'Eczema shouldn't control you; you should control eczema': qualitative process evaluation of online behavioural interventions to support young people and parents/carers of children with eczema.

BACKGROUND: There is a lack of well-conducted randomized controlled trials evaluating the effectiveness of theory-based online interventions for eczema. To address these deficiencies, we previously developed and demonstrated the effectiveness of two online behavioural interventions: Eczema Care Online for parents/carers of children with eczema, and Eczema Care Online for young people with eczema. OBJECTIVES: To explore the views and experiences of people who have used the Eczema Care Online interventions to provide insights into how the interventions worked and identify contextual factors that may impede users' engagement with the interventions. METHODS: Qualitative semistructured interviews were conducted with 17 parents/carers of children with eczema and 17 young people with eczema. Participants were purposively sampled from two randomized controlled trials of the interventions and recruited from GP surgeries in England. Transcripts were analysed using inductive thematic analysis, and intervention modifications were identified using the person-based approach table of changes method. RESULTS: Both young people and parents/carers found the interventions easy to use, relatable and trustworthy, and perceived that they helped them to manage their eczema, thus suggesting that Eczema Care Online may be acceptable to its target groups. Our analysis suggested that the interventions may reduce eczema severity by facilitating empowerment among its users, specifically through improved understanding of, and confidence in, eczema management, reduced treatment concerns, and improved treatment adherence and management of irritants/triggers. Reading about the experiences of others with eczema helped people to feel 'normal' and less alone. Some (mainly young people) expressed firmly held negative beliefs about topical corticosteroids, views that were not influenced by the intervention. Minor improvements to the design and navigation of the Eczema Care Online interventions and content changes were identified and made, ready for wider implementation. CONCLUSIONS: People with eczema and their families can benefit from reliable information, specifically information on the best and safest ways to use their eczema treatments early in their eczema journey. Together, our findings from this study and the corresponding trials suggest wider implementation of Eczema Care Online (EczemaCareOnline.org.uk) is justified.

The Relationship Between Adult Attachment and Complicated Grief: A Systematic Review.

Attachment insecurity, including attachment anxiety and attachment avoidance, is proposed as a key factor disrupting adaptive recovery following bereavement, resulting in complicated grief. However, findings are inconsistent across studies. This review aimed to synthesise existing research on attachment patterns in adults experiencing complicated grief to better understand this relationship. 22 cross-sectional and longitudinal studies (5149 participants), published between 2003 and 2020, met inclusion criteria. Higher levels of attachment anxiety were consistently associated with symptoms of complicated grief. Higher levels of attachment avoidance were associated with symptoms of complicated grief, although this relationship was less consistent. The review has implications for clinical practice as bereaved adults with insecure attachment histories may be particularly vulnerable to experiencing complicated grief. The research is limited by the reliance on mainly cross-sectional studies. Future research should focus on longitudinal studies, and studies that explore men's experiences, and of individuals living in non-Western countries.

Why do hospital prescribers continue antibiotics when it is safe to stop? Results of a choice experiment survey.

BACKGROUND: Deciding whether to discontinue antibiotics at early review is a cornerstone of hospital antimicrobial stewardship practice worldwide. In England, this approach is described in government guidance ('Start Smart then Focus'). However, < 10% of hospital antibiotic prescriptions are discontinued at review, despite evidence that 20-30% could be discontinued safely. We aimed to quantify the relative importance of factors influencing prescriber decision-making at review. METHODS: We conducted an online choice experiment, a survey method to elicit preferences. Acute/general hospital prescribers in England were asked if they would continue or discontinue antibiotic treatment in 15 hypothetical scenarios. Scenarios were described according to six attributes, including patients' presenting symptoms and whether discontinuation would conflict with local prescribing guidelines. Respondents' choices were analysed using conditional logistic regression. RESULTS: One hundred respondents completed the survey. Respondents were more likely to continue antibiotics when discontinuation would 'strongly conflict' with local guidelines (average marginal effect (AME) on the probability of continuing + 0.194 (p < 0.001)), when presenting symptoms more clearly indicated antibiotics (AME of urinary tract infection symptoms + 0.173 (p < 0.001) versus unclear symptoms) and when patients had severe frailty/comorbidities (AME = + 0.101 (p < 0.001)). Respondents were less likely to continue antibiotics when under no external pressure to continue (AME = - 0.101 (p < 0.001)). Decisions were also influenced by the risks to patient health of continuing/discontinuing antibiotic treatment. CONCLUSIONS: Guidelines that conflict with antibiotic discontinuation (e.g. pre-specify fixed durations) may discourage safe discontinuation at review. In contrast, guidelines conditional on patient factors/treatment response could help hospital prescribers discontinue antibiotics if diagnostic information suggesting they are no longer needed is available.

