Unpacking the Cinderella black box of complex intervention development through the Partners at Care Transitions (PACT) programme of research.

INTRODUCTION: Complex intervention development has been described as the 'Cinderella' black box in health services research. Greater transparency in the intervention development process is urgently needed to help reduce research waste. METHODS: We applied a new consensus-based framework for complex intervention development to our programme of research, in which we developed an intervention to improve the safety and experience of care transitions for older people. Through this process, we aimed to reflect on the framework's utility for intervention development and identify any important gaps within it to support its continued development. FINDINGS: The framework was a useful tool for transparent reporting of the process of complex intervention development. We identified potential 'action' gaps in the framework including 'consolidation of evidence' and 'development of principles' that could bracket and steer decision-making in the process. CONCLUSIONS: We consider that the level of transparency demonstrated in this report, aided through use of the framework, is essential in the quest for reducing research waste. PATIENT OR PUBLIC CONTRIBUTION: We have involved our dedicated patient and public involvement group in all work packages of this programme of research. Specifically, they attended and contributed to co-design workshops and contributed to finalizing the intervention for the pilot evaluation. Staff also participated by attending co-design workshops, helping us to prioritize content ideas for the intervention and supporting the development of intervention components outside of the workshops.

A qualitative formative evaluation of a patient facing intervention to improve care transitions for older people moving from hospital to home.

BACKGROUND: The Partners at Care Transitions (PACTs) intervention was developed to support older people's involvement in hospital to improve outcomes at home. A booklet, question card, record sheet, induction leaflet, and patient-friendly discharge letter support patients to be more involved in their health and wellbeing, medications, activities of daily living and post-discharge care. We aimed to assess intervention acceptability, identify implementation tools, and further develop the intervention. METHODS: This was a qualitative formative evaluation involving three wards from one hospital. We recruited 25 patients aged 75 years and older. Ward staff supported intervention delivery. Data were collected in wards and patients' homes, through semi-structured interviews, observation, and documentary analysis. Data were analysed inductively and iteratively with findings sorted according to the research aims. RESULTS: Patients and staff felt there was a need for, and understood the purpose of, the PACT intervention. Most patients read the booklet but other components were variably used. Implementation challenges included time, awareness, and balancing intervention benefits against risks. Changes to the intervention and implementation included clarifying the booklet's messages, simplifying the discharge letter to reduce staff burden, and using prompts and handouts to promote awareness. CONCLUSION: The PACT intervention offers a promising new way to improve care transitions for older people by supporting patient involvement in their care. After further development of the intervention and implementation package, it will undergo further testing. PATIENT OR PUBLIC CONTRIBUTION: This study regularly consulted a panel representing the local patient community, who supported the development of this intervention and its implementation.

Doing involvement: A qualitative study exploring the 'work' of involvement enacted by older people and their carers during transition from hospital to home.

CONTEXT: Being involved in one's care is prioritised within UK healthcare policy to improve care quality and safety. However, research suggests that many older people struggle with this. DESIGN: We present focused ethnographic research exploring older peoples' involvement in healthcare from hospital to home. RESULTS: We propose that being involved in care is a dynamic form of labour, which we call 'involvement work' (IW). In hospital, many patients 'entrust' IW to others; indeed, when desired, maintaining control, or being actively involved, was challenging. Patient and professionals' expectations, alongside hospital processes, promoted delegation; staff frequently did IW on patients' behalf. Many people wanted to resume IW postdischarge, but struggled because they were out of practice. DISCUSSION: Preference and capacity for involvement was dynamic, fluctuating over time, according to context and resource accessibility. The challenges of resuming IW were frequently underestimated by patients and care providers, increasing dependence on others post-discharge and negatively affecting peoples' sense and experience of (in)dependence. CONCLUSIONS: A balance needs to be struck between respecting peoples' desire/capacity for non-involvement in hospital while recognising that 'delegating' IW can be detrimental. Increasing involvement will require patient and staff roles to be reframed, though this must be done acknowledging the limits of patient desire, capability,and resources. Hospital work should be (re)organised to maximise involvement where possible and desired. PATIENT/PUBLIC CONTRIBUTION: Our Patient and Public Involvement and Engagement Panel contributed to research design, especially developing interview guides and patient-facing documentation. Patients were key participants within the study; it is their experiences represented.

