Effectiveness of Self-guided Tailored Implementation Strategies in Integrating and Embedding Internet-Based Cognitive Behavioral Therapy in Routine Mental Health Care: Results of a Multicenter Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Internet-based cognitive behavioral therapy (iCBT) services for common mental health disorders have been found to be effective. There is a need for strategies that improve implementation in routine practice. One-size-fits-all strategies are likely to be ineffective. Tailored implementation is considered as a promising approach. The self-guided integrated theory-based Framework for intervention tailoring strategies toolkit (ItFits-toolkit) supports local implementers in developing tailored implementation strategies. Tailoring involves identifying local barriers; matching selected barriers to implementation strategies; developing an actionable work plan; and applying, monitoring, and adapting where necessary. OBJECTIVE: This study aimed to compare the effectiveness of the ItFits-toolkit with implementation-as-usual (IAU) in implementing iCBT services in 12 routine mental health care organizations in 9 countries in Europe and Australia. METHODS: A stepped-wedge cluster randomized trial design with repeated measures was applied. The trial period lasted 30 months. The primary outcome was the normalization of iCBT delivery by service providers (therapists, referrers, IT developers, and administrators), which was measured with the Normalization Measure Development as a proxy for implementation success. A 3-level linear mixed-effects modeling was applied to estimate the effects. iCBT service uptake (referral and treatment completion rates) and implementation effort (hours) were used as secondary outcomes. The perceived satisfaction (Client Satisfaction Questionnaire), usability (System Usability Scale), and impact of the ItFits-toolkit by implementers were used to assess the acceptability of the ItFits-toolkit. RESULTS: In total, 456 mental health service providers were included in this study. Compared with IAU, the ItFits-toolkit had a small positive statistically significant effect on normalization levels in service providers (mean 0.09, SD 0.04; P=.02; Cohen d=0.12). The uptake of iCBT by patients was similar to that of IAU. Implementers did not spend more time on implementation work when using the ItFits-toolkit and generally regarded the ItFits-toolkit as usable and were satisfied with it. CONCLUSIONS: The ItFits-toolkit performed better than the usual implementation activities in implementing iCBT services in routine practice. There is practical utility in the ItFits-toolkit for supporting implementers in developing and applying effective tailored implementation strategies. However, the effect on normalization levels among mental health service providers was small. These findings warrant modesty regarding the effectiveness of self-guided tailored implementation of iCBT services in routine practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03652883; https://clinicaltrials.gov/ct2/show/NCT03652883. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04686-4.

Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals.

BACKGROUND: Inconsistent and poorly coordinated systems of tracheostomy care commonly result in frustrations, delays, and harm. Quality improvement strategies described by exemplar hospitals of the Global Tracheostomy Collaborative have potential to mitigate such problems. This 3 yr guided implementation programme investigated interventions designed to improve the quality and safety of tracheostomy care. METHODS: The programme management team guided the implementation of 18 interventions over three phases (baseline/implementation/evaluation). Mixed-methods interviews, focus groups, and Hospital Anxiety and Depression Scale questionnaires defined outcome measures, with patient-level databases tracking and benchmarking process metrics. Appreciative inquiry, interviews, and Normalisation Measure Development questionnaires explored change barriers and enablers. RESULTS: All sites implemented at least 16/18 interventions, with the magnitude of some improvements linked to staff engagement (1536 questionnaires from 1019 staff), and 2405 admissions (1868 ICU/high-dependency unit; 7.3% children) were prospectively captured. Median stay was 50 hospital days, 23 ICU days, and 28 tracheostomy days. Incident severity score reduced significantly (n=606; P<0.01). There were significant reductions in ICU (-;0.25 days month-1), ventilator (-;0.11 days month-1), tracheostomy (-;0.35 days month-1), and hospital (-;0.78 days month-1) days (all P<0.01). Time to first vocalisation and first oral intake both decreased by 7 days (n=733; P<0.01). Anxiety decreased by 44% (from 35.9% to 20.0%), and depression decreased by 55% (from 38.7% to 18.3%) (n=385; both P<0.01). Independent economic analysis demonstrated £33 251 savings per patient, with projected annual UK National Health Service savings of £275 million. CONCLUSIONS: This guided improvement programme for tracheostomy patients significantly improved the quality and safety of care, contributing rich qualitative improvement data. Patient-centred outcomes were improved along with significant efficiency and cost savings across diverse UK hospitals. CLINICAL TRIAL REGISTRATION: IRAS-ID-206955; REC-Ref-16/LO/1196; NIHR Portfolio CPMS ID 31544.

Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

BACKGROUND: Understanding and measuring implementation processes is a key challenge for implementation researchers. This study draws on Normalization Process Theory (NPT) to develop an instrument that can be applied to assess, monitor or measure factors likely to affect normalization from the perspective of implementation participants. METHODS: An iterative process of instrument development was undertaken using the following methods: theoretical elaboration, item generation and item reduction (team workshops); item appraisal (QAS-99); cognitive testing with complex intervention teams; theory re-validation with NPT experts; and pilot testing of instrument. RESULTS: We initially generated 112 potential questionnaire items; these were then reduced to 47 through team workshops and item appraisal. No concerns about item wording and construction were raised through the item appraisal process. We undertook three rounds of cognitive interviews with professionals (n = 30) involved in the development, evaluation, delivery or reception of complex interventions. We identified minor issues around wording of some items; universal issues around how to engage with people at different time points in an intervention; and conceptual issues around the types of people for whom the instrument should be designed. We managed these by adding extra items (n = 6) and including a new set of option responses: 'not relevant at this stage', 'not relevant to my role' and 'not relevant to this intervention' and decided to design an instrument explicitly for those people either delivering or receiving an intervention. This version of the instrument had 53 items. Twenty-three people with a good working knowledge of NPT reviewed the items for theoretical drift. Items that displayed a poor alignment with NPT sub-constructs were removed (n = 8) and others revised or combined (n = 6). The final instrument, with 43 items, was successfully piloted with five people, with a 100% completion rate of items. CONCLUSION: The process of moving through cycles of theoretical translation, item generation, cognitive testing, and theoretical (re)validation was essential for maintaining a balance between the theoretical integrity of the NPT concepts and the ease with which intended respondents could answer the questions. The final instrument could be easily understood and completed, while retaining theoretical validity. NoMAD represents a measure that can be used to understand implementation participants' experiences. It is intended as a measure that can be used alongside instruments that measure other dimensions of implementation activity, such as implementation fidelity, adoption, and readiness.

Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT).

INTRODUCTION: Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated. METHODS: Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample. RESULTS: We obtained 831 completed questionnaires, an average response rate of 39% (range: 22-77%). Full completion of items was 50% (n = 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach's alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89). CONCLUSIONS: The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.

Making sense of a cognitive behavioural therapy intervention for fear of falling: qualitative study of intervention development.

BACKGROUND: Fear of Falling (FoF) is commonly reported among older adults (up to 50%) and can impact negatively on physical and social activities, mood and quality of life. This paper explores the development, acceptability and feasibility of a cognitive behavioural therapy intervention (CBTi) for FoF. METHODS: The process evaluation of the CBTi development phase of an RCT (conducted in the UK) reported here, used ethnographic methods. Data included: interviews with patients and carers (n = 16), clinic staff (n = 6) and the psychologists developing the CBTi (n = 3); observational field notes and transcripts of intervention development meetings (n = 9) and stakeholder engagement meetings (n = 2); and informal discussions with staff developing the CBTi (n = 8). Data collection and thematic analysis were guided by Normalisation Process Theory (NPT). RESULTS: The process evaluation showed two domains of work necessary to develop a CBTi that made sense to stakeholders, and that could be delivered as part of an RCT. For the psychologists developing the content of the CBTi, a growing understanding of the complexity of FoF highlighted the need for an individualised rather than a manualised intervention. For the research team, the work involved adapting the structures and processes of the RCT to address preliminary concerns over the acceptability and feasibility of the proposed CBTi. CONCLUSIONS: Theory-based approaches to process evaluation can sensitise researchers to contested understandings about proposed interventions that could undermine implementation. Drawing on the coherence construct of NPT, this study emphasises the nature and extent of work required to ensure an intervention makes sufficient sense to key stakeholders in order to maximise chances of successful implementation.