Mediators of change in cognitive behavior therapy and interpersonal psychotherapy for eating disorders: A secondary analysis of a transdiagnostic randomized controlled trial.

OBJECTIVE: Understanding the mechanisms of action of psychological treatments is a key first step in refining and developing more effective treatments. The present study examined hypothesized mediators of change of enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED). METHOD: A series of mediation studies were embedded in a randomized controlled trial (RCT) comparing 20 weeks of CBT-E and IPT-ED in a transdiagnostic, non-underweight sample of patients with eating disorders (N = 130) consecutively referred to the service. Three hypothesized mediators of change in CBT-E (regular eating, weighing frequency, and shape checking) and the key hypothesized mediator of IPT-ED (interpersonal problem severity) were studied. RESULTS: The data supported regular eating as being a mediator of the effect of CBT-E on binge-eating frequency. The findings were inconclusive regarding the role of the other putative mediators of the effects of CBT-E; and were similarly inconclusive for interpersonal problem severity as a mediator of the effect of IPT-ED. DISCUSSION: This research highlights the potential benefits of embedding mediation studies within RCTs to better understand how treatments work. The findings supported the role of regular eating in reducing patients' binge-eating frequency. Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them. Key methodological issues to address in future work include the need to capture both behavioral and cognitive processes of change in CBT-E, and identifying key time points for change in IPT-ED.

Strengthening Relationships Within Intensive Psychiatric Care: Staff Perceptions of an Attachment Training Intervention.

INTRODUCTION: Intensive psychiatric care units can be challenging environments in which to build strong staff-patient relationships. Attachment theory may provide a useful model for strengthening relationships in this setting. AIM: The aim of this study was to explore staff perceptions of the utility of attachment theory for understanding patient behaviour in the intensive psychiatric care setting. METHODS: Semi-structured interviews were conducted with 11 multi-disciplinary staff members. Interviews focused on the staff member's experience of learning about attachment theory and applying this perspective to their work on the ward. Transcripts were analysed using reflexive thematic analysis. RESULTS: The analysis led to the development of three themes: engaging the reflective self, new perspective on others and cohesive ward culture. CONCLUSION: Staff reported that learning about attachment theory supported them to better understand patient distress and associated behaviours. Notably, staff also used attachment theory to reflect on both their own internal states and the internal states of their colleagues. These reflections were suggested to bolster staff wellbeing and improve the ward milieu. IMPLICATIONS FOR PRACTICE: Integrating attachment theory into team formulation, ward rounds and reflective practice groups could have a benefit for clinical practice, staff wellbeing and team cohesion in this setting.

Online behavioural interventions for children and young people with eczema: a quantitative evaluation.

BACKGROUND: Two online behavioural interventions (one website for parents/carers of children with eczema; and one for young people with eczema) have been shown in randomised controlled trials to facilitate a sustained improvement in eczema severity. AIM: To describe intervention use and examine potential mediators of intervention outcomes and contextual factors that may influence intervention delivery and outcomes. DESIGN AND SETTING: Quantitative process evaluation in UK primary care. METHOD: Parents/carers and young people were recruited through primary care. Intervention use was recorded and summarised descriptively. Logistic regression explored sociodemographic and other factors associated with intervention engagement. Mediation analysis investigated whether patient enablement (ability to understand and cope with health issues), treatment use, and barriers to adherence were mediators of intervention effect. Subgroup analysis compared intervention effects among pre-specified participant subsets. RESULTS: A total of 340 parents/carers and 337 young people were recruited. Most parents/carers (87%, n = 148/171) and young people (91%, n = 153/168) in the intervention group viewed the core introduction by 24 weeks. At 24 weeks, users had spent approximately 20 minutes on average on the interventions. Among parents/carers, greater intervention engagement was associated with higher education levels, uncertainty about carrying out treatments, and doubts about treatment efficacy at baseline. Among young people, higher intervention use was associated with higher baseline eczema severity. Patient enablement (the ability to understand and cope with health issues) accounted for approximately 30% of the intervention effect among parents/carers and 50% among young people. CONCLUSION: This study demonstrated that positive intervention outcomes depended on a modest time commitment from users. This provides further support that the wider implementation of Eczema Care Online is justified.

Cost-effectiveness of two online interventions supporting self-care for eczema for parents/carers and young people.

OBJECTIVE: To estimate the cost-effectiveness of online behavioral interventions (EczemaCareOnline.org.uk) designed to support eczema self-care management for parents/carers and young people from an NHS perspective. METHODS: Two within-trial economic evaluations, using regression-based approaches, adjusting for baseline and pre-specified confounder variables, were undertaken alongside two independent, pragmatic, parallel group, unmasked randomized controlled trials, recruiting through primary care. Trial 1 recruited 340 parents/carers of children aged 0-12 years and Trial 2 337 young people aged 13-25 years with eczema scored ≥ 5 on Patient-Oriented Eczema Measure (POEM). Participants were randomized (1:1) to online intervention plus usual care or usual care alone. Resource use, collected via medical notes review, was valued using published unit costs in UK £Sterling 2021. Quality-of-life was elicited using proxy CHU-9D in Trial 1 and self-report EQ-5D-5L in Trial 2. RESULTS: The intervention was dominant (cost saving and more effective) with a high probability of cost-effectiveness (> 68%) in most analyses. The exception was the complete case cost-utility analysis for Trial 1 (omitting participants with children aged < 2), with adjusted incremental cost savings of -£34.15 (95% CI - 104.54 to 36.24) and incremental QALYs of - 0.003 (95% CI - 0.021 to 0.015) producing an incremental cost per QALY of £12,466. In the secondary combined (Trials 1 and 2) cost-effectiveness analysis, the adjusted incremental cost was -£20.35 (95% CI - 55.41 to 14.70) with incremental success (≥ 2-point change on POEM) of 10.3% (95% CI 2.3-18.1%). CONCLUSION: The free at point of use online eczema self-management intervention was low cost to run and cost-effective. TRIAL REGISTRATION: This trial was registered prospectively with the ISRCTN registry (ISRCTN79282252). URL www.EczemaCareOnline.org.uk .

Antibiotic review kit for hospitals (ARK-Hospital): a stepped-wedge cluster-randomised controlled trial.

