General practitioners' experiences of emergency care and treatment planning in England: a focus group study.

BACKGROUND: Emergency Care and Treatment Plans are recommended for all primary care patients in the United Kingdom who are expected to experience deterioration of their health. The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) was developed to integrate resuscitation decisions with discussions about wider goals of care. It summarises treatment recommendations discussed and agreed between patients and their clinicians for a future emergency situation and was designed to meet the needs of different care settings. Our aim is to explore GPs' experiences of using ReSPECT and how it transfers across the primary care and secondary care interface. METHODS: We conducted five focus groups with GPs in areas being served by hospitals in England that have implemented ReSPECT. Participants were asked about their experience of ReSPECT, how they initiate ReSPECT-type conversations, and their experiences of ReSPECT-type recommendations being communicated across primary and secondary care. Focus groups were transcribed and analysed using Thematic Analysis. RESULTS: GPs conceptualise ReSPECT as an end of life planning document, which is best completed in primary care. As an end of life care document, completing ReSPECT is an emotional process and conversations are shaped by what a 'good death' is thought to be. ReSPECT recommendations are not always communicated or transferable across care settings. A focus on the patient's preferences around death, and GPs' lack of specialist knowledge, could be a barrier to completion of ReSPECT that is transferable to acute settings. CONCLUSION: Conceptualising ReSPECT as an end of life care document suggests a difference in how general practitioners understand ReSPECT from its designers. This impacts on the transferability of ReSPECT recommendations to the hospital setting.

Are completed ReSPECT plans facilitating person-centred care? An evaluation of completed plans in UK general practice.

Background: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) includes agreed clinical recommendations for a person's care in a future emergency which have been informed by discussion of the person's preferences. Previous evaluation of ReSPECT plans in acute NHS hospitals found inconsistencies in recording patient's preferences and involvement in the plan, and infrequent justification for recommendations. Aim: To explore to what extent ReSPECT recommendations reflect individual preferences, as documented in the plan. Methods: ReSPECT plans of adults were collected from 11 General Practices in England. We adapted an evaluation tool used previously to analyse ReSPECT plans in acute settings. Free text sections for individual values/preferences and clinical recommendations were examined for clarity, consistency and congruency between them. Results: We retrieved 141 ReSPECT plans. Patients or those close to the patient were recorded as being consulted in most plans (94%). Individual preferences were completed in 57% of plans. Clinical recommendations reflected individual preferences by directly referencing the person and their preferences (31%), by being consistent with the documented preferences (30%), or by using the same wording as the preferences (6%). Conclusion: While many clinical recommendations reflect individual preferences, the preferences themselves are only recorded in just over half of ReSPECT plans. This is problematic, because the recording of individual preferences facilitates person-centred care, both directly by informing recommendations and indirectly when used to guide decision-making in situations not anticipated in the plan. Future training for clinicians should emphasize the need to document the personal values section of the plan.

Facilitating cardiopulmonary resuscitation training in high-risk areas of England: A study protocol.

Introduction: Bystanders' interventions improve chances of survival from out-of-hospital cardiac arrest (OHCA) before Emergency Medical Services arrive. Some areas in England are of concern. These high-risk areas have a higher incidence of cardiac arrest combined with lower-than-average bystander CPR rates and are characterised by higher proportions of minority ethnic group residents and deprivation.Collaborating with people from the Black African and Caribbean and South Asian minority communities in deprived areas of England, we aim to develop and evaluate the implementation of theoretically informed intervention(s) to address factors contributing to lower bystander intervention rates. Methods: The study is a collaborative realist enquiry, informed by the Theoretical Domains Framework and associated Behaviour Change Wheel. It consists of 1) a realist evidence synthesis to produce initial program theories developed from primary workshop data and published evidence. It will include identifying factors contributing to the issue and potential interventions to address them; 2) theoretically informed intervention development, using the initial program theories and behaviour change theory and 3) a realist mixed methods implementation evaluation with embedded feasibility.Public involvement (PPI) as study team and public advisory group members is key to this study.We will conduct realist evidence synthesis, qualitative and statistical analyses appropriate to the various methods used. Dissemination: We will develop a dissemination plan and materials targeted to members of the public in high-risk areas as well as academic outputs. We will hold an event for participating community groups and stakeholders to share findings and seek advice on next steps. Study registration: ISRCTN90350842. Registration date 28.03.2023. The study was registered after its start date.

