Exploring the perspectives of healthcare professionals on providing supported asthma self-management for Bangladeshi and Pakistani people in the UK.

BACKGROUND: Self-management support improves asthma outcomes and is widely recommended in guidelines, yet it is poorly implemented in routine practice. There may be additional challenges in the context of ethnic minority groups, where making sense of culture may be necessary. This study aimed to explore the perspectives of healthcare professionals on supporting UK Bangladeshi and Pakistani patients to self-manage their asthma. METHODS: One-to-one semi-structured interviews with professionals (primary and secondary care; medical and nursing) who routinely provide asthma care to Bangladeshi or Pakistani patients. Topics addressed included perceptions of professionals in supporting patients with asthma self-management and ideas for improving culturally competent care. Data were analysed thematically. RESULTS: Nine professionals, from a range of ethnic backgrounds, with considerable experience of treating patients from these communities were interviewed. Despite organisational restrictions (language and time/resources) and expressed gaps in cultural knowledge and training, all interviewees reported attempting to tailor support according to culture. They used their perception of the patient's culture (e.g., big families and family involvement), integrated with their perception of patients' ability to self-manage (e.g., degree of responsibility taken for asthma), to formulate theories about how to culturally adapt their approach to supported self-management, e.g., supporting barriers in understanding asthma. There was consensus that gaps in cultural knowledge of professionals needed to be addressed through training or information. Interventions recommended for patients included basic education, group meetings, and culturally relevant action plans. CONCLUSION: In the absence of formal training and constrained by organisational limitations, self-management support was adapted based on personal and professional perception of culture. These ideas were based on experience and formulated a chain of reasoning. Professionals recognised the limitations of this approach and potential to overgeneralise their perceptions of culture and adaptations of supported self-management. Interventions were desired and need to address professional training in cultural competence and the provision of culturally relevant materials.

A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.

Background: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Aim: Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation. Design: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Setting: Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone. Participants: Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Intervention: The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral. Main outcome measures: Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Results: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference £770.24, 95% confidence interval -£27.91 to £1568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants' lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive-behavioural approach intervention, but high-intensity cognitive-behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. Conclusions: The tailored cognitive-behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Trial registration: This trial is registered as ISRCTN59537391. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/146/02) and is published in full in Health Technology Assessment; Vol. 28, No. 1. See the NIHR Funding and Awards website for further award information.

People with long-standing lung problems, such as chronic obstructive pulmonary disease, often also have anxiety and depression, which further reduces their quality of life. Two existing treatments could help. Pulmonary rehabilitation (a programme of exercise and education) improves both the physical and mental health of people with chronic obstructive pulmonary disease. Cognitive­behavioural therapy (a talking therapy) may reduce anxiety and depression. The TANDEM [Tailored intervention for Anxiety and Depression Management in chronic obstructive pulmonary disease (COPD)] intervention linked these two treatments by providing talking therapy based on cognitive­behavioural therapy during the waiting time following referral for pulmonary rehabilitation. The TANDEM treatment was delivered by respiratory healthcare professionals (e.g. nurses or physiotherapists) trained to deliver the talking therapy in six to eight weekly sessions. The sessions were conducted in the participant's home (or another convenient location), with brief telephone support during the pulmonary rehabilitation. Of 423 participants recruited to the study, 242 participants received TANDEM talking therapy and 181 participants received usual care (including a referral to pulmonary rehabilitation). We measured mental health, quality of life, social life, attendance at pulmonary rehabilitation and healthcare use in both groups at 6 and 12 months. Forty-three carers joined the study and we assessed their mental well-being. We interviewed patients, carers and health professionals to find out their views and experience of the TANDEM treatment. We also examined whether or not the TANDEM treatment was good value for money. The TANDEM treatment did not improve the mental or the physical health of people with chronic obstructive pulmonary disease. In addition, the TANDEM treatment cost the NHS an extra £770 per patient, which was not good value for money. The TANDEM treatment was well received, and many participants told us how it had helped them. Heath-care professionals noted how participants did not just have chronic obstructive pulmonary disease, but were coping with many physical, mental and social problems. The TANDEM intervention was not effective and, therefore, other strategies will be needed to help people with chronic obstructive pulmonary disease and mental health problems live with their condition.

