UK Medical Research Council Framework Research Articles

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.

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.

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.

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.

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.

Implementation of the Practice Programme for Upright Positions in the Second Stage of Labour and the birth experience of Chinese women: A qualitative study

ObjectiveUpright positions in the second stage of labour are recommended by many international organizations. However, they have not been widely used worldwide, especially in China. One of the important factors is the absence of a practice programme based on the best available evidence. We thus developed a Practice Programme for Upright Positions in the Second Stage of Labour following the UK Medical Research Council framework. Under the guidance of the programme, whether the use of upright positions can improve the maternal birth experience is a question of great concern. This study aimed to explore the birth experience of Chinese women who adopted upright positions in the second stage of labour. DesignThis qualitative descriptive study was conducted as part of an implementation study that developed an evidence-based intervention and used strategies to integrate the evidence-based intervention into routine obstetric clinical practice. SettingThe maternity department of a tertiary comprehensive hospital in Hebei Province, China. ParticipantsSemi-structured interviews with twelve eligible women who adopted upright positions in the second stage of labour were conducted between March and April 2022. Qualitative data were analyzed by using conventional content analysis. FindingsThe average age of included women was 26.5 ± 3.5 years, and ten of them were primiparous women. Eight women adopted epidural analgesia during labour to relieve labour pain. All women gave birth in at least one type of upright position in the passive second stage of labour and adopted the semi-recumbent position in the active second stage of labour. Through conventional content analysis, we found that the use of upright positions in the second stage of labour could possibly promote an overall positive birth experience. Women giving birth in upright positions generally perceived they were more involved in their birthing process, and had greater physical and mental capacity to cope with childbirth. Key conclusionsWomen have a positive birth experience when using upright positions in the second stage of labour. Implications for practiceThis study suggests upright positions could improve women's birth experience and have the potential to be widely applied in clinical practice.

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.

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.

Prevention of physical restraints in the acute care setting (PROTECT): study protocol for a cluster-randomised controlled pilot study

IntroductionPhysical restraints (PR) are regularly used in acute care settings, although evidence for their effectiveness and safety (eg, for prevention of falls) is lacking. Their use is associated with adverse...

Codevelopment and evaluation of a multicomponent intervention to improve HPV vaccination in France

Abstract Background HPV vaccine coverage (VC) in France has always been lower than in most high-income countries. The French authorities launched in 2018 the PrevHPV national research program aimed at codeveloping with stakeholders and evaluating the impact of a multicomponent intervention to improve HPV VC among French adolescents. Methods We identified three components to address main barriers to HPV vaccination in France: adolescents’ and parents’ education and motivation (component 1); general practitioners (GPs)’ training (component 2); and access to vaccination at school (component 3). We developed the intervention using the UK Medical Research Council framework for developing complex interventions as a guide. We used (i) findings from published evidence; (ii) primary data on knowledge, attitudes, behavior and preferences collected through a mixed methods approach (quantitative/qualitative studies, discrete choice experiment); (iii) the advice of stakeholders (e.g., adolescents, parents, school nurses, GPs) involved in working groups. We will evaluate the effectiveness, efficiency and implementation of the components (applied alone or in combination) through a pragmatic cluster randomized controlled trial. The primary endpoint is the HPV VC (≥ 1 dose) among adolescents aged 11-14 years, 2 months after the end of the intervention, at the municipality level. Results Primary data highlighted the need to improve adolescents, parents and school staff knowledge on HPV and to help GPs communicate with patients on this topic. They provided guidance on the most effective communication contents. For each component, we codeveloped tools with a participatory approach (e.g., eHealth tools for adolescents, a decision aid tool for GPs). The trial will end in June 2022; 90 middle schools (i.e., about 40,000 adolescents) and 46 GPs accepted to participate. Conclusions Should the intervention prove effective, results from the implementation evaluation will help us refine it before scaling it up. Key messages • The PrevHPV study is supported by the French health authorities and conducted by a multidisciplinary consortium to tackle a long-lasting public health concern in France. • It will add to the small number of studies that compared the effectiveness of various strategies to promote HPV vaccination and will provide key results on cost-effectiveness and implementation.