Why are some ReSPECT conversations left incomplete? A qualitative case study analysis.

Background: As an emergency care and treatment planning process (ECTP), a key feature of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is the engagement of patients and/or their representatives in conversations about treatment options including, but not limited to, cardiopulmonary resuscitation (CPR). However, qualitative research suggests that some ReSPECT conversations lead to partial or no decision-making about treatment recommendations. This paper explores why some ReSPECT conversations are left incomplete. Methods: Drawing on observation and interview data collected in four National Health Service (NHS) hospital sites in England, this paper offers an in-depth exploration of six case studies in which ReSPECT conversations were incomplete. Using thematic analysis, we triangulate fieldnote data documenting these conversations with interview data in which the doctors who conducted these conversations shared their perceptions and reflected on their decision-making processes. Results: We identified two themes, both focused on 'mismatch': (1) Mismatch between the doctor's clinical priorities and the patient's/family's immediate needs; and (2) mismatch between the doctor's conversation scripts, which included patient autonomy, the feasibility of CPR, and what medicine can and should do to prolong a patient's life, and the patient's/family's understandings of these concepts. Conclusions: This case study analysis of six ReSPECT conversations found that mismatch between doctors' priorities and understandings and those of patients and/or their relatives led to incomplete ReSPECT conversations. Future research should explore methods to overcome these mismatches.

Implementation of ReSPECT in acute hospitals: A retrospective observational study.

AIMS: To evaluate, in UK acute hospitals, the early implementation of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT), which embeds cardiopulmonary resuscitation (CPR) recommendations within wider emergency treatment plans. To understand for whom and how the process was being used and the quality of form completion. METHODS: A retrospective observational study evaluating emergency care and treatment planning approaches used in acute UK hospitals (2015-2019), and in six English hospital trusts the extent of ReSPECT use, patient characteristics and completion quality in a sample 3000 patient case notes. RESULTS: The use of stand-alone Do Not Attempt Cardiopulmonary Resuscitation forms fell from 133/186 hospitals in 2015 to 64/186 in 2019 (a 38% absolute reduction). ReSPECT accounted for 52% (36/69) of changes. In the six sites, ReSPECT was used for approximately 20% of patients (range 6%-41%). They tended to be older, to have had an emergency medical admission, to have cognitive impairment and a lower predicted 10 year survival. Most (653/706 (92%)) included a 'not for attempted resuscitation' recommendation 551/706 (78%) had at least one other treatment recommendation. Capacity was not recorded on 13% (95/706) of forms; 11% (79/706) did not record patient/family involvement. CONCLUSIONS: ReSPECT use accounts for 52% of the change, observed between 2015 and 2019, from using standalone DNACPR forms to approaches embedding DNACPR decisions within in wider emergency care plans in NHS hospitals in the UK. Whilst recommendations include other emergencies most still tend to focus on recommendations relating to CPR. Completion of ReSPECT forms requires improvement. STUDY REGISTRATION: https://www.isrctn.com/ISRCTN11112933.

Impact of community initiatives on non-EMS bystander CPR rates in West Yorkshire between 2014 and 2018.