How is tailored implementation undertaken using a self-guided toolkit? Qualitative study of the ItFits-toolkit in the ImpleMentAll project.

BACKGROUND: The process of tailored implementation is ill-defined and under-explored. The ItFits-toolkit was developed and subsequently tested as a self-guided online platform to facilitate implementation of tailored strategies for internet-based cognitive behavioural therapy (iCBT) services. In ImpleMentAll, ItFits-toolkit had a small but positive effect on the primary outcome of iCBT normalisation. This paper investigates, from a qualitative perspective, how implementation teams developed and undertook tailored implementation using the toolkit within the trial. METHODS: Implementation teams in thirteen sites from nine countries (Europe and Australia) used the ItFits-toolkit for six months minimum, consistent with the trial protocol. A qualitative process evaluation was conducted. Descriptive data regarding goals, barriers, strategies, and implementation plans collected within the toolkit informed qualitative data collection in real time. Qualitative data included remote longitudinal interviews (n = 55) with implementation team members (n = 30) and observations of support calls (n = 19) with study sites. Qualitative data were analysed thematically, using a team-based approach. RESULTS: Implementation teams developed and executed tailored implementation projects across all steps in the toolkit process. Working in a structured way but with room for flexibility, decisions were shaped by team members' ideas and goals, iterative stakeholder engagement, internal and external influences, and the context of the ImpleMentAll project. Although teams reported some positive impacts of their projects, 'time', both for undertaking the work, and for seeing project impacts, was described as a key factor in decisions about implementation strategies and assessments of success. CONCLUSION: This study responds directly to McHugh et al.'s (2022) call for empirical description of what implementation tailoring looks like in action, in service settings. Self-guided facilitation of tailored implementation enables implementers in service settings to undertake tailoring within their organisations. Implementation tailoring takes considerable time and involves detailed work but can be supported through the provision of implementation science informed guidance and materials, iterative and ongoing stakeholder engagement, and working reflectively in response to external influencing factors. Directions for advancement of tailored implementation are suggested.

From theory to 'measurement' in complex interventions: methodological lessons from the development of an e-health normalisation instrument.

BACKGROUND: Although empirical and theoretical understanding of processes of implementation in health care is advancing, translation of theory into structured measures that capture the complex interplay between interventions, individuals and context remain limited. This paper aimed to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring implementation processes relating to e-health interventions; and (2) identify key issues and methodological challenges for advancing work in this field. METHODS: A 30-item instrument (Technology Adoption Readiness Scale (TARS)) for measuring normalisation processes in the context of e-health service interventions was developed on the basis on Normalization Process Theory (NPT). NPT focuses on how new practices become routinely embedded within social contexts. The instrument was pre-tested in two health care settings in which e-health (electronic facilitation of healthcare decision-making and practice) was used by health care professionals. RESULTS: The developed instrument was pre-tested in two professional samples (N=46; N=231). Ratings of items representing normalisation 'processes' were significantly related to staff members' perceptions of whether or not e-health had become 'routine'. Key methodological challenges are discussed in relation to: translating multi-component theoretical constructs into simple questions; developing and choosing appropriate outcome measures; conducting multiple-stakeholder assessments; instrument and question framing; and more general issues for instrument development in practice contexts. CONCLUSIONS: To develop theory-derived measures of implementation process for progressing research in this field, four key recommendations are made relating to (1) greater attention to underlying theoretical assumptions and extent of translation work required; (2) the need for appropriate but flexible approaches to outcomes measurement; (3) representation of multiple perspectives and collaborative nature of work; and (4) emphasis on generic measurement approaches that can be flexibly tailored to particular contexts of study.

