Medical Research Council Framework Research Articles

Shared decision making for patients with kidney failure to improve end-of-life care: Development of the DESIRE intervention.

To describe the development of a shared decision making intervention for planning end-of-life care for patients with kidney failure, their relatives and health professionals in kidney services. End-of-life care conversations within standard disease management consultations are challenging for patients with kidney failure, their relatives and health professionals. End-of-life care planning is about making difficult decisions in advance, which is why health professionals need shared decision making skills to be able to initiate end-of-life conversations. Health professionals report needing more skills to raise the issue of end-of-life care options within consultations and patients want to be able to discuss issues important to them about future care plans. The development design was guided by the UK Medical Research Council's framework and a user-centred approach was applied. Four workshops were conducted with end users. The Template for Intervention Description and Replication for Population Health and Policy interventions was used to shape which questions needed to be answered through the workshops and to present the intervention. The International Patient Decision Aid Standards (IPDAS) criteria set the standards to be achieved. Areas considered significant to a shared decision making intervention were training of health professionals, conversations about end-of-life care, planning and evaluation of the decisions, reporting decisions in health records and repetition of consultation. The development process went through 14 iterations. An intervention named DESIRE was developed that comprises: (1) a training programme for health professionals; (2) shared decision making conversations; and (3) a patient decision aid. The intervention met 30 out of 33 IPDAS criteria. DESIRE is intended to support shared decision making about planning end-of-life care among patients with kidney failure, their relatives and health professionals. The study provides important tools for the stakeholders engaged that can be used within different models of care. What problem did the study address? International guidelines recommend health professionals involve patients with kidney failure in making decisions about end-of-life care, but there is variation in how this is implemented within and across kidney services. Furthermore, patients, relatives and health professionals find it challenging to initiate conversations about end-of-life care. What were the main findings? The study resulted in the development of a complex intervention, called DESIRE, about shared decision making and planning end-of-life care for patients with kidney failure, their relatives and health professionals in kidney services, including a training programme for health professionals, shared decision making conversations and a patient decision aid. Where and on whom will the research have an impact? The research contributes a shared decision making intervention to patients in the later stage of kidney failure, their relatives and health professionals. We believe that the DESIRE intervention could be introduced during consultations with health professionals at an earlier stage of the patient's illness trajectory, as well as being applied to other chronic diseases. This intervention development research is reported according to the GUIDance for the rEporting of intervention Development (GUIDED) checklist and the DEVELOPTOOLS Reporting Checklist. Patients, relatives and health professionals have been involved throughout the research process as part of the research team and advisory board. For this study, the advisory board has particularly contributed to the development process of the DESIRE intervention by actively participating in the four workshops, in the iterations between the workshops and in the preparation of the manuscript.

Developing a multidisciplinary medication review and deprescribing intervention in primary care for older people living with frailty

Abstract Introduction Reducing overprescribing in primary care through targeted structured medication reviews (SMRs) is a national priority. Shared decision-making and a multidisciplinary team (MDT) approach to SMR are recommended for successful deprescribing (stop/reduce inappropriate medications) among older people, specifically those with frailty. Aim To develop a multidisciplinary medication review and deprescribing intervention in primary care for older people with frailty. Methods The intervention development involved two stages and was informed by the Medical Research Council framework for complex intervention. Stage one involved intervention planning and included: 1) a realist review of 28 articles that identified 35 context-mechanism-outcome (CMO) configurations for successful MDT medication review and deprescribing in primary care[1] and 2) a qualitative study with 26 primary care healthcare professionals (HCPs) including GPs, pharmacists, and advanced clinical practitioners, and 13 older people with polypharmacy and their informal carers recruited from two general practices within Wessex. Using the person-based approach, drawing on the COM-B model for behaviour change, and a normalisation process theory lens, the findings of these two studies informed the development of intervention’s guiding principles. Stage two involved intervention development based on six co-design online workshops with key stakeholders (n=25), including primary care HCPs recruited from across the South region, patient and carer representatives, and the research management team. The intervention guiding principles were presented in these workshops and possible intervention content, format and delivery were proposed, discussed and refined through an iterative process. Workshop data were analysed drawing on a rapid analysis method and a final version of the intervention was agreed. Results The final version of the complex intervention consisted of five main components based on findings from stages one and two: 1) Proactive identification of patients with frailty and polypharmacy for targeted SMR using the electronic frailty index embedded in primary care health systems and the UK national polypharmacy prescribing comparators, 2) HCPs preparation to conduct SMR through targeted education on deprescribing and identifying and prioritising high-risk medications for deprescribing using evidence-based deprescribing tool(s), 3) Preparing and educating patients and carers about the purpose of SMR and reasons for potentially stopping or changing medications (patient leaflet sent prior to SMR), 4) Conducting a person-centred SMR that includes in-person, phone or virtual appointments tailored to patient and carer needs and preferences, involving other MDT members based on their expertise, documenting and sharing any agreed changes with patients and other staff members, and 5) Tailored follow-up plans that allow continuity of care and management and include highlighting specific signs and symptoms for patients and carers to monitor following medication changes, and arranging further contact through text, phone or in-person follow-up appointment. Conclusion The use of multiple research methods has led to the development of a complex MDT medication review and deprescribing intervention for older people with frailty and drawing on behaviour and implementation theories could potentially maximise the intervention’s feasibility, acceptability and successful implementation. A mixed-method study in primary care is currently underway to test the feasibility and acceptability of intervention implementation, in preparation for a full trial.

