Development Of Complex Interventions Research Articles

Person-centred medicine in the care home setting: development of a complex intervention.

Person-centred medicine is recommended in the care of older patients. Yet, involvement of care home residents and relatives in medication processes remains limited in routine care. Therefore, we aimed to develop a complex intervention focusing on resident and relative involvement and interprofessional communication to support person-centred medicine in the care home setting. The development took place from October 2021 to March 2022 in the Municipality of Aarhus, Denmark. The study followed the Medical Research Council guidance on complex intervention development using a combination of theoretical, evidence-based, and partnership approaches. The patient involvement tool, the PREparation of Patients for Active Involvement in medication Review (PREPAIR), was included in a preliminary intervention model. Study activities included developing programme theory, engaging stakeholders, and exploring key uncertainties through interviews, co-producing workshops, and testing with end-users to develop the intervention and an implementation strategy. The Consolidated Framework for Implementation Research and the Interprofessional Shared Decision Making Model were used. Data were analysed using a rapid analysis approach. Before the workshops, six residents and four relatives were interviewed. Based on their feedback, PREPAIR was modified to the PREPAIR care home to fit the care home population. In total, ten persons participated in the co-producing workshops, including health care professionals and municipal managerial and quality improvement staff. The developed intervention prototype was tested for three residents and subsequently refined to the final intervention, including two fixed components (PREPAIR care home and an interprofessional medication communication template) delivered in a flexible three-stage workflow. Additionally, a multi-component implementation strategy was formed. In line with the developed programme theory, the intervention supported health care professionals´ awareness about resident and relative involvement. It provided a structure for involvement, empowered the residents to speak, and brought new insights through dialogue, thereby supporting involvement in medication-related decisions. The final intervention was perceived to be relevant, acceptable, and feasible in the care home setting. Our results indicate that the final intervention may be a viable approach to facilitate person-centred medicine through resident and relative involvement. This will be further explored in a planned feasibility study.

Development and validation of the physical exercise program “Active Mums” for postpartum recovery: application of the CReDECI-2 guidelines

Postpartum physical activity is a public health issue. Reporting on the quality of exercise interventions designs must be ensured in view of the reproducibility and successful implementation of such studies. The objective was to develop and preliminary validate a physical exercise program for postpartum recovery, aiming to promote physical fitness and health of the new mothers. The study was carried out through the three stages of development, piloting, and evaluation. The Consensus on Exercise Reporting Template (CERT) was used to describe the postpartum exercise program. The Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare (CReDECI2) was followed to develop and preliminary validate the program. A tailored postpartum exercise program was developed based on evidence-based international recommendations to be implemented by qualified exercise professionals. A pilot intervention of 16 weeks was carried out, engaging a group of postpartum women. The viability of the program was subsequently evaluated by all participants. The present work provided guidance to develop a study protocol with a larger sample in order to prove the effectiveness of a supervised postpartum exercise program on selected parameters of health.

Understanding engagement in diet and dementia prevention research among British South Asians: a short report of findings from a patient and public involvement group.

Dementia is a global public health challenge. Evidence suggests that individuals from South Asian communities are an at-risk group for dementia, partly as a result of early and cumulative exposure to known dementia risk factors, such as obesity and type 2 diabetes. There needs to be more culturally appropriate community engagement to increase awareness of dementia and identify better strategies to encourage participation in dementia-related research. We aimed to better understand the barriers and facilitators towards engaging with, and participating in, diet and dementia related research among British South Asians. This was achieved using a public and patient involvement (PPI) approach. A community-based, engagement event involving information sharing from experts and roundtable discussions with South Asian communities (n = 26 contributors) was held in June 2023 in Newcastle-upon-Tyne, UK. Collaboration from preidentified PPI representatives (n = 3) informed the content and structure of PPI activities, as well as recruitment. Data were synthesised using template analysis, a form of codebook thematic analysis. This involved deductively analysing data using relevant a priori themes, which were expanded upon, or modified, via inductive analysis. The findings highlighted the importance of trust, representation and appreciation of cultural barriers as facilitators to engagement in diet and dementia risk reduction research. Consideration of language barriers, time constraints, social influences and how to embed community outreach activities were reported as driving factors to maximise participation. This PPI work will inform the design and co-creation of a culturally adapted dietary intervention for brain health in accordance with the Medical Research Council and National Institute for Health and Care Research guidance for developing complex interventions.