Validation of the Partners at Care Transitions Measure (PACT-M): assessing the quality and safety of care transitions for older people in the UK.

BACKGROUND: The Partners at Care Transitions Measure (PACT-M) is a patient-reported questionnaire for evaluation of the quality and safety of care transitions from hospital to home, as experienced by older adults. PACT-M has two components; PACT-M 1 to capture the immediate post discharge period and PACT-M 2 to assess the experience of managing care at home. In this study, we aim to examine the psychometric properties, factor structure, validity and reliability of the PACT-M. METHODS: We administered the PACT-M over the phone and by mail, within one week post discharge with 138 participants and one month after discharge with 110 participants. We performed principal components analysis and factors were assessed for internal consistency, reliability and construct validity. RESULTS: Reliability was assessed by calculating Cronbach's alpha for the 9-item PACT-M 1 and 8-item PACT-M 2 and exploratory factor analysis was performed to evaluate dimensionality of the scales. Principal components analysis was chosen using pair-wise deletion. Both PACT-M 1 and PACT-M 2 showed high internal consistency and good internal reliability values and conveyed unidimensional scale characteristics with high reliability scores; above 0.8. CONCLUSIONS: The PACT-M has shown evidence to suggest that it is a reliable measure to capture patients' perception of the quality of discharge arrangements and also on patients' ability to manage their care at home one month post discharge. PACT-M 1 is a marker of patient experience of transition and PACT-M 2 of coping at home.

Delivering exceptionally safe transitions of care to older people: a qualitative study of multidisciplinary staff perspectives.

BACKGROUND: Transitions of care are often risky, particularly for older people, and shorter hospital stays mean that patients can go home with ongoing care needs. Most previous research has focused on fundamental system flaws, however, care generally goes right far more often than it goes wrong. We explored staff perceptions of how high performing general practice and hospital specialty teams deliver safe transitional care to older people as they transition from hospital to home. METHODS: We conducted a qualitative study in six general practices and four hospital specialties that demonstrated exceptionally low or reducing readmission rates over time. Data were also collected across four community teams that worked into or with these high-performing teams. In total, 157 multidisciplinary staff participated in semi-structured focus groups or interviews and 9 meetings relating to discharge were observed. A pen portrait approach was used to explore how teams across a variety of different contexts support successful transitions and overcome challenges faced in their daily roles. RESULTS: Across healthcare contexts, staff perceived three key themes to facilitate safe transitions of care: knowing the patient, knowing each other, and bridging gaps in the system. Transitions appeared to be safest when all three themes were in place. However, staff faced various challenges in doing these three things particularly when crossing boundaries between settings. Due to pressures and constraints, staff generally felt they were only able to attempt to overcome these challenges when delivering care to patients with particularly complex transitional care needs. CONCLUSIONS: It is hypothesised that exceptionally safe transitions of care may be delivered to patients who have particularly complex health and/or social care needs. In these situations, staff attempt to know the patient, they exploit existing relationships across care settings, and act to bridge gaps in the system. Systematically reinforcing such enablers may improve the delivery of safe transitional care to a wider range of patients. TRIAL REGISTRATION: The study was registered on the UK Clinical Research Network Study Portfolio (references 35272 and 36174 ).

How older people enact care involvement during transition from hospital to home: A systematic review and model.