AIIMS ICU Rehabilitation (AIR): development and description of intervention for home rehabilitation of chronically ill tracheostomized patients

Background The paucity of state-supported rehabilitation for chronically ill patients with long-term tracheostomies has ramifications of prolonged hospital-stay, increased burden on acute-care resources, and nosocomial infections. Few interventions describe home rehabilitation of adult tracheostomized patients. Almost none involve stakeholders. This paper describes the All-India Institute of Medical Sciences (AIIMS) ICU rehabilitation (AIR) healthcare intervention developed to facilitate home rehabilitation of chronically ill tracheostomized patients. Methods The AIR intervention development was based on the experience-based codesign theory (EBCD). A core research-committee studied prevalent knowledge and gaps in the area. Patients-carer and health-care stakeholders’ experiences of barriers and facilitators to home care resulted in an intervention with interlinked components: family-carer training, equipment bank, m-health application, and follow-up, guided by the Medical Research Council (MRC) framework. Healthcare stakeholders (doctors, nurses, medical equipment vendors) and patient-carer dyads were engaged to gather experiences at various stages to form smaller codesign teams for each component. Multiple codesign meetings iteratively allowed refinement of the intervention over one year. The Template for Intervention Description and Replication (TIDieR) checklist was used to report the AIR intervention. Results The first component comprised a minimum of three bedside hands-on training sessions for carers relating to tracheostomy suction, catheter care, monitoring oxygenation, enteral feeding, skincare, and physiotherapy, buttressed by pictorial-books and videos embedded in a mobile-application. The second was an equipment-bank involving a rental-retrieval model. The third component was a novel m-health tool for two-way communication with the core group and community of other patient-carers in the project for follow-up and troubleshooting. Home visits on days 7 and 21 post-discharge assessed patient hygiene, nutrition, physiotherapy, and established contact with the nearest primary healthcare facility for the future. Conclusions Findings support the EBCD-based development using active feedback from stakeholders. Assessment of feasibility, process and effectiveness evaluation will follow.

Promoting meaningful activities by occupational therapy in elderly care in Belgium: the ProMOTE intervention

BackgroundOlder people want to age in place. Despite advancing functional limitations and their desire of aging in place, they are not always faithful to therapy that maintains independence and promotes safety. Occupational therapists can facilitate aging in place. Occupational therapy is defined as the therapeutic use of everyday life occupations with persons, groups, or populations for the purpose of enhancing or enabling participation.AimTo describe the content a high-adherence-to-therapy and evidence-based occupational therapy intervention to optimize functional performance and social participation of home-based physically frail older adults and wellbeing of their informal caregiver, and the research activities undertaken to design this intervention.MethodsA roadmap was created to develop the occupational therapy intervention. This roadmap is based on the Medical Research Council (MRC) framework and is supplemented with elements of the Intervention Mapping approach. The TIDieR checklist is applied to describe the intervention in detail. A systematic review and two qualitative studies substantiated the content of the intervention scientifically.ResultsThe application of the first two phases of the MRC framework resulted in the ProMOTE intervention (Promoting Meaningful activities by Occupational Therapy in Elderly). The ProMOTE intervention is a high-adherence-to-therapy occupational therapy intervention that consists of six steps and describes in detail the evidence-based components that are required to obtain an operational intervention for occupational therapy practice.ConclusionThis study transparently reflects on the process of a high-quality occupational therapy intervention to optimize the functional performance and social participation of the home-based physically frail older adult and describes the ProMOTE intervention in detail. The ProMOTE intervention contributes to safely aging in place and to maintaining social participation. The designed intervention goes beyond a description of the ‘what’. The added value lies in the interweaving of the ‘why’ and ‘how’. By describing the ‘how’, our study makes the concept of ‘therapeutic use-of-self’ operational throughout the six steps of the occupational therapy intervention. A further rigorous study of the effect of the ProMOTE intervention on adherence, functional performance and social participation is recommended based to facilitate the implementation of this intervention on a national level in Belgium.