Development of a community intervention combining social media-based health education plus exercise programme (SHEEP) to improve muscle function among young-old adults with possible sarcopenia: Co-design approach

ObjectivesThere is no precedent for the use of social media in preventing sarcopenia. The aim of this study is to develop a social media-based intervention programme for the young-old population in the community in China to improve their awareness and behaviours regarding sarcopenia prevention. Study designUsing guidelines for developing complex interventions, this study was divided into two main phases: a co-development phase and a preliminary test phase. Both were carried out in Changsha, China. The development phase employed co-design methodology with relevant stakeholders, including two rounds of consultation with patient and public involvement (12 members) and two rounds of focus groups (30 participants); this was followed by the three-week preliminary test phase (22 participants). Main outcome measuresThis study evaluated the consultation with patient and public involvement, and mainly collected qualitative data from the two rounds of focus group interviews and a final semi-structured interview following the preliminary test, so as to explore the participants' experiences, comments, and suggestions for revising the social media-based intervention. Handgrip strength was also evaluated. ResultsThe health education included seven videos of 4–6 min each related to sarcopenia, including information on the concept, influencing factors, adverse effects, manifestations, screening methods, and preventions. The exercise video consisted of four types of training (warm-up, aerobic, resistance, and flexibility training) and lasted 30 min, with a suggested engagement of at least 3 days/week. The specific contents and “dosage” of the final intervention were unanimously favourable to the diverse stakeholders involved (older adults with possible sarcopenia, experts, researchers). After the preliminary test, an improvement in handgrip strength was observed, from M15.92±SD5.22 kg to M19.13±SD5.44 kg (T = −5.44, P < 0.001). Subgroup analysis revealed that this improvement was evident in both men and women. ConclusionsThe social media-based intervention was universally endorsed by the participants and showed indications of a positive influence on sarcopenia. A feasibility study is now needed.

Cost-effectiveness of incentives for physical activity in coronary heart disease in Germany: pre-trial health economic model of a complex intervention following the new MRC framework

ObjectivesThe German Incentives for Physical Activity in Cardiac Patients trial is a three-arm, randomised controlled trial for secondary prevention of coronary heart disease (CHD). Guidance for developing complex interventions recommends...

P080 Supporting shared decision-making about osteoporosis medicines: Combining multiple methods to develop the prototype iFraP intervention

Abstract Background/Aims Shared decision-making (SDM) is a joint process in which a person and healthcare professional work together to reach decisions about care. The iFraP (Improving uptake of Fracture Prevention drug treatments) intervention comprises computerised decision aid (DA), Fracture Liaison Service (FLS) clinician training package, and information resources to support SDM about osteoporosis medicines. This abstract details our multi-method approach to develop this intervention. Methods Intervention development was underpinned by the Medical Research Council guidelines for development of complex interventions. Four studies guided intervention prototype development, including (1) an evidence synthesis of existing osteoporosis DAs to examine quality and effectiveness; (2) a review of patient information about osteoporosis to evaluate quality and optimal language for talking about osteoporosis; (3) a Delphi consensus survey with patients, carers, and health professionals to gain consensus on intervention content, informed by an evidence review of relevant clinical guidelines and behavioural theories; (4) and focus groups and interviews with patients recently attending FLS, FLS clinicians and general practitioners (GPs) to explore current FLS practice, and barriers and facilitators to change. Expert stakeholders and public contributors informed each sub-study. Results Studies one and two informed design of the iFraP computerised DA. Evidence reviews of existing osteoporosis DAs and patient information found that they did not meet patient needs and identified poor readability, variable quality, and unbalanced and confusing content. Public contributors preferred DAs which were individualised, and together with expert stakeholders, supported the development of understandable explanations of osteoporosis and osteoporosis medicines to include in iFraP resources. Study three identified essential components of the FLS consultation which directly informed DA content. Study four identified the need for complementary iFraP information resources, training, and potential barriers to iFraP DA use. Patients expressed that they did not feel adequately prepared for their FLS consultation, leading to the development of an enhanced leaflet to accompany their FLS appointment letter. Patients, FLS clinicians, and GPs all expressed the need for a patient-friendly individualised summary of the FLS consultation, to facilitate consistent information across services and reinforce FLS messaging. This finding informed development of the iFraP Bone Health Record, an individualised, easy-read PDF print-out of the iFraP DA. FLS clinicians identified training needs relating to communicating risk, involving patients in decisions and clinical decision-making. Barriers to use included concerns that the DA would increase consultation duration, and that SDM may undermine their goal to facilitate medicine adherence. Identified barriers to use and training needs informed the content and delivery of the interactive eLearning and role play session, with consideration of theoretically-informed behaviour change techniques. Conclusion The iFraP complex intervention development work demonstrates the use of multiple methods to develop an evidence-based and theoretically-driven intervention in-preparation for testing. Disclosure L. Bullock: None. J. Fleming: None. E.M. Clark: None. S. Leyland: None. S. Thomas: Grants/research support; ST owns Prescribing Decision Support Ltd that developed the iFraP decision aid. C. Gidlow: None. T.W. O'Neill: Grants/research support; TON is supported by the NIHR Manchester Biomedical Research Centre. C.P. Iglesias-Urrutia: None. A. Hawarden: Grants/research support; AH is funded by a Versus Arthritis Clinical Research Fellowship (reference 22726). F. Manning: None. J. Protheroe: None. J. Lefroy: None. S. Ryan: None. R. Horne: None. C.D. Mallen: Grants/research support; CM is funded by the NIHR Applied Research Collaboration West Midlands and the NIHR School for Primary Care Research. C. Jinks: Grants/research support; CJ is part funded by NIHR Applied Research Collaboration (ARC) West Midlands. Z. Paskins: Consultancies; ZP has received consultancy fees from UCB Pharma. Grants/research support; ZP is funded by the National Institute for Health Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy].

