UK community health visiting: challenges faced during lean implementation

This paper presents an overview of the challenges and potential of lean implementation for the health visiting service in England and examines the rhetoric and the reality of the situation. It is coauthored by academic researchers and senior service providers so as to embrace the multidimensional issues impacting on this subject. If lean thinking is to be implemented in relation to health visiting, it is important to understand how it is likely to be viewed by practitioners and line managers in settings where it is used. In order to contextualize the discussion, an introduction to the roles, systems, and structures of health visiting are provided. The literature on what lean implementation is, what it means, and in particular the application and potential of the approach to primary care and public health services is reviewed. The process and findings from a focus group convened within a large primary care organization in the National Health Service during their lean implementation is reported. The paper concludes that it is important for staff at all levels to see a clear link between strategic aims and objectives and the planning processes operated by providers and commissioners. It appears that the successful introduction of lean thinking should focus more on productive working and thereby reducing waste. This has the potential to refresh workforce models to ensure that health visiting and other practitioners liberate the use of their specialist knowledge and skills. In a context of enhanced partnership working, the stage is then set for providers to add value to the whole system and together improve service user outcomes

Frailty Nurse and GP-led models of care in Care Homes: The role of contextual factors impacting Enhanced in Care Homes framework implementation

BACKGROUND: The Enhanced Health for Care homes (EHCH) framework is an innovative response to provide more proactive, preventative approaches to care for residents living in care homes. It involves co-producing a shared vision with primary care. As part of EHCH a UK clinical commissioning group supported GP’s in two localities to implement their preferred delivery approach involving a new Frailty Nurse-led (FN-led) model in care homes alongside an existing General Practitioner-led (GP-led) model. This paper focuses on implementation of the new FN-led model. METHODS: A qualitative study design was adopted. Forty-eight qualitative semi-structured interviews were undertaken across six care home sites in a Northern locality: three implementing the FN-led and three engaged in an existing GP-led model. Participants included residents, family members, care home managers, care staff, and health professionals working within the EHCH framework. RESULTS: Two overarching themes were generated from data analysis: Unanticipated implementation issues and Unintended consequences. Unsuccessful attempts to recruit Frailty Nurses (FN) with enhanced clinical skills working at the desired level (UK NHS Band 7) led to an unanticipated evolution in the implementation process of the FN-led model towards ‘training posts’. This prompted misaligned role expectations subsequently provoking unexpected temporary outcomes regarding role-based trust. The existing, well understood nature of the GP-led model may have further exacerbated these unintended consequences. CONCLUSION: Within the broader remit of embedding EHCH frameworks, the implementation of new FN roles needed to evolve due to unforeseen recruitment issues. Wider contextual factors are not in the control of those developing new initiatives and cannot always be foreseen, highlighting how wider factors can force evolution of planned implementation processes with unintended consequences. However, the unintended consequences in this study highlight the need for careful consideration of information dissemination (content and timing) to key stakeholders, and the influence of existing ways of working

Residents transitioning between hospital and care homes: protocol for codesigning a systems-level response to safety issues (SafeST study)

Introduction: The aim of this study is to develop a better understanding of incident reporting in relation to transitions in care between hospital and care home, and to codesign a systems- level response to safety issues for patients transitioning between hospital and care home. Methods and analysis: Two workstreams (W) will run in parallel. W1 will aim to develop a taxonomy of incident reporting in care homes, underpinned by structured interviews (N=150) with care home representatives, scoping review of care home incident reporting systems, and a review of incident reporting policy related to care homes. The taxonomy will be developed using a standardised approach to taxonomy development. W2 will be structured in three phases (P). P1a will consist of ≤40 interviews with care home staff to develop a better understanding of their specific internal systems for reporting incidents, and P1b will include ≤30 interviews with others involved in transitions between hospital and care home. P1a and P1b will also examine the impact of the SARS- CoV- 2 pandemic on safe transitions. P2 will consist of a retrospective documentary analysis of care home data relating to resident transitions, with data size and sampling determined based on data sources identified in P1a. A validated data extraction form will be adapted before use. P3 will consist of four validation and codesign workshops to develop a service specification using National Health Service Improvement’s service specification framework, which will then be mapped against existing systems and recommendations produced. Framework analysis informed by the heuristic of systemic risk factors will be the primary mode of analysis, with content analysis used for analysing incident reports. Ethics and dissemination: The study has received university ethical approval and Health Research Authority approval. Findings will be disseminated to commissioners, providers and regulators who will be able to use the codesigned service specification to improve integrated care

Challenges and improvements associated with transitions between hospitals and care homes during the COVID-19 pandemic: a qualitative study with care home and healthcare staff in England