Using evidence-based co-design to develop a hybrid delivered exercise intervention that aims to increase confidence to exercise in people with haemophilia.

Due to advances in treatments, people with haemophilia (PWH) are living longer. They are not as active as the general population due to joint damage and lack confidence to be active due to concerns about further bleeds and pain. There is a need to facilitate healthy aging through promotion of physical activity (PA) and exercise. Changing patient beliefs and increasing physical literacy and confidence to move are thought to be key to helping PWH become more active. This paper describes the development of an exercise and behaviour change intervention to improve confidence to exercise in PWH. The 4-stage Medical Research Council framework for complex intervention development was used. Stakeholders included 17 PWH and 7 physiotherapists working in haemophilia. Seven online focus group meetings were held. The final intervention is a hybrid 12-week physiotherapist led progressive exercise programme. Classes are 45 min including Pilates, High intensity interval training and balance elements, together with discussion sessions focusing on PA recommendations, the types and benefits of different exercise styles and the effects of PA, together with the effects of aging for PWH. The COM-B model of behaviour change was used to develop the intervention. Co-design helps to produce an intervention that understands the stakeholders needs. Through this process the intervention developed to incorporate not only increasing PA but also confidence to exercise. The use of behaviour change theory identified the behaviour techniques included in the intervention and aims to increase physical literacy in this population.

Nurse-led family-based approach in primary health care for patients with type 2 diabetes mellitus: a qualitative study

ABSTRACT Purpose The prevalence of Type 2 diabetes is rapidly increasing, with 537 million people estimated to have diabetes in 2021. The literature suggests that nurses can deliver effective person-centred diabetes care and that families can be essential in supporting patients. Thus, a Nurse-led Family-based (NLFB) approach may be particularly effective. This study aims to explore the perceptions of nurses, adults with type 2 diabetes, and family members regarding the NLFB intervention. Methods Guided by the UK Medical Research Council Framework, this seminal study adopted a qualitative, descriptive approach with content analysis. Data were obtained through 16 semi-structured, in-depth interviews. Themes emerged based on an inductive process using constant comparison (Graneheim and Lundman 2004). The COREQ checklist was used in ensuring rigour. Results Three main themes emerged includes: (1) nurses’ experiences with current diabetes care practices, (2) stakeholders’ views on the development of a NLFB approach, and (3) merging the nurse-led family aspects into the diabetes care. The key challenges are the dominant medical model, lack of specialist nurses, and time. The key facilitators are knowledge and social support. Conclusion The study recommends stakeholders embrace nursing empowerment strategies and involve families to enhance the nurses’ advanced roles and family inclusion in healthcare.

Medical assistance in dying for mental illness: a complex intervention requiring a correspondingly complex evaluation approach.

Medical assistance in dying for mental illness as a sole underlying medical condition (MAiD MI-SUMC) is a controversial and complex policy in terms of psychosocial and ethical medical practice implications. We discuss the status of MAiD MI-SUMC in Canada and argue for the use of the UK Medical Research Council's framework on complex interventions in programme evaluations of MAiD MI-SUMC. It is imperative to carefully and rigorously evaluate the implementation of MAiD MI-SUMC to ensure an understanding of the multiple facets of implementation in contexts permeated by unique social, economic, cultural and historical influences, with a correspondingly diverse array of outcomes. This requires a complexity-informed programme evaluation focused on context-dependent mechanisms and stakeholder experiences, including patients, service providers and other people affected by the policy. It is also important to consider the economic impact on health and social welfare systems. Such evaluations can provide the data needed to guide evidence-informed decision-making that can contribute to safer implementation and refinement of MAiD MI-SUMC.

