Evaluation Of Complex Interventions Research Articles

A Study to Explore the Feasibility of Using a Social Return on Investment Approach to Evaluate Short Breaks

Short breaks help maintain caring relationships, enabling people to remain living in their own homes and contributing significant economic benefit to public services. However, relatively little is known about the added social value generated by community-based short breaks. To address this evidence gap, we explored the feasibility of using a social return on investment (SROI) evaluation to explore a day support service in North Wales for people living with dementia and their unpaid carers. Following good practice for evaluating complex interventions, we developed a logic model based on the literature and interviews to understand the mechanisms and outcomes of the day support service. Using questionnaires, we quantified outcomes for the current service cohort, which included people living with dementia, unpaid carers, and paid companions. Seven people living with dementia, three unpaid carers, and four companions completed questionnaires. By following the SROI analysis approach, three key learning points were identified. The first was around ways to capture outcomes from all stakeholder subgroups expected to experience material change. The second concerned the importance of collecting longitudinal data. This included the need to consider how to adapt the SROI method to work with small populations. The third concerned how to value “maintenance” of wellbeing as well as improved wellbeing.

Reporting Rigor of Cancer Rehabilitation Interventions: Application of the CReDECI-2 Guidelines.

Clear reporting of cancer rehabilitation interventions is critical for interpreting and translating research into clinical practice. This study sought to examine the completeness of intervention reporting of cancer rehabilitation interventions addressing disability and to identify which elements are most frequently missing. This was a secondary analysis of randomized controlled trials included in two systematic reviews examining effectiveness of cancer rehabilitation interventions that address cancer-related disability, including functional outcomes. Eligible trials were reviewed for intervention reporting rigor using the Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare 2 checklist. Intervention descriptions for cancer rehabilitation interventions were generally incomplete. Approximately 85% ( n = 157) of trials described ≤50% of Criteria for Reporting the Development and Evaluation of Complex Interventions in Healthcare 2 checklist items. Commonly underreported items included description of the intervention's underlying theoretical basis, fidelity, description of process evaluation or external conditions influencing intervention delivery, and costs or required resources for intervention delivery. The findings reveal that cancer rehabilitation intervention descriptions lacked necessary detail in this body of literature. Poor descriptions limit the translation of research to clinical practice. To ensure higher-quality study design and reporting, future intervention research should incorporate an intervention reporting checklist to ensure more complete descriptions for research and practice.

The Benefits and Complexities of Integrating Mixed Method Findings Using the Pillar Integration Process: A Workplace Health Intervention Case Study

The Pillar Integration Process was developed to facilitate integration of mixed method data, but there is limited historical application of this approach in complex intervention evaluation. To test the applicability of the technique, this paper presents two case studies examining the efficacy of a workplace intervention. The research included a pilot RCT and process evaluation. The case studies illustrate the benefits of applying the Pillar Integration Process to elicit a comprehensive understanding of intervention efficacy and to design better interventions. This paper contributes to the mixed methods research by advancing the technique through considering inherent philosophical assumptions, and evidencing the value of integrating methods within, as well as across, “qualitative” and “quantitative” categories.

Development and feasibility of a mHealth intervention to improve guardians' adherence to children's follow up care after treatment for acute lymphoblastic leukemia in Tanzania: An overview of the GuardiansCan project.

Cancer is a leading cause of death during childhood and in low- and middle-income countries (LMICs) survival rates can be as low as 20%. A leading reason for low childhood cancer survival rates in LMICs such as Tanzania is treatment abandonment. Contributing factors include poor communication between healthcare providers and children's guardians (guardians), insufficient cancer knowledge, and psychological distress. Our aim is to respond to Tanzanian guardians' poor adherence to children's follow-up care after treatment for acute lymphoblastic leukemia with the help of mHealth technology. Our goal is to increase guardians' adherence to children's medications and follow-up visits; and secondly to decrease their psychological distress. Following the Medical Research Council (MRC) Framework for developing and evaluating complex interventions, we will undertake the GuardiansCan project in an iterative phased approach to develop an mHealth intervention for subsequent testing. Public contribution activities will be implemented throughout via a Guardians Advisory Board consisting of guardians of children with acute lymphoblastic leukemia. We will examine the acceptability, feasibility, and perceived impact of public contribution activities via an impact log and semi-structured interviews (Study I). In Phase One (intervention development) we will explore guardians' needs and preferences for the provision of follow-up care reminders, information, and emotional support using focus group discussions and photovoice (Study II). We will then co-design the mHealth intervention with guardians, healthcare professionals, and technology experts using participatory action research (Study III). In Phase Two (feasibility) we will examine clinical, methodological, and procedural uncertainties associated with the intervention and study methods in a single-arm pre-post mixed methods pragmatic feasibility study (Study IV). Data collection for the GuardiansCan project is anticipated to take three years. We plan to commence Study I by recruiting Guardians Advisory Board members in autumn 2023. By systematically following the intervention development and feasibility phases of the MRC Framework, and working alongside an advisory board of guardians, we intend to develop an acceptable, culturally appropriate, feasible, and relevant mHealth intervention with the potential to increase guardians' adherence to children's follow-up care after treatment of acute lymphoblastic leukemia, leading to a positive impact on children's health and chances to survive and reduced suffering for guardians. n/a.