AIM: Bystander CPR rates have steadily increased in England between 2014 and 2018. In West Yorkshire, there have been two important developments during this time. We aimed to describe whether postcode districts (PCDs) with more cumulative annual 'Restart a Heart' (RSAH) and/or Community First Responder (CFR) scheme activity between 2014 and 2018 were associated with greater improvements in non-EMS bystander CPR rates for out-of-hospital cardiac arrest (OHCA) when compared with PCDs in the same region with lesser or no such historic activity during the same time period. METHOD: We collated data from the OHCA Outcomes Registry for all non-EMS witnessed OHCA in West Yorkshire treated by Yorkshire Ambulance Service. We analysed clusters of PCDs with high and low levels of RSAH and CFR activity between 2014 and 2018 using descriptive statistics, and comparisons were made between groups using chi-square and t-test. RESULTS: The reported bystander CPR rate for non-EMS witnessed OHCA cases for West Yorkshire rose from 38.4% in 2014 to 69.7% in 2018. The largest increases were seen in PCDs with high RSAH activity (+34.3%) and in the combination of high RSAH and low CFR activity (+38.5%). There was no significant difference when considering the interaction between RSAH and CFR groups. CONCLUSION: The data infers the possibility of a non-significant association between improved non-EMS bystander CPR rates and RSAH training and CFR scheme activity. We recommend coordinated mass training, in particular for children in regions where CPR is not a mandatory part of the school curriculum.

Assessing the quality of ReSPECT documentation using an accountability for reasonableness framework.

BACKGROUND: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) form, which supports the ReSPECT process, is designed to prompt clinicians to discuss wider emergency treatment options with patients and to structure the documentation of decision-making for greater transparency. METHODS: Following an accountability for reasonableness framework (AFR), we analysed 141 completed ReSPECT forms (versions 1.0 and 2.0), collected from six National Health Service (NHS) hospitals in England during the early adoption of ReSPECT. Structured through an evaluation tool developed for this study, the analysis assessed the extent to which the records reflected consistency, transparency, and ethical justification of decision-making. RESULTS: Recommendations relating to CPR were consistently recorded on all forms and were contextualised within other treatment recommendations in most forms. The level of detail provided about treatment recommendations varied widely and reasons for treatment recommendations were rarely documented. Patient capacity, patient priorities and preferences, and the involvement of patients/relatives in ReSPECT conversations were recorded in some, but not all, forms. Clinicians almost never documented their weighing of potential burdens and benefits of treatments on the ReSPECT forms. CONCLUSION: In most ReSPECT forms, CPR recommendations were captured alongside other treatment recommendations. However, ReSPECT form design and associated training should be modified to address inconsistencies in form completion. These modifications should emphasise the recording of patient values and preferences, assessment of patient capacity, and clinical reasoning processes, thereby putting patient/family involvement at the core of good clinical practice. Version 3.0 of ReSPECT responds to these issues.

Why, when and how do secondary-care clinicians have emergency care and treatment planning conversations? Qualitative findings from the ReSPECT Evaluation study.

BACKGROUND: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is an emergency care and treatment planning (ECTP) process, developed to offer a patient-centred approach to deciding about and recording treatment recommendations. Conversations between clinicians and patients or their representatives are central to the ReSPECT process. This study aims to understand why, when, and how ReSPECT conversations unfold in practice. METHODS: ReSPECT conversations were observed in hospitals within six acute National Health Service (NHS) trusts in England; the clinicians who conducted these conversations were interviewed. Following observation-based thematic analysis, five ReSPECT conversation types were identified: resuscitation and escalation; confirmation of decision; bad news; palliative care; and clinical decision. Interview-based thematic analysis examined the reasons and prompts for each conversation type, and the level of detail and patient engagement in these different conversations. RESULTS: Whereas resuscitation and escalation conversations concerned possible futures, palliative care and bad news conversations responded to present-tense changes. Conversations were timed to respond to organisational, clinical, and patient/relative prompts. While bad news and palliative care conversations included detailed discussions of treatment options beyond CPR, this varied in other conversation types. ReSPECT conversations varied in doctors' engagement with patient/relative preferences, with only palliative care conversations consistently including an open-ended approach. CONCLUSIONS: While ReSPECT supports holistic, person-centred, anticipatory decision-making in some situations, a gap remains between the ReSPECT's aims and their implementation in practice. Promoting an understanding and valuing of the aims of ReSPECT among clinicians, supported by appropriate training and structural support, will enhance ReSPECT conversations.