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.

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.

Brain-IT: Targeting the brain using information technology for secondary prevention of mild neurocognitive disorder

Brain-IT: Targeting the brain using information technology for secondary prevention of mild neurocognitive disorder

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.

Development of a complex Interdisciplinary Nurse-coordinated SELf-MAnagement (INSELMA) intervention for patients with inflammatory arthritis

BackgroundApart from a consistent focus on treating inflammation, patients with inflammatory arthritis (IA) report a range of unmet needs. Many experience not only residual symptoms but also various other physical, psychological, and social effects. Therefore, this study aimed to develop a complex Interdisciplinary Nurse-coordinated self-management (INSELMA) intervention for patients with IA, as an add-on treatment to usual outpatient care for those with substantial disease impact.MethodsThis study followed the British Medical Research Council’s updated framework for developing complex interventions. The process encompassed the following steps: (1) The evidence base was identified; (2) workshops were held, involving 38 relevant stakeholders (managers, physicians, nurses, physiotherapists, occupational therapists, social workers, psychologists from hospitals and municipalities, and two patient research partners), to discuss and further develop the preliminary ideas; (3) relevant theories were identified (i.e., self-efficacy, acceptance and commitment therapy, and health literacy); (4) the intervention was modeled and remodeled and (5) the results, describing the final INSELMA intervention and outcomes.ResultsThe INSELMA intervention encompasses an initial biopsychosocial assessment, which is performed by a rheumatology nurse. Then, activities that the participant wishes to improve are identified and goals are set. The nurse refers the participant to a multidisciplinary team and coordinates their support and relevant services in the participant’s municipality. In addition, the health professionals have the opportunity to hold two interdisciplinary conferences during the intervention period. The participant and the health professionals work to achieve the set goals during a 6-month period, which ends with a status assessment and a discussion of further needs. The INSELMA intervention aims to increase self-management, reduce the impact of IA (e.g., pain, fatigue, sleep problems, and absenteeism), and increase self-efficacy, quality of life, mental well-being, work ability, and physical activity.ConclusionsThe development of the INSELMA intervention involved stakeholders from two Danish rheumatology outpatient clinics, patient research partners and municipalities. We believe that we have identified important mechanisms to increase the self-management and quality of life of people with IA and to decrease the disease impact in those who are substantially affected. The health professionals involved have developed competences in delivering the intervention and it is ready to be tested in a feasibility study.

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).