Understanding implementation context and social processes through integrating Normalization Process Theory (NPT) and the Consolidated Framework for Implementation Research (CFIR).

BACKGROUND: For successful implementation of an innovation within a complex adaptive system, we need to understand the ways that implementation processes and their contexts shape each other. To do this, we need to explore the work people do to make sense of an innovation and integrate it into their workflow and the contextual elements that impact implementation. Combining Normalization Process Theory (NPT) with the Consolidated Framework for Implementation Research (CFIR) offers an approach to achieve this. NPT is an implementation process theory that explains how changes in the way people think about and use an innovation occurs, while CFIR is a framework that categorizes and describes contextual determinants across five domains that influence implementation. We demonstrate through a case example from our prior research how we integrated NPT and CFIR to inform the development of the interview guide, coding manual, and analysis of the findings. METHODS: In collaboration with our stakeholders, we selected NPT and CFIR to study the implementation process and co-developed an interview guide to elicit responses that would illuminate concepts from both. We conducted, audio-recorded, and transcribed 28 interviews with various professionals involved with the implementation. Based on independent coding of select transcripts and team discussion comparing, clarifying, and crystallizing codes, we developed a coding manual integrating CFIR and NPT constructs. We applied the integrated codes to all interview transcripts. RESULTS: Our findings highlight how integrating CFIR domains with NPT mechanisms adds explanatory strength to the analysis of implementation processes, with particular implications for practical strategies to facilitate implementation. Multiple coding across both theoretical frames captured the entanglement of process and context. Integrating NPT and CFIR enriched understandings of how interactions between implementation processes and contextual determinants shaped each other during implementation. CONCLUSION: The integration of NPT and CFIR provides guidance to identify and explore complex entangled interactions between agents, processes, and contextual conditions within and beyond organizations to embed innovations into routine practices. Nuanced understandings gained through this approach moves understandings beyond descriptions of determinants to explain how change occurs or not during implementation. Mechanism-based explanations illuminate concrete practical strategies to support implementation.

"We couldn't think in the box if we tried. We can't even find the damn box": A qualitative study of the lived experiences of autistic adults and relatives of autistic adults.

Autistic children grow to become autistic adults, and autism is increasingly diagnosed in adulthood and later life. This qualitative study aimed to understand experiences of autism throughout adulthood. A national cohort study of autistic adults and relatives of autistic adults (ASC-UK), enabled purposive recruitment of a diverse sample. Semi-structured interviews were conducted with 29 autistic adults (aged 20-71 years), mostly diagnosed in adulthood, and 16 relatives (aged 31-81 years) of autistic adults diagnosed across both childhood and adulthood (including some with learning disability). Interview topics included health, relationships, education, employment, quality of life and everyday experiences. Thematic analysis of the accounts of the autistic adults identified six key themes relating to their experiences: (1) diagnosis as validating yet limiting; (2) supportive and non-supportive social agents; (3) the "invisibility" of the needs of autistic adults; (4) health in the context of autism; (5) staying 'outside' the circle; and (6) multiple lives with autism. Data from relatives about autistic adult experiences gave additional perspectives on these themes. Experiences reported in other studies-of 'difference' from others, challenges of social engagement, and learning to 'conform' to society's expectations-were evident and relevant to male and female autistic adults, across all age groups, and unrelated to stage of life when diagnosed. Some expressed disappointment with their lives, but others were proud of their achievements. Education and employment, whilst challenging for many, were also rewarding for some. Health care and social services were often experienced as inaccessible, inappropriate, or lacking understanding of the individual's needs. We conclude that greater public understanding of autism as experienced in adulthood is needed. Key priorities are improving the availability of 'appropriate' health and social care services for autistic adults and families, and providing practical support to enable enhanced participation in life.