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.

Stakeholder views on the barriers and facilitators of psychosocial interventions to address reduction in aggressive challenging behaviour in adults with intellectual disabilities.

Background: Success of psychosocial interventions in reducing aggressive challenging behaviour is likely to be related not only to mechanistic aspects, but also to therapeutic and system factors. The study aims to examine the facilitators and barriers that influence whether psychosocial interventions for aggressive challenging behaviour in adults with intellectual disabilities lead to positive change. Methods: We conducted 42 semi-structured interviews with adults with intellectual disabilities and aggressive challenging behaviour, family/paid carers, and professionals engaged in or delivering a psychosocial intervention across the UK. Data were analysed thematically using a framework approach. Results: Stakeholders considered therapeutic and supportive relationships and personalised care as facilitating factors of psychosocial interventions to address aggressive challenging behaviour. The operational structure of community intellectual disability services and conflicting expectations of professionals and carers were the main contextual barriers that impeded the implementation of psychosocial interventions addressing aggressive challenging behaviour in adults with intellectual disabilities. Conclusions: Findings highlight the valued components that maximise positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions to reduce aggressive challenging behaviour in adults with intellectual disabilities.

The current study looked at what factors that lead to good outcomes from therapies that aim to reduce aggressive challenging behaviour in adults with learning disabilities. We also looked at the factors that may prevent positive change ( i.e., reduction in aggressive challenging behaviour). We interviewed 42 people including 14 adults with learning disabilities, 13 carers (6 family; 7 paid) and 13 professionals across the UK. All stakeholders agreed that supportive relationships between the person with a learning disability and their therapist, staff consistent, personalised therapy and involvement of the person with a learning disability and their carer(s) in care planning facilitate the reduction of aggressive challenging behaviour. On the other hand, differences in expectations between professionals and carers, personal reasons ( e.g. being the right timing for a person), and the way community learning disability services currently run may stop people from having the opportunity to take part in therapy are barriers to positive change such as reduction of aggressive challenging behaviour. The study findings highlight the valued components that maximise the positive change in adults with intellectual disabilities who display aggressive challenging behaviour. Several operational adjustments including referral criteria, roles of professionals and workforce issues need to be addressed in services to maximise the implementation of psychosocial interventions to reduce aggressive challenging behaviour in adults with intellectual disabilities.

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

Understanding interventions delivered in the emergency department targeting improved asthma outcomes beyond the emergency department: an integrative review.

OBJECTIVES: The emergency department (ED) represents a place and moment of opportunity to provide interventions to improve long-term asthma outcomes, but feasibility, effectiveness and mechanisms of impact are poorly understood. We aimed to review the existing literature on interventions that are delivered in the ED for adults and adolescents, targeting asthma outcomes beyond the ED, and to code the interventions according to theory used, and to understand the barriers and facilitators to their implementation. METHODS: We systematically searched seven electronic databases and research registers, and manually searched reference lists of included studies and relevant reviews. Both quantitative and qualitative studies that reported on interventions delivered in the ED which aimed to improve asthma outcomes beyond management of the acute exacerbation, for adolescents or adults were included. Methodological quality was assessed using the Mixed Methods Appraisal Tool and informed study interpretation. Theory was coded using the Theoretical Domains Framework. Findings were summarised by narrative synthesis. RESULTS: 12 articles were included, representing 10 unique interventions, including educational and medication-based changes (6 randomised controlled trials and 4 non-randomised studies). Six trials reported statistically significant improvements in one or more outcome measures relating to long-term asthma control, including unscheduled healthcare, asthma control, asthma knowledge or quality of life. We identified limited use of theory in the intervention designs with only one intervention explicitly underpinned by theory. There was little reporting on facilitators or barriers, although brief interventions appeared more feasible. CONCLUSION: The results of this review suggest that ED-based asthma interventions may be capable of improving long-term outcomes. However, there was significant variation in the range of interventions, reported outcomes and duration of follow-up. Future interventions would benefit from using behaviour change theory, such as constructs from the Theoretical Domains Framework. PROSPERO REGISTRATION NUMBER: CRD 42020223058.