Background: Care home residents transitioning from hospital are at risk of receiving poor-quality care with their safety being challenged by the SARS-CoV-2 virus (COVID-19) pandemic. Little is known about how care home staff worked with hospital staff and other healthcare professionals to address these challenges and make improvements to increase patient safety. Objective: To gain insight into how the COVID-19 pandemic influenced the safety of transitions between hospital and care home. Method: Semi-structured interviews were conducted with care home staff and healthcare professionals involved in hospital to care home transitions including doctors, nurses, paramedics, pharmacists, social workers, and occupational therapists. Commonalities and patterns in the data were identified using thematic analysis. Results: Seventy participants were interviewed. Three themes were developed, first, ‘new challenges’, described care homes were pressurised to receive hospital patients amidst issues with COVID-19 testing, changes to working practices and contentious media attention, which all impacted staff negatively. Second, ‘dehumanisation’ described how care home residents were treated, being isolated from others amounted to feelings of being imprisoned, caused fear and engendered negative reactions from families. Third, ‘better ways of working’ described how health and social care workers developed relationships that improved integration and confidence and benefited care provision. Conclusion: The COVID-19 pandemic contributed to and compounded high-risk hospital-to-care home discharges. Government policy failed to support care homes. Rapid discharge objectives exposed a myriad of infection control issues causing inhumane conditions for care home residents. However, staff involved in transitions continued to provide and improve upon care provision

Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. Trial registration Current Controlled Trials ISRCTN61568050

Extracellular vesicles generated by placental tissues ex vivo: A transport system for immune mediators and growth factors

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/144634/1/aji12860_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/144634/2/aji12860.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/144634/3/aji12860-sup-0001-Supinfo.pd

Oral Abstracts 7: RA ClinicalO37. Long-Term Outcomes of Early RA Patients Initiated with Adalimumab Plus Methotrexate Compared with Methotrexate Alone Following a Targeted Treatment Approach

Background: This analysis assessed, on a group level, whether there is a long-term advantage for early RA patients treated with adalimumab (ADA) + MTX vs those initially treated with placebo (PBO) + MTX who either responded to therapy or added ADA following inadequate response (IR). Methods: OPTIMA was a 78- week, randomized, controlled trial of ADA + MTX vs PBO + MTX in MTX-naïve early (<1 year) RA patients. Therapy was adjusted at week 26: ADA + MTX-responders (R) who achieved DAS28 (CRP) <3.2 at weeks 22 and 26 (Period 1, P1) were re-randomized to withdraw or continue ADA and PBO + MTX-R continued randomized therapy for 52 weeks (P2); IR-patients received open-label (OL) ADA + MTX during P2. This post hoc analysis evaluated the proportion of patients at week 78 with DAS28 (CRP) <3.2, HAQ-DI <0.5, and/or ΔmTSS ≤0.5 by initial treatment. To account for patients who withdrew ADA during P2, an equivalent proportion of R was imputed from ADA + MTX-R patients. Results: At week 26, significantly more patients had low disease activity, normal function, and/or no radiographic progression with ADA + MTX vs PBO + MTX (Table 1). Differences in clinical and functional outcomes disappeared following additional treatment, when PBO + MTX-IR (n = 348/460) switched to OL ADA + MTX. Addition of OL ADA slowed radiographic progression, but more patients who received ADA + MTX from baseline had no radiographic progression at week 78 than patients who received initial PBO + MTX. Conclusions: Early RA patients treated with PBO + MTX achieved comparable long-term clinical and functional outcomes on a group level as those who began ADA + MTX, but only when therapy was optimized by the addition of ADA in PBO + MTX-IR. Still, ADA + MTX therapy conferred a radiographic benefit although the difference did not appear to translate to an additional functional benefit. Disclosures: P.E., AbbVie, Merck, Pfizer, UCB, Roche, BMS—Provided Expert Advice, Undertaken Trials, AbbVie—AbbVie sponsored the study, contributed to its design, and participated in the collection, analysis, and interpretation of the data, and in the writing, reviewing, and approval of the final version. R.F., AbbVie, Pfizer, Merck, Roche, UCB, Celgene, Amgen, AstraZeneca, BMS, Janssen, Lilly, Novartis—Research Grants, Consultation Fees. S.F., AbbVie—Employee, Stocks. A.K., AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, Pfizer, Roche, UCB—Research Grants, Consultation Fees. H.K., AbbVie—Employee, Stocks. S.R., AbbVie—Employee, Stocks. J.S., AbbVie, Amgen, AstraZeneca, BMS, Celgene, Centocor-Janssen, GlaxoSmithKline, Lilly, Pfizer (Wyeth), MSD (Schering-Plough), Novo-Nordisk, Roche, Sandoz, UCB—Research Grants, Consultation Fees. R.V., AbbVie, BMS, GlaxoSmithKline, Human Genome Sciences, Merck, Pfizer, Roche, UCB Pharma—Consultation Fees, Research Support. Table 1.Week 78 clinical, functional, and radiographic outcomes in patients who received continued ADA + MTX vs those who continued PBO + MTX or added open-label ADA following an inadequate response ADA + MTX, n/N (%)a PBO + MTX, n/N (%)b Outcome Week 26 Week 52 Week 78 Week 26 Week 52 Week 78 DAS28 (CRP) <3.2 246/466 (53) 304/465 (65) 303/465 (65) 139/460 (30)*** 284/460 (62) 300/460 (65) HAQ-DI <0.5 211/466 (45) 220/466 (47) 224/466 (48) 150/460 (33)*** 203/460 (44) 208/460 (45) ΔmTSS ≤0.5 402/462 (87) 379/445 (86) 382/443 (86) 330/459 (72)*** 318/440 (72)*** 318/440 (72)*** DAS28 (CRP) <3.2 + ΔmTSS ≤0.5 216/462 (47) 260/443 (59) 266/443 (60) 112/459 (24)*** 196/440 (45) 211/440 (48)*** DAS28 (CRP) <3.2 + HAQ-DI <0.5 + ΔmTSS ≤0.5 146/462 (32) 168/443 (38) 174/443 (39) 82/459 (18)*** 120/440 (27)*** 135/440 (31)** aIncludes patients from the ADA Continuation (n = 105) and OL ADA Carry On (n = 259) arms, as well as the proportional equivalent number of responders from the ADA Withdrawal arm (n = 102). bIncludes patients from the MTX Continuation (n = 112) and Rescue ADA (n = 348) arms. Last observation carried forward: DAS28 (CRP) and HAQ-DI; Multiple imputations: ΔmTSS. ***P < 0.001 and **iP < 0.01, respectively, for differences between initial treatments from chi-squar