Translational framework for implementation evaluation and research: Protocol for a qualitative systematic review of studies informed by Normalization Process Theory (NPT) [version 1; peer review: 2 approved].

Background: Normalization Process Theory (NPT) identifies mechanisms that have been demonstrated to play an important role in implementation processes. It is now widely used to inform feasibility, process evaluation, and implementation studies in healthcare and other areas of work. This qualitative synthesis of NPT studies aims to better understand how NPT explains observed and reported implementation processes, and to explore the ways in which its constructs explain the implementability, enacting and sustainment of complex healthcare interventions. Methods: We will systematically search Scopus, PubMed and Web of Science databases and use the Google Scholar search engine for citations of key papers in which NPT was developed. This will identify English language peer-reviewed articles in scientific journals reporting (a) primary qualitative or mixed methods studies; or, (b) qualitative or mixed methods evidence syntheses in which NPT was the primary analytic framework. Studies may be conducted in any healthcare setting, published between June 2006 and 31 December 2021. We will perform a qualitative synthesis of included studies using two parallel methods: (i) directed content analysis based on an already developed coding manual; and (ii) unsupervised textual analysis using Leximancer® topic modelling software. Other: We will disseminate results of the review using peer reviewed publications, conference and seminar presentations, and social media (Facebook and Twitter) channels. The primary source of funding is the National Institute for Health Research ARC North Thames. No human subjects or personal data are involved and no ethical issues are anticipated.

Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development.

BACKGROUND: Normalisation Process Theory (NPT) is frequently used to inform qualitative research that aims to explain and evaluate processes that shape late-stage translation of innovations in the organisation and delivery of healthcare. A coding manual for qualitative researchers using NPT will facilitate transparent data analysis processes and will also reduce the cognitive and practical burden on researchers. OBJECTIVES: (a) To simplify the theory for the user. (b) To describe the purposes, methods of development, and potential application of a coding manual that translates normalisation process theory (NPT) into an easily usable framework for qualitative analysis. (c) To present an NPT coding manual that is ready for use. METHOD: Qualitative content analysis of papers and chapters that developed normalisation process theory, selection and structuring of theory constructs, and testing constructs against interview data and published empirical studies using NPT. RESULTS: A coding manual for NPT was developed. It consists of 12 primary NPT constructs and conforms to the Context-Mechanism-Outcome configuration of realist evaluation studies. Contexts are defined as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and reframing organisational logics are enacted. Mechanisms are defined as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and reflexive monitoring. Outcomes are defined as effects that make visible how things change as implementation processes proceed and include intervention mobilisation, normative restructuring, relational restructuring, and sustainment. CONCLUSION: The coding manual is ready to use and performs three important tasks. It consolidates several iterations of theory development, makes the application of NPT simpler for the user, and links NPT constructs to realist evaluation methods. The coding manual forms the core of a translational framework for implementation research and evaluation.

Integrating telecare for chronic disease management in the community: what needs to be done?

BACKGROUND: Telecare could greatly facilitate chronic disease management in the community, but despite government promotion and positive demonstrations its implementation has been limited. This study aimed to identify factors inhibiting the implementation and integration of telecare systems for chronic disease management in the community. METHODS: Large scale comparative study employing qualitative data collection techniques: semi-structured interviews with key informants, task-groups, and workshops; framework analysis of qualitative data informed by Normalization Process Theory. Drawn from telecare services in community and domestic settings in England and Scotland, 221 participants were included, consisting of health professionals and managers; patients and carers; social care professionals and managers; and service suppliers and manufacturers. RESULTS: Key barriers to telecare integration were uncertainties about coherent and sustainable service and business models; lack of coordination across social and primary care boundaries, lack of financial or other incentives to include telecare within primary care services; a lack of a sense of continuity with previous service provision and self-care work undertaken by patients; and general uncertainty about the adequacy of telecare systems. These problems led to poor integration of policy and practice. CONCLUSION: Telecare services may offer a cost effective and safe form of care for some people living with chronic illness. Slow and uneven implementation and integration do not stem from problems of adoption. They result from incomplete understanding of the role of telecare systems and subsequent adaption and embeddedness to context, and uncertainties about the best way to develop, coordinate, and sustain services that assist with chronic disease management. Interventions are therefore needed that (i) reduce uncertainty about the ownership of implementation processes and that lock together health and social care agencies; and (ii) ensure user centred rather than biomedical/service-centred models of care.

