Title: DEveloping a Complex Intervention for DEteriorating patients using theoretical modelling (DECIDE study)
Funder: Health Education England

Abstract: 1. Background Patients who deteriorate in hospital are at risk of adverse outcomes including: cardiac arrest, unplanned intensive care admission, and death (2, 3). Deteriorating patients frequently have physiological antecedents detectable by monitoring vital signs (4-6), including: heart rate; respiratory rate; blood pressure; temperature; oximetry; consciousness level.To improve hospital staff response to a deteriorating patient, rapid response systems (RRS) have been developed and implemented (7). The RRS frequently includes an afferent limb' and an efferent limb' (7). The ideal actions or behaviours associated with the afferent limb are performed in sequence and include: monitoring a patient's vital signs; recognising abnormality; and informing a more senior or expert clinician (termed escalation) (7-9). The efferent limb is concerned with the response following escalation.To facilitate timely recognition of deteriorating patients, early warning score (EWS) tools have been implemented in many UK acute care hospitals. Here, an aggregate score is generated from vital signs. As part of the afferent limb, nurses are prompted to act on the EWS (8). Despite implementation of these tools, there is evidence that nurses do not always act in accordance with escalation guidance (2, 10, 11). Patients deteriorating without recognition, or appropriate and timely escalation, is termed afferent limb failure' (ALF). Whilst studies have aimed to elucidate reasons for ALF (12-14), knowledge gaps remain. Behavioural approaches have been proposed to overcome these problems, but no reports of successful strategies could be found (15).The DECIDE project will use a behavioural approach incorporating various methods (including structured observation), to advance the existing body of knowledge, and enable development of theory-based interventions targeting barriers and enablers to ideal afferent limb behaviours.2. Research aims and questionsAim: to develop a theory-based complex intervention to enhance enablers and overcome barriers to performing ideal afferent limb behaviours. Specific research questions: What are the behaviours expected of hospital staff within the afferent limb of the RRS? What extent do expected behaviours correspond to observed behaviours in clinical practice? Where in the sequence of observed behaviours does ALF occur and why might it be happening? Can an acceptable theory-based, complex intervention be developed to facilitate more consistent and appropriate responses to a high EWS? 3. Plan of investigationPhase 1: A case study approach (with hospital staff level as cases) will be used to theorise the causal pathway to ALF. Data collection strategies will include structured observation on hospital wards, field notes and brief, un-recorded interviews with participants.Phase 2: Recorded, semi-structured interviews will be conducted with nursing staff using a TDF-informed topic guide. Transcripts will be coded (deductively) into the 14 TDF domains and then (inductively) into themes using framework analysis (16). Priority domains will be identified and mapped to appropriate behaviour change techniques (BCTs) using published methods (17).Phase 3: The content and mode of delivery will be developed using co-production methods. Nominal groups will be held with clinical stakeholders to explore how BCTs could be delivered. Participants will rank BCTs/mode of delivery combinations according to local acceptability.4. Benefit to patients and the NHS (within 5 years of completion) Increase organisational (Trust level) understanding of nursing staff behaviour when they are monitoring patients and escalating care. This increase in understanding in itself may lead to the adoption of ideal afferent limb behaviours, by some staff, in certain clinical areas, benefiting small numbers of deteriorating patients within the Trust. Feasibility testing (year 1 post-doctoral) and randomised evaluation (years 2-5 post-doctoral) of a complex implementation intervention targeting behaviours that contribute to ALF will potentially benefit patients in intervention wards, with scale-up to follow, leading to wider benefit.

Lay abstract: Part of a nurse's role is to monitor patients' clinical condition. This typically involves measuring and recording blood pressure, heart rate, breathing rate, temperature and oxygen level. Taking these measurements (known as clinical observations) at intervals allows nurses to detect when a patient is becoming more unwell and needs to be seen by a senior nurse or a doctor. If this process fails, and the patient's condition starts to worsen without recognition, there is a higher risk that the patient will collapse or die.To support nurses in recognising deteriorating patients, specific tools have been developed and are used widely in hospitals within the UK. These tools provide a record of the measurements, whilst also generating an early warning score' (EWS) for each patient every time clinical observations are carried out. As a rule, the higher the score, the greater the risk that the patient will continue to deteriorate. Importantly, the charts also instruct nursing staff on what action to take based on the EWS. If a patient has a medium or high score, nursing staff should contact a senior nurse or doctor for additional help. Unfortunately, there is evidence that these instructions are not always followed, leaving unwell patients at risk of further deterioration.The aim of this research is to develop an intervention to change the behaviour of nurses when they are reacting to a high EWS from a patient. For this research, behaviour is defined as: the way a nurse acts or conducts him/herself in response to a high EWS. To develop this intervention, it is important to first understand what the ideal behaviours' are so that inappropriate responses, or non-responses, can be identified and staff can be supported to change them. Clearly describing ideal behaviours will be addressed in the first phase of this project.In phase one, the researcher will spend time observing the nurses (registered nurses (RN) and un-registered health care assistants (HCA)) on the wards of an NHS hospital. The researcher will pay attention to what nurses do when they are monitoring patients and responding to a high EWS. Nurses will be observed throughout the day, at night, and at weekends, to ensure that different ways of behaving at different times are seen. The behaviours observed on the wards will be compared to the ideal behaviours set out in published information and hospital policies (for example, if the patient has an EWS greater than 7, notify the doctor within 5 minutes). Gaps between the behaviours seen on the wards and the ideal behaviours will be explored in phase two.In phase two, RNs and HCAs will be interviewed to explore their beliefs about the causes of the behaviour observed in phase one. Some of the staff interviewed will have demonstrated ideal behaviour' when responding to a high EWS, whilst others will have demonstrated an inappropriate response or a non-response. Interview data will be analysed using a model of behaviour change called the Theoretical Domains Framework (TDF). The TDF has 14 domains' which cover the main factors influencing behaviour of health care staff. Example domains include: skills, knowledge, motivation and emotion. Analysing the interview data using the TDF will allow us to identify the likely causes of behaviour and to group them under these domain headings. After grouping, the research team will use structured methods to decide which domains are likely to be the most important or key' to influencing staff behaviour and therefore should be targeted by the intervention. For each of the key domains, techniques for changing behaviour will be needed. A framework, developed by experts in behavioural science, will be used to match each of the key domains to a technique for behaviour change. An example of this is: if skills' were identified from the interviews as being a key barrier to using the EWS effectively, it is advised in the framework that rehearsal of relevant skills' is a suitable behaviour change technique (BCT).In phase three, after a list of possible BCTs has been developed, the researcher will bring together a group of clinical staff from the hospital to take part in a structured group process designed for problem solving and decision making. During the process, group members will discuss how the BCTs could be delivered on the wards before ranking them, and their delivery, according to how acceptable they are. The BCTs ranked the highest during this process will be considered first by the research team when they are discussing and agreeing the content of the intervention.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE