Development of theoretically informed audit and feedback: An exemplar from a complex implementation strategy to improve asthma self-management in UK primary care.

RATIONALE: Audit and feedback is an evidence-based implementation strategy, but studies reporting the use of theory to guide design elements are limited. AIMS AND OBJECTIVES: Within the context of a programme of research aiming to improve the implementation of supported asthma self-management in UK primary care (IMPlementing IMProved Asthma self-management as RouTine [IMP2 ART]), we aimed to design and develop theoretically-informed audit and feedback that highlighted supported asthma self-management provision and areas for improvement in primary care general practices. METHOD: Aligned with the Medical Research Council (MRC) complex intervention framework, the audit and feedback was developed in three phases: (1) Development: literature and theory exploration, and prototype audit and feedback design; (2) Feasibility: eliciting feedback on the audit and feedback from general practice staff (n = 9); (3) Prepiloting: delivering the audit and feedback within the IMP2 ART implementation strategy (incorporating patient and professional resources and an asthma review template) and eliciting clinician feedback (n = 9). RESULTS: Audit and feedback design was guided by and mapped to existing literature suggestions and theory (e.g., Theoretical Domains Framework, Behaviour Change Technique Taxonomy). Feedback on the prototype audit and feedback confirmed feasibility but identified some refinements (a need to highlight supporting self-management and importance of asthma action plans). Prepiloting informed integration with other IMP2 ART programme strategies (e.g., patient resources and professional education). CONCLUSION: We conclude that a multistage development process including theory exploration and mapping, contributed to the design and delivery of the audit and feedback. Aligned with the MRC framework, the IMP2 ART strategy (incorporating the audit and feedback) is now being tested in a UK-wide cluster randomised controlled trial.

IMP2ART: development of a multi-level programme theory integrating the COM-B model and the iPARIHS framework, to enhance implementation of supported self-management of asthma in primary care.

BACKGROUND: Supported asthma self-management, incorporating an asthma action plan and annual clinical review, has been recommended by UK/global guidelines for over three decades. However, implementation remains poor, as only around a third of individuals receive basic asthma care, according to the UKs leading respiratory charity Asthma and Lung UK. A systematic review of implementation studies recommended that a whole systems approach targeting patients, healthcare professional education, and organisations is needed to improve implementation of supported asthma self-management in primary care. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a national Hybrid-II implementation cluster randomised controlled trial that aims to evaluate such an approach. This paper describes the development of the implementation strategy for IMP2ART with particular focus on the integration of multiple level theories. METHODS: The Medical Research Council design and evaluation of complex interventions framework and the Person-Based Approach to intervention development were used as guidance for stages of strategy development. Specifically, we (i) set up a multidisciplinary team (including practicing and academic clinicians, health psychologists, public health and patient colleagues), (ii) reviewed and integrated evidence and theory, (iii) developed guiding principles, (iv) developed prototype materials, and (v) conducted a pre-pilot study before final refinement. RESULTS: The implementation strategy included resources for patients, team-based and individual healthcare professional education, practice audit and feedback, and an asthma review template, as well as a facilitator role accessible to primary care practices for 12 months. The synthesis of the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) and Capability, Opportunity, Motivation and Behaviour (COM-B) frameworks led to an evolved framework bringing together important implementation and behaviour change elements which will be used as a basis for the study process evaluation. CONCLUSIONS: A description of rigorous implementation strategy development for the IMP2ART study is provided along with newly theorised integration of implementation and behaviour change science which may be of benefit to others targeting implementation in primary care. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2nd December 2019.

Health, Wellbeing, and Social Interaction: An International and Demographic Analysis of Perceived Life Changes and the Positives and Negatives of the COVID-19 Lockdown.

Research suggests that people's experiences of COVID-19 lockdowns have been detrimental to their lives and wellbeing. The current research compared the experiences and perceptions on health, wellbeing and social interaction of 300 UK adults and 450 adults in California. Individuals reported whether aspects of their life had changed for the better, worse, or not at all during lockdown in April 2020, and what the "best" and "worst" things about lockdown were. There were more similarities than differences in the regional comparison of perceptions of changes in specific aspects of 'health and wellbeing' and 'social interaction'. Both regions reported the same number and nature of best and worst things about lockdown. Overarching themes of 'health, self and wellbeing', 'being with others', and 'concerns with daily living' were identified. Although reports of life changes and the positives and negatives of lockdown were similar across different demographic groups, some differences were present by age, sex, relationship, and family-status. Incorporating knowledge of unified and positive experiences of lockdown can be useful in informing future lockdown restrictions and supporting the population when restrictions are lifted.

Psychological impact of the COVID-19 pandemic on people with asthma: a co-produced mixed-methods study.

OBJECTIVE: When COVID-19 was declared a pandemic there was concern that people living with asthma were at high-risk of poor outcomes. We aimed to explore the psychological impact of living with asthma in the United Kingdom during the pandemic. METHODS AND MEASURES: Our mixed methods study, co-designed with patient and public involvement colleagues, included an online survey to detect anxiety/depression/post-traumatic stress disorder (PTSD) and health beliefs; and qualitative interviews. We recruited 849 participants for the survey and interviewed 26 between May and June 2020. Audio-recorded interviews were transcribed verbatim, and analysed thematically. RESULTS: The survey identified that 77% of respondents were experiencing symptoms of anxiety, 77% were experiencing symptoms of depression, and PTSD was of concern for 61%. Two-thirds of respondents felt the pandemic had changed how they managed their asthma (n = 568, 66.9%), and over half felt that they had not been given adequate health information about COVID-19 (n = 495, 58.3%). Qualitative interviews identified five themes (1) health communication, (2) interaction with healthcare, (3) COVID-19-related concerns, (4) impact on mental health, and (5) behaviour change. CONCLUSION: Psychological distress was prevalent in people with asthma during the early stage of the pandemic. Understanding this may be useful to inform future healthcare/policy planning.

Personalised management and supporting individuals to live with their asthma in a primary care setting.

INTRODUCTION: Complementing recognition of biomedical phenotypes, a primary care approach to asthma care recognizes diversity of disease, health beliefs, and lifestyle at a population and individual level. AREAS COVERED: We review six aspects of personalized care particularly pertinent to primary care management of asthma: personalizing support for individuals living with asthma; targeting asthma care within populations; managing phenotypes of wheezy pre-school children; personalizing management to the individual; meeting individual preferences for provision of asthma care; optimizing digital approaches to enhance personalized care. EXPERT OPINION: In a primary care setting, personalized management and supporting individuals to live with asthma extend beyond the contemporary concepts of biological phenotypes and pharmacological 'treatable traits' to encompass evidence-based tailored support for self-management, and delivery of patient-centered care including motivational interviewing. It extends to how we organize clinical practiceand the choices provided in mode of consultation. Diagnostic uncertainty due to recognition of phenotypes of pre-school wheeze remains a challenge for primary care. Digital health can support personalized management, but there are concerns about increasing inequities. This broad approach reflects the traditionally holistic ethos of primary care ('knowing their patients and understanding their communities'), but the core concepts resonate with all healthcare.

IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial.

BACKGROUND: Asthma is a common long-term condition and major public health problem. Supported self-management for asthma that includes a written personalised asthma action plan, supported by regular professional review, reduces unscheduled consultations and improves asthma outcomes and quality of life. However, despite unequivocal inter/national guideline recommendations, supported self-management is poorly implemented in practice. The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) implementation strategy has been developed to address this challenge. The aim of this implementation trial is to determine whether facilitated delivery of the IMP2ART strategy increases the provision of asthma action plans and reduces unscheduled care in the context of routine UK primary care. METHODS: IMP2ART is a parallel group, cluster randomised controlled hybrid II implementation trial. One hundred forty-four general practices will be randomly assigned to either the IMP2ART implementation strategy or control group. Following a facilitation workshop, implementation group practices will receive organisational resources to help them prioritise supported self-management (including audit and feedback; an IMP2ART asthma review template), training for professionals and resources to support patients to self-manage their asthma. The control group will continue with usual asthma care. The primary clinical outcome is the between-group difference in unscheduled care in the second year after randomisation (i.e. between 12 and 24 months post-randomisation) assessed from routine data. Additionally, a primary implementation outcome of asthma action plan ownership at 12 months will be assessed by questionnaire to a random sub-group of people with asthma. Secondary outcomes include the number of asthma reviews conducted, prescribing outcomes (reliever medication and oral steroids), asthma symptom control, patients' confidence in self-management and professional support and resource use. A health economic analysis will assess cost-effectiveness, and a mixed methods process evaluation will explore implementation, fidelity and adaptation. DISCUSSION: The evidence for supported asthma self-management is overwhelming. This study will add to the literature regarding strategies that can effectively implement supported self-management in primary care to reduce unscheduled consultations and improve asthma outcomes and quality of life. TRIAL REGISTRATION: ISRCTN15448074. Registered on 2 December 2019.

Development of a patient-centred electronic review template to support self-management in primary care: a mixed-methods study.

BACKGROUND: Electronic templates are frequently used in long-term condition (LTC) reviews (for example, asthma) to act as reminders and improve documentation; however, they can restrict patient-centred care and opportunities for patients to discuss concerns and self-management. AIM: The IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) programme aimed to develop a patient-centred asthma review template that encourages supported self-management. DESIGN & SETTING: This was a mixed-methods study, which integrated qualitative and systematic review data, primary care Professional Advisory Group feedback, and qualitative data from clinician interviews. METHOD: Aligned with the Medical Research Council complex intervention framework, a template was developed in the following three phases: (1) development phase, which consisted of a qualitative exploration with clinicians and patients, a systematic review, and prototype template development; (2) feasibility pilot phase, which involved feedback from clinicians (n = 7); and (3) pre-piloting phase, which consisted of delivering the template within the IMP2ART implementation strategy (incorporating the template with patient and professional resources) and eliciting clinician feedback (n = 6). RESULTS: Template development was guided by the preliminary qualitative work and the systematic review. A prototype template was developed with an opening question to establish patient agendas, and a closing prompt to confirm agendas have been addressed and an asthma action plan provided. The feasibility pilot identified refinements needed, including focusing the opening question on asthma. Pre-piloting ensured integration with the IMP2ART strategy. CONCLUSION: Following the multi-stage development process, the implementation strategy, including the asthma review template, is now being tested in a cluster randomised controlled trial.

Asynchronous digital health interventions for reviewing asthma: A mixed-methods systematic review protocol.

INTRODUCTION: People living with asthma require regular reviews to address their concerns and questions, assess control, review medication, and support self-management. However, practical barriers to attending face-to-face consultations might limit routine reviews. Reviewing asthma using asynchronous digital health interventions could be convenient for patients and an efficient way of maintaining communication between patients and healthcare professionals and improving health outcomes. We, therefore, aim to conduct a mixed-methods systematic review to assess the effectiveness of reviewing asthma by asynchronous digital health interventions and explore the views of patients and healthcare professionals about the role of such interventions in delivering asthma care. METHODS: We will search MEDLINE, Embase, Scopus, PsycInfo, CINAHL, and Cochrane Library from 2001 to present without imposing any language restrictions. We are interested in studies of asynchronous digital health interventions used either as a single intervention or contributing to mixed modes of review. Two review authors will independently screen titles and abstracts, and retrieve potentially relevant studies for full assessment against the eligibility criteria and extract data. Disagreements will be resolved by discussion with the review team. We will use 'Downs and Black' checklist, 'Critical Appraisal Skills Programme', and 'Mixed Methods Appraisal Tool' to assess methodological quality of quantitative, qualitative, and mixed-methods studies respectively. After synthesising quantitative (narrative synthesis) and qualitative (thematic synthesis) data separately, we will integrate them following methods outlined in the Cochrane Handbook for Systematic Reviews of Interventions. CONCLUSION: The findings of this review will provide insights into the role of asynchronous digital health interventions in the routine care of people living with asthma. TRIAL REGISTRATION: Systematic review registration: PROSPERO registration number: CRD42022344224.