Barriers and facilitators to implementing interventions for medically unexplained symptoms in primary and secondary care: A systematic review.

OBJECTIVE: To integrate existing literature on barriers and facilitators to implementing interventions for Medically Unexplained Symptoms (MUS) in primary and secondary care. METHOD: Systematic review following PRISMA guidelines. A search of PsychINFO/Pubmed/Web of Science was performed to select studies focusing on MUS-interventions and implementation. All included papers were checked for quality and bias. A narrative synthesis approach was used to describe the included papers by implementation level, ranging from the specific intervention to the broader economic/political context. RESULTS: 20 (quantitative/qualitative/mixed design) papers were included, but the quantitative studies especially, lacked methodological quality, with possible publication bias as a result. Results showed that the intervention needs to be acceptable and in line with daily practice routines. The professional's attitude and skills are important for implementation success, as well as for overcoming problems in the professional-patient interaction. If patients stick to finding a somatic cause, this hampers implementation. A lack of time is a frequently mentioned barrier at the organizational level. Barriers/facilitators at the social context level and at the economic/political level were barely reported on in the included papers. CONCLUSION: Results were integrated into an existing implementation model, as an example of how MUS-interventions can be successfully implemented in practice.

Combining Realist approaches and Normalization Process Theory to understand implementation: a systematic review.

BACKGROUND: Realist approaches and Normalization Process Theory (NPT) have both gained significant traction in implementation research over the past 10 years. The aim of this study was therefore to explore how the approaches are combined to understand problems of implementation, to determine the degree of complementarity of the two approaches and to provide practical approaches for using them together. METHODS: Systematic review of research studies combining Realist and NPT approaches. Realist methodology is concerned with understanding and explaining causation, that is, how and why policies, programmes and interventions achieve their effects. NPT is a theory of implementation that explains how practices become normalised. Databases searched (January 2020) were ASSIA, CINAHL, Health Research Premium Collection via Proquest (Family Health Database, Health & Medical Collection, Health Management Database, MEDLINE, Nursing & Allied Health Database, Psychology Database, Public Health Database) and PsycARTICLES. Studies were included if the author(s) stated they used both approaches: a scientific Realist perspective applying the principles of Pawson and Tilley's Realist Evaluation or Pawson's Realist Synthesis and Normalization Process Theory either solely or in addition to other theories. Two authors screened records; discrepancies were reviewed by a third screener. Data was extracted by three members of the team and a narrative synthesis was undertaken. RESULTS: Of 245 total records identified, 223 unique records were screened and 39 full-text papers were reviewed, identifying twelve papers for inclusion in the review. These papers represented eight different studies. Extent and methods of integration of the approaches varied. In most studies (6/8), Realist approaches were the main driver. NPT was mostly used to enhance the explanatory power of Realist analyses, informing development of elements of Contexts, Mechanisms and Outcomes (a common heuristic in realist work). Authors' reflections on the integration of NPT and Realist approaches were limited. CONCLUSIONS: Using Realist and NPT approaches in combination can add explanatory power for understanding the implementation of interventions and programmes. Attention to detailed reporting on methods and analytical process when combining approaches, and appraisal of theoretical and practical utility is advised for advancing knowledge of applying these approaches in research. SYSTEMATIC REVIEW REGISTRATION: Not registered.

Implementing innovative evidence-based perinatal mental health screening for women of refugee background.