Complex interventions for aggressive challenging behaviour in adults with intellectual disability: A rapid realist review informed by multiple populations.

OBJECTIVES: Approximately 10% of people with intellectual disability display aggressive challenging behaviour, usually due to unmet needs. There are a variety of interventions available, yet a scarcity of understanding about what mechanisms contribute to successful interventions. We explored how complex interventions for aggressive challenging behaviour work in practice and what works for whom by developing programme theories through contexts-mechanism-outcome configurations. METHODS: This review followed modified rapid realist review methodology and RAMESES-II standards. Eligible papers reported on a range of population groups (intellectual disability, mental health, dementia, young people and adults) and settings (community and inpatient) to broaden the scope and available data for review. RESULTS: Five databases and grey literature were searched and a total of 59 studies were included. We developed three overarching domains comprising of 11 contexts-mechanism-outcome configurations; 1. Working with the person displaying aggressive challenging behaviour, 2. Relationships and team focused approaches and 3. Sustaining and embedding facilitating factors at team and systems levels. Mechanisms underlying the successful application of interventions included improving understanding, addressing unmet need, developing positive skills, enhancing carer compassion, and boosting staff self-efficacy and motivation. CONCLUSION: The review emphasises how interventions for aggressive challenging behaviour should be personalised and tailored to suit individual needs. Effective communication and trusting relationships between service users, carers, professionals, and within staff teams is essential to facilitate effective intervention delivery. Carer inclusion and service level buy-in supports the attainment of desired outcomes. Implications for policy, clinical practice and future directions are discussed. PROSPERO REGISTRATION NUMBER: CRD42020203055.

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.

Generational perspective on asthma self-management in the Bangladeshi and Pakistani community in the United Kingdom: A qualitative study.

BACKGROUND: Self-management strategies improve asthma outcomes, although interventions for South Asian populations have been less effective than in White populations. Both self-management and culture are dynamic, and factors such as acculturation and generation have not always been adequately reflected in existing cultural interventions. We aimed to explore the perspectives of Bangladeshi and Pakistani people in the United Kingdom, across multiple generations (first, second and third/fourth), on how they self-manage their asthma, with a view to suggesting recommendations for cultural interventions. METHODS: We purposively recruited Bangladeshi and Pakistani participants, with an active diagnosis of asthma from healthcare settings. Semi-structured interviews in the participants' choice of language (English, Sylheti, Standard Bengali or Urdu) were conducted, and data were analysed thematically. RESULTS: Twenty-seven participants (13 Bangladeshi and 14 Pakistani) were interviewed. There were generational differences in self-management, influenced by complex cultural processes experienced by South Asians as part of being an ethnic minority group. Individuals from the first generation used self-management strategies congruent to traditional beliefs such as 'sweating' and often chose to travel to South Asian countries. Generations born and raised in the United Kingdom learnt and experimented with self-management based on their fused identities and modified their approach depending on whether they were in familial or peer settings. Acculturative stress, which was typically higher in first generations who had migration-related stressors, influenced the priority given to asthma self-management throughout generations. The amount and type of available asthma information as well as social discussions within the community and with healthcare professionals also shaped asthma self-management. CONCLUSIONS: Recognizing cultural diversity and its influence of asthma self-management can help develop effective interventions tailored to the lives of South Asian people. PATIENT OR PUBLIC CONTRIBUTION: Patient and Public Involvement colleagues were consulted throughout to ensure that the study and its materials were fit for purpose.

STOP- a training intervention to optimise treatment for smoking cessation in community pharmacies: cluster randomised controlled trial.