Shared decision-making and planning end-of-life care for patients with end-stage kidney disease: a protocol for developing and testing a complex intervention

BackgroundInternationally, it has been stressed that advance care planning integrated within kidney services can lead to more patients being involved in decisions for end-of-life care. In Denmark, there is no systematic approach to advance care planning and end-of-life care interventions within kidney services. A shared decision-making intervention for planning end-of-life care may support more effective treatment management between patients with end-stage kidney disease, their relatives and the health professionals. The purpose of this research is to find evidence to design a shared decision-making intervention and test its acceptability to patients with end-stage kidney disease, their relatives, and health professionals in Danish kidney services.MethodsThis research project will be conducted from November 2020 to November 2023 and is structured according to the UK Medical Research Council framework for complex intervention design and evaluation research. The development phase research includes mixed method surveys. First, a systematic literature review synthesising primary empirical evidence of patient-involvement interventions for patients with end-stage kidney disease making end-of-life care decisions will be conducted. Second, interview methods will be carried out with patients with end-stage kidney disease, relatives, and health professionals to identify experiences of involvement in decision-making and decisional needs when planning end-of-life care. Findings will inform the co-design of the shared decision-making intervention using an iterative process with our multiple-stakeholder steering committee. A pilot test across five kidney units assessing if the shared decision-making intervention is acceptable and feasible to patients, relatives, and health professionals providing services to support delivery of care in kidney services.DiscussionThis research will provide evidence informing the content and design of a shared decision-making intervention supporting patient-professional planning of end-of-life care for patients with end-stage kidney disease, and assessing its acceptability and feasibility when integrated within Danish kidney units. This research is the first step to innovating the involvement of patients in end-of-life care planning with kidney professionals.

An interactive web-based programme on relapse management for people with multiple sclerosis (POWER@MS2) - development, feasibility, and pilot testing of a complex intervention.

IntroductionDespite the lack of high-quality evidence regarding its long-term effectiveness, intravenous corticosteroid therapy is recommended as the standard treatment of acute multiple sclerosis relapses in Germany. High financial expenses and the equivalent effectiveness of oral corticosteroid therapy contrast with this trend. There is an urgent need to provide patients with evidence-based and comprehensible information on relapse management and to actively involve patients in relapse treatment decisions. Web-based decision support on relapse management could be an effective measure to empower people with multiple sclerosis making informed treatment decisions.ObjectivesTo develop a web-based programme on relapse management for people with multiple sclerosis and evaluate the feasibility and acceptability of the intervention.MethodsThe study followed the first two phases of the UK Medical Research Council Framework for complex interventions. The first phase involved the development of an interactive web-based programme on relapse management. The second phase focused on the feasibility and pilot testing of the programme with people with multiple sclerosis and experts with a professional background in multiple sclerosis. Data was obtained using questionnaires with closed- and open-ended questions as well as qualitative semi-structured telephone interviews. Quantitative data was analyzed descriptively, whereas qualitative data was clustered by topic.ResultsFeasibility of the intervention programme was tested with 10 people with multiple sclerosis and 10 experts. Feasibility testing indicated good practicability and acceptance of the content. After revision, the programme was piloted with seven people with multiple sclerosis and three experts. The results showed good acceptance in both groups. Based on the feedback, a final revision was performed.ConclusionFeasibility and pilot testing indicated good user-friendliness, acceptance, and practicability of the programme. The programme is currently evaluated in a randomized controlled trial (Registration Number on ClinicalTrials.gov: NCT04233970). It is expected that the programme will have a positive impact on patients' relapse management and strengthen their autonomy and participation.

Process evaluation of an intervention to improve access to injectable contraceptive services through patent medicine vendors in Nigeria: a mixed methods study

BackgroundThe low utilisation of modern contraceptives in many low- and middle-income countries remains a challenge. Patent medicine vendors (PMVs) that operate in the informal health sector, have the potential to address this challenge. Between 2015 and 2018, the Population Council, in collaboration with the Federal and State Ministries of Health and the Pharmacy Council of Nigeria, trained PMVs in six states to deliver injectable contraceptive services. Outcome evaluation demonstrated increased client uptake of injectable contraceptive services; however, there is limited information on how and why the intervention influenced outcomes. This study was conducted to elucidate the processes and mechanism through which the previous intervention influenced women’s utilisation of injectable contraceptive services.MethodsThe study utilised a mixed methods, convergent parallel design guided by the UK Medical Research Council framework. Quantitative data were obtained from 140 trained PMVs and 145 of their clients in three states and 27 in-depth interviews were conducted among relevant stakeholders. The quantitative data were analysed descriptively, while the qualitative data were analysed thematically.ResultsThe results revealed that even after the completion of the PMV study which had a time-bound government waiver for injectable contraceptive service provision by PMVs, they continued to stock and provide injectables in response to the needs of their clients contrary to the current legislation which prohibits this. The causal mechanism that influenced women’s utilisation of injectable contraceptives were the initial training that the PMV received; the favourable regulatory environment as demonstrated in the approval provided by government for PMVs to provide injectable contraceptives for the duration of the study; and the satisfaction and the confidence the female clients had developed in the ability of the PMVs to serve them. However, there were gaps with regards to the consistent supply of quality injectable contraceptive commodities and in PMVs use of job aids. Referral and linkages to government or private-owned facilities were also sub-optimal.ConclusionPMVs continue to play important roles in family planning service provision; this underscores the need to formalize and scale-up this intervention to aid their integral roles coupled with multi-faceted initiatives to enhance the quality of their services.