Development of the Recommended Summary Plan for eEmergency Care and Treatment (ReSPECT).

INTRODUCTION: Do-not-attempt-cardiopulmonary-resuscitation (DNACPR) practice has been shown to be variable and sub-optimal. This paper describes the development of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT). ReSPECT is a process which encourages shared understanding of a patient's condition and what outcomes they value and fear, before recording clinical recommendations about cardiopulmonary-resuscitation (CPR) within a broader plan for emergency care and treatment. METHODS: ReSPECT was developed iteratively, with integral stakeholder engagement, informed by the Knowledge-to-Action cycle. Mixed methods included: synthesis of existing literature; a national online consultation exercise; cognitive interviews with users; a patient-public involvement (PPI) workshop and a usability pilot, to ensure acceptability by both patients and professionals. RESULTS: The majority (89%) of consultation respondents supported the concept of emergency care and treatment plans. Key features identified in the evaluation and incorporated into ReSPECT were: The importance of discussions between patient and clinician to inform realistic treatment preferences and clarity in the resulting recommendations recorded by the clinician on the form. The process is compliant with UK mental capacity laws. Documentation should be recognised across all health and care settings. There should be opportunity for timely review based on individual need. CONCLUSION: ReSPECT is designed to facilitate discussions about a person's preferences to inform emergency care and treatment plans (including CPR) for use across all health and care settings. It has been developed iteratively with a range of stakeholders. Further research will be needed to assess the influence of ReSPECT on patient-centred decisions, experience and health outcomes.

Characteristics of neighbourhoods with high incidence of out-of-hospital cardiac arrest and low bystander cardiopulmonary resuscitation rates in England.

Aims: The aim of the project was to identify the neighbourhood characteristics of areas in England where out-of-hospital cardiac arrest (OHCA) incidence was high and bystander cardiopulmonary resuscitation (BCPR) was low using registry data. Methods and results: Analysis was based on 67 219 cardiac arrest events between 1 April 2013 and 31 December 2015. Arrest locations were geocoded to give latitude/longitude. Postcode district was chosen as the proxy for neighbourhood. High-risk neighbourhoods, where OHCA incidence based on residential population was >127.6/100 000, or based on workday population was >130/100 000, and BCPR in bystander witnessed arrest was <60% were observed to have: a greater mean residential population density, a lower workday population density, a lower rural-urban index, a higher proportion of people in routine occupations and lower proportion in managerial occupations, a greater proportion of population from ethnic minorities, a greater proportion of people not born in UK, and greater level of deprivation. High-risk areas were observed in the North-East, Yorkshire, South-East, and Birmingham. Conclusion: The study identified neighbourhood characteristics of high-risk areas that experience a high incidence of OHCA and low bystander resuscitation rate that could be targeted for programmes of training in cardiopulmonary resuscitation and automated external defibrillator use.

Attitudes to Cardiopulmonary Resuscitation and Defibrillator Use: A Survey of UK Adults in 2017.

