Lymphoedema specialists embedded into community nurse and wound services: impacts and outcomes.

BACKGROUND: Lymphoedema is a progressive condition causing significant alterations to life, exerting pressures on unscheduled care from complications including cellulitis and wounds. An on the ground education programme (OGEP) was implemented to raise knowledge, competence and confidence in lymphoedema management in community clinical services. The aim of this study was to explore the impact and outcomes of the OGEP intervention. METHODS: Data were captured before and after OGEP on 561 lymphoedema patients in the community setting. Data recorded included resource use, costs and outcomes (EQ-5D-5L and LYMPROM). RESULTS: Data demonstrated statistically significant reductions in resource allocations including staff visits (P<0.001), cellulitis admissions (P<0.001), compression consumables and wound dressing costs (P<0.001). Overall, the total mean per patient cost decreased from £1457.10 to £964.40 (including intervention) with outcomes significantly improved in EQ-5D-5L/LYMPROM scores. CONCLUSION: The analysis suggests the OGEP intervention may offer reductions in resource costs and improvements in patient outcomes. OGEP may therefore provide an innovative solution in future care delivery.

Impact of an educational intervention on hand hygiene practice among nursing students, with a focus on hand drying efficacy.

Background: Hand hygiene and its significance for reducing the spread of infection is well evidenced and has been brought into sharp focus following the COVID-19 pandemic. Although a crucial clinical skill in ensuring safe healthcare, little is known regarding nursing students' effectiveness of hand hygiene practice. Aim: The aim of this study was to evaluate the impact of an educational intervention on hand hygiene practice, designed by the research team for first year pre-registration nursing students. Particular emphasis was placed upon hand drying technique and time. Methodology: 825 nursing students were observed and assessed for their hand hygiene practice in a clinical suite at a university setting. Nursing students were observed for compliance against set outcome measures involving hand hygiene preparation, hand and wrist washing technique, hand drying technique and time. Data were analysed quantitatively using SPSS. Results: The educational intervention had a significant impact on the clinical skills learning of nursing students. 779 students passed the assessment at the first attempt (94.4%). Of the 46 students that failed to meet the necessary criteria, 45 satisfied the criteria at the second attempt; giving an overall optimal compliance of 99.9%. 99.6% of students complied with recommended hand drying standards. Conclusion: This study offers an important contribution to the development and delivery of nursing education programmes. The educational intervention improved compliance with recommended hand hygiene technique and practice. Lack of attention to hand drying may negate effective hand hygiene in healthcare.

Evaluating the cost of managing patients with cellulitis in Wales, UK: A 20-year population-scale study.

This study aimed to estimate costs associated with managing patients with cellulitis from the UK National Health Service (NHS) perspective. The analysis was undertaken through the Secure Anonymised Information Linkage Databank, which brings together population-scale, individual-level anonymised linked data from a wide range of sources, including 80% of primary care general practices within Wales (population coverage ~3.2 million). The data covered a 20-year period from 1999 to 2019. All patients linked to the relevant codes were tracked through primary care settings, recording the number of general practice visits (number of days with an event recorded) and number of in-patient stays. Resources were valued in monetary terms (£ sterling), with costs determined from national published sources of unit costs. These resources were then extrapolated out to reflect UK NHS costs. This is the first attempt to estimate the financial burden of cellulitis using routine data sources on a national scale. The estimated direct annual costs to the Welsh NHS (£28 554 338) are considerable. In-Patient events and length of stay costs are the main cost drivers, with annual Welsh NHS estimates of £19 664 126 with primary care events costing £8 890 212. Initiatives to support patients and healthcare professionals in identifying early signs/risks of cellulitis, improve the accuracy of initial diagnosis, prevent cellulitis recurrence, and improve evidence-based treatment pathways would result in major financial savings, to both the Welsh and UK NHS. In light of these findings, Wales has developed the innovative National Lymphoedema cellulitis Improvement Programme to address these burdens; providing a proactive model of cellulitis care.

A spotlight on lymphoedema Did Not Attends: Demographics and workforce costs.