BACKGROUND: Community pharmacies serve people with high levels of tobacco-related illness, but throughput in NHS Stop Smoking Services in pharmacies remains relatively low. We investigated the effectiveness of a complex intervention to increase service uptake and retention. METHODS: We randomised 60 pharmacies in England and Wales to the STOP intervention or usual practice in a pragmatic, parallel-group, controlled trial over 11 months. Smokers were blind to the allocation. The intervention was theory-based consultation skills training for pharmacy staff with environmental prompts (badges, calendars and behavioural cues). The primary outcome was the number of smokers attending an initial consultation and setting a quit date. RESULTS: The intervention made no significant difference in setting a quit date, retention or quit rate. A total of 631 adult smokers (service users) enrolled and set a quit date in intervention pharmacies compared to 641 in usual practice pharmacies, a rate ratio of 0.75 (95% CI 0.46 to 1.23) adjusted for site and number of prescriptions. A total of 432 (68%) service users were retained at 4 weeks in intervention and 500 (78%) in usual practice pharmacies (odds ratio 0.80, 0.41 to 1.55). A total of 265 (42%) service users quit smoking at 4 weeks in intervention and 276 (43%) in usual practice pharmacies (0.96, 0.65 to 1.43). The pharmacy staff were positive about the intervention with 90% (56/62) stating that it had improved their skills. Sixty-eight per cent would strongly recommend the training to others although there was no difference in self-efficacy for service delivery between arms. Seventy of 131 (53%) service users did not complete the 6-month follow-up assessment. However, 55/61 (90%) service users who completed follow-up were satisfied or very satisfied with the service. All usual practice arm service users (n = 33) and all but one in the intervention arm (n = 27) would recommend the service to smokers. CONCLUSIONS: We found high levels of retention and acceptable quit rates in the NHS pharmacy stop smoking service. Despite pharmacy staff providing positive feedback on the STOP intervention, it made no difference to service throughput. Thus, other factors may currently limit service capacity to help smokers to quit. TRIAL REGISTRATION: ISRCTN, ISRCTN16351033 . Retrospectively registered.

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.

School-based self-management intervention using theatre to improve asthma control in adolescents: a pilot cluster-randomised controlled trial.

BACKGROUND: Children with poorly controlled asthma have higher rates of unplanned healthcare use and school absences, as well as lower rates of medication adherence and knowledge. They also feel less comfortable using their medication at school, due to social fears and bullying. In this study, this was addressed through two school-based self-management interventions piloted to determine which one to use in a full trial. METHODS: We sought to assess the feasibility and acceptability of two school-based self-management intervention aimed at improving asthma control. Schools in London were randomised to (i) a theatre workshop for the whole year group aimed at raising awareness of asthma in schools, followed by self-management workshops for children (full intervention), (ii) theatre workshop alone (theatre only), or (iii) usual care (controls). Opt-out consent was obtained from parents. The study was a cluster randomised pilot trial, using London schools as the unit of allocation. Our primary aim was to assess the feasibility of delivering a self-management intervention in schools aimed at improving the asthma control test (ACT) score at 6 months. Secondary outcomes included acceptability of the school-based interventions, suitability of the theatre intervention and the full intervention with the self-management workshops, and generation of randomised data to inform future power calculations. Data were analysed by generalised mixed-effect models. RESULTS: The recruitment strategy for this trial was effective. Five schools were randomised to full intervention (189 children), four to theatre only (103 children), and six to controls (83 children). Asthma control test (ACT) score at baseline and 6 months was obtained from 178/358 participating children. Compared with the controls, there were no large differences found in ACT score with the full intervention; knowledge and perception of asthma improved though. GP and hospital visits increased in the full intervention group. Compared with controls, ACT score was unchanged in the theatre only group. CONCLUSION: The asthma self-management intervention trial in schools is feasible and acceptable. The full intervention consisting of both theatre and self-management workshop for asthmatics tended to be better suited to improve outcomes than the theatre intervention on its own. This full intervention should be the one carried forward into a main trial if funding for further research was sought. Further work is needed to understand why there was evidence that unscheduled visits to healthcare professionals increased with the full intervention. TRIAL REGISTRATION: The study was registered on the clinical trials database on 14th May 2018 (ID NCT03536416 ).

The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD).