Exploring the contribution of case study research to the evidence base for occupational therapy: a scoping review

BackgroundCase study research is generating interest to evaluate complex interventions. However, it is not clear how this is being utilized by occupational therapists or how feasible it is to contribute to the evidence base. This scoping review explores case study research within occupational therapy in terms of how it is defined, the methodological characteristics adopted, such as data collection and analysis, and the range of practice contexts in which it is applied. We consider the viability of case study research for contributing to our evidence base.MethodsOpinion, text and empirical studies within an occupational therapy practice context were included. A three-step extensive search following Joanna Briggs Institute methodology was conducted in June 2020 and updated in July 2021 across ten databases, websites, peer-reviewed and grey literature from 2016 onwards. Study selection was completed by two independent reviewers. A data extraction table was developed and piloted and data charted to align with research questions. Data extraction was completed by one reviewer and a 10% sample cross checked by another.ResultsEighty-eight studies were included in the review consisting of (n = 84) empirical case study and (n = 4) non-empirical papers. Case study research has been conducted globally, with a range of populations across different settings. The majority were conducted in a community setting (n = 48/84; 57%) with populations experiencing neurodevelopmental disorder (n = 32/84; 38%), stroke (n = 14/84;17%) and non-diagnosis specific (n = 13/84; 15%). Methodologies adopted quantitative (n = 42/84; 50%), mixed methods (n = 22/84; 26%) and qualitative designs (n = 20/84; 24%). However, identifying the methodology and ‘case’ was a challenge due to methodological inconsistencies.ConclusionsCase study research is useful when large-scale inquiry is not appropriate; for cases of complexity, early intervention efficacy, theory testing or when small participant numbers are available. It appears a viable methodology to contribute to the evidence base for occupation and health as it has been used to evaluate interventions across a breadth of occupational therapy practice contexts. Viability could be enhanced through consistent conduct and reporting to allow pooling of case data. A conceptual model and description of case study research in occupational therapy is proposed to support this.Systematic review registrationOpen Science Framework 10.17605/OSF.IO/PCFJ6.

Choice architecture interventions promoting sustained healthier food choice and consumption by students in a secondary school setting: a systematic review of intervention studies.

To systematically review the impact of choice architecture interventions (CAI) on the food choice of healthy adolescents in a secondary school setting. Factors potentially contributing to the effectiveness of CAI types and numbers implemented and its long-term success were examined. PUBMED and Web of Science were systematically searched in October 2021. Publications were included following predefined inclusion criteria and grouped according to the number and duration of implemented interventions. Intervention impact was determined by a systematic description of the reported quantitative changes in food choice and/or consumption. Intervention types were compared with regard to food selection and sustained effects either during or following the intervention. CAI on food choice of healthy adolescents in secondary schools. Not applicable. Fourteen studies were included; four randomised controlled trials and five each of controlled or uncontrolled pre-post design, respectively. Four studies implemented a single CAI type, with ten implementing > 1. Three studies investigated CAI effects over the course of a school year either by continuous or repeated data collection, while ten studies' schools were visited on selected days during an intervention. Twelve studies reported desired changes in overall food selection, yet effects were not always significant and appeared less conclusive for longer-term studies. This review found promising evidence that CAI can be effective in encouraging favourable food choices in healthy adolescents in a secondary school setting. However, further studies designed to evaluate complex interventions are needed.

Implementing a psychosocial care approach in pediatric inpatient care: process evaluation of the pilot Child Life Specialist program at the University Hospital of Munich, Germany.