This unique evaluation aimed to estimate, the financial impact of non-attendance on a nation-wide hospital lymphoedema service. Along with gaining some understanding of patient characteristics of those who Did Not Attend (DNA) and were subsequently discharged. The evaluation design interrogated existing performance data from 2012 to 2022. This information was used to estimate the costs incurred based on national published sources and pay scales. Staffing costs of over £1.1 m in one decade related to the financial impact of over 23 000 unattended lymphoedema appointments. The characteristics of 870 patients from 2019/2020 were also evaluated suggesting that those with a wound alongside complex lymphoedema were less likely to DNA appointments. Two-thirds of patients were managing two or more comorbidities-obesity, cardiac conditions and diabetes being the most common. It seems likely that some DNAs are avoidable by adapting appointment administrative processes and greater understanding of patients' perception of value. However, the reasons for DNA are likely to be varied and nuanced so potentially a small proportion are unavoidable. Modernising appointment processes and identifying patient value may help minimise DNA costs in the future.

Estimating the cost consequence of the early use of botulinum toxin in post-stroke spasticity: Secondary analysis of a randomised controlled trial.

OBJECTIVE: To estimate the cost-consequence of treating spasticity early with botulinum toxin in the acute stroke unit. DESIGN: Secondary cost-consequence analysis, using data from a double-blind randomised-controlled trial. SETTING: Single-centre specialised stroke unit. SUBJECTS AND INTERVENTIONS: Patients with Action Research Arm Test grasp-score of <2 and who developed spasticity within six weeks of a first stroke were randomised to receive injections of: 0.9% sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment). MAIN MEASURES: Resource use costs were calculated for the study. Mean contracture costs for each group were calculated. The Barthel Index and Action Research Arm Test were used to generate a cost per unit of improvement. RESULTS: There were no significant differences associated with early treatment use. The mean contracture cost for the treatment group was £817 and for the control group was £2298 (mean difference = -£1481.1(95% CI -£2893.5, -£68.7) (p = 0.04). The cost per unit of improvement for the Barthel Index was -£1240 indicating that the intervention costs less and is more effective. The cost per unit of improvement for the Action Research Arm Test was -£450 indicating that the intervention costs less and is more effective. CONCLUSIONS: Treating spasticity early in stroke patients at risk of contractures with botulinum toxin leads to a significant reduction in contracture costs. The cost per improvement of Barthel and Action Research Arm Test indicates that the intervention costs less and is more effective. TRIAL REGISTRATION DATA: EudraCT(2010-021257-39) and ClinicalTrials.gov-Identifier:NCT01882556.

Evaluating nursing opinion and perception of maggot therapy for hard-to-heal wound management.

OBJECTIVE: Maggot therapy (MT) or larval debridement therapy is a recognised, effective but underutilised treatment for the management of hard-to-heal wounds and infected ulcers. It is available on NHS prescription in the UK, where wound management is predominantly nurse-led. Anecdotal reports and published literature suggest that nurses may be reluctant to utilise the therapy. The aim of this study was to evaluate the feelings and opinions of nurses regarding the use of MT. METHOD: The first stage of this mixed-methods study was a focus group held to discuss MT and opinions of specialist nurse clinicians. Next, an anonymised web-based online survey was launched through the Nursing Times journal and distributed through social media targeting all nurses. Finally, in-depth interviews were held with specialist and generalist nurses. RESULTS: Awareness of MT among all nurses was extremely high. A breakdown of results showed that MT was much more highly regarded by wound specialist nurses than non-wound specialist nurses. The latter exhibited a greater level of reluctance to administer the therapy, with almost one-third of these nurses surveyed saying they found maggots disgusting and that the idea of MT made their skin crawl. In-depth interviews revealed that a lack of knowledge about MT was a prime concern. CONCLUSION: Wound specialist nurses are more likely to embrace MT than non-wound nurse specialists, who report a varying degree of wariness to MT. Our study highlights a need for better education and training in MT for all nurses, to address issues with acceptance and willingness to treat or help treat patients with hard-to-heal wounds which are suitable for MT.

An exploration of public perceptions and attitudes towards maggot therapy.