BACKGROUND: Current models of patient-enacted involvement do not capture the nuanced dynamic and interactional nature of involvement in care. This is important for the development of flexible interventions that can support patients to 'reach-in' to complex health-care systems. OBJECTIVE: To develop a dynamic and interactional model of patient-enacted involvement in care. SEARCH STRATEGY: Electronic search strategy run in five databases and adapted to run in an Internet search engine supplemented with searching of reference lists and forward citations. INCLUSION CRITERIA: Qualitative empirical published reports of older people's experiences of care transitions from hospital to home. DATA EXTRACTION AND SYNTHESIS: Reported findings meeting our definition of involvement in care initially coded into an existing framework. Progression from deductive to inductive coding leads to the development of a new framework and thereafter a model representing changing states of involvement. MAIN RESULTS: Patients and caregivers occupy and move through multiple states of involvement in response to perceived interactions with health-care professionals as they attempt to resolve health- and well-being-related goals. 'Non-involvement', 'information-acting', 'challenging and chasing' and 'autonomous-acting' were the main states of involvement. Feeling uninvolved as a consequence of perceived exclusion leads patients to act autonomously, creating the potential to cause harm. DISCUSSION AND CONCLUSION: The model suggests that involvement is highly challenging for older people during care transitions. Going forward, interventions which seek to support patient involvement should attempt to address the dynamic states of involvement and their mediating factors.

Developing a measure to assess the quality of care transitions for older people.

BACKGROUND: The transition of older patients (over 65 years of age) from hospital to their own home is a time when patients are at high risk. No measure currently exists to assess the experience, quality and safety of care transitions relevant to UK population. We aim to describe the development and initial testing of the Partners at Care Transitions Measure (PACT-M) as a patient-reported questionnaire for evaluation of the quality and safety of care transitions from hospital to home in older patients. METHODS: We used an established measure development procedure which includes conceptualising the components of care transitions, item development, conducting a modified Delphi process and pilot-testing of the PACT-M with patients over 65 years old using telephone administration. RESULTS: Pilot testing of the PACT-M suggests that the components identified cover the issues of most importance to patients. Face validity testing showed that the measure in its current form is acceptable to older patients. CONCLUSIONS: The measure developed in this study shows promise for use by those involved in planning, implementing and evaluating discharge care, and could be used to inform interventions to improve the transition from hospital to home for older patients.

Interventions for treating anxiety after stroke.

BACKGROUND: Approximately 20% of stroke patients experience clinically significant levels of anxiety at some point after stroke. Physicians can treat these patients with antidepressants or other anxiety-reducing drugs, or both, or they can provide psychological therapy. This review looks at available evidence for these interventions. This is an update of the review first published in October 2011. OBJECTIVES: The primary objective was to assess the effectiveness of pharmaceutical, psychological, complementary, or alternative therapeutic interventions in treating stroke patients with anxiety disorders or symptoms. The secondary objective was to identify whether any of these interventions for anxiety had an effect on quality of life, disability, depression, social participation, caregiver burden, or risk of death. SEARCH METHODS: We searched the trials register of the Cochrane Stroke Group (January 2017). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2017, Issue 1: searched January 2017); MEDLINE (1966 to January 2017) in Ovid; Embase (1980 to January 2017) in Ovid; the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1937 to January 2017) in EBSCO; and PsycINFO (1800 to January 2017) in Ovid. We conducted backward citation searches of reviews identified through database searches and forward citation searches of included studies. We contacted researchers known to be involved in related trials, and we searched clinical trials registers for ongoing studies. SELECTION CRITERIA: We included randomised trials including participants with a diagnosis of both stroke and anxiety for which treatment was intended to reduce anxiety. Two review authors independently screened and selected titles and abstracts for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We performed a narrative review. We planned to do a meta-analysis but were unable to do so as included studies were not sufficiently comparable. MAIN RESULTS: We included three trials (four interventions) involving 196 participants with stroke and co-morbid anxiety. One trial (described as a 'pilot study') randomised 21 community-dwelling stroke survivors to four-week use of a relaxation CD or to wait list control. This trial assessed anxiety using the Hospital Anxiety and Depression Scale and reported a reduction in anxiety at three months among participants who had used the relaxation CD (mean (standard deviation (SD) 6.9 (± 4.9) and 11.0 (± 3.9)), Cohen's d = 0.926, P value = 0.001; 19 participants analysed).The second trial randomised 81 participants with co-morbid anxiety and depression to paroxetine, paroxetine plus psychotherapy, or standard care. Mean levels of anxiety severity scores based on the Hamilton Anxiety Scale (HAM-A) at follow-up were 5.4 (SD ± 1.7), 3.8 (SD ± 1.8), and 12.8 (SD ± 1.9), respectively (P value < 0.01).The third trial randomised 94 stroke patients, also with co-morbid anxiety and depression, to receive buspirone hydrochloride or standard care. At follow-up, the mean levels of anxiety based on the HAM-A were 6.5 (SD ± 3.1) and 12.6 (SD ± 3.4) in the two groups, respectively, which represents a significant difference (P value < 0.01). Half of the participants receiving paroxetine experienced adverse events that included nausea, vomiting, or dizziness; however, only 14% of those receiving buspirone experienced nausea or palpitations. Trial authors provided no information about the duration of symptoms associated with adverse events. The trial of relaxation therapy reported no adverse events.The quality of the evidence was very low. Each study included a small number of participants, particularly the study of relaxation therapy. Studies of pharmacological agents presented details too limited to allow judgement of selection, performance, and detection bias and lack of placebo treatment in control groups. Although the study of relaxation therapy had allocated participants to treatment using an adequate method of randomisation, study recruitment methods might have introduced bias, and drop-outs in the intervention group may have influenced results. AUTHORS' CONCLUSIONS: Evidence is insufficient to guide the treatment of anxiety after stroke. Further well-conducted randomised controlled trials (using placebo or attention controls) are required to assess pharmacological agents and psychological therapies.