Child Life Specialists (CLSs) are psychosocial care professionals of child development and health who focus on the individual needs and rights of young patients. CLSs accompany sick children and focus on the children's perspective and their reality of life. CLS programs are already established in clinical settings in the United States and other Anglophone countries but have not yet been piloted in the German health care setting, neither has their implementation been evaluated in this context. This study aimed to explore the factors influencing the implementation of a pilot CLS program in pediatric inpatient care at the Dr. von Hauner Children's Hospital at the University Hospital of Munich, Germany. Building on methods commonly employed in the evaluation of complex interventions, we developed a logic model to guide the process evaluation of our program. Semi-structured interviews with four groups of stakeholders were conducted in person or via videoconferencing between June 2021 and January 2022. Data was analyzed collectively using the method of qualitative content analysis by Mayring. Fifteen individual interviews were conducted with patients (children aged 5-17 years, n = 4), parents (n = 4), CLSs (n = 4) and other health professionals (n = 3). Factors influencing the implementation were identified on three levels: system, staff and intervention. On the system level, a clearer definition of CLSs' tasks and responsibilities was perceived as important and would likely lead to a delineation from other (psychosocial) professions and a reduction of potential resistances. On the staff level, lacking training opportunities and feelings of being insufficiently skilled were limiting the CLSs professional self-confidence. On the intervention level, the emergence of a unique characteristic of the CLSs' work (i.e., preparation for medical procedures) supported the acceptance of the new program. The implementation of a CLS program into an established hospital system with existing psychosocial care services is challenging. Our results contribute to a better understanding of implementation processes of such an additional psychosocial care approach and provide recommendations for addressing upcoming challenges.

Editorial introductions.

Current Opinion in Otolaryngology & Head and Neck Surgery was launched in 1993. It is one of a successful series of review journals whose unique format is designed to provide a systematic and critical assessment of the literature as presented in the many primary journals. The fields of otolaryngology and head and neck surgery are divided into 11 sections that are reviewed once a year. Each section is assigned a Section Editor, a leading authority in the area, who identifies the most important topics at that time. Here we are pleased to introduce the Journal's Section Editors for this issue. SECTION EDITORS Jo PattersonJo PattersonDr Jo Patterson is a Professor of Speech and Language Therapist and Associate Head of Research at the University of Liverpool and The Liverpool Head and Neck Centre. Her research portfolio includes proof of concept work, cohort studies, feasibility studies, multi-centre randomized control trials and the development and evaluation of complex interventions. She is committed to involving patients and keeping them central to research and service development. In 2016, she received a Royal College of Speech and Language Therapy Fellowship in recognition of her contribution towards the advancement of the profession, both as an academic and a practicing Speech and Language Therapist. As their specialist advisor, she represents the organisation on a number of committees and councils, contributing towards policy and strategic direction. She has extensively developed research capacity for Speech and Language Therapists nationally through grant and fellowship applications and provision of MSc and PhD supervision, teaching and mentorship. She continues to balance her time between clinical and academic practice. H Fiona RobinsonH Fiona RobinsonMiss Fiona Robinson qualified as a Speech Therapist from Birmingham Polytechnic, UK in 1980, and in 2004, she was awarded Master of Science (Merit) (Advanced practice – Voice) from the University of Newcastle, UK, with study into the efficacy of voice therapy for vocal fold paralysis. In 2006, in recognition of her contribution to the speech and language therapy profession in the UK, Miss Robinson was elected to the Fellowship of the Royal College of Speech and Language Therapists (RCSLT). She has completed a post-graduate certificate in Medical Education at the University of Nottingham, UK with a particular interest in the development of E-learning. Her clinical interests include the diagnosis and rehabilitation of speech and swallowing disorders related to head and neck cancer, including surgical voice restoration, and the management of dysphonia. Currently she is working within the National Health Service (NHS) and is Director of SVS Associates, a company which runs skills training for speech and language therapists. Johannes FaganJohannes FaganDr Johan Fagan is Professor and Chairman of Otorhinolaryngology at the University of Cape Town in South Africa. He has authored 200 peer reviewed articles and book chapters. A major interest has been to advance head and neck surgery in Africa and the Developing World. To this end he self-publishes two free open access textbooks, “The Open Access Atlas of Otolaryngology, Head & Neck Operative Surgery” and the “Open Access Guide to Audiology and Hearing Aids”.