OBJECTIVE: The aim of the study was to explore public opinion and perceptions of maggot therapy (larval therapy), a treatment option for hard-to-heal wounds. METHOD: The study used a mixed-method approach to obtain quantitative and qualitative data. A focus group was convened to explore opinions and views of maggot therapy with a small group of members of the public. Analysis of emerging themes from the focus group was used to design an anonymised web-based survey, which was made available online to members of the public through email and social media. RESULTS: The focus group participants identified four key themes concerning the acceptability of maggot therapy. The subsequent online survey was completed by 412 participants, analysis of which revealed some worries and fears. Only 36% of survey participants agreed that they would accept maggot therapy as a first choice for a hypothetical painful wound, although this number increased with wound severity. The most predominant concerns regarding maggot therapy were sensation and a feeling of disgust associated with the therapy. However, participants could see some benefits to maggot therapy. CONCLUSION: Our study showed that public perception of maggot therapy is varied. Survey participants expressed worries and fears associated with its use. However, positive relationships existed between knowledge scores and potential acceptability of maggot therapy, suggesting that information dissemination and education may be an important factor in public perception and acceptability of maggot therapy.

Medicines prescribed for asthma, discontinuation and perinatal outcomes, including breastfeeding: A population cohort analysis.

OBJECTIVES: To explore associations between exposures to medicines prescribed for asthma and their discontinuation in pregnancy and preterm birth [<37 or <32 weeks], SGA [<10th and <3rd centiles], and breastfeeding at 6-8 weeks. METHODS: Design. A population-based cohort study. Setting. The Secure Anonymised Information Linkage [SAIL] databank in Wales, linking maternal primary care data with infant outcomes. Population. 107,573, 105,331, and 38,725 infants born 2000-2010 with information on premature birth, SGA and breastfeeding respectively, after exclusions. Exposures. maternal prescriptions for asthma medicines or their discontinuation in pregnancy. Methods. Odds ratios for adverse pregnancy outcomes were calculated for the exposed versus the unexposed population, adjusted for smoking, parity, age and socio-economic status. RESULTS: Prescriptions for asthma, whether continued or discontinued during pregnancy, were associated with birth at<32 weeks' gestation, SGA <10th centile, and no breastfeeding (aOR 1.33 [1.10-1.61], 1.10 [1.03-1.18], 0.93 [0.87-1.01]). Discontinuation of asthma medicines in pregnancy was associated with birth at<37 weeks' and <32 weeks' gestation (aOR 1.22 [1.06-1.41], 1.53 [1.11-2.10]). All medicines examined, except ICS and SABA prescribed alone, were associated with SGA <10th centile. CONCLUSIONS: Prescription of asthma medicines before or during pregnancy was associated with higher prevalence of adverse perinatal outcomes, particularly if prescriptions were discontinued during pregnancy. Women discontinuing medicines during pregnancy could be identified from prescription records. The impact of targeting close monitoring and breastfeeding support warrants exploration.

Cost of managing patients with venous leg ulcers.

The aim of this study was to estimate costs associated with the management of patients with venous leg ulcers (VLUs) from the perspective of the UK National Health Service (NHS). The analysis was undertaken through the Secure Anonymised Information Linkage Databank which brings together and anonymously links a wide range of person-based data from around 75% of general practitioner (GP) practices within Wales (population coverage ~2.5 million). The data covered an 11-year period from 2007 to 2017. All patients linked to the relevant codes were tracked through primary care settings, recording the number of GP practice visits (number of days with an event recorded), and wound treatment utilisation (eg, dressings, bandages, etc.) Resources were valued in monetary terms (£ sterling) and the costs were determined from national published sources of unit costs. This is the first attempt to estimate the costs of managing of VLUs using routine data sources. The direct costs to the Welsh NHS are considerable and represent 1.2% of the annual budget. Nurse visits are the main cost driver with annual estimates of £67.8 million. At a UK level, these costs amount to £1.98 billion. Dressings and compression bandages are also major cost drivers with annual Welsh estimates of £828 790. The direct cost of managing patients with VLUs is £7706 per patient per annum, which translates to an annual cost of over £2 billion, when extrapolated to the UK population. The primary cost driver is the number of district nurse visits. Initiatives to reduce healing times through improving accuracy of initial diagnosis, and improved evidence-based treatment pathways would result in major financial savings.