The development of a novel sexual health promotion intervention for young people with mental ill-health: the PROSPEct project

BackgroundYoung people with mental ill-health experience higher rates of high-risk sexual behaviour, have poorer sexual health outcomes, and lower satisfaction with their sexual wellbeing compared to their peers. Ensuring good sexual health in this cohort is a public health concern, but best practice intervention in the area remains under-researched. This study aimed to co-design a novel intervention to address the sexual health needs of young people with mental ill-health to test its effectiveness in a future trial undertaken in youth mental health services in Melbourne, Australia.MethodsWe followed the 2022 Medical Research Council (MRC) guidelines for developing and evaluating complex interventions. This involved synthesising evidence from the ‘top down’ (published evidence) and ‘bottom up’ (stakeholder views). We combined systematic review findings with data elicited from qualitative interviews and focus groups with young people, carers, and clinicians and identified critical cultural issues to inform the development of our intervention.ResultsExisting evidence in the field of sexual health in youth mental health was limited but suggested the need to address sexual wellbeing as a concept broader than an absence of negative health outcomes. The Information-Motivation-Belief (IMB) model was chosen as the theoretical Framework on which to base the intervention. Interviews/focus groups were conducted with 29 stakeholders (18 clinicians, three carers, and eight young people). Synthesis of the evidence gathered resulted in the co-design of a novel intervention consisting of an initial consultation and four 60-90-minute sessions delivered individually by a young ‘sex-positive’ clinician with additional training in sexual health. Barriers and supports to intervention success were also identified.ConclusionsUsing the MRC Framework has guided the co-design of a potentially promising intervention that addresses the sexual health needs of young people with mental ill-health. The next step is to test the intervention in a one-arm feasibility trial.

Developing interventions to improve detection of depression in primary healthcare settings in rural Ethiopia.

The poor detection of depression in primary healthcare (PHC) in low- and middle-income countries continues to threaten the plan to scale up mental healthcare coverage. To describe the process followed to develop an intervention package to improve detection of depression in PHC settings in rural Ethiopia. The study was conducted in Sodo, a rural district in south Ethiopia. The Medical Research Council's framework for the development of complex interventions was followed. Qualitative interviews, observations of provider-patient communication, intervention development workshops and pre-testing of the screening component of the intervention were conducted to develop the intervention. A multicomponent intervention package was developed, which included (a) manual-based training of PHC workers for 10 days, adapted from the World Health Organization's Mental Health Gap Action Programme Intervention Guide, with emphasis on depression, locally identified depressive symptoms, communication skills, training by people with lived experience and active learning methods; (b) screening for culturally salient manifestations of depression, using a four-item tool; (c) raising awareness among people attending out-patient clinics about depression, using information leaflets and health education; and (d) system-level interventions, such as supportive supervision, use of posters at health facilities and a decision support mobile app. This contextualised, multicomponent intervention package may lead to meaningful impact on the detection of depression in PHC in rural Ethiopia and similar settings. The intervention will be pilot tested for feasibility, acceptability and effectiveness before its wider implementation.

Development of a digital intervention for psychedelic preparation (DIPP)

Psychedelic substances induce profound alterations in consciousness. Careful preparation is therefore essential to limit adverse reactions, enhance therapeutic benefits, and maintain user safety. This paper describes the development of a self-directed, digital intervention for psychedelic preparation. Drawing on elements from the UK Medical Research Council (MRC) framework for developing complex interventions, the design was informed by a four-factor model of psychedelic preparedness, using a person-centred approach. Our mixed-methods investigation consisted of two studies. The first involved interviews with 19 participants who had previously attended a ‘high-dose’ psilocybin retreat, systematically exploring their preparation behaviours and perspectives on the proposed intervention. The second study engaged 28 attendees of an ongoing psilocybin retreat in co-design workshops, refining the intervention protocol using insights from the initial interviews. The outcome is a co-produced 21-day digital course (Digital Intervention for Psychedelic Preparation (DIPP)), that is organised into four modules: Knowledge–Expectation, Psychophysical–Readiness, Safety–Planning, and Intention–Preparation. Fundamental components of the course include daily meditation practice, supplementary exercises tied to the weekly modules, and mood tracking. DIPP provides a comprehensive and scalable solution to enhance psychedelic preparedness, aligning with the broader shift towards digital mental health interventions.