Developing a theoretically informed education programme within the context of a complex implementation strategy in UK primary care: an exemplar from the IMP2ART trial.

BACKGROUND: IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a programme of work developing and evaluating a strategy for implementing supported asthma self-management in UK primary care. The strategy encompasses patient-facing resources, professional education, and organisational approaches to embed supported self-management. This paper reports the development of a theoretically informed interprofessional education programme which aims to raise awareness of and enable healthcare professionals to deliver effective supported self-management. METHODS: Aligned with the Medical Research Council (MRC) Complex Intervention Framework, the multidisciplinary team developed educational content in three phases: (1) developmental phase, identifying educational and behaviour change theory to guide development, in consultation with a professional advisory group; (2) feasibility pilot phase, testing the education using a 'think-aloud' method; and (3) pre-pilot phase, delivering the education within the IMP2ART strategy. RESULTS: The developmental phase identified educational and behaviour change theory and the need to provide two education modules: (1) a team module to raise awareness of supported asthma self-management for the whole team and (2) an individual study module for those who conduct asthma reviews with patients. The feasibility pilot highlighted content and design features in need of refinement and the pre-pilot identified substantial changes to the delivery strategy for the education modules. CONCLUSIONS: A multi-stage development process, aligned with the MRC Framework, contributed to the module design and delivery. Prior explorative work, multi-disciplinary team discussions, and professional advisory group consultation, informed the initial development, and in-practice testing and pre-pilot stages enabled refinement. In our experience, there were important benefits of working together as an educationalist/researcher team. The education programme, a core component of the implementation strategy, is now being tested in the IMP2ART UK-wide cluster randomised controlled trial.

Delivery of supported self-management in remote asthma reviews: A systematic rapid realist review.

BACKGROUND: The COVID-19 pandemic forced health care systems globally to adapt quickly to remote modes of health care delivery, including for routine asthma reviews. A core component of asthma care is supporting self-management, a guideline-recommended intervention that reduces the risk of acute attacks, and improves asthma control and quality of life. OBJECTIVE: We aimed to explore context and mechanisms for the outcomes of clinical effectiveness, acceptability and safety of supported self-management delivery within remote asthma consultations. DESIGN: The review followed standard methodology for rapid realist reviews. An External Reference Group (ERG) provided expert advice and guidance throughout the study. We systematically searched four electronic databases and, with ERG advice, selected 18 papers that explored self-management delivery during routine asthma reviews. SETTING, PARTICIPANTS AND INTERVENTION: Health care professional delivery of supported self-management for asthma patients during remote (specifically including telephone and video) consultations. MAIN OUTCOME MEASURES: Data were extracted using Context-Mechanism-Outcome (C-M-O) configurations and synthesised into overarching themes using the PRISMS taxonomy of supported self-management as a framework to structure the findings. RESULTS: The review findings identified how support for self-management delivered remotely was acceptable (often more acceptable than in-person consultations), and was a safe and effective alternative to face-to-face reviews. In addition, remote delivery of supported self-management was associated with; increased patient convenience, improved access to and attendance at remote reviews, and offered continuity of care. DISCUSSION: Remote delivery of supported self-management for asthma was generally found to be clinically effective, acceptable, and safe with the added advantage of increasing accessibility. Remote reviews could provide the core content of an asthma review, including remote completion of asthma action plans. CONCLUSION: Our findings support the option of remote delivery of routine asthma care for those who have this preference, and offer healthcare professionals guidance on embedding supported self-management into remote asthma reviews. PATIENT AND PUBLIC CONTRIBUTION: Patient and public contribution was provided by a representative of the Asthma UK Centre for Applied Research (AUKCAR) patient and public involvement (PPI) group. The PPI representative reviewed the findings, and feedback and comments were considered. This lead to further interpretations of the data which were included in the final manuscript.