Development of an internet-delivered cognitive behavioral therapy program for use in combination with exercise therapy and education by patients at increased risk of chronic pain following total knee arthroplasty

BackgroundApproximately 20% of patients experience chronic pain after total knee arthroplasty (TKA). Due to the growing number of TKA procedures, this will affect an increasing number of people worldwide. Catastrophic thinking, dysfunctional illness perception, poor mental health, anxiety and depression characterize these non-improvers, and indicate that these patients may need individualized treatment using a treatment approach based on the bio-psycho-social health model. The present study developed an internet-delivered cognitive behavioral therapy (iCBT) program to be combined with exercise therapy and education for patients with knee osteoarthritis (OA) at increased risk of chronic pain after TKA.MethodsThe development process followed the first two phases of the UK Medical Research Council framework for complex interventions. In the development phase, the first prototype of the iCBT program was developed based on literature review, established iCBT programs and multidisciplinary workshops. The feasibility phase consisted of testing the program, interviewing users, condensing the program, and tailoring it to the patient group. A physiotherapist manual was developed and adapted to physiotherapists who will serve as mentors.ResultsThe development process resulted in an iCBT program consisting of 10 modules with educational texts, videos and exercises related to relevant topics such as goalsetting, stress and pain, lifestyle, automatic thoughts, mindfulness, selective attention, worry and rumination. A physiotherapist manual was developed to guide the physiotherapists in supporting the patients through the program and to optimize adherence to the program.ConclusionsThe iCBT program is tailored to patients at risk of chronic pain following TKA, and may be useful as a supplement to surgery and/or exercise therapy. A multicentre RCT will evaluate the iCBT program in combination with an exercise therapy and education program. This novel intervention may be a valuable contribution to the treatment of OA patients at risk of chronic pain after TKA.Trial registrationThe RCT is pre-registered at ClinicalTrials.gov: NCT03771430 11/12/2018.

Optimising personal continuity for older patients in general practice: a study protocol for a cluster randomised stepped wedge pragmatic trial

BackgroundContinuity of care, in particular personal continuity, is a core principle of general practice and is associated with many benefits such as a better patient-provider relationship and lower mortality. However, personal continuity is under pressure due to changes in society and healthcare. This affects older patients more than younger patients. As the number of older patients will double the coming decades, an intervention to optimise personal continuity for this group is highly warranted.MethodsFollowing the UK Medical Research Council framework for complex Interventions, we will develop and evaluate an intervention to optimise personal continuity for older patients in general practice. In phase 0, we will perform a literature study to provide the theoretical basis for the intervention. In phase I we will define the components of the intervention by performing surveys and focus groups among patients, general practitioners, practice assistants and practice nurses, concluded by a Delphi study among members of our group. In phase II, we will test and finalise the intervention with input from a pilot study in two general practices. In phase III, we will perform a stepped wedge cluster randomised pragmatic trial. The primary outcome measure is continuity of care from the patients’ perspective, measured by the Nijmegen Continuity Questionnaire. Secondary outcome measures are level of implementation, barriers and facilitators for implementation, acceptability and feasibility of the intervention. In phase IV, we will establish the conditions for large-scale implementation.DiscussionThis is the first study to investigate an intervention for improving personal continuity for older patients in general practice. If proven effective, our intervention will enable General practitioners to improve the quality of care for their increasing population of older patients. The pragmatic design of the study will enable evaluation in real-life conditions, facilitating future implementation.Trial registration numberNetherlands Trial Register, trial NL8132. Registered 2 November 2019.

Development of a Framework and the Content for a Psychoeducational Internet-Delivered Intervention for Women after Treatment for Gynecological Cancer.

The number of women treated for gynecological cancer is increasing. At the same time, the duration of in-patient hospitalization has decreased, and follow-up with its primary focus on early recognition of recurrence does not meet all patients’ needs. One method of follow-up may be digital intervention. This study describes the development of a psychoeducational Internet-delivered intervention targeting women’s psychosocial needs during the follow-up period after treatment for gynecological cancer. The project consisted of three phases following the UK Medical Research Council Framework guidelines for the development of complex interventions. Phase one identified the evidence in the field, phase two identified the relevant theoretical framework, and phase three included a two-year work process including focus group interviews and think aloud interviews with users. Through the steps of literature review, theoretical framework, and an iterative development process with users and other stakeholders, a six-week program was developed. The program included psychoeducational information, multimedia, exercises, and weekly telephone follow-up with a dedicated nurse. This Internet-delivered intervention can be a novel method for addressing the gap in the provision of follow-up for women after treatment for gynecological cancer.