Background Bystander cardiopulmonary resuscitation ( CPR ) and public access defibrillator ( PAD ) use can save the lives of people who experience out-of-hospital cardiac arrest. Little is known about the proportions of UK adults trained, their characteristics and willingness to act if witnessing an out-of-hospital cardiac arrest, or the public's knowledge regarding where the nearest PAD is located. Methods and Results An online survey was administered by YouGov to a nonprobabilistic purposive sample of UK adults, achieving 2084 participants, from a panel that was matched to be representative of the population. We used descriptive statistics and multivariate logistic regression modeling for analysis. Almost 52% were women, 61% were aged <55 years, and 19% had witnessed an out-of-hospital cardiac arrest. Proportions ever trained were 57% in chest-compression-only CPR, 59% in CPR , and 19.4% in PAD use. Most with training in any resuscitation technique had trained at work (54.7%). Compared with people not trained, those trained in PAD use said they were more likely to use one (odds ratio: 2.61), and those trained in CPR or chest-compression-only CPR were more likely to perform it (odds ratio: 5.39). Characteristics associated with being trained in any resuscitation technique included youth, female sex, higher social grade, and full-time employment. Conclusions In the United Kingdom, training makes a difference in people's willingness to act in the event of a cardiac arrest. Although there is considerable opportunity to increase the proportion of the general population trained in CPR , consideration should be also given to encouraging training in PAD use and targeting training for those who are older or from lower social grades.

Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary edema.

BACKGROUND: Non-invasive positive pressure ventilation (NPPV) has been widely used to alleviate signs and symptoms of respiratory distress due to cardiogenic pulmonary edema. NPPV prevents alveolar collapse and helps redistribute intra-alveolar fluid, improving pulmonary compliance and reducing the pressure of breathing. OBJECTIVES: To determine the effectiveness and safety of NPPV in the treatment of adult patients with cardiogenic pulmonary edema. SEARCH STRATEGY: We undertook a comprehensive search of the following databases in April 2005: CENTRAL, MEDLINE, EMBASE, CINAHL, DARE and LILACS. We also reviewed reference lists of included studies and contacted experts, equipment manufacturers, and the Cochrane Heart Group. We did not apply language restrictions. SELECTION CRITERIA: We selected blinded or unblinded randomized or quasi-randomized clinical trials, reporting on adult patients with acute or acute-on-chronic cardiogenic pulmonary edema and where NPPV (continuous positive airway pressure (CPAP)) and/or bilevel NPPV plus standard medical care was compared with standard medical care alone. DATA COLLECTION AND ANALYSIS: Two authors independently selected articles and abstracted data using a standardized data collection form. We evaluated study quality with emphasis on allocation concealment, adherence to the intention-to-treat principle and losses to follow-up. MAIN RESULTS: We included 21 studies involving 1,071 participants. Compared to standard medical care, NPPV significantly reduced hospital mortality (RR 0.6, 95% CI 0.45 to 0.84) and endotracheal intubation (RR 0.53, 95% CI 0.34 to 0.83) with numbers needed to treat of 13 and 8, respectively. We found no difference in hospital length of stay with NPPV, however, intensive care unit stay was reduced by 1 day (WMD -1.07 days, 95% CI -1.60 to -0.53). Compared to standard medical care, we did not observe significant increases in the incidence of acute myocardial infarction with NPPV during (RR 1.24, 95% CI 0.79 to 1.95) or after (RR 0.82, 95% CI 0.09 to 7.54) its application. AUTHORS' CONCLUSIONS: NPPV, especially CPAP, in addition to standard medical care is an effective and safe intervention for the treatment of adult patients with acute cardiogenic pulmonary edema.

Development of an evidence-based complex intervention for community rehabilitation of patients with hip fracture using realist review, survey and focus groups.