Effectiveness and perceptions of using templates in long-term condition reviews: a systematic synthesis of quantitative and qualitative studies.

BACKGROUND: Review templates are commonly used in long-term condition (LTC) consultations to standardise care for patients and promote consistent data recording. However, templates may affect interactions during the review and, potentially, inhibit patient-centred care. AIM: To systematically review the literature about the impact that LTC review templates have on process and health outcomes, and the views of health professionals and patients on using review templates in consultations. DESIGN AND SETTING: Parallel qualitative and quantitative systematic reviews. METHOD: Following Cochrane methodology, nine databases were searched (1995-2019; updated July 2020) for clinical trials and qualitative studies of LTC templates in healthcare settings. Duplicate selection, risk-of-bias assessment, and data extraction were performed. The quantitative and qualitative analyses were conducted in parallel, and findings synthesised narratively. RESULTS: In total, 12 qualitative and 14 quantitative studies were included (two studies reported both qualitative and quantitative data, and were included in both analyses). Review templates were well used, but the only study to assess health outcomes showed no effect. Templates can improve documentation of key measures and act as a reminder tool; however, they can restrict the review process, and risk health professionals' agendas being prioritised over those of patients. Templates may also limit opportunities to discuss individuals' concerns about living with their condition and act as a barrier to providing patient-centred care. CONCLUSION: Future research should evaluate health, as well as process, outcomes. The potential benefits of templates in improving documentation should be balanced against concerns that 'tick boxes' may override patient agendas, unless templates are designed to promote patient-centred care.

A systematic review of interventions addressing limited health literacy to improve asthma self-management.

BACKGROUND: Supported asthma self-management improves health outcomes. However, people with limited health literacy, especially in lower-middle-income countries (LMICs), may need tailored interventions to enable them to realise the benefits. We aimed to assess the clinical effectiveness of asthma self-management interventions targeted at people with limited health literacy and to identify strategies associated with effective programmes. METHODS: Following Cochrane methodology, we searched ten databases (January 1990 - June 2018; updated October 2019), without language restriction. We included controlled experimental studies whose interventions targeted health literacy to improve asthma self-management. Selection of papers, extraction of data and quality assessment were done independently by two reviewers. The primary outcomes were clinical (asthma control) and implementation (adoption/adherence to intervention). Analysis was narrative. RESULTS: We screened 4318 titles and abstracts, reviewed 52 full-texts and included five trials. One trial was conducted in a LMIC. Risk of bias was low in one trial and high in the other four studies. Clinical outcomes were reported in two trials, both at high risk of bias: one of which reported a reduction in unscheduled care (number of visits in 6-month (SD); Intervention:0.9 (1.2) vs Control:1.8 (2.4), P = 0.001); the other showed no effect. None reported uptake or adherence to the intervention. Behavioural change strategies typically focused on improving an individual's psychological and physical capacity to enact behaviour (eg, targeting asthma-related knowledge or comprehension). Only two interventions also targeted motivation; none sought to improve opportunity. Less than half of the interventions used specific self-management strategies (eg, written asthma action plan) with tailoring to limited health literacy status. Different approaches (eg, video-based and pictorial action plans) were used to provide education. CONCLUSIONS: The paucity of studies and diversity of the interventions to support people with limited health literacy to self-manage their asthma meant that the impact on health outcomes remains unclear. Given the proportion of the global population who have limited health literacy skills, this is a research priority. PROTOCOL REGISTRATION: PROSPERO CRD 42018118974.