A Caregiver Digital Intervention to Support Shared Decision Making in Child and Adolescent Mental Health Services: Development Process and Stakeholder Involvement Analysis.

BackgroundParents and caregivers are generally recognized by literature and the law as key to child and adolescent mental health decisions. Digital interventions are increasingly being used to support care and treatment in child and adolescent mental health services (CAMHS). However, evidence of the design and development process is generally not made available.ObjectiveIn light of calls for more transparency, this paper aims to describe the development of an evidence-based, theoretically informed digital decision support intervention for parents and caregivers of young people accessing CAMHS.MethodsThe intervention was developed in line with the UK Medical Research Council framework for developing complex interventions. The process incorporated the steps for developing patient decision aids, as follows: assessing need, assessing feasibility; defining objectives; identifying the framework of decision support; and selecting the methods, designs, and dissemination approach. We synthesized theory, research, international guidelines, and input from relevant stakeholders using an iterative design approach.ResultsThe development steps resulted in Power Up for Parents, a decision support intervention, with five key features (ie, decisions, goals, journey, support, and resources). The intervention aims to encourage discussion, allow parents to ask questions during sessions or seek further information between sessions, and allow service providers to tailor the shared decision-making process to accommodate the needs of the parent and child.ConclusionsWe confirmed that it is possible to use input from end users—integrated with theory and evidence—to create digital interventions to be used in CAMHS. Key lessons with implications for practice, policy, and implementation science, along with preliminary findings, are presented.International Registered Report Identifier (IRRID)RR2-10.2196/14571

Developing a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia

Background: Antipsychotics are commonly prescribed to people living with dementia in nursing home settings, despite strong guideline recommendations against their use except in limited circumstances. We aimed to transparently describe the development process for a complex intervention targeting appropriate requesting and prescribing of antipsychotics to nursing home residents with dementia in Ireland, by nurses and general practitioners (GPs) respectively. Methods: We report the development process for the ‘Rationalising Antipsychotic Prescribing in Dementia’ (RAPID) complex intervention, in accordance with the ‘Guidance for reporting intervention development studies in health research’ (GUIDED) checklist. The UK Medical Research Council framework for developing and evaluating complex interventions guided our overall approach, incorporating evidence and theory into the intervention development process. To unpack the intervention development process in greater detail, we followed the Behaviour Change Wheel approach. Guided by our stakeholders, we conducted three sequential studies (systematic review and qualitative evidence synthesis, primary qualitative study and expert consensus study), to inform the intervention development. Results: The RAPID complex intervention was developed in collaboration with a broad range of stakeholders, including people living with dementia and family carers, between 2015 and 2017. The finalised RAPID complex intervention was comprised of the following three components; 1) Education and training sessions with nursing home staff; 2) Academic detailing with GPs; 3) Introduction of an assessment tool to the nursing home. Conclusions: This paper describes the steps used by the researchers to develop a complex intervention targeting antipsychotic prescribing to nursing home residents with dementia in Ireland, according to the GUIDED checklist. We found that the GUIDED checklist provided a useful way of reporting all elements in a cohesive manner and complemented the other tools and frameworks used. Transparency in the intervention development processes can help in the translation of evidence into practice.

A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Development Study.

The World Health Organization has developed the Integrated Care of Older People (ICOPE) strategy, a program based on the measurement of intrinsic capacity (IC) as “the composite of all physical and mental attributes on which an individual can draw”. Multicomponent interventions appear to be the most effective approach to enhance IC and to prevent frailty and disability since adapted physical activity is the preventive intervention that has shown the most evidence in the treatment of frailty and risk of falls. Our paper describes the development of a multi-domain group-based intervention addressed to older people living in the community, aimed at improving and/or maintaining intrinsic capacity by means of promoting physical activity, healthy nutrition, and psychological wellbeing in older people. The process of intervention development is described following the Guidance for reporting intervention development studies in health research (GUIDED). The result of this study is the AMICOPE intervention (Aptitude Multi-domain group-based intervention to improve and/or maintain IC in Older PEople) built upon the ICOPE framework and described following the Template for Intervention Description and Replication (TIDieR) guidelines. The intervention consists of 12 face-to-face sessions held weekly for 2.5 h over three months and facilitated by a pair of health and social care professionals. This study represents the first stage of the UK Medical Research Council framework for developing and evaluating a complex intervention. The next step should be carrying out a feasibility study for the AMICOPE intervention and, at a later stage, assessing the effectiveness in a randomized controlled trial.