BACKGROUND: Strategies to reduce antibiotic overuse in hospitals depend on prescribers taking decisions to stop unnecessary antibiotic use. There is scarce evidence for how to support these decisions. We evaluated a multifaceted behaviour change intervention (ie, the antibiotic review kit) designed to reduce antibiotic use among adult acute general medical inpatients by increasing appropriate decisions to stop antibiotics at clinical review. METHODS: We performed a stepped-wedge, cluster (hospital)-randomised controlled trial using computer-generated sequence randomisation of eligible hospitals in seven calendar-time blocks in the UK. Hospitals were eligible for inclusion if they admitted adult non-elective general or medical inpatients, had a local representative to champion the intervention, and could provide the required study data. Hospital clusters were randomised to an implementation date occurring at 1-2 week intervals, and the date was concealed until 12 weeks before implementation, when local preparations were designed to start. The intervention effect was assessed using data from pseudonymised routine electronic health records, ward-level antibiotic dispensing, Clostridioides difficile tests, prescription audits, and an implementation process evaluation. Co-primary outcomes were monthly antibiotic defined daily doses per adult acute general medical admission (hospital-level, superiority) and all-cause mortality within 30 days of admission (patient level, non-inferiority margin of 5%). Outcomes were assessed in the modified intention-to-treat population (ie, excluding sites that withdrew before implementation). Intervention effects were assessed by use of interrupted time series analyses within each site, estimating overall effects through random-effects meta-analysis, with heterogeneity across prespecified potential modifiers assessed by use of meta-regression. This trial is completed and is registered with ISRCTN, ISRCTN12674243. FINDINGS: 58 hospital organisations expressed an interest in participating. Three pilot sites implemented the intervention between Sept 25 and Nov 20, 2017. 43 further sites were randomised to implement the intervention between Feb 12, 2018, and July 1, 2019, and seven sites withdrew before implementation. 39 sites were followed up for at least 14 months. Adjusted estimates showed reductions in total antibiotic defined daily doses per acute general medical admission (-4·8% per year, 95% CI -9·1 to -0·2) following the intervention. Among 7 160 421 acute general medical admissions, the ARK intervention was associated with an immediate change of -2·7% (95% CI -5·7 to 0·3) and sustained change of 3·0% (-0·1 to 6·2) in adjusted 30-day mortality. INTERPRETATION: The antibiotic review kit intervention resulted in sustained reductions in antibiotic use among adult acute general medical inpatients. The weak, inconsistent intervention effects on mortality are probably explained by the onset of the COVID-19 pandemic. Hospitals should use the antibiotic review kit to reduce antibiotic overuse. FUNDING: UK National Institute for Health and Care Research.

Eczema Care Online: development and qualitative optimisation of an online behavioural intervention to support self-management in young people with eczema.

OBJECTIVES: To describe the development of Eczema Care Online (ECO), an online behaviour change intervention for young people with eczema (phase I); and explore and optimise the acceptability of ECO among this target group using think-aloud interviews (phase II). METHODS: Theory-based, evidence-based and person-based approaches to intervention development were used. In phase I, a qualitative systematic review and qualitative interviews developed an in-depth understanding of the needs and challenges of young people with eczema. Guiding principles highlighted key intervention design objectives and features to address the needs of this target group to maximise user engagement. Behavioural analysis and logic modelling developed ECO's hypothesised programme theory. In phase II, qualitative think-aloud interviews were carried out with 28 young people with eczema and the intervention was optimised based on their feedback. RESULTS: The final intervention aimed to reduce eczema severity by supporting treatment use (emollients, topical corticosteroids/topical calcineurin inhibitors), management of irritants/triggers, emotional management and reducing scratching. Generally, young people expressed positive views of intervention content and design in think-aloud interviews. Quotes and stories from other young people with eczema and ECO's focus on living with eczema (not just topical treatments) were valuable for normalising eczema. Young people believed ECO addressed knowledge gaps they had from childhood and the safety information about topical corticosteroids was reassuring. Negative feedback was used to modify ECO. CONCLUSIONS: A prototype of the ECO intervention was developed using rigorous and complementary intervention development approaches. Subsequent think-aloud interviews helped optimise the intervention, demonstrated ECO is likely to be acceptable to this target group, and provided support for our guiding principles including key design objectives and features to consider when developing interventions for this population. A randomised controlled trial and process evaluation of the intervention is underway to assess effectiveness and explore user engagement with the intervention's behavioural goals.

Supporting families managing childhood eczema: developing and optimising eczema care online using qualitative research.

BACKGROUND: Childhood eczema is often poorly controlled owing to underuse of emollients and topical corticosteroids (TCS). Parents/carers report practical and psychosocial barriers to managing their child's eczema, including child resistance. Online interventions could potentially support parents/carers; however, rigorous research developing such interventions has been limited. AIM: To develop an online behavioural intervention to help parents/carers manage and co-manage their child's eczema. DESIGN AND SETTING: Intervention development using a theory-, evidence-, and person-based approach (PBA) with qualitative research. METHOD: A systematic review and qualitative synthesis of studies (n = 32) and interviews with parents/carers (n = 30) were used to identify barriers and facilitators to effective eczema management, and a prototype intervention was developed. Think-aloud interviews with parents/carers (n = 25) were then used to optimise the intervention to increase its acceptability and feasibility. RESULTS: Qualitative research identified that parents/carers had concerns about using emollients and TCS, incomplete knowledge and skills around managing eczema, and reluctance to transitioning to co-managing eczema with their child. Think-aloud interviews highlighted that, while experienced parents/carers felt they knew how to manage eczema, some information about how to use treatments was still new. Techniques for addressing barriers included providing a rationale explaining how emollients and TCS work, demonstrating how to use treatments, and highlighting that the intervention provided new, up-to-date information. CONCLUSION: Parents/carers need support in effectively managing and co-managing their child's eczema. The key output of this research is Eczema Care Online for Families, an online intervention for parents/carers of children with eczema, which is being evaluated in a randomised trial.