A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting.

BACKGROUND: A healthy diet, taking exercise, and not smoking or consuming alcohol in excess are important to reduce the risk of cardiovascular disease either alone or in combination with statin medication. Health education, including providing information to patients on healthy living and guidance on how to achieve it, is a key nursing function. OBJECTIVES: This study aims first to assess the feasibility of conducting a full-scale trial of lifestyle referral assessment as shown by recruitment rate, data collection, and follow-up and second to assess proof of concept and explore possible mechanisms of change. METHODS: This was a single-center, randomized, 2-arm, parallel-group, unblinded feasibility trial conducted in an acute teaching hospital trust. Participants were followed up at 3 and 6 months after randomization. RESULTS: Eight hundred eighty-seven patients were screened for eligibility, of whom 132 (15%) were randomized into the trial. Of the patients allocated to the individualized assessment, 27% accepted referral or self-referred by 3 months in comparison to 5% allocated to the usual assessment. CONCLUSIONS: We demonstrated that a full-scale trial is feasible and that an individualized approach increased the number of patients accepting referral to a formal program and initiating lifestyle change. However, we should consider the aim of the assessment and ways in which the process of change can be optimized in order to produce long-term benefit for patients. TRIAL REGISTRATION: current controlled trials ISRCTN41781196.

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

BACKGROUND AND PURPOSE: We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. METHODS: A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. RESULTS: Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. CONCLUSIONS: This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305.

Understanding the challenges and successes of implementing 'hybrid' interventions in healthcare settings: findings from a process evaluation of a patient involvement trial.