A COM-B and Theoretical Domains Framework Mapping of the Barriers and Facilitators to Effective Communication and Help-Seeking Among People With, or Seeking a Diagnosis Of, Endometriosis

Endometriosis is a chronic condition in which tissue resembling the endometrium grows outside the womb, causing severe chronic pain. People with endometriosis report difficulty in help-seeking and communicating with healthcare professionals, contributing to diagnosis delays and ineffective management. The present study aimed to identify barriers and facilitators to effective communication using the Theoretical Domains Framework (TDF) and COM-B model to inform behavior change intervention development. This study was a qualitative semi-structured interview and open-ended survey design. Thematic Analysis was utilized to identify barriers and facilitators to effective communication which were mapped to the TDF and COM-B model. Four women aged 25 to 44 with a formal diagnosis of endometriosis participated in interviews. Thirty-three participants, aged 20–48 years, participated in the online survey, 21 of whom had a diagnosis of endometriosis (12 were currently seeking diagnosis). Five COM-B domains were identified: reflective motivation, social and physical opportunity, physical and psychological capability. Ten TDF domains were reflected in concerns surrounding dismissal, disempowerment, social norms, beliefs about consequences, cognitive resources, reinforcement, and environmental context and resources, among others. This is the first study to identify barriers and facilitators of effective communication and help-seeking in light of established behavioral change theory and frameworks for comprehensive intervention design. This provides a comprehensive explanation of challenges in help-seeking for endometriosis and represents the first step in the development of complex interventions to improve help-seeking and communication for people with endometriosis. Interventions targeting salient barriers will have greater potential to change behavior and improve outcomes.

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.

P93: Characteristics of complex, non-pharmacological cognitive stimulation interventions for people with dementia in nursing homes: systematic review

Objective:Several guidelines propose the use of cognitive stimulation (CS) in people with dementia. Multi-component CS interventions seem most effective in improving cognitive function, quality of life, and behavioral and psychological symptoms of dementia. For successful implementation, it is important to analyze CS interventions in detail in order to identify frequently used and potentially effective components. The aim of this systematic review is to identify, describe and summarise multicomponent CS interventions conducted in nursing homes aiming to improve cognitive function, quality of life, mood, and behavior of people with dementia in nursing homes.Methods:This review is based on established methodological frameworks for systematic evidence syntheses. We conducted a database search in February 2021, using PubMed, CENTRAL, PsycINFO, ALOIS and CINAHL. Two independent reviewers assessed all search results for eligible studies and assessed studies’ methodological quality using the Cochrane Risk of Bias tool for RCTs and the Joanna Briggs Institute checklist for quasi-experimental studies. Evaluation and intervention development studies of any design examining multicomponent interventions CS were included. Components of included intervention programs were analyzed using the TIDieR and CReDECI 2 criteria following a narrative analysis.Results:We identified 19,992 references and included 45 publications. We observed large heterogeneity regarding intervention components, delivery, materials, mode of delivery, intervention provider, and intervention duration. Intervention components included for example reminiscence therapy, activities of daily living, cognitive exercises or reality orientation. Risk of bias was generally low. Reporting of complex interventions was frequently insufficient. No study reported patient and public involvement (PPI) at any stage of the research process.Conclusion:This systematic review is the first to describe complex CS interventions conducted in nursing homes in detail. Results indicate the need for more detailed intervention description for future studies based on TIDieR and CReDECI2 guidelines to allow reliable replication of these interventions. Despite enormous research activities, many questions regarding the implementation and efficacy are still unanswered as process evaluations are lacking. In addition, reproducibility of interventions is hardly possible due to limited reporting. Future studies should use established frameworks for the development, evaluation and implementation of complex interventions and apply PPI concepts.

Development of a self‐help behavioural activation intervention INVOLVERA for people with dementia: a qualitative study