Incentives for physical activity in cardiac patients in Germany: pre-trial health economic modelling

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): University Hospital Düsseldorf Cardiovascular disease (CVD) is the most prevalent non-communicable disease and the leading cause of death globally. Evidence suggests that exercise-based interventions in secondary prevention can mitigate adverse health events. Implementing incentive schemes for patients to engage in physical activity (PA) might be a promising approach to improve adherence. The INPHY trial, a complex intervention that is currently being developed at the University Hospital Düsseldorf, aims at improving PA in people with coronary heart disease (CHD) using monetary and social incentives. The UK Medical Research Council (MRC) framework for the development and evaluation of complex interventions recommends pre-trial health economic modelling to inform the design of the trial. A decision-analytic Markov model was developed to evaluate the costs and benefits of exercise-based, incentivized secondary prevention interventions from a health services provider. A cohort of individuals with a history of myocardial infarction was followed in the model from age 65 years through a total of 25 1-year Markov cycles. Primary outcomes included costs, quality-adjusted life-years (QALY) gained and incremental cost-effectiveness ratios (ICERs). Sensitivity and scenario analyses were performed to reflect parameter and model uncertainty. In the base-case, the incremental QALYs gained from the monetary and social incentives, relative to control, were respectively estimated at 0.01 [95% CI 0.00-0.01] and 0.03 [95% CI 0.02-0.05]. In comparison to control, the implementation of the monetary and social incentive interventions increased the costs by 795€ [95% CI 697-884] and 831€ [95% CI 593-1,191], respectively. ICERs were 24,473€ [95% CI 15,871-38,868] and 112,015€ [95% CI 81,140-169,888] per QALY gained for the social and monetary incentive interventions, respectively. At a per-capita gross domestic product threshold (GDP) of 43,000€/QALY for Germany, the probability that the social and monetary incentive intervention would be seen as cost effective was 100% and 0%, respectively. Exercise-based secondary prevention using incentivized reinforcement schemes might offer a cost-effective strategy to reduce the burden of CHD, offering good value for money in preventing a significant non-communicable disease. Translation of these findings into policy and practice alongside rigorous monitoring and evaluation is important. More epidemiological research from Germany is recommended to reduce the remaining model uncertainty surrounding this decision.

Development of "LvL UP 1.0": a smartphone-based, conversational agent-delivered holistic lifestyle intervention for the prevention of non-communicable diseases and common mental disorders.

Non-communicable diseases (NCDs) and common mental disorders (CMDs) are the leading causes of death and disability worldwide. Lifestyle interventions via mobile apps and conversational agents present themselves as low-cost, scalable solutions to prevent these conditions. This paper describes the rationale for, and development of, "LvL UP 1.0″, a smartphone-based lifestyle intervention aimed at preventing NCDs and CMDs. A multidisciplinary team led the intervention design process of LvL UP 1.0, involving four phases: (i) preliminary research (stakeholder consultations, systematic market reviews), (ii) selecting intervention components and developing the conceptual model, (iii) whiteboarding and prototype design, and (iv) testing and refinement. The Multiphase Optimization Strategy and the UK Medical Research Council framework for developing and evaluating complex interventions were used to guide the intervention development. Preliminary research highlighted the importance of targeting holistic wellbeing (i.e., both physical and mental health). Accordingly, the first version of LvL UP features a scalable, smartphone-based, and conversational agent-delivered holistic lifestyle intervention built around three pillars: Move More (physical activity), Eat Well (nutrition and healthy eating), and Stress Less (emotional regulation and wellbeing). Intervention components include health literacy and psychoeducational coaching sessions, daily "Life Hacks" (healthy activity suggestions), breathing exercises, and journaling. In addition to the intervention components, formative research also stressed the need to introduce engagement-specific components to maximise uptake and long-term use. LvL UP includes a motivational interviewing and storytelling approach to deliver the coaching sessions, as well as progress feedback and gamification. Offline materials are also offered to allow users access to essential intervention content without needing a mobile device. The development process of LvL UP 1.0 led to an evidence-based and user-informed smartphone-based intervention aimed at preventing NCDs and CMDs. LvL UP is designed to be a scalable, engaging, prevention-oriented, holistic intervention for adults at risk of NCDs and CMDs. A feasibility study, and subsequent optimisation and randomised-controlled trials are planned to further refine the intervention and establish effectiveness. The development process described here may prove helpful to other intervention developers.