INTRODUCTION: 'Hybrid' interventions in which some intervention components are fixed across sites and others are flexible (locally created) are thought to allow for adaptation to the local context while maintaining fidelity. However, there is little evidence regarding the challenges and facilitators of implementing hybrid interventions. This paper reports on a process evaluation of a patient safety hybrid intervention called Your Care Needs You (YCNY). YCNY was tested in the Partners at Care Transitions (PACT) randomised controlled trial and aimed to enhance older patients and their families' involvement in their care in order to achieve safer transitions from hospital to home. METHODS: The process evaluation took place across eight intervention wards taking part in the PACT trial. 23 interviews and 37 informal conversations were conducted with National Health Service (NHS) staff. Patients (n=19) were interviewed twice, once in hospital and once after discharge. Interviews with staff and patients concerned the delivery and experiences of YCNY. Ethnographic observations (n=81 hours) of relevant activities (eg, multidisciplinary team meetings, handovers, etc) were undertaken. RESULTS: The main finding relates to how staff understood and engaged with YCNY, which then had a major influence on its implementation. While staff broadly valued the aims of YCNY, staff from seven out of the eight wards taking part in the process evaluation enacted YCNY in a mostly task-based manner. YCNY implementation often became a hurried activity which concentrated on delivering fixed intervention components rather than a catalyst for culture change around patient involvement. Factors such as understaffing, constraints on staff time and the COVID-19 pandemic contributed towards a 'taskification' of intervention delivery, which meant staff often did not have capacity to creatively devise flexible intervention components. However, one ward with a sense of distributed ownership of YCNY had considerable success implementing flexible components. DISCUSSION: Hybrid interventions may allow aspects of an intervention to be adapted to the local context. However, the current constrained and pressured environment of the NHS left staff with little ability to creatively engage with devising flexible intervention components, despite recognising the need for and being motivated to deliver the intervention.

Managing nurse redeployment during the Covid-19 pandemic, lessons for future redeployment: A qualitative study.

BACKGROUND: The mass redeployment of nurses was critical across countries necessitated by the acute health impact of Covid-19. Knowledge was limited regarding how to manage nurse redeployment or the impact that redeployment might have. Redeployment continues, particularly in response to the current staffing crisis and surges such as winter pressures. This study aims to address these gaps in evidence to inform guidance on how best to manage nurse redeployment in practice. OBJECTIVES: First, to understand the processes and underpinning decisions made by managers when managing nurse redeployment prior to and during the Covid-19 pandemic. Second, to identify the lessons that can be learned to improve the management of on-going nurse redeployment. DESIGN: Qualitative study utilising semi-structured interviews and focus groups with nurse managers (ISRCTN: 18172749). SETTING(S): Three acute National Health Service (NHS) Trusts in England with geographical and ethnic diversity, and different Covid-19 contexts. PARTICIPANTS: Thirty-two nurse managers and four Human Resource advisors responsible for redeploying nurses or receiving and supporting redeployed nurses. METHODS: Participants took part in face-to-face or virtual semi-structured interviews from February 2021 to November 2021 and virtual focus groups from July to December 2021. Qualitative data were analysed using reflexive thematic analysis. RESULTS: Four themes were evident in the data, capturing four distinctive phases of the redeployment process. There was a fundamental mismatch between how different parts of the nursing and managerial workforce conceived of their decision-making responsibilities across different phases. This led to managers taking inconsistent and sometimes contradictory approaches when redeploying nurses, and a disconnect between nursing staff at all levels of the chain of command. Furthermore, in conjunction with limited guidance in operationalising redeployment and the distressing experiences vocalised by nurses, nurse managers found nurse redeployment logistically and emotionally challenging; and felt 'caught in the middle' of meeting both their managerial and mentoring responsibilities. This became increasingly challenging during subsequent phases of redeployment and remained challenging once the pandemic waned. CONCLUSIONS: The approach to nurse redeployment in response to the Covid-19 pandemic prioritised nurse staffing numbers over personal well-being. Key principles of good practice relating to nurse redeployment during the Covid-19 pandemic can be applied to improve future redeployment of nurses and support positive outcomes. Having a planned approach for staff redeployment during normal service delivery comprising operational guidance for those tasked with implementing redeployment, that is scalable in a crisis setting, would be beneficial for the nursing workforce.

Nurses' experiences and sense making of COVID-19 redeployment and the impact on well-being, performance, and turnover intentions: A longitudinal multimethod study.