Basic science232. Certolizumab pegol prevents pro-inflammatory alterations in endothelial cell function

Background: Cardiovascular disease is a major comorbidity of rheumatoid arthritis (RA) and a leading cause of death. Chronic systemic inflammation involving tumour necrosis factor alpha (TNF) could contribute to endothelial activation and atherogenesis. A number of anti-TNF therapies are in current use for the treatment of RA, including certolizumab pegol (CZP), (Cimzia ®; UCB, Belgium). Anti-TNF therapy has been associated with reduced clinical cardiovascular disease risk and ameliorated vascular function in RA patients. However, the specific effects of TNF inhibitors on endothelial cell function are largely unknown. Our aim was to investigate the mechanisms underpinning CZP effects on TNF-activated human endothelial cells. Methods: Human aortic endothelial cells (HAoECs) were cultured in vitro and exposed to a) TNF alone, b) TNF plus CZP, or c) neither agent. Microarray analysis was used to examine the transcriptional profile of cells treated for 6 hrs and quantitative polymerase chain reaction (qPCR) analysed gene expression at 1, 3, 6 and 24 hrs. NF-κB localization and IκB degradation were investigated using immunocytochemistry, high content analysis and western blotting. Flow cytometry was conducted to detect microparticle release from HAoECs. Results: Transcriptional profiling revealed that while TNF alone had strong effects on endothelial gene expression, TNF and CZP in combination produced a global gene expression pattern similar to untreated control. The two most highly up-regulated genes in response to TNF treatment were adhesion molecules E-selectin and VCAM-1 (q 0.2 compared to control; p > 0.05 compared to TNF alone). The NF-κB pathway was confirmed as a downstream target of TNF-induced HAoEC activation, via nuclear translocation of NF-κB and degradation of IκB, effects which were abolished by treatment with CZP. In addition, flow cytometry detected an increased production of endothelial microparticles in TNF-activated HAoECs, which was prevented by treatment with CZP. Conclusions: We have found at a cellular level that a clinically available TNF inhibitor, CZP reduces the expression of adhesion molecule expression, and prevents TNF-induced activation of the NF-κB pathway. Furthermore, CZP prevents the production of microparticles by activated endothelial cells. This could be central to the prevention of inflammatory environments underlying these conditions and measurement of microparticles has potential as a novel prognostic marker for future cardiovascular events in this patient group. Disclosure statement: Y.A. received a research grant from UCB. I.B. received a research grant from UCB. S.H. received a research grant from UCB. All other authors have declared no conflicts of interes