BACKGROUND: TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. METHODS: We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. CONCLUSION: Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial).

Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.

Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD).

BACKGROUND: Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process. METHODS: Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here. RESULTS: Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation. CONCLUSIONS: The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial.

BACKGROUND: Twice-weekly supervised aerobic and resistance exercise for 12 weeks reduces fatigue and improves quality of life in men on Androgen Deprivation Therapy for prostate cancer. Despite the National Institute for Health and Care Excellence (NICE) proposing this as standard of care, it does not routinely take place in practice. Healthcare professionals are in a prime position to deliver and integrate these recommendations. A change in the behaviour of clinical teams is therefore required. In this paper, we describe the development of a training package for healthcare professionals using theory and evidence to promote delivery of such recommendations as standard care. METHODS: The intervention development process was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. Target behaviours were identified from the literature and thirty-five prostate cancer care healthcare professionals (including oncologists, consultant urologists, clinical nurse specialists, physiotherapists, general practitioners and commissioners) were interviewed to understand influences on these behaviours. The Theoretical Domains Framework was used to identify theoretical constructs for change. Behaviour change techniques were selected based on theory and evidence and were translated into intervention content. The intervention was refined with the input of stakeholders including healthcare professionals, patients, and exercise professionals in the form of rehearsal deliveries, focus groups and a workshop. RESULTS: Seven modifiable healthcare professional target behaviours were identified to support the delivery of the NICE recommendations including identifying eligible patients suitable for exercise, recommending exercise, providing information, exercise referral, providing support and interpret and feedback on progress. Ten domains from the Theoretical Domain's Framework were identified as necessary for change, including improving knowledge and skills, addressing beliefs about consequences, and targeting social influences. These were targeted through twenty-two behaviour change techniques delivered in a half-day, interactive training package. Based on initial feedback from stakeholders, the intervention was refined in preparation for evaluation. CONCLUSIONS: We designed an intervention based on theory, evidence, and stakeholder feedback to promote and support the delivery of NICE recommendations. Future work will aim to test this training package in a multi-centre randomised trial. If proven effective, the development and training package will provide a template for replication in other clinical populations, where exercise has proven efficacy but is insufficiently implemented.

Towards implementing exercise into the prostate cancer care pathway: development of a theory and evidence-based intervention to train community-based exercise professionals to support change in patient exercise behaviour (The STAMINA trial).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommend that men on androgen deprivation therapy (ADT) for prostate cancer should receive supervised exercise to manage the side-effects of treatment. However, these recommendations are rarely implemented into practice. Community-based exercise professionals (CBEPs) represent an important target group to deliver the recommendations nationally, yet their standard training does not address the core competencies required to work with clinical populations, highlighting a need for further professional training. This paper describes the development of a training package to support CBEPs to deliver NICE recommendations. METHODS: Development of the intervention was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. In step one, target behaviours, together with their barriers and facilitators were identified from a literature review and focus groups with CBEPs (n = 22) and men on androgen deprivation therapy (n = 26). Focus group outputs were mapped onto the Theoretical Domains Framework (TDF) to identify theoretical constructs for change. In step two, behaviour change techniques and their mode of delivery were selected based on psychological theories and evidence to inform intervention content. In step three, the intervention was refined following delivery and subsequent feedback from intervention recipients and stakeholders. RESULTS: Six modifiable CBEPs target behaviours were identified to support the delivery of the NICE recommendations. Nine domains of the TDF were identified as key determinants of change, including: improving knowledge and skills and changing beliefs about consequences. To target the domains, we included 20 BCTs across 8 training modules and took a blended learning approach to accommodate different learning styles and preferences. Following test delivery to 11 CBEPs and feedback from 28 stakeholders, the training package was refined. CONCLUSION: Established intervention development approaches provided a structured and transparent guide to intervention development. A training package for CBEPs was developed and should increase trust amongst patients and health care professionals when implementing exercise into prostate cancer care. Furthermore, if proven effective, the development and approach taken may provide a blueprint for replication in other clinical populations where exercise has proven efficacy but is insufficiently implemented.