The development of a trauma informed care framework for residential services for adults with an intellectual disability: Implications for policy and practice

AbstractTrauma informed care has become an evidenced based approach for inpatient and residential services for people in the general population who are likely to have been impacted by trauma. Given the increased vulnerability to psychological trauma for adults with an intellectual disability, it should follow that residential services for adults with an intellectual disability would also benefit from a trauma informed care approach. Two focus groups and individual interviews with seven adults with an intellectual disability and six workshops with seven service providers were conducted to co‐produce a trauma informed care framework for residential services that was evidence‐based and guided by established models (MRC, Developing and evaluating complex interventions, London: MRC & NIHR, 2019; Wight et al., Journal of Epidemiology and Community Health, 70, 520–525, 2016). The framework was developed into four chapters: ‘Setting the context’; ‘Organisational change’; ‘Workforce development’; and ‘Trauma focussed services’. A logic model outlining the mechanisms of change was refined over the course of the co‐production workshops. This is the first study to develop and co‐produce a trauma informed care framework for residential and supported living accommodation for adults with an intellectual disability. The framework has implications for local policy and practice in its current cultural context. Future development is required to operationalise and test the framework and to explore its adaptability to international contexts.

“What I wanted to do was build myself back up and prepare”: qualitative findings from the PERCEPT trial of prehabilitation during autologous stem cell transplantation in myeloma

BackgroundThe addition of qualitative methodology to randomised controlled trials evaluating complex interventions allows better understanding of contextualised factors and their potential influence on trial delivery and outcomes, as well as opportunities for feedback on trial participation to improve future trial protocols. This study explored the experiences of participation in cancer rehabilitation research during active cancer treatment. Participants were people living with haematological cancer myeloma, undergoing autologous stem cell transplantation (ASCT) recruited to the PERCEPT myeloma pilot trial.MethodsA qualitative semi-structured interview study, embedded within a pilot randomised controlled trial of a physiotherapist-led exercise intervention delivered before, during and after ASCT among people living with myeloma. Transcripts were analysed using reflexive thematic analysis.ResultsInterviews from 16 trial participants (n = 8 intervention group; n = 8 control group; mean age 61 years, 56% male) were analysed. Four main themes were identified: (1) “It’s not just beneficial for me, it’s for people after me as well”; (2) Disparities in experience of recovery – expectations, feeling prepared and support; (3) “What I wanted to do was build myself back up and prepare”; (4) Active ingredients – participants’ experience of the trial intervention. Participants reported both altruistic and perceived personal gain as motivators for enrolling in the trial. Disappointment caused by allocation to control arm may have led to participants seeking exercise elsewhere, indicating possible contamination of control condition. Disparities in experience of recovery from transplant were evident with intervention participants reporting greater trajectory of recovery.ConclusionsThe findings from this embedded qualitative study highlight numerous considerations required when designing pilot and efficacy trials of complex interventions. The addition of qualitative investigation offers greater understanding of motivations for participation, intervention mechanisms at play as well as effects of participation that may impact interpretation of quantitative outcomes.Trial registrationQualitative findings from a prospectively registered pilot trial (ISRCTN15875290), registered 13/02/2019.

Nurse-Led Telephone Follow-Up Intervention for Titrating and Tapering Opioids in Chronic Pain Patients – A Feasibility Study

Opioids in chronic non-cancer pain are debated, but remain a part of the pain treatment for selected patients. Research is scarce on the relieving and adverse effects of opioids, and how to deliver opioid treatment in this patient group. This study's purpose was to assess the feasibility of a nurse-led telephone follow-up intervention for titrating or tapering opioids, including a pilot study of the intervention outcomes. The feasibility assessment and process evaluation were performed according to the UK Medical Research Council (MRC) framework for evaluating complex interventions. A pilot study of the intervention outcomes was also performed. With a retrospective, descriptive, and longitudinal approach, we analyzed reports from 32 patients who titrated or tapered opioids. Information on demography, sleep satisfaction, health status, pain intensity/bothersomeness, opioid doses, and side effects was derived from the Oslo Pain Registry. Descriptive statistics, t-tests, and chi-square tests were used to analyze registry data. The study findings indicate that the intervention is feasible. Areas of impact were lack of a sound theory basis, unclear allocation criteria, and inconsistent and non-validated measurement tools. Mechanisms of change were interprofessional collaboration, nurses' knowledge and competencies, predictability, and availability. Statistical analyses showed no between-groups differences in demographical-, clinical-, and pain characteristics, except those who titrated opioids were significantly older than patients tapering opioids (P=0.010). All patients reported poor health and side effects at baseline. Those who tapered opioids had a significant reduction in opioid use (P=0.004). Titrating opioids was associated with a significant increase in side effects (P=0.038). Considering the limitations and the strengths of the intervention, the present study indicates that the nurse-led telephone follow-up program is a feasible intervention. With the right adjustments and improvements, the intervention is eligible for a larger efficacy study.

Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial

BackgroundPulmonary rehabilitation (PR) is a core component of management people with chronic obstructive pulmonary disease (COPD); yet, people with COPD face significant barriers to attending centre-based PR programs. The emergence of new models of PR, remotely delivered directly into people’s homes, has the potential to improve rehabilitation access and completion by providing patients with a choice of rehabilitation location (centre or home). However, offering patients a choice of rehabilitation model is not usual practice. We are undertaking a 14-site cluster randomised controlled trial to determine whether offering choice of PR location improves rehabilitation completion rates resulting in reduced all-cause unplanned hospitalisation over 12 months. The aim of this paper is to describe the protocol for the process evaluation of the HomeBase2 trial.MethodsA mixed methods process evaluation, to be undertaken in real time, has been developed in accordance with UK Medical Research Council (MRC) recommendations on process evaluation of complex interventions. This protocol describes the intended use of two theoretical frameworks (RE-AIM framework (Reach; Effectiveness; Adoption; Implementation; Maintenance) and Theoretical Domains Framework (TDF)) to synthesise findings and interpret data from a combination of qualitative (semi-structured interviews) and quantitative (questionnaires, clinical outcome data, intervention fidelity) methodologies. Data will be collected at an intervention, patient and clinician level. Qualitative and quantitative data will be used to derive context-specific potential and actual barriers and facilitators to offering patients choice of rehabilitation location. Acceptability and sustainability of the intervention will be evaluated for future scale-up.DiscussionThe process evaluation described here will appraise the clinical implementation of offering a choice of rehabilitation program location for people with COPD. It will identify and evaluate key factors for future scale-up and sustainability and scale-up of offering choice of pulmonary rehabilitation program model for people.Trial registrationClinicalTrials.gov NCT04217330 Registration date: January 3 2020.

Development of the ¡Vamos por Mas! parenting program to prevent substance use among Chilean adolescents.

In Chile, the prevalence of tobacco, alcohol and drug use among adolescents is very high. Decades of research indicate that parenting interventions reduce these risky behaviors. However, there are no parenting interventions validated in Chile to prevent adolescent substance use. This article reports the development of the ¡Vamos por Mas! (¡VxM!) program following the recommendations of the Medical Research Council's framework for designing and evaluating complex interventions. After identifying key intervention components, a preliminary version of a substance-use prevention program was designed. The preliminary intervention targeted families with adolescents in fifth and sixth grade and had four components: personalized feedback, in-person workshops, virtual engagement, and family support, to deliver positive-youth development and family-strengthening content. Then, students, guardians, school staff and community experts from different school systems (N = 111) evaluated the preliminary version of the program through a convergent parallel mixed methods study, including focus groups (N = 14) and surveys (N = 101). In general, all participants had positive perceptions of the program and valued its purpose, strategies, objectives and contents. Suggestions included expanding the purpose to promote healthy relationships, focusing on schools with low and intermediate socioeconomic vulnerability, including self-control content, removing the personalized feedback component and adding two additional components: school partnership and external supervision, among other improvements. With this information, the final version of the ¡VxM! program was developed. After a rigorous intervention development process, the ¡VxM! program is ready to be piloted and evaluated in a randomized trial.

Co-producing a physical activity intervention in two forensic psychiatry settings in the UK: The IMPACT study