Experiential training course on spirituality for multidisciplinary palliative care teams in a hospital setting: a feasibility study

BackgroundThere is widespread agreement about the importance of spiritual training programs (STPs) for healthcare professionals caring for cancer patients, and that reflecting on one’s spirituality is the first step. Health professionals (HPs) working in hospitals must develop this dimension to guarantee the quality of life as well as spiritual and emotional support. In this paper, we propose a possible training format for hospital professionals and assess its implementation.MethodsThis is a phase 0-I study that follows the Medical Research Council (MRC) framework. The program was implemented for hospital palliative care specialists. The program included one theory lesson, three spiritual interactions, four pieces of reflective writing, and two individual follow-up sessions for each participant. The evaluation was performed quantitatively according to the MRC framework and qualitatively according to Moore’s framework with data triangulation from interviews, reflective writings, and indicators.ResultsThe program was implemented for palliative care physicians, nurses, psychologists, and bioethicists according to the plan, and the program components were highly appreciated by the participants. The results suggest the feasibility of a training course with some corrections, regarding both the components of the training and organizational issues. The qualitative analysis confirmed a shift in the meaning of the themes we identified. The trainees went from intrapersonal spirituality to interpersonal spirituality (engagement with the other person’s spirituality, acknowledging their unique spiritual and cultural worldviews, beliefs, and practices), with colleagues, patients, and people close to them. The training had an impact on Moore’s Level 3b.ConclusionsSpiritual training for hospital professionals working in palliative care is feasible. Having time dedicated to spirituality and the ongoing mentorship of spiritual care professionals were suggested as key elements. The next step is increasing awareness of spirituality from our hospital reality and creating a stable competent group (with nurses, chaplains, nuns, counselors, etc.) with the support of the management.

Monthly engagement with EIP keyworkers was associated with a five-fold increase in the odds of engagement with psychosocial interventions.

Early intervention in psychosis (EIP) supports people who are experiencing their first episode of psychosis (FEP). A new Model of Care (MoC) for EIP services was launched in Ireland in 2019. Three EIP demonstration sites were chosen to test this MoC through a 'hub and spoke' approach. These services were a new way of organising care for people experiencing FEP, based upon a recovery model of care, and which sought to standardise care, improve access by clinically led multidisciplinary teams. This included newly created EIP keyworker roles whereby keyworkers assumed responsibilities regarding assessment, comprehensive individual care planning and coordination of care. A mixed methods design utilising the UK Medical Research Council's process evaluation framework. Purposive sampling techniques were utilised. Descriptive analyses and logistic regression were performed to examine how increased keyworker engagement influenced the use of other psychosocial interventions within the EIP demonstration sites. Thematic analyses was used for qualitative data. There was a strong positive relationship between keyworker contacts and psychosocial interventions offered. Specifically, the odds of achieving at least monthly engagement with cognitive behavioural therapy for psychosis (CBTp; (5.76 (2.43-13.64), p < 0.001), and behavioural family therapy (BFT; (5.52(1.63-18.69, p < 0.006)) increased by fivefold with each additional monthly keyworker contact. For individual placement support (IPS) each additional monthly keyworker contact was associated with a three-fold increase in the odds of achieving monthly attendance with IPS (3.73 (1.64-8.48), p < 0.002). Qualitative results found that the EIP keyworker role as viewed by both service users and staff as a valuable nodal point, with a particular emphasis on care coordination and effective communication. This study advances the understanding of keyworker effects through qualitative evidence of keyworkers functioning as a "linchpin" to the service, while the positive response association between keyworker contacts and engagement with other services provides quantitative support for keyworkers reducing the organisational or structural barriers to service access. Given the importance of these positions, health systems should ensure that EIP programmes identify qualified and experienced staff to fill these roles, as well as allocate the appropriate funding and protected time to support keyworker engagement and impact.

Development of a Multimodal, Physiotherapist-Led, Vocational Intervention for People with Inflammatory Arthritis and Reduced Work Ability: A Mixed-Methods Design Study.