The benefits of raising awareness of lymphoedema among care home staff.

BACKGROUND: Patients with lymphoedema referred to a lymphoedema service from care homes in one health board area in Wales were often complex cases, with repeated cellulitis, a history of falls and other complications. A pilot project was initiated to develop education and raise awareness of lymphoedema among care home staff. AIMS: To enable care staff to identify residents with lymphoedema, promote prompt referrals, raise the importance of skin care and exercise in the management of lymphoedema and estimate the likely costs from complications associated with lymphoedema. METHODS: An education tool was developed and 47 care homes were asked to participate. A lymphoedema therapist carried out a scoping review of the residents. RESULTS: Forty-four care homes agreed to participate in the project with 1216 education packs being issued to care home staff. Initial findings suggest that of the 960 residents reviewed, 262 had lymphoedema (27%); 4% suffered with frequent falls, 1% had wounds and 3% had recurrent cellulitis. Only 13% (35/262) of residents with lymphoedema were known to the local lymphoedema service. Of the 31 residents reporting cellulitis, 81% had lymphoedema; of the 11 residents identified with a wound, 100% had lymphoedema and of the 40 residents reporting falls, 70% had lymphoedema. CONCLUSION: This educational project has identified the value of raising awareness of lymphoedema within care homes.

Antidepressant prescriptions, discontinuation, depression and perinatal outcomes, including breastfeeding: A population cohort analysis.

OBJECTIVES: To explore associations between exposure to antidepressants, their discontinuation, depression [medicated or unmediated] and preterm birth [<37 and <32 weeks], small for gestational age (SGA) [<10th and <3rd centiles], breastfeeding [any] at 6-8 weeks. METHODS: Design: A population-based cohort study. Setting: The Secure Anonymised Information Linkage [SAIL] databank in Wales, linking maternal primary care data with infant outcomes. Participants: 107,573, 105,331, and 38,725 infants born 2000-2010 with information on prematurity, SGA and breastfeeding respectively, after exclusions. Exposures: Maternal antidepressant prescriptions in trimesters 2 or 3, discontinuation after trimester 1, recorded diagnosis of depression [medicated or unmediated] in pregnancy. Methods: Odds ratios for adverse pregnancy outcomes were calculated, adjusted for smoking, parity, socio-economic status, and depression. RESULTS: Exclusive formula feeding at 6-8 weeks was associated with prescriptions in trimesters 2 or 3 for any antidepressants (adjusted odds ratio [aOR] 0.81, 95% confidence intervals 0.67-0.98), SSRIs [aOR 0.77, 0.62-0.95], particularly higher doses [aOR 0.45, 0.23-0.86], discontinuation of antidepressants or SSRIs after trimester 1 (aOR 0.70, 0.57-0.83 and 0.66, 0.51-0.87), diagnosis of depression aOR 0.76 [0.70-0.82), particularly if medicated (aOR 0.70, 0.58-0.85), rather than unmedicated (aOR 0.87, 0.82-0.92). Preterm birth at <37 and <32 weeks' gestation was associated with diagnosis of depression (aOR 1.27, 1.17-1.38, and 1.33, 1.09-1.62), particularly if medicated (aOR 1.56, 1.23-1.96, and 1.63, 0.94-2.84); birth at <37 weeks was associated with antidepressants, (aOR 1.24, 1.04-1.49]. SGA <3rd centile was associated with antidepressants (aOR 1.43, 1.07-1.90), and SSRIs (aOR 1.46, 1.06-2.00], particularly higher doses [aOR 2.10, 1.32-3.34]. All adverse outcomes were associated with socio-economic status and smoking. IMPLICATIONS: Exposure to antidepressants or depression increased risks of exclusive formula feeding at 6-8 weeks, and prescription of antidepressants was associated with SGA <3rd centile. Prescription of antidepressants offers a useful marker to target additional support and additional care before and during pregnancy and lactation.

Initiatives and evaluations: the life of a lymphoedema researcher.