IntroductionIn the UK there are 3500 individuals detained in medium secure forensic psychiatry units. Service users in such settings have complex and serious mental illness (SMI), often with co-morbid physical health problems and a life expectancy of at least 10 years shorter than the general population. They often have low levels of physical activity. There is little evidence about physical activity interventions for medium secure service users in the United Kingdom.ObjectivesOur objective is to co-produce, with medium secure service users, the content and delivery of an intervention to increase physical activity. We shall assess feasibility, acceptability and pilot data collection methods for outcomes relevant for a future randomised controlled trial.MethodsThis is a 24-month mixed-methods project that will follow the Medical Research Council (MRC) framework Developing and Evaluating Complex Interventions. The study has 4 phases.- Phases 1-2 will gather information required to co-develop an evidence based intervention in Phase 3.- Phase 4 will assess the intervention in a feasibility study, evaluating and testing the intervention for a future pilot study.Study settings: Two NHS Medium Secure In-Patient Psychiatric Hospitals in the UK.ResultsThis paper presents the findings from the Phase 1 questionnaire and focus groups with service users and hospital staff that identified the barriers and facilitators to physical activity in such settings. The results are then discussed in relation to the Phase 2 qualitative results that explored stakeholders’ and service users’ opinions into how to increase physical activity among medium secure service users by identifying potential elements for inclusion in a physical activity intervention, to gain insight into how we can establish engagement of this group with the intervention, maintain commitment, avoid drop-out and develop the intervention design. All findings are presented using the Capability, Opportunity, and Motivation Model of Behaviour (COM-B model), which is widely used to identify what needs to change for a behaviour change intervention to be effective.ConclusionsThe findings of Phases 1-2 are allowing the team to move forward with Phase 3 that is currently developing an intervention to increase physical activity for adult inpatient service users in the medium secure units. This phase will be guided by the MRC framework and the COM-B model to define the target behaviours and select the most suitable intervention components (functions and techniques) and implementation approach.Disclosure of InterestNone Declared

Feasibility and Acceptability of an Internet of Things-Enabled Sedentary Behavior Intervention: Mixed Methods Study.

Encouraging office workers to break up prolonged sedentary behavior (SB) at work with regular microbreaks can be beneficial yet challenging. The Internet of Things (IoT) offers great promise for delivering more subtle and hence acceptable behavior change interventions in the workplace. We previously developed an IoT-enabled SB intervention, called WorkMyWay, by applying a combination of theory-informed and human-centered design approaches. According to the Medical Research Council's framework for developing and evaluating complex interventions such as WorkMyWay, process evaluation in the feasibility phase can help establish the viability of novel modes of delivery and identify facilitators and barriers to successful delivery. This study aims to evaluate the feasibility and acceptability of the WorkMyWay intervention and its technological delivery system. A mixed methods approach was adopted. A sample of 15 office workers were recruited to use WorkMyWay during work hours for 6 weeks. Questionnaires were administered before and after the intervention period to assess self-report occupational sitting and physical activity (OSPA) and psychosocial variables theoretically aligned with prolonged occupational SB (eg, intention, perceived behavioral control, prospective memory and retrospective memory of breaks, and automaticity of regular break behaviors). Behavioral and interactional data were obtained through the system database to determine adherence, quality of delivery, compliance, and objective OSPA. Semistructured interviews were conducted at the end of the study, and a thematic analysis was performed on interview transcripts. All 15 participants completed the study (attrition=0%) and on average used the system for 25 tracking days (out of a possible 30 days; adherence=83%). Although no significant change was observed in either objective or self-report OSPA, postintervention improvements were significant in the automaticity of regular break behaviors (t14=2.606; P=.02), retrospective memory of breaks (t14=7.926; P<.001), and prospective memory of breaks (t14=-2.661; P=.02). The qualitative analysis identified 6 themes, which lent support to the high acceptability of WorkMyWay, though delivery was compromised by issues concerning Bluetooth connectivity and factors related to user behaviors. Fixing technical issues, tailoring to individual differences, soliciting organizational supports, and harnessing interpersonal influences could facilitate delivery and enhance acceptance. It is acceptable and feasible to deliver an SB intervention with an IoT system that involves a wearable activity tracking device, an app, and a digitally augmented everyday object (eg, cup). More industrial design and technological development work on WorkMyWay is warranted to improve delivery. Future research should seek to establish the broad acceptability of similar IoT-enabled interventions while expanding the range of digitally augmented objects as the modes of delivery to meet diverse needs.

Towards an evolutionary approach to learning from assumptions: Lessons from the evaluation of Dancing with Parkinson’s