AbstractBackgroundDespite dementia being highly prevalent there is a lack of interventions to support people with dementia, and their informal caregivers, to live well. A guided, self‐help, behavioural activation‐based intervention (INVOLVERA), designed to support people with dementia to re‐engage with pleasurable, routine, and self‐care activities they have stopped doing, may represent a solution (Svedin et al., 2021). An innovative aspect of INVOLVERA is that support to the person with dementia to use INVOLVERA is provided by an informal caregiver, who themselves receives guidance from a healthcare professional. To enhance intervention acceptability and relevance interventions should meet the needs and preferences of the target population. Following Phase I (Development) of the Medical Research Council’s Framework for the development of complex interventions (Skivington et al., 2021), this study explores the needs and preferences of people with dementia, informal caregivers, and professional stakeholders to enhance the acceptability and relevancy of INVOLVERA for people with dementia.MethodsSemi‐structured interviews and focus group discussions were held with people with dementia (n = 8), informal caregivers (n = 19), healthcare professionals (n = 18), and community stakeholders (n = 7). A written draft of INVOLVERA and proposed intervention delivery model were provided to participants. Open‐ended questions explored intervention content, language and intervention delivery preferences. Data were analysed using manifest content analysis.ResultsOne overarching theme: Tailoring and flexibility, and three categories: Intervention process, material and context; Support and guidance; and Time derived from analysis. Results informed the following adaptations: (1) increased flexibility of intervention delivery (e.g., outside of traditional healthcare settings); (2) additional guidance and training to informal caregivers; (3) reduced written material (to minimise treatment burden); (4) modernisation of design and illustrations; (5) improved relevance of case stories and illustrations to the Swedish context; and (6) increased diversity of persons in case stories.ConclusionThis study highlights the importance of developing interventions alongside stakeholders. We anticipate the approach will optimise the acceptability and relevancy of INVOLVERA. Next, we will examine the acceptability and feasibility of INVOLVERA.

Co-designing a nature-based intervention to promote postnatal mental health for mothers and their infants: a complex intervention development study in England

ObjectivesThere is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively...

Development of a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers: A multi-method study

BackgroundDelirium is a common yet challenging condition in older hospitalized patients, associated with various adverse outcomes. Environmental factors, such as room changes, may contribute to the development or severity of delirium. Most previous research has focused on preventing and reducing this condition by addressing risk factors and facilitating reorientation during hospital stay. ObjectiveWe aimed to systematically develop a complex intervention to prevent delirium in older hospitalized patients by optimizing discharge and transfer processes and involving caregivers during and after these procedures. The intervention combines stakeholder and expert opinions, evidence, and theory. This article provides guidance and inspiration to research groups in developing complex interventions according to the recommendations in the Medical Research Council framework for complex interventions. Design and methodsA stepwise multi-method study was conducted. The preparation phase included analysis of the context and current practice via focus groups. Based on these results, an expert workshop was organized, followed by a Delphi survey. Finally, the intervention was modeled and a program theory was developed, including a logic model. ResultsA complex intervention was developed in an iterative process, involving healthcare professionals, delirium experts, researchers, as well as caregiver and patient representatives. The key intervention component is an 8-point-program, which provides caregivers with recommendations for preventing delirium during the transition phase and in the post-discharge period. Information materials (flyers, handbook, videos, posters, defined “Dos and Don'ts”, discharge checklist), training for healthcare professionals, and status analyses are used as implementation strategies. In addition, roles were established for gatekeepers to act as leaders, and champions to serve as knowledge multipliers and trainers for the multi-professional team in the hospitals. ConclusionsThis study serves as an example of how to develop a complex intervention. In an additional step, the intervention and implementation strategies will be investigated for feasibility and acceptability in a pilot study with an accompanying process evaluation. Tweetable abstractDelirium prevention can benefit from optimizing discharge and transfer processes and involving caregivers of older patients in these procedures. Study registrationDRKS00017828, German Register of Clinical Studies, date of registration 17.09.2019.

Co-designing a recruitment strategy for lung cancer screening in high-risk individuals: protocol for a mixed-methods study

Background Lung cancer is a significant cause of cancer-related mortality globally, with early detection through screening critical to improving patient outcomes. However, recruiting high-risk individuals, particularly in deprived populations, for screening remains a considerable challenge. This study aims to co-design a targeted recruitment strategy for lung cancer screening, tailored to the specific needs and experiences of high-risk individuals, in collaboration with a Patient and Public Involvement (PPI) panel and expert stakeholders in Ireland. Methods We will employ a mixed-methods design guided by the Medical Research Council (MRC) framework for developing complex interventions. Our approach will integrate systematic review findings on screening participation interventions, evaluation of the recruitment strategy's feasibility in an Irish context, and the application of behavioural science frameworks. The target population includes individuals over 55 years, either current smokers or those who quit within the last year, who reside in highly deprived areas. Conclusion This co-designed recruitment strategy will combine evidence-based research, local context understanding, and stakeholder input to develop a solution that is both scientifically robust and tailored to the target population's needs. This patient-centred approach aims to increase the potential for successful implementation of lung cancer screening programs, thereby improving early detection and patient outcomes.