Ioan Humphreys, Research Assistant, College of Human and Health Sciences, Swansea University ( i.humphreys@swansea.ac.uk ), describes his involvement in evaluating some exciting initiatives to improve care.

Pilot evaluation of the management of chronic oedema in community settings project.

AIMS: The aim of this economic analysis was to estimate the economic impact of the On the Ground Education Programme (OGEP) within one local University Health Board (UHB) in Wales. BACKGROUND: The burden of managing chronic oedema can be considerable to the NHS. Developing innovative solutions to the care and management of patients with chronic oedema has the potential to deliver prudent, cost-effective and high quality care within NHS Wales. DESIGN: The study was a pilot Evaluation of the OGEP using retrospectively and prospectively collected patient recalled data. METHODS: A questionnaire collected health care service use data prior to receiving the OGEP (baseline) and at 3 months follow-up from 97 patients during the period June 2016 and January 2017. In addition, we analysed a patient reported health outcome using the EQ-5D 5L, which was completed by patients at the same two assessment points. RESULTS/FINDINGS: The total cost of managing chronic oedema in the 97 patients recruited was £563 729 (mean patient cost £5812 SD (£5870) at baseline and £445 098 (including the addition of intervention costs) (mean patient cost £4589 (SD £5465) at 3 months follow-up. Improvements in the EQ-5D 5L score increasing from 0.40 (SD 0.25) at baseline to 0.54 (SD 0.23) at 3 months follow-up. CONCLUSIONS: Our research show health care resource use and costs decreased, while health-related quality of life scores increased.

Managing chronic oedema and wet legs in the community: a service evaluation.

Patients with chronic oedema and 'wet legs' are frequently seen in the community setting, with research indicating that more than half of community nurses' caseloads are patients with chronic oedema. However, a lack of nurse education and standardised care pathways for this condition has been identified. In June 2016, the Welsh Government supported the development of the On the Ground Education Project (OGEP), which aimed to raise community nurses' awareness and recognition of chronic oedema and wet legs, to improve the management of these conditions, and to support the efficient use of community nurses' time and resources. AIM: To investigate the potential economic benefits of the OGEP and its effects on patients' quality of life. METHOD: The OGEP was implemented between June 2016 and March 2017. During this time, 725 patients were assessed and chronic oedema was diagnosed in 426 (59%) of them. Of these, 100 patients were purposively recruited and 97 completed the pilot service evaluation. Data were collected observationally before and after the OGEP was implemented. Baseline measurements of resources, costs and outcomes were captured at the time the patients were initially identified and at a follow-up review three months later. The EQ-5D-5L tool was used to measure patients' health-related quality of life before and after the OGEP was implemented. Data were analysed using Microsoft Excel and SPSS Version 22. RESULTS: Following implementation of the OGEP, there was a significant decrease in the number of district nurse home visits, (P=<0.001), GP surgery appointments (P=0.003) and episodes of cellulitis (P=<0.001). The EQ-5D-5L utility scores showed that patients' quality of life improved after the OGEP was implemented, from a baseline of 0.401 (SD 0.254) to 0.537 (SD 0.231) at the three-month follow-up review. CONCLUSION: The OGEP may support the efficient use of community nurses' time and resources, reduce costs to the NHS, and improve the quality of life of patients with chronic oedema and wet legs.

Evaluation of the economic impact of a national lymphoedema service in Wales.

Lymphoedema Network Wales has focused on maximising the impact of its service through the effective use of available resources to ensure high-quality and consistent care for people with lymphoedema across Wales. The aim of this evaluation was to estimate the economic impact of a national lymphoedema service on the NHS Wales budget. Work was undertaken to determine the care pathway within Lymphoedema Network Wales and develop a hypothetical 'world without' the service as a comparator. The four groups of patients that made up the pathways were group 0: 'at risk', group 1-2: 'uncomplicated lymphoedema', group 3: 'complicated/complex' and group 4: 'palliative care'. Overall resource utilisation between 6 months pre- and 6 months post-entry indicated that there were significant cost reductions to be seen after lymphoedema service entry for all patients in each group. This evaluation provides estimates that suggest that the service is likely to be cost saving when people with lymphoedema are managed within Lymphoedema Network Wales rather than in a 'world without' the service.