OBJECTIVES: To develop an evidence and theory-based complex intervention for improving outcomes in elderly patients following hip fracture. DESIGN: Complex-intervention development (Medical Research Council (MRC) framework phase I) using realist literature review, surveys and focus groups of patients and rehabilitation teams. SETTING: North Wales. PARTICIPANTS: Surveys of therapy managers (n=13), community and hospital-based physiotherapists (n=129) and occupational therapists (n=68) throughout the UK. Focus groups with patients (n=13), their carers (n=4) and members of the multidisciplinary rehabilitation teams in North Wales (n=13). RESULTS: The realist review provided understanding of how rehabilitation interventions work in the real-world context and three programme theories were developed: improving patient engagement by tailoring the intervention to individual needs; reducing fear of falling and improving self-efficacy to exercise and perform activities of daily living; and coordination of rehabilitation delivery. The survey provided context about usual rehabilitation practice; focus groups provided data on the experience, acceptability and feasibility of rehabilitation interventions. An intervention to enhance usual rehabilitation was developed to target these theory areas comprising: a physical component consisting of six additional therapy sessions; and a psychological component consisting of a workbook to enhance self-efficacy and a patient-held goal-setting diary for self-monitoring. CONCLUSIONS: A realist approach may have advantages in the development of evidence-based interventions and can be used in conjunction with other established methods to contribute to the development of potentially more effective interventions. A rehabilitation intervention was developed which can be tested in a future randomised controlled trial (MRC framework phases II and III). TRIAL REGISTRATION NUMBER: ISRCTN22464643, Pre-results.

Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR).

BACKGROUND: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking. OBJECTIVES: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation. DESIGN: Phase I - realist review, survey and focus groups to develop the rehabilitation package. Phase II - parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study. SETTING: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge. PARTICIPANTS: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area. INTERVENTIONS: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients' self-efficacy and increasing the amount and quality of patients' practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions. MAIN OUTCOME MEASURES: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale - International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers. RESULTS: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n = 32; intervention, n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen's d = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen's d = 0.31) and 1.3 (Cohen's d = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22464643. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information.

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture.

OBJECTIVE: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture. SETTING: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community. PARTICIPANTS: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area. INTERVENTION: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers. RESULTS: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported. CONCLUSIONS: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT. TRIAL REGISTRATION NUMBER: ISRCTN22464643; Results.

The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework.

BACKGROUND: The case has been made for more and better theory-informed process evaluations within trials in an effort to facilitate insightful understandings of how interventions work. In this paper, we provide an explanation of implementation processes from one of the first national implementation research randomized controlled trials with embedded process evaluation conducted within acute care, and a proposed extension to the Promoting Action on Research Implementation in Health Services (PARIHS) framework. METHODS: The PARIHS framework was prospectively applied to guide decisions about intervention design, data collection, and analysis processes in a trial focussed on reducing peri-operative fasting times. In order to capture a holistic picture of implementation processes, the same data were collected across 19 participating hospitals irrespective of allocation to intervention. This paper reports on findings from data collected from a purposive sample of 151 staff and patients pre- and post-intervention. Data were analysed using content analysis within, and then across data sets. RESULTS: A robust and uncontested evidence base was a necessary, but not sufficient condition for practice change, in that individual staff and patient responses such as caution influenced decision making. The implementation context was challenging, in which individuals and teams were bounded by professional issues, communication challenges, power and a lack of clarity for the authority and responsibility for practice change. Progress was made in sites where processes were aligned with existing initiatives. Additionally, facilitators reported engaging in many intervention implementation activities, some of which result in practice changes, but not significant improvements to outcomes. CONCLUSIONS: This study provided an opportunity for reflection on the comprehensiveness of the PARIHS framework. Consistent with the underlying tenant of PARIHS, a multi-faceted and dynamic story of implementation was evident. However, the prominent role that individuals played as part of the interaction between evidence and context is not currently explicit within the framework. We propose that successful implementation of evidence into practice is a planned facilitated process involving an interplay between individuals, evidence, and context to promote evidence-informed practice. This proposal will enhance the potential of the PARIHS framework for explanation, and ensure theoretical development both informs and responds to the evidence base for implementation.

A pragmatic cluster randomised trial evaluating three implementation interventions.

BACKGROUND: Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. METHODS: A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients' experiences, and stakeholders' experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. RESULTS: Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. CONCLUSIONS: This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions' impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance. TRIAL REGISTRATION: ISRCTN18046709--Peri-operative Implementation Study Evaluation (POISE).