Work ability of people with rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) is reduced, but underexamined as a clinical treatment target. The evidence on vocational interventions indicates that delivery by a single healthcare professional (HCP) may be beneficial. Physiotherapist (PT)-led interventions have potential because PTs are most commonly consulted by RA/axSpA patients in the Netherlands. The aim was to develop a PT-led, vocational intervention for people with RA/axSpA and reduced work ability. Mixed-methods design based on the Medical Research Council (MRC) framework for developing and evaluating complex interventions, combining a rapid literature review and six group meetings with: patient representatives (n = 6 and 10), PTs (n = 12), (occupational) HCPs (n = 9), researchers (n = 6) and a feasibility test in patients (n = 4) and PTs (n = 4). An intervention was developed and evaluated. Patient representatives emphasized the importance of PTs' expertise in rheumatic diseases and work ability. The potential for PTs to support patients was confirmed by PTs and HCPs. The feasibility test confirmed adequate feasibility and underlined necessity of training PTs in delivery. The final intervention comprised work-focussed modalities integrated into conventional PT treatment (10-21 sessions over 12 months), including a personalized work-roadmap to guide patients to other professionals, exercise therapy, patient education and optional modalities. A mixed-methods design with stakeholder involvement produced a PT-led, vocational intervention for people with RA/axSpA and reduced work ability, tested for feasibility and ready for effectiveness evaluation.

Examining the implementation of a community paediatric clinic in a socially disadvantaged Irish community: A retrospective process evaluation.

Understanding interventions and their implementation is essential for improving community initiatives. Kidscope is a community paediatric development clinic providing free health and developmental assessment and onward referral for children aged zero to six years in an urban area of southern Ireland where many children experience complex needs. Established in 2010, Kidscope developed an inter-disciplinary, multi-agency community team by drawing on the strengths of local services and practitioners to deliver holistic approaches to child health and development. Recent studies examining stakeholder engagement and Kidscope outcomes highlighted the need to examine implementation to better understand the processes and mechanisms of the clinic and how events have affected outcomes. Guided by the UK Medical Research Council Framework for Developing and Evaluating Complex Interventions, this study used a post-hoc qualitative process evaluation study design with multiple data sources; stakeholder perspectives (interviews, focus group, questionnaires) and document analysis (annual reports, meeting minutes, work plans). A diverse set of research questions were developed in conjunction with a Patient and Public Involvement Group. Guiding frameworks supported thematic analysis of primary data, document analysis of secondary data, and triangulation of findings across datasets. Data analysis yielded 17 themes and 18 sub-themes. Successful implementation hinged on developing a coalition of linked practitioners and services whose skills were utilised and enhanced within Kidscope to deliver a high-quality healthcare model to vulnerable children and families. Relational and multi-disciplinary working, innovative approaches to implementation and sustainability, training and education provision, and the accessible community location were among the mechanisms of change resulting in improved child, family, practitioner, and system-level outcomes. External factors such as COVID-19 and deficits in Ireland's disability services posed significant barriers to fidelity. This study provides evidence of the processes, mechanisms, and model of care employed by a community-based paediatric clinic to successfully engage society's most vulnerable families and promote health equity. This study makes an important contribution to the field of implementation research by offering an example of a robust approach to conceptualising and measuring implementation outcomes of community healthcare initiative in a changing, real-world context.

Co-designing a culturally-sensitive theory-driven advance care planning game with Chinese older adults and healthcare providers

Background: Advance care planning can be challenging because discussing end-of-life care often has negative connotations. Gamification is a novel approach to encourage advance care planning conversations in Western culture. Aim: To co-design a game with multiple stakeholders to promote advance care planning in Chinese communities. Design: A two-phase design guided by the Medical Research Council framework for developing complex interventions was adopted between May 2019 and August 2020. In phase I, a game prototype was developed based on literature review, expert consultation and end-user consultation. In Phase II, the game prototype was tested among end-users and refined according to their feedback and expertise of a multi-disciplinary team through an iterative process. Setting/participants: Experts in the field of aged care, palliative care, life education and game development and Chinese community-dwelling adults aged 60 years or older. Results: A board game called ‘The Five Tastes Found in a Grocery Store’ was developed. The game design was shaped by Bandura’s Self-efficacy theory and feedback from experts and end-users. The participants generally found the gaming experience enjoyable and appreciated the opportunity to discuss end-of-life care openly. Conclusions: This study is the first to develop an evidence-informed, theory-based, culturally sensitive game for promoting advance care planning in the Chinese community using a co-design approach.