Background: During Covid-19 nurses were redeployed to new teams and specialties at a level never previously experienced. Little is known about how nurses made sense of and coped with this situation and what we can learn from this for future redeployment approaches. Objectives: We sought to understand how nurses made sense of ongoing redeployment during the COVID-19 pandemic and how this related to their psychological distress, burnout, turnover intentions, and perceived performance. Design: A longitudinal multi-method design. (ISRCTN: 18,172,749). Settings: Three acute National Health Service (NHS) Trusts in England, selected for diversity in geographical location and ethnicity, with different COVID-19 contexts. Participants: Sixty-two nurses (90 % female; 83 % white) who experienced different types of redeployment during the pandemic, with an average of 17 year's post-registration experience (mean age 41 years). Methods: We gathered both interview and survey data from 62 nurses across two or three time points in 2020-2021 and sought to find commonalities and differences in patterns of experience using Pen Portrait analysis. Results: The pandemic redeployment process was life-changing for all nurses, personally and professionally. The research uncovered an intertwined pattern of identity and sensemaking as nurses coped with COVID-19 redeployment. Three sensemaking 'journeys' were evident, involving professional identity as a nurse and identification with one's organisation. Nurses in journey one: 'Organisational Identification and Professional Identity Maintained' (n = 28) had the best outcomes for wellbeing, burnout, performance, and retention. Those experiencing the 'Devaluation of Organisational Identification But Maintenance of Professional Identity' journey (n = 24) maintained their professional identity, but their organisational identification deteriorated. Journey three nurses: 'Devaluation of both Organisational Identification and Professional Identity' (n = 10) had the worst outcomes for wellbeing, burnout, performance, and retention. A salient nurse identity triggered stoicism and resilient behaviours while external cues of control, support and contextual awareness affected organisational identification. Conclusions: Nurses made sense of their experiences of redeployment during Covid-19 differently which, in turn affected their outcomes. Given the stark differences in how nurses perceived their psychological distress, burnout, turnover intentions and performance across the journeys, the importance of understanding the cues (e.g. having autonomy) associated with each journey is apparent. Thus, our research provides clear guidance for managers to help them support nurses during redeployment.

A qualitative synthesis of factors influencing maintenance of lifestyle behaviour change in individuals with high cardiovascular risk.

BACKGROUND: Management of cardiovascular risk factors includes commitment from patients to adhere to prescribed medications and adopt healthy lifestyles. Unfortunately many fail to take up and maintain the four key healthy behaviours (not smoking, having a balanced diet, limiting alcohol consumption and being more active). Five factors (beliefs, knowledge, transport and other costs, emotions, and friends and family support) are known to predict uptake of lifestyle behaviour change. The key factors influencing maintenance of healthy lifestyles are not known but would be helpful to support the development of relapse prevention programmes for this population. Our review aimed to clarify the main patient perceived factors thought to influence maintenance of changed healthy lifestyles. METHODS: We performed a systematic review of qualitative observational studies and applied the principles of content synthesis and thematic analysis to extract reported factors (barriers and facilitators) considered by individuals to be influential in maintaining changed healthy lifestyle behaviours. Factors were then organised into an existing framework of higher order categories which was followed by an analysis of the interrelationships between factors to identify key themes. RESULTS: Twenty two studies met our inclusion criteria. Participants reported barriers and facilitators within 13 categories, the majority of which were facilitators. The most commonly reported influences were those relating to social support (whether provided formally or informally), beliefs (about the self or the causes and management of poor health, and the value of maintaining lifestyle behaviours), and other psychological factors (including attitude, thinking and coping styles, and problem solving skills). Physical activity was the most commonly investigated behaviour in four categories, but overall, the main barriers and facilitators were related to a range of behaviours. Through analysis of the interrelationships between factors within categories, 'social support', 'education and knowledge', and 'beliefs and emotions' were all considered key themes. CONCLUSIONS: Our review suggests that for the most part, factors that influence lifestyle change are also important for maintaining healthy behaviours. This indicates that addressing these barriers and facilitators within lifestyle support programmes would also be of value in the longer-term.

Evaluating an intervention to improve the safety and experience of transitions from hospital to home for older people (Your Care Needs You): a protocol for a cluster randomised controlled trial and process evaluation.

BACKGROUND: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home. METHODS: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards. DISCUSSION: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts. TRIAL REGISTRATION: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020.