Eczema Care Online behavioural interventions to support self-care for children and young people: two independent, pragmatic, randomised controlled trials.

OBJECTIVE: To determine the effectiveness of two online behavioural interventions, one for parents and carers and one for young people, to support eczema self-management. DESIGN: Two independent, pragmatic, parallel group, unmasked, randomised controlled trials. SETTING: 98 general practices in England. PARTICIPANTS: Parents and carers of children (0-12 years) with eczema (trial 1) and young people (13-25 years) with eczema (trial 2), excluding people with inactive or very mild eczema (≤5 on POEM, the Patient-Oriented Eczema Measure). INTERVENTIONS: Participants were randomised (1:1) using online software to receive usual eczema care or an online (www.EczemaCareOnline.org.uk) behavioural intervention for eczema plus usual care. MAIN OUTCOME MEASURES: Primary outcome was eczema symptoms rated using POEM (range 0-28, with 28 being very severe) every four weeks over 24 weeks. Outcomes were reported by parents or carers for children and by self-report for young people. Secondary outcomes included POEM score every four weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, perceived barriers to treatment use, and intervention use. Analyses were carried out separately for the two trials and according to intention-to-treat principles. RESULTS: 340 parents or carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised. The mean baseline POEM score was 12.8 (standard deviation 5.3) for parents and carers and 15.2 (5.4) for young people. Three young people withdrew from follow-up but did not withdraw their data. All randomised participants were included in the analyses. At 24 weeks, follow-up rates were 91.5% (311/340) for parents or carers and 90.2% (304/337) for young people. After controlling for baseline eczema severity and confounders, compared with usual care groups over 24 weeks, eczema severity improved in the intervention groups: mean difference in POEM score -1.5 (95% confidence interval -2.5 to -0.6; P=0.002) for parents or carers and -1.9 (-3.0 to -0.8; P<0.001) for young people. The number needed to treat to achieve a 2.5 difference in POEM score at 24 weeks was 6 in both trials. Improvements were sustained to 52 weeks in both trials. Enablement showed a statistically significant difference favouring the intervention group in both trials: adjusted mean difference at 24 weeks -0.7 (95% confidence interval -1.0 to -0.4) for parents or carers and -0.9 (-1.3 to -0.6) for young people. No harms were identified in either group. CONCLUSIONS: Two online interventions for self-management of eczema aimed at parents or carers of children with eczema and at young people with eczema provide a useful, sustained benefit in managing eczema severity in children and young people when offered in addition to usual eczema care. TRIAL REGISTRATION: ISRCTN registry ISRCTN79282252.

Children's Views and Experiences of Treatment Adherence and Parent/Child Co-Management in Eczema: A Qualitative Study.

Eczema affects one in five children and can have a substantial impact on quality of life. This qualitative study aimed to explore children's views and experiences of eczema and what may affect treatment adherence from their perspective. We conducted semi-structured, face-to-face interviews with children with eczema aged 6-12 years from March to July 2018. Interviews were transcribed verbatim and analysed using inductive thematic analysis. We found that children do not typically view eczema as a long-term condition, and topical treatments (predominately emollients) were seen to provide effective symptom relief. Uncertainty around co-managing at home was expressed as children typically felt that parental reminders and assistance with applying different types of topical treatments were still needed. For some children, eczema can be difficult to manage at school due to a lack of convenient access and appropriate spaces to apply creams and psychosocial consequences such as attracting unwanted attention from peers and feeling self-conscious. Treatment adherence could be supported by reinforcing that eczema is a long-term episodic condition, providing clear information about regular emollient use, practical advice such as setting reminders to support co-management at home, and working with schools to facilitate topical treatment use when necessary.