PROBLEM: National guidelines recommend repeated screening for depression and anxiety for all women in the perinatal period. Routine screening in pregnancy is limited due to service, community and individual barriers. BACKGROUND: Perinatal depression and perinatal anxiety affect up to 20% of all women. Women of refugee background are at even greater risk for perinatal mental health conditions due to refugee experiences and resettlement stressors. AIM: To evaluate the acceptability and feasibility of a perinatal mental health screening program for women of refugee background from the perspective of health professionals. METHODS: A mixed methods design guided by the Normalization Process Theory was used. Data were collected at a dedicated refugee antenatal clinic in the south-eastern suburbs of Melbourne, Australia. An online survey (n=38), focus groups (n=2; 13 participants) and semi-structured interviews (n=8; 11 participants) with health professionals were conducted. FINDINGS: Under the four constructs of the Normalization Process Theory, health professionals reported improvements in identifying and referring women with mental health issues, more open and in-depth conversations with women about mental health and valued using an evidenced-based measure. Key issues included professional development, language barriers and time constraints. DISCUSSION: Implementing a perinatal mental health screening program has been positively received. Strategies for sustainability include professional development and the addition of audio versions of the measures. CONCLUSION: This perinatal mental health screening program is acceptable and a feasible option for health professionals. Health professionals value providing more holistic care and have more open discussion with women about mental health.

Future patients? Telehealthcare, roles and responsibilities.

Increasing use of information and communication technologies is said to be transforming health care. Telehealthcare enables medical consultations to be conducted between patients and health professionals across different locations. Such technologies imply new relationships between patients and health professionals. This study aimed to understand how policy and practice in relation to telehealthcare suggests new conceptualisations of 'the patient'. In-depth semistructured interviews (n = 38) were conducted with key informants from across the UK, known to have involvement or interest in telehealthcare from a variety of perspectives: health professionals (n = 11), patient advocates (n = 7), telemedicine experts (n = 6), policy-makers (n = 4), administrators (n = 4), researchers (n = 3) and technologists (n = 3). Interviews were conducted either in person or over the telephone, and were audio-recorded. Data were analysed thematically with ongoing cross-validation of data interpretation between members of the research team. The results indicated divergent views about the role of the patient, although accounts of patients becoming 'educated self-managers', taking on a more active role in their healthcare, were predominant. Beliefs about the impact of telehealthcare on patients were focused on perceived 'priorities' such as access, location of services, confidentiality and choice; however, there remains little understanding of the trade-offs that patients are willing to make in the context of technologically mediated health care. The results also highlight ideas around how patients relate to technologies; the extent to which technologies might fragment care and medicine in new or unexpected ways, and participation and absence of patients in decision-making about policies and services. The results of this study have important implications for the ways in which relationships between health professionals and patients are managed in practice, and raise important questions for public participation in service development.

Process evaluation for complex interventions in primary care: understanding trials using the normalization process model.

BACKGROUND: The Normalization Process Model is a conceptual tool intended to assist in understanding the factors that affect implementation processes in clinical trials and other evaluations of complex interventions. It focuses on the ways that the implementation of complex interventions is shaped by problems of workability and integration. METHOD: In this paper the model is applied to two different complex trials: (i) the delivery of problem solving therapies for psychosocial distress, and (ii) the delivery of nurse-led clinics for heart failure treatment in primary care. RESULTS: Application of the model shows how process evaluations need to focus on more than the immediate contexts in which trial outcomes are generated. Problems relating to intervention workability and integration also need to be understood. The model may be used effectively to explain the implementation process in trials of complex interventions. CONCLUSION: The model invites evaluators to attend equally to considering how a complex intervention interacts with existing patterns of service organization, professional practice, and professional-patient interaction. The justification for this may be found in the abundance of reports of clinical effectiveness for interventions that have little hope of being implemented in real healthcare settings.

Cognitive-behavioural therapy-based intervention to reduce fear of falling in older people: therapy development and randomised controlled trial - the Strategies for Increasing Independence, Confidence and Energy (STRIDE) study.