Suicide risk assessment in the emergency department: An investigation of current practice in Scotland.

BACKGROUND: Suicide is a global public health issue. Approximately one third of individuals who complete suicide have attended an emergency department in the year preceding their death. The aim of this study was to investigate current suicide risk assessment practices across emergency department clinicians in Scotland. METHODS: A mixed-methods design was employed. A total of 112 surveys for emergency department clinicians were posted to 23 emergency departments in Scotland between March and September 2016. Follow-up semi-structured interviews were also conducted exploring clinician's experiences of suicide risk assessment. Interviews were analysed using thematic analysis. RESULTS: Fifty-one emergency department clinicians across 17 emergency departments completed the survey. Thirty-five (68.6%) participants were currently using a suicide risk assessment tool; with most using locally developed tools and proformas (n = 20, 62.5%) or the SAD PERSONS scale (n = 13, 40.6%). Remaining participants (n = 16, 31.4%) did not use suicide risk assessment tools during assessment. Variation in practice was found both across and within emergency departments. Six clinicians participated in follow-up interviews, which identified four major themes: Clinician Experiences of Suicide Risk Assessment; Components of Suicide Risk Assessment; Clinical Decision-Making; and Supporting Clinicians. CONCLUSIONS: There is substantial variation in current practice, with around two-thirds of clinicians using a variety of empirically and locally developed tools, and a third using their judgement alone. Clinicians find suicide risk assessment a challenging part of their role and discuss the need for increased training, and appropriate and helpful guidelines to improve practice.

Protective Factors of Suicide and Suicidal Behavior Relevant to Emergency Healthcare Settings: A Systematic Review and Narrative Synthesis of Post-2007 Reviews.

Suicide is a major public health concern and, with recent societal changes, such as economic and technological changes, there may be emerging protective factors that mitigate suicide risk that are unrecognized in emergency healthcare. This systematic review aims to identify protective factors for suicide that can feasibly be assessed in time-limited emergency healthcare settings. A systematic review of reviews was conducted via PsycINFO, CINAHL and Medline (2007-2015). Reviews were assessed for methodological quality using AMSTAR. A total of 24 reviews met the inclusion criteria and 8 were assessed as high quality and included in a narrative synthesis. Known protective factors were identified (e.g., social support), along with emerging protective factors (e.g., internet support). The review synthesizes recent research evidence on protective factors and discusses their relevance to emergency healthcare.

Risk Factors for Suicide and Suicidal Behavior Relevant to Emergency Health Care Settings: A Systematic Review of Post-2007 Reviews.

Suicide is a global public health problem, and with recent economic and societal changes, there may be emerging risk factors unrecognized by health care professionals. The aim of this systematic review was to update existing suicide risk factor literature applicable to emergency health care settings. A total of 35 articles identified from PsycINFO, CINAHL, and Medline met the inclusion criteria. Results supported the significance of existing suicide risk factors and identified emerging risk factors. The review provides a high-quality update of risk factor literature that could be applied to emergency health care settings; however, further research is needed to confirm emerging risk factors.

Alcohol Brief Intervention in a university setting: A small-scale experimental study.

Alcohol misuse among university students is commonplace. This study aimed to assess whether Alcohol Brief Intervention would be effective in reducing hazardous alcohol consumption in students compared to an alcohol information leaflet. Participants ( n = 125) assessed as higher risk drinkers using the Alcohol Use Disorders Identification Test Consumption were randomly assigned to receive an Alcohol Brief Intervention ( n = 67) or an information leaflet ( n = 58), with 82 (66%) completing a follow-up assessment. Alcohol consumption ( F(1, 80) = 14.52, p < 0.001) and the Alcohol Use Disorders Identification Test Consumption scores ( F(1, 80) = 23.63, p < 0.001) significantly decreased in both groups post-intervention; however, the groups did not significantly differ. Further research is recommended.