy (v1) for developing an existing quality improvement intervention. The tools are compatible with the pragmatic P-D-S-A cycle approach generally used in quality improvement work.

Characterising an implementation intervention in terms of behaviour change techniques and theory: the 'Sepsis Six' clinical care bundle.

BACKGROUND: Sepsis is a major cause of death from infection, with a mortality rate of 36 %. This can be halved by implementing the 'Sepsis Six' evidence-based care bundle within 1 h of presentation. A UK audit has shown that median implementation rates are 27-47 % and interventions to improve this have demonstrated minimal effects. In order to develop more effective implementation interventions, it is helpful to obtain detailed characterisations of current interventions and to draw on behavioural theory to identify mechanisms of change. The aim of this study was to illustrate this process by using the Behaviour Change Wheel; Behaviour Change Technique (BCT) Taxonomy; Capability, Opportunity, Motivation model of behaviour; and Theoretical Domains Framework to characterise the content and theoretical mechanisms of action of an existing intervention to implement Sepsis Six. METHODS: Data came from documentary, interview and observational analyses of intervention delivery in several wards of a UK hospital. A broad description of the intervention was created using the Template for Intervention Description and Replication framework. Content was specified in terms of (i) component BCTs using the BCT Taxonomy and (ii) intervention functions using the Behaviour Change Wheel. Mechanisms of action were specified using the Capability, Opportunity, Motivation model and the Theoretical Domains Framework. RESULTS: The intervention consisted of 19 BCTs, with eight identified using all three data sources. The BCTs were delivered via seven functions of the Behaviour Change Wheel, with four ('education', 'enablement', 'training' and 'environmental restructuring') supported by the three data sources. The most frequent mechanisms of action were reflective motivation (especially 'beliefs about consequences' and 'beliefs about capabilities') and psychological capability (especially 'knowledge'). CONCLUSIONS: The intervention consisted of a wide range of BCTs targeting a wide range of mechanisms of action. This study demonstrates the utility of the Behaviour Change Wheel, the BCT Taxonomy and the Theoretical Domains Framework, tools recognised for providing guidance for intervention design, for characterising an existing intervention to implement evidence-based care.

Technical note: Assessment of blinding of hand hygiene observers in randomized controlled trials of hand hygiene interventions.

Trials evaluating interventions to improve health care workers' hand hygiene compliance use directly observed compliance as a primary outcome measure. Observers should be blinded to the intervention and the effectiveness of blinding assessed to prevent systematic bias. The literature has not addressed this issue, and this study describes a robust and pragmatic method for assessing the adequacy of blinding in hand hygiene intervention trials.

The ORION statement: guidelines for transparent reporting of outbreak reports and intervention studies of nosocomial infection.

The quality of research in hospital epidemiology (infection control) must be improved to be robust enough to influence policy and practice. In order to raise the standards of research and publication, a CONSORT equivalent for these largely quasi-experimental studies has been prepared by the authors of two relevant systematic reviews, following consultation with learned societies, editors of journals, and researchers. The ORION (Outbreak Reports and Intervention Studies Of Nosocomial infection) statement consists of a 22 item checklist, and a summary table. The emphasis is on transparency to improve the quality of reporting and on the use of appropriate statistical techniques. The statement has been endorsed by a number of professional special interest groups and societies. Like CONSORT, ORION should be considered a "work in progress", which requires ongoing dialogue for successful promotion and dissemination. The statement is therefore offered for further public discussion. Journals and research councils are strongly recommended to incorporate it into their submission and reviewing processes. Feedback to the authors is encouraged and the statement will be revised in 2 years.