The complex intervention day hospice — a quality-assured study on the implementation, realization, and benefits with model character for Germany (IMPULS) using the example of “Day hospice Adiuvantes”

BackgroundCurrently, a conclusive experience on the uniform implementation and benefits of day hospice structures and interventions is lacking in Germany. The following questions should be clarified: (1) Which structural conditions and interventional measures should be established in day hospices from the point of view of patients, relatives, and specialist staff?; (2) Are the planned structures or interventions feasible and implementable under real conditions and accepted by patients, relatives, and staff?; (3) How can a final implementation and intervention catalog for day hospices be designed?; (4) Is this final catalog of services feasible, reasonable, economical, and effective under everyday conditions in day hospices?MethodsWe planned to perform a multistage investigation, guided by the Medical Research Council Framework for the development and evaluation of complex interventions. In Stage 1, an initial theoretical construct on structures and interventions will be established through an extensive literature and guideline review on day hospices and through qualitative interviews. In a nominal group process, we will create a catalog of offers. In Stage 2, feasibility testing is conducted in a single-day hospice under real-life conditions using quantitative quality indicators and qualitative interviews. Structures and interventions can be adapted here if necessary. In a second nominal group process, a final structure and offer catalog is created, which is then implemented in Stage 3 in the day hospice under investigation and evaluated under real daily conditions through a process and effectiveness test. For this purpose, qualitative and quantitative quality indicators will be used and a comparative cohort of patients who are not cared for in the day hospice – but in the same network structure (oncology–palliative care network Lower Bavaria) – is examined.DiscussionFinally, the initial statements on the reasonable and realizable structures or interventions in day hospices and their benefits in daily real-life conditions as well as possible optimization processes shall be made.Trial registrationThe study was retrospectively registered in the German Clinical Trials Register (DRKS-ID DRKS00031613, registration date April 04, 2023) and the display portal of the Center for Clinical Trials of the University Hospital Regensburg (Z-2022-1734-6, registration date July 01, 2023).

Co-development and testing of an extended community pharmacy model of service delivery for managing osteoarthritis: protocol for a sequential, multi-methods study (PharmOA)

BackgroundOsteoarthritis is a common, painful and disabling long-term condition. Delivery of high-quality guideline-informed osteoarthritis care that successfully promotes and maintains supported self-management is imperative. However, osteoarthritis care remains inconsistent, including under use of core non-pharmacological approaches of education, exercise and weight loss.Community pharmacies are an accessible healthcare provider. United Kingdom government initiatives are promoting their involvement in a range of long-term conditions, including musculoskeletal conditions. It is not known what an enhanced community pharmacy role for osteoarthritis care should include, what support is needed to deliver such a role, and whether it would be feasible and acceptable to community pharmacy teams. In this (PharmOA) study, we aim to address these gaps, and co-design and test an evidence-based extended community pharmacy model of service delivery for managing osteoarthritis.MethodsInformed by the Theoretical Domains Framework, Normalisation Process Theory, and the Medical Research Council (MRC) framework for developing complex interventions, we will undertake a multi-methods study involving five phases:1. Systematic review to summarise currently available evidence on community pharmacy roles in supporting adults with osteoarthritis and other chronic (non-cancer) pain.2. Cross-sectional surveys and one-to-one qualitative interviews with patients, healthcare professionals and pharmacy staff to explore experiences of current, and potential extended community pharmacy roles, in delivering osteoarthritis care.3. Stakeholder co-design to: a) agree on the extended role of community pharmacies in osteoarthritis care; b) develop a model of osteoarthritis care within which the extended roles could be delivered (PharmOA model of service delivery); and c) refine existing tools to support community pharmacies to deliver extended osteoarthritis care roles (PharmOA tools).4. Feasibility study to explore the acceptability and feasibility of the PharmOA model of service delivery and PharmOA tools to community pharmacy teams.5. Final stakeholder workshop to: a) finalise the PharmOA model of service delivery and PharmOA tools, and b) if applicable, prioritise recommendations for its wider future implementation.DiscussionThis novel study paves the way to improving access to and availability of high-quality guideline-informed, consistent care for people with osteoarthritis from within community pharmacies.

Application of behavioural theories, models, and frameworks in pharmacy practice research based on published evidence: a scoping review.