Seal or Varnish? A randomised controlled trial to determine the relative cost and effectiveness of pit and fissure sealant and fluoride varnish in preventing dental decay.

BACKGROUND: Fissure sealant (FS) and fluoride varnish (FV) have been shown to be effective in preventing dental caries when tested against a no-treatment control. However, the relative clinical effectiveness and cost-effectiveness of these interventions is unknown. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- and 7-year-olds and to determine their acceptability. DESIGN: A randomised controlled allocation-blinded clinical trial with two parallel arms. SETTING: A targeted population programme using mobile dental clinics (MDCs) in schools located in areas of high social and economic deprivation in South Wales. PARTICIPANTS: In total, 1016 children were randomised, but one parent subsequently withdrew permission and so the analysis was based on 1015 children. The randomisation of participants was stratified by school and balanced for sex and primary dentition baseline caries levels using minimisation in a 1 : 1 ratio for treatments. A random component was added to the minimisation algorithm, such that it was not completely deterministic. Of the participants, 514 were randomised to receive FS and 502 were randomised to receive FV. INTERVENTIONS: Resin-based FS was applied to caries-free FPMs and maintained at 6-monthly intervals. FV was applied at baseline and at 6-month intervals over the course of 3 years. MAIN OUTCOME MEASURES: The proportion of children developing caries into dentine (decayed, missing, filled teeth in permanent dentition, i.e. D4-6MFT) on any one of up to four treated FPMs after 36 months. The assessors were blinded to treatment allocation; however, the presence or absence of FS at assessment would obviously indicate the probable treatment received. Economic measures established the costs and budget impact of FS and FV and the relative cost-effectiveness of these technologies. Qualitative interviews determined the acceptability of the interventions. RESULTS: At 36 months, 835 (82%) children remained in the trial: 417 in the FS arm and 418 in the FV arm. The proportion of children who developed caries into dentine on a least one FPM was lower in the FV arm (73; 17.5%) than in the FS arm (82, 19.6%) [odds ratio (OR) 0.84, 95% confidence interval (CI) 0.59 to 1.21; p = 0.35] but the difference was not statistically significant. The results were similar when the numbers of newly decayed teeth (OR 0.86, 95% CI 0.60 to 1.22) and tooth surfaces (OR 0.85, 95% CI 0.59 to 1.21) were examined. Trial fidelity was high: 95% of participants received five or six of the six scheduled treatments. Between 74% and 93% of sealants (upper and lower teeth) were intact at 36 months. The costs of the two technologies showed a small but statistically significant difference; the mean cost to the NHS (including intervention costs) per child was £500 for FS, compared with £432 for FV, a difference of £68.13 (95% CI £5.63 to £130.63; p = 0.033) in favour of FV. The budget impact analysis suggests that there is a cost saving of £68.13 (95% CI £5.63 to £130.63; p = 0.033) per child treated if using FV compared with the application of FS over this time period. An acceptability score completed by the children immediately after treatment and subsequent interviews demonstrated that both interventions were acceptable to the children. No adverse effects were reported. LIMITATIONS: There are no important limitations to this study. CONCLUSIONS: In a community oral health programme utilising MDCs and targeted at children with high caries risk, the twice-yearly application of FV resulted in caries prevention that is not significantly different from that obtained by applying and maintaining FSs after 36 months. FV proved less expensive. FUTURE WORK: The clinical effectiveness and cost-effectiveness of FS and FV following the cessation of active intervention merits investigation. TRIAL REGISTRATION: EudraCT number 2010-023476-23, Current Controlled Trials ISRCTN17029222 and UKCRN reference 9273. 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. 21. See the NIHR Journals Library website for further project information.

Improving Mental Health Through the Regeneration of Deprived Neighborhoods: A Natural Experiment.