This paper highlights how learnings from exploring assumptions can be strengthened by taking an evolutionary approach to theory building and analysis. We discuss theory-driven evaluation applied to a community-based intervention implemented by Dancing With Parkinson’s in Toronto, Canada, targeting Parkinson’s disease (PD), a neurodegenerative condition affecting movement. A major gap in the literature is understanding the mechanisms by which dance might make a difference in the daily lives of people living with PD. This study was an early exploratory evaluation to better understand mechanisms and short-term outcomes. Conventional thinking generally favors “permanent” over “transitory” changes, and “long-term” over “short-term” effects. Yet, for people living with degenerative conditions (and also people experiencing chronic pain and other chronic symptoms), transitory and short-term changes may be highly valued and welcomed relief. In order to study and link multiple longitudinal events to explore key linkages in the theory of change, we piloted the use of diaries, with brief entries filled out daily by participants. The aim was to better understand the short-term experiences of participants using their daily routines as a means of learning about potential mechanisms, what matters to participants, and to see if small effects could be observed on days when participants danced versus days when they did not dance and also longitudinally over several months. Our initial theoretical stance began with a view of dance as exercise and the well-established benefits of exercise; yet, we explored through the diary data collected, as well as client interviews and literature review, potential other mechanisms of dancing (such as group interaction, touch, stimulation by the music, and esthetics including “feeling lovely”). This paper does not develop a full, comprehensive theory of dance but moves towards a more comprehensive view that locates dance within the routine activities of participants’ daily lives. We argue that given the challenges of evaluating complex interventions comprising multiple, interacting components, there is a need for an evolutionary learning process to understand heterogeneities in mechanisms -- what works for whom -- when faced with knowledge incompleteness in the theory of change.

Development of a complex intervention (safe and secure) to support non-western migrant patients with palliative care needs and their families.

International evidence supports the benefits of early use of palliative care, although the best use of services is often under-utilised among Danish migrants. The study aims to develop a theoretically informed, evidence-based intervention to increase support in palliative care service provision among non-western migrant patients with a life-threatening disease and their families in Denmark. The overall approach was guided by the United Kingdom Medical Research Council framework for developing and evaluating complex interventions by involving stakeholders for example patients, family caregivers, and healthcare professionals. The intervention was developed iteratively by incorporating theory and evidence. Evidence was synthesized from a systematic review, semi-structured interviews, and group discussions with patients (n=8), family caregivers (n=11), healthcare professionals (n=10); and three workshops with migrants (n=5), social and healthcare professionals (n=6). The study took place in six different settings in two regions across Denmark. The safe and secure complex intervention is a healthcare professional (e.g. nurse, physiotherapist, or occupational therapist) led patient-centred palliative care intervention at the basic level. The final intervention consists of three components 1. Education and training sessions, 2. Consultations with the healthcare professional, and 3. Coordination of care. This study describes the development of a supportive palliative care intervention for non-western migrant patients with palliative care needs and their families, followed by a transparent and systematic reporting process. A palliative care intervention combining multiple components targeting different stakeholders, is expected that safe and secure is more suitable and well customized in increasing access and use of palliative care services for non-western migrant families in Denmark.

An interdisciplinary nationwide complex intervention for lifespan neurodevelopmental service development: Underpinning principles and realist programme theory.

People seeking support for neurodevelopmental differences often report waiting too long for assessment and diagnosis, as well as receiving inadequate support in educational and health settings. The National Autism Implementation Team (NAIT) developed a new national improvement programme in Scotland, focusing on assessment, diagnosis, educational inclusion, and professional learning. The NAIT programme was conducted within health and education services across the lifespan for a range of neurodevelopmental differences, including autism, developmental coordination disorder, developmental language disorder, and attention deficit hyperactivity disorder. NAIT included a multidisciplinary team, with the involvement of an expert stakeholder group, clinicians, teachers, and people with lived experience. This study explores how the NAIT programme was planned, delivered, and received over three years. We performed a retrospective evaluation. We collected data from review of programme documents, consultation with programme leads and consultation with professional stakeholders. A theory-based analysis was completed, drawing on the Medical Research Council Framework for developing and evaluating complex interventions, and realist analysis methods. We developed a programme theory of the contexts (C), mechanisms (M), and outcomes (O) influencing the NAIT programme, based on comparison and synthesis of evidence. A key focus was on identifying the factors that contributed to the successful implementation of NAIT activities across different domains, including practitioner, institutional and macro levels. On synthesis of the data, we identified the key principles underlying the NAIT programme, the activities and resources utilised by the NAIT team, 16 aspects of context, 13 mechanisms, and 17 outcome areas. Mechanisms and outcomes were grouped at practitioner level, service level and macro level. The programme theory is pertinent to observed practice changes across all stages of referral, diagnosis and support processes within health and education services for neurodivergent children and adults. This theory-informed evaluation has resulted in a clearer and more replicable programme theory that can be used by others with similar aims. This paper illustrates the value of NAIT, as well as realist and complex interventions methodologies as tools for policymakers, practitioners, and researchers.