BACKGROUND: Falls cause fear, anxiety and loss of confidence, resulting in activity avoidance, social isolation and increasing frailty. The umbrella term for these problems is 'fear of falling', seen in up to 85% of older adults who fall. Evidence of effectiveness of physical and psychological interventions is limited, with no previous studies examining the role of an individually delivered cognitive-behavioural therapy (CBT) approach. OBJECTIVES: Primary objective To develop and then determine the effectiveness of a new CBT intervention (CBTi) delivered by health-care assistants (HCAs) plus usual care compared with usual care alone in reducing fear of falling. Secondary objectives To measure the impact of the intervention on falls, injuries, functional abilities, anxiety/depression, quality of life, social participation and loneliness; investigate the acceptability of the intervention for patients, family members and professionals and factors that promote or inhibit its implementation; and measure the costs and benefits of the intervention. DESIGN: Phase I CBTi development. Phase II Parallel-group patient randomised controlled trial (RCT) of the new CBTi plus usual care compared with usual care alone. SETTING: Multidisciplinary falls services. PARTICIPANTS: Consecutive community-dwelling older adults, both sexes, aged ≥ 60 years, with excessive or undue fear of falling per Falls Efficacy Scale-International (FES-I) score of > 23. INTERVENTIONS: Phase I Development of the CBTi. The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting. Phase II RCT. The CBTi was delivered by HCAs weekly for 8 weeks, with a 6-month booster session plus usual care. MAIN OUTCOME MEASURES: These were assessed at baseline, 8 weeks, 6 months and 12 months. Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months. Secondary outcome measures These comprised falls, injuries, anxiety/depression [Hospital Anxiety and Depression Scale (HADS)], quality of life, social participation, loneliness and measures of physical function. There were process and health-economic evaluations alongside the trial. RESULTS: Four hundred and fifteen patients were recruited, with 210 patients randomised to CBTi group and 205 to the control group. There were significant reductions in mean FES-I [-4.02; 95% confidence interval (CI) -5.95 to -2.1], single-item numerical fear of falling scale (-1.42; 95% CI -1.87 to 1.07) and HADS (-1; 95% CI -1.6 to -0.3) scores at 12 months in the CBTi group compared with the usual care group. There were no differences in the other secondary outcome measures. Most patients found the CBTi acceptable. Factors affecting the delivery of the CBTi as part of routine practice were identified. There was no evidence that the intervention was cost-effective. CONCLUSIONS: Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services. There was no impact on other measures. FURTHER WORK: Further work should focus on a joint CBTi and physical training approach to fear of falling, more rational targeting of CBTi, the possibility of mixed group and individual CBTi, and the cost-effectiveness of provision of CBTi by non-specialists. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78396615. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 56. See the NIHR Journals Library website for further project information.

Improving the normalization of complex interventions: measure development based on normalization process theory (NoMAD): study protocol.

BACKGROUND: Understanding implementation processes is key to ensuring that complex interventions in healthcare are taken up in practice and thus maximize intended benefits for service provision and (ultimately) care to patients. Normalization Process Theory (NPT) provides a framework for understanding how a new intervention becomes part of normal practice. This study aims to develop and validate simple generic tools derived from NPT, to be used to improve the implementation of complex healthcare interventions. OBJECTIVES: The objectives of this study are to: develop a set of NPT-based measures and formatively evaluate their use for identifying implementation problems and monitoring progress; conduct preliminary evaluation of these measures across a range of interventions and contexts, and identify factors that affect this process; explore the utility of these measures for predicting outcomes; and develop an online users' manual for the measures. METHODS: A combination of qualitative (workshops, item development, user feedback, cognitive interviews) and quantitative (survey) methods will be used to develop NPT measures, and test the utility of the measures in six healthcare intervention settings. DISCUSSION: The measures developed in the study will be available for use by those involved in planning, implementing, and evaluating complex interventions in healthcare and have the potential to enhance the chances of their implementation, leading to sustained changes in working practices.