Pharmacy practice research often focuses on the design, implementation and evaluation of pharmacy services and interventions. The use of behavioural theory in intervention research allows understanding of interventions' mechanisms of action and are more likely to result in effective and sustained interventions. To collate, summarise and categorise the reported behavioural frameworks, models and theories used in pharmacy practice research. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and EBSCO (CINAHL PLUS, British Education index, ERIC) were systematically searched to capture all pharmacy practice articles that had reported the use of behavioural frameworks, theories, or models since inception of the database. Results were filtered to include articles published in English in pharmacy practice journals. Full-text screening and data extraction were independently performed by two reviewers. A narrative synthesis of the data was adopted. Studies were reviewed for alignment to the UK Medical Research Council (MRC) framework to identify in which phase(s) of the research that the theory/model/framework had been employed. Fifty articles met the inclusion criteria; a trend indicating an increasing frequency of behavioural theory/frameworks/models within pharmacy practice research was identified; the most frequently reported were Theory of Planned Behaviour and Theoretical Domains Framework. Few studies provided explicit and comprehensive justification for adopting a specific theory/model/framework and description of how it underpinned the research was lacking. The majority were investigations exploring determinants of behaviours, or facilitators and barriers to implementing or delivering a wide range of pharmacy services and initiatives within a variety of clinical settings (aligned to Phase 1 UK MRC framework). This review serves as a useful resource for future researchers to inform their investigations. Greater emphasis to adopt a systematic approach in the reporting of the use of behavioural theories/models/frameworks will benefit pharmacy practice research and will support researchers in utilizing behavioural theories/models/framework in aspects of pharmacy practice research beyond intervention development.

Development of a Multimodal, Personalized Intervention of Virtual Reality Integrated Within Physiotherapy for Patients With Complex Chronic Low-Back Pain.

Chronic low-back pain (CLBP) is the leading cause of years lived with disability. Physiotherapy is the most common treatment option for CLBP, but effects are often unsatisfactory. Virtual reality (VR) offers possibilities to enhance the effectiveness of physiotherapy treatment. Primary aim was to develop and test a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP. This study describes an intervention development process using mixed methods design that followed the Medical Research Council (MRC) framework. This involved a cocreation process with patients, physiotherapists, and researchers. A draft intervention was constructed based on a literature review and focus groups, and subsequently tested in a feasibility study and evaluated in focus groups. Focus group data were analyzed using thematic analysis. This intervention development process resulted in a final intervention. Focus group data showed that VR and physiotherapy can strengthen each other when they are well integrated, and that VR needs to be administered under the right conditions including flawless technology, physiotherapists with sufficient affinity and training, and the right expectations from patients. The draft intervention was considered feasible after evaluation by four patients and three physiotherapists and was further complemented by expanding the training for physiotherapists and improving the protocols for physiotherapists and patients. The final intervention consisted of a 12-week physiotherapy treatment with three integrated VR modules: pain education, physical exercise, and relaxation. Using the MRC framework in cocreation with the end users, a personalized VR intervention integrated within a physiotherapy treatment for patients with CLBP was developed. This intervention was found to be feasible and will subsequently be evaluated for (cost-)effectiveness in a cluster randomized controlled trial.

A sports‐related injury prevention program for Dutch youth volleyball players: Process evaluation alongside a quasi‐randomized controlled trial

AbstractObjectiveThis process evaluation aimed to gain insight into the implementation of the VolleyVeilig Youth program by Dutch volleyball clubs within the context of an effectiveness trial.MethodsWe applied the UK Medical Research Council framework for process evaluations and assessed the context, implementation and mechanisms of impact. Trainers participating in the effectiveness trial were asked to complete a questionnaire at the end of the study. A subsample of the trainers based on the self‐reported adherence score was invited to participate in an interview accordingly. We used a thematic analysis to present the data.ResultsThirty‐one trainers (100%) completed the questionnaire, and seven agreed to participate in an interview. Although adherence gradually decreased over the volleyball season, most trainers reported partially adhere with the program until the end of the study. The main themes included factors associated with the (1) VolleyVeilig Youth program, (2) trainer, (3) players, and (4) volleyball club.ConclusionAlthough (partial) adherence to the VolleyVeilig Youth program was high in this study, implementation strategies must be developed to target the barriers reported by the trainers before the program can be successfully implemented nationwide in the Netherlands.