Neighborhood-level interventions provide an opportunity to better understand the impact of neighborhoods on health. In 2001, the Welsh Government, United Kingdom, funded Communities First, a program of neighborhood regeneration delivered to the 100 most deprived of the 881 electoral wards in Wales. In this study, we examined the association between neighborhood regeneration and mental health. Information on regeneration activities in 35 intervention areas (n = 4,197 subjects) and 75 control areas (n = 6,695 subjects) was linked to data on mental health from a cohort study with assessments made in 2001 (before regeneration) and 2008 (after regeneration). Propensity score matching was used to estimate the change in mental health in intervention neighborhoods versus control neighborhoods. Baseline differences between intervention and control areas were of similar magnitude as produced by paired randomization of neighborhoods. Regeneration was associated with an improvement in the mental health of residents in intervention areas compared with control neighborhoods (ß = 1.54, 95% confidence interval: 0.50, 2.59), suggesting a reduction in socioeconomic inequalities in mental health. There was a dose-response relationship between length of residence in regeneration neighborhoods and improvements in mental health (P-trend = 0.05). These results show that targeted regeneration of deprived neighborhoods can improve mental health.

Support and Assessment for Fall Emergency Referrals (SAFER) 2: a cluster randomised trial and systematic review of clinical effectiveness and cost-effectiveness of new protocols for emergency ambulance paramedics to assess older people following a fall with referral to community-based care when appropriate.

BACKGROUND: Emergency calls are frequently made to ambulance services for older people who have fallen, but ambulance crews often leave patients at the scene without any ongoing care. We evaluated a new clinical protocol which allowed paramedics to assess older people who had fallen and, if appropriate, refer them to community-based falls services. OBJECTIVES: To compare outcomes, processes and costs of care between intervention and control groups; and to understand factors which facilitate or hinder use. DESIGN: Cluster randomised controlled trial. PARTICIPANTS: Participating paramedics at three ambulance services in England and Wales were based at stations randomised to intervention or control arms. Participants were aged 65 years and over, attended by a study paramedic for a fall-related emergency service call, and resident in the trial catchment areas. INTERVENTIONS: Intervention paramedics received a clinical protocol with referral pathway, training and support to change practice. Control paramedics continued practice as normal. OUTCOMES: The primary outcome comprised subsequent emergency health-care contacts (emergency admissions, emergency department attendances, emergency service calls) or death at 1 month and 6 months. Secondary outcomes included pathway of care, ambulance service operational indicators, self-reported outcomes and costs of care. Those assessing outcomes remained blinded to group allocation. RESULTS: Across sites, 3073 eligible patients attended by 105 paramedics from 14 ambulance stations were randomly allocated to the intervention group, and 2841 eligible patients attended by 110 paramedics from 11 stations were randomly allocated to the control group. After excluding dissenting and unmatched patients, 2391 intervention group patients and 2264 control group patients were included in primary outcome analyses. We did not find an effect on our overall primary outcome at 1 month or 6 months. However, further emergency service calls were reduced at both 1 month and 6 months; a smaller proportion of patients had made further emergency service calls at 1 month (18.5% vs. 21.8%) and the rate per patient-day at risk at 6 months was lower in the intervention group (0.013 vs. 0.017). Rate of conveyance to emergency department at index incident was similar between groups. Eight per cent of trial eligible patients in the intervention arm were referred to falls services by attending paramedics, compared with 1% in the control arm. The proportion of patients left at scene without further care was lower in the intervention group than in the control group (22.6% vs. 30.3%). We found no differences in duration of episode of care or job cycle. No adverse events were reported. Mean cost of the intervention was £17.30 per patient. There were no significant differences in mean resource utilisation, utilities at 1 month or 6 months or quality-adjusted life-years. In total, 58 patients, 25 paramedics and 31 stakeholders participated in focus groups or interviews. Patients were very satisfied with assessments carried out by paramedics. Paramedics reported that the intervention had increased their confidence to leave patients at home, but barriers to referral included patients' social situations and autonomy. CONCLUSIONS: Findings indicate that this new pathway may be introduced by ambulance services at modest cost, without risk of harm and with some reductions in further emergency calls. However, we did not find evidence of improved health outcomes or reductions in overall NHS emergency workload. Further research is necessary to understand issues in implementation, the costs and benefits of e-trials and the performance of the modified Falls Efficacy Scale. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60481756 and PROSPERO CRD42013006418. 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. 13. See the NIHR Journals Library website for further project information.