A systematic review of patient reported factors associated with uptake and completion of cardiovascular lifestyle behaviour change.

BACKGROUND: Healthy lifestyles are an important facet of cardiovascular risk management. Unfortunately many individuals fail to engage with lifestyle change programmes. There are many factors that patients report as influencing their decisions about initiating lifestyle change. This is challenging for health care professionals who may lack the skills and time to address a broad range of barriers to lifestyle behaviour. Guidance on which factors to focus on during lifestyle consultations may assist healthcare professionals to hone their skills and knowledge leading to more productive patient interactions with ultimately better uptake of lifestyle behaviour change support. The aim of our study was to clarify which influences reported by patients predict uptake and completion of formal lifestyle change programmes. METHODS: A systematic narrative review of quantitative observational studies reporting factors (influences) associated with uptake and completion of lifestyle behaviour change programmes. Quantitative observational studies involving patients at high risk of cardiovascular events were identified through electronic searching and screened against pre-defined selection criteria. Factors were extracted and organised into an existing qualitative framework. RESULTS: 374 factors were extracted from 32 studies. Factors most consistently associated with uptake of lifestyle change related to support from family and friends, transport and other costs, and beliefs about the causes of illness and lifestyle change. Depression and anxiety also appear to influence uptake as well as completion. Many factors show inconsistent patterns with respect to uptake and completion of lifestyle change programmes. CONCLUSION: There are a small number of factors that consistently appear to influence uptake and completion of cardiovascular lifestyle behaviour change. These factors could be considered during patient consultations to promote a tailored approach to decision making about the most suitable type and level lifestyle behaviour change support.

Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care.

BACKGROUND: The 'Your Care Needs You' (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. METHODS: A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. RESULTS: Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients' health, capacity, and preferences. CONCLUSIONS: If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. TRIAL REGISTRATION: ISRCTN: 51154948.

Interventions for treating anxiety after stroke.

BACKGROUND: Approximately 20% of stroke patients experience anxiety at some point after stroke. OBJECTIVES: To determine if any treatment for anxiety after stroke decreases the proportion of patients with anxiety disorders or symptoms, and to determine the effect of treatment on quality of life, disability, depression, social participation, risk of death or caregiver burden. SEARCH METHODS: We searched the trials register of the Cochrane Stroke Group (October 2010), CENTRAL (The Cochrane Library 2010, Issue 4), MEDLINE (1950 to October 2010), EMBASE (1947 to October 2010), PsycINFO (1806 to October 2010), Allied and Complementary Medicine database (AMED) (1985 to October 2010), Cumulative Index to Nursing and Allied Health (CINAHL) (1982 to October 2010), Proquest Digital Dissertations (1861 to October 2010), and Psychological Database for Brain Impairment Treatment Efficacy (PsycBITE) (2004 to October 2010). In an effort to identify further published, unpublished and ongoing trials, we searched trial registries and major international stroke conference proceedings, scanned reference lists, and contacted select individuals known to the review team who are actively involved in psychological aspects of stroke research, and the Association of the British Pharmaceutical Industry. SELECTION CRITERIA: Two review authors independently screened and selected titles and abstracts for inclusion in the review. Randomised trials of any intervention in patients with stroke where the treatment of anxiety was an outcome were eligible. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data for analysis. We performed a narrative review. A meta-analysis was planned but not carried out as studies were not of sufficient quality to warrant doing so. MAIN RESULTS: We included two trials (three interventions) involving 175 participants with co-morbid anxiety and depression in the review. Both trials used the Hamilton Anxiety Scale (HAM-A) to assess anxiety, and neither included a placebo control group. One trial randomised 81 patients to paroxetine, paroxetine plus psychotherapy or standard care. Mean level of anxiety severity scores were 58% and 71% lower in the paroxetine, and paroxetine plus psychotherapy groups respectively compared with those in standard care at follow-up (P < 0.01). The second trial randomised 94 stroke patients, also with co-morbid anxiety and depression, to receive buspirone hydrochloride or standard care. At follow-up, the mean level of anxiety was significantly lower for those receiving buspirone relative to controls (P < 0.01). Half of the participants receiving paroxetine experienced adverse events that included nausea, vomiting or dizziness; however, only 14% of those receiving buspirone experienced nausea or palpitations. No information was provided about the duration of symptoms associated with adverse events. AUTHORS' CONCLUSIONS: There is insufficient evidence to guide the treatment of anxiety after stroke. The data available suggest that pharmaceutical therapy (paroxetine and buspirone) may be effective in reducing anxiety symptoms in stroke patients with co-morbid anxiety and depression. No information was available for stroke patients with anxiety only. Randomised placebo controlled trials are needed.

Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial.

BACKGROUND: Patients, particularly older people, often experience safety issues when transitioning from hospital to home. Although the evidence is currently equivocal as to how we can improve this transition of care, interventions that support patient involvement may be more effective. The 'Your Care Needs You' (YCNY) intervention supports patients to 'know more' and 'do more' whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required. The intervention aims to reduce emergency hospital readmissions and improve safety and experience during the transition to home. METHODS: As part of the Partners At Care Transitions (PACT) programme of research, a multi-centred cluster randomised controlled trial (cRCT) will be conducted to explore the feasibility of the YCNY intervention and trial methodology. Data will be used to refine the intervention and develop a protocol for a definitive cRCT.Ten acute hospital wards (the clusters) from varying medical specialties including older peoples' medicine, trauma and orthopaedics, cardiology, intermediate care, and stroke will be randomised to deliver YCNY or usual care on a 3:2 basis. Up to 200 patients aged 75 years and over and discharged to their own homes will be recruited to the study. Patients will complete follow-up questionnaires at 5-, 30-, and 90-days post-discharge and readmission data up to 90-days post-discharge will be extracted from their medical records.Study outcomes will include measures of feasibility (e.g. screening, recruitment, and retention data) and processes required to collect routine data at a patient and ward level. In addition, interviews and observations involving up to 24 patients/carers and 28 staff will be conducted to qualitatively assess the acceptability, usefulness, and feasibility of the intervention and implementation package to patients and staff. A separate sub-study will be conducted to explore how accurately primary outcome data (30-day emergency hospital readmissions) can be gathered for the definitive cRCT. DISCUSSION: This study will establish the feasibility of the YCNY intervention which aims to improve safety and experience during transitions of care. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of the YCNY intervention in a definitive cluster randomised controlled trial. TRIAL REGISTRATION: UK Clinical Research Network Portfolio: 42191; ISTCRN: ISRCTN51154948. Registered 16/07/2019.

Structured re-assessment system at 6 months after a disabling stroke: a randomised controlled trial with resource use and cost study.

BACKGROUND: national policy recommends routine re-assessment of disabled patients and their carers at 6 months after stroke onset. The clinical and resource outcomes of this policy were investigated. DESIGN: prospective, single-blind, randomised controlled trial in two centres. PARTICIPANTS: a total of 265 patients with a disabling stroke and their carers. INTERVENTIONS: a structured re-assessment system for patients and their carers at 6 months post-stroke or existing care. OUTCOME MEASURES: primary: patient independence (Frenchay activities index) and carer stress (general health questionnaire 28). Secondary: activities of daily living, mood state, satisfaction with services, carer strain index, health and social service resource use and costs. RESULTS: independence at 12 months post-stroke was similar in both groups (Frenchay activities index, adjusted mean difference 0.64; 95% confidence interval -0.74-2.02). Emotional distress in carers was similar in both groups (general health questionnaire 28, mean difference 0.02; 95% confidence interval -0.95-1.00). Results for the secondary outcome measures and total mean costs were similar for both groups. The intervention group patients used 301 fewer hospital bed days and 1,631 fewer care home bed days. CONCLUSIONS: the structured, systematic re-assessment for patients and their carers was not associated with any clinically significant evidence of benefit at 12 months. Health and social care resource use and mean cost per patient were broadly similar in both groups. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Register; number: ISRCTN55412871.