Supporting self-care for eczema: protocol for two randomised controlled trials of ECO (Eczema Care Online) interventions for young people and parents/carers.

INTRODUCTION: Eczema care requires management of triggers and various treatments. We developed two online behavioural interventions to support eczema care called ECO (Eczema Care Online) for young people and ECO for families. This protocol describes two randomised controlled trials (RCTs) aimed to evaluate clinical and cost-effectiveness of the two interventions. METHODS AND ANALYSIS: Design: Two independent, pragmatic, unmasked, parallel group RCTs with internal pilots and nested health economic and process evaluation studies. Setting: Participants will be recruited from general practitioner practices in England. Participants: Young people aged 13-25 years with eczema and parents and carers of children aged 0-12 years with eczema, excluding inactive or very mild eczema (five or less on Patient-Oriented Eczema Measure (POEM)). Interventions: Participants will be randomised to online intervention plus usual care or to usual eczema care alone. Outcome measures: Primary outcome is eczema severity over 24 weeks measured by POEM. Secondary outcomes include POEM 4-weekly for 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, health service and treatment use. Process measures include treatment adherence, barriers to adherence and intervention usage. Our sample sizes of 303 participants per trial are powered to detect a group difference of 2.5 (SD 6.5) in monthly POEM scores over 24 weeks (significance 0.05, power 0.9), allowing for 20% loss to follow-up. Cost-effectiveness analysis will be from a National Health Service and personal social service perspective. Qualitative and quantitative process evaluation will help understand the mechanisms of action and participant experiences and inform implementation. ETHICS AND DISSEMINATION: The study has been approved by South Central Oxford A Research Ethics Committee (19/SC/0351). Recruitment is ongoing, and follow-up will be completed by mid-2022. Findings will be disseminated to participants, the public, dermatology and primary care journals, and policy makers. TRIAL REGISTRATION NUMBER: ISRCTN79282252.

Patient engagement with antibiotic messaging in secondary care: a qualitative feasibility study of the 'review and revise' experience.

BACKGROUND: We aimed to investigate and optimise the acceptability and usefulness of a patient leaflet about antibiotic prescribing decisions made during hospitalisation, and to explore individual patient experiences and preferences regarding the process of antibiotic prescription 'review and revise' which is a key strategy to minimise antibiotic overuse in hospitals. METHODS: In this qualitative study, run within the feasibility study of a large, cluster-randomised stepped wedge trial of 36 hospital organisations, a series of semi-structured, think-aloud telephone interviews were conducted and data were analysed using thematic analysis. Fifteen adult patients who had experienced a recent acute medical hospital admission during which they had been prescribed antimicrobials and offered a patient leaflet about antibiotic prescribing were recruited to the study. RESULTS: Participants reacted positively to the leaflet, reporting that it was both an accessible and important source of information which struck the appropriate balance between informing and reassuring. Participants all valued open communication with clinicians, and were keen to be involved in antibiotic prescribing decisions, with individuals reporting positive experiences regarding antibiotic prescription changes or stopping. Many participants had prior experience or knowledge of antibiotics and resistance, and generally welcomed efforts to reduce antibiotic usage. Overall, there was a feeling that healthcare professionals (HCPs) are trusted experts providing the most appropriate treatment for individual patient conditions. CONCLUSIONS: This study offers novel insights into how patients within secondary care are likely to respond to messages advocating a reduction in the use of antibiotics through the 'review and revise' approach. Due to the level of trust that patients place in their care provider, encouraging HCPs within secondary care to engage patients with greater communication and information provision could provide great advantages in the drive to reduce antibiotic use. It may also be beneficial for HCPs to view patient experiences as cumulative events that have the potential to impact future behaviour around antibiotic use. Finally, pre-testing messages about antibiotic prescribing and resistance is vital to dispelling any misconceptions either around effectiveness of treatment for patients, or perceptions of how messages may be received. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12674243 (10 April 2017).

Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial.

BACKGROUND: To ensure patients continue to get early access to antibiotics at admission, while also safely reducing antibiotic use in hospitals, one needs to target the continued need for antibiotics as more diagnostic information becomes available. UK Department of Health guidance promotes an initiative called 'Start Smart then Focus': early effective antibiotics followed by active 'review and revision' 24-72 h later. However in 2017, < 10% of antibiotic prescriptions were discontinued at review, despite studies suggesting that 20-30% of prescriptions could be stopped safely. METHODS/DESIGN: Antibiotic Review Kit for Hospitals (ARK-Hospital) is a complex 'review and revise' behavioural intervention targeting healthcare professionals involved in antibiotic prescribing or administration in inpatients admitted to acute/general medicine (the largest consumers of non-prophylactic antibiotics in hospitals). The primary study objective is to evaluate whether ARK-Hospital can safely reduce the total antibiotic burden in acute/general medical inpatients by at least 15%. The primary hypotheses are therefore that the introduction of the behavioural intervention will be non-inferior in terms of 30-day mortality post-admission (relative margin 5%) for an acute/general medical inpatient, and superior in terms of defined daily doses of antibiotics per acute/general medical admission (co-primary outcomes). The unit of observation is a hospital organisation, a single hospital or group of hospitals organised with one executive board and governance framework (National Health Service trusts in England; health boards in Northern Ireland, Wales and Scotland). The study comprises a feasibility study in one organisation (phase I), an internal pilot trial in three organisations (phase II) and a cluster (organisation)-randomised stepped-wedge trial (phase III) targeting a minimum of 36 organisations in total. Randomisation will occur over 18 months from November 2017 with a further 12 months follow-up to assess sustainability. The behavioural intervention will be delivered to healthcare professionals involved in antibiotic prescribing or administration in adult inpatients admitted to acute/general medicine. Outcomes will be assessed in adult inpatients admitted to acute/general medicine, collected through routine electronic health records in all patients. DISCUSSION: ARK-Hospital aims to provide a feasible, sustainable and generalisable mechanism for increasing antibiotic stopping in patients who no longer need to receive them at 'review and revise'. TRIAL REGISTRATION: ISRCTN Current Controlled Trials, ISRCTN12674243 . Registered on 10 April 2017.

Intervention planning for the REDUCE maintenance intervention: a digital intervention to reduce reulceration risk among patients with a history of diabetic foot ulcers.

OBJECTIVES: To develop a comprehensive intervention plan for the REDUCE maintenance intervention to support people who have had diabetic foot ulcers (DFUs) to sustain behaviours that reduce reulceration risk. METHODS: Theory-based, evidence-based and person-based approaches to intervention development were used. In phase I of intervention planning, evidence was collated from a scoping review of the literature and qualitative interviews with patients who have had DFUs (n=20). This was used to identify the psychosocial needs and challenges of this population and barriers and facilitators to the intervention's target behaviours: regular foot checking, rapid self-referral in the event of changes in foot health, graded and regular physical activity and emotional management. In phase II, this evidence was combined with expert consultation to develop the intervention plan. Brief 'guiding principles' for shaping intervention development were created. 'Behavioural analysis' and 'logic modelling' were used to map intervention content onto behaviour change theory to comprehensively describe the intervention and its hypothesised mechanisms. RESULTS: Key challenges to the intervention's target behaviours included patients' uncertainty regarding when to self-refer, physical limitations affecting foot checking and physical activity and, for some, difficulties managing negative emotions. Important considerations for the intervention design included a need to increase patients' confidence in making a self-referral and in using the maintenance intervention and a need to acknowledge that some intervention content might be relevant to only some patients (emotional management, physical activity). The behavioural analysis identified the following processes hypothesised to facilitate long-term behaviour maintenance including increasing patients' skills, self-efficacy, knowledge, positive outcome expectancies, sense of personal control, social support and physical opportunity. CONCLUSIONS: This research provides a transparent description of the intervention planning for the REDUCE maintenance intervention. It provides insights into potential barriers and facilitators to the target behaviours and potentially useful behaviour change techniques to use in clinical practice.