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Treating and preventing influenza in aged care facilities: a cluster randomised controlled trial.

ABSTRACT: BACKGROUND: Influenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor) is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T) versus treatment and prophylaxis (T&P) in Aged Care Facilities (ACFs). Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs. METHODS AND FINDINGS: We performed a cluster randomised controlled trial in 16 ACFs, that followed a policy of either "T"-oseltamivir treatment (75 mg twice a day for 5 days)-or "T&P"-treatment and prophylaxis (75 mg once a day for 10 days) for influenza outbreaks over three years, in addition to enhanced surveillance. The primary outcome measure was the attack rate of influenza. Secondary outcomes measures were deaths, hospitalisation, pneumonia and adverse events. Laboratory testing was performed to identify the viral cause of influenza-like illness (ILI) outbreaks. The study period 30 June 2006 to 23 December 2008 included three southern hemisphere winters. During that time, influenza was confirmed as the cause of nine of the 23 ILI outbreaks that occurred amongst the 16 ACFs. The policy of T&P resulted in a significant reduction in the influenza attack rate amongst residents: 93/255 (36%) in residents in T facilities versus 91/397 (23%) in T&P facilities (p=0.002). We observed a non-significant reduction in staff: 46/216 (21%) in T facilities versus 47/350 (13%) in T&P facilities (p=0.5). There was a significant reduction in mean duration of outbreaks (T=24 days, T&P=11 days, p=0.04). Deaths, hospitalisations and pneumonia were non-significantly reduced in the T&P allocated facilities. Drug adverse events were common but tolerated. CONCLUSION: Our trial lacked power but these results provide some support for a policy of "treatment and prophylaxis" with oseltamivir in controlling influenza outbreaks in ACFs. TRIAL REGISTRATION: [corrected] Australian Clinical Trials Registry ACTRN12606000278538.

SUBMITTER: Booy R

PROVIDER: S-EPMC3474842 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Treating and preventing influenza in aged care facilities: a cluster randomised controlled trial.

Booy Robert R Lindley Richard I RI Dwyer Dominic E DE Yin Jiehui K JK Heron Leon G LG Moffatt Cameron R M CR Chiu Clayton K CK Rosewell Alexander E AE Dean Anna S AS Dobbins Timothy T Philp David J DJ Gao Zhanhai Z MacIntyre C Raina CR

PloS one 20121017 10

<h4>Background</h4>Influenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor) is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T) versus treatment and prophylaxis (T&P) in Aged Care Facilities (ACFs). Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs.<h4>Methods and findings</h4>We performed a clu ...[more]

PMID: 23082123

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Project description:OBJECTIVES:(1) To develop methods for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records at low cost; (2) to assess the effectiveness of text messaging influenza vaccine reminders in increasing vaccine uptake in patients with chronic conditions. DESIGN:Cluster randomised trial with general practices as clusters. SETTING:English primary care. PARTICIPANTS:156 general practices, who used text messaging software, who had not previously used text message influenza vaccination reminders. Eligible patients were aged 18-64 in 'at-risk' groups. INTERVENTIONS:Practices were randomly allocated to either an intervention or standard care arm in the 2013 influenza season (September to December). Practices in the intervention arm were asked to send a text message influenza vaccination reminder to their at-risk patients under 65. Practices in the standard care arm were asked to continue their influenza campaign as planned. BLINDING:Practices were not blinded. Analysis was performed blinded to practice allocation. MAIN OUTCOME MEASURES:Practice-level influenza vaccine uptake among at-risk patients aged 18-64 years. RESULTS:77 practices were randomised to the intervention group (76 analysed, n at-risk patients=51,121), 79 to the standard care group (79 analysed, n at-risk patients=51,136). The text message increased absolute vaccine uptake by 2.62% (95% CI -0.09% to 5.33%), p=0.058, though this could have been due to chance. Within intervention clusters, a median 21.0% (IQR 10.2% to 47.0%) of eligible patients were sent a text message. The number needed to treat was 7.0 (95% CI -0.29 to 14.3). CONCLUSIONS:Patient follow-up using routine electronic health records is a low cost method of conducting cluster randomised trials. Text messaging reminders are likely to result in modest improvements in influenza vaccine uptake, but levels of patients being texted need to markedly increase if text messaging reminders are to have much effect. TRIAL REGISTRATION NUMBER:ISRCTN48840025.

Project description:BACKGROUND:In countries undergoing rapid economic transition such as China, rates of increase in childhood obesity exceed that in the West. However, prevention trials in these countries are inadequate in both quantity and methodological quality. In high-income countries, recent reviews have demonstrated that school-based prevention interventions are moderately effective but have some methodological limitations. To address these issues, this study evaluated clinical- and cost- effectiveness of the Chinese Primary School Children Physical Activity and Dietary Behaviour Changes Intervention (CHIRPY DRAGON) developed using the United Kingdom Medical Research Council complex intervention framework to prevent obesity in Chinese primary-school-aged children. METHODS AND FINDINGS:In this cluster-randomised controlled trial, we recruited 40 state-funded primary schools from urban districts of Guangzhou, China. A total of 1,641 year-one children with parent/guardian consent took part in baseline assessments prior to stratified randomisation of schools (intervention arm, 20 schools, n = 832, mean age = 6.15 years, 55.6% boys; control arm n = 809, mean age = 6.14 years, 53.3% boys). The 12-month intervention programme included 4 school- and family-based components delivered by 5 dedicated project staff. We promoted physical activity and healthy eating behaviours through educational and practical workshops, family activities, and supporting the school to improve physical activity and food provision. The primary outcome, assessed blind to allocation, was between-arm difference in body mass index (BMI) z score at completion of the intervention. A range of prespecified, secondary anthropometric, behavioural, and psychosocial outcomes were also measured. We estimated cost effectiveness based on quality-adjusted life years (QALYs), taking a public sector perspective. Attrition was low with 55 children lost to follow up (3.4%) and no school dropout. Implementation adherence was high. Using intention to treat analysis, the mean difference (MD) in BMI z scores (intervention - control) was -0.13 (-0.26 to 0.00, p = 0.048), with the effect being greater in girls (MD = -0.18, -0.32 to -0.05, p = 0.007, p for interaction = 0.015) and in children with overweight or obesity at baseline (MD = -0.49, -0.73 to -0.25, p < 0.001, p for interaction < 0.001). Significant beneficial intervention effects were also observed on consumption of fruit and vegetables, sugar-sweetened beverages and unhealthy snacks, screen-based sedentary behaviour, and physical activity in the intervention group. Cost effectiveness was estimated at £1,760 per QALY, with the probability of the intervention being cost effective compared with usual care being at least 95% at a willingness to pay threshold of £20,000 to 30,000 per QALY. There was no evidence of adverse effects or harms. The main limitations of this study were the use of dietary assessment tools not yet validated for Chinese children and the use of the UK value set to estimate QALYS. CONCLUSIONS:This school- and family-based obesity prevention programme was effective and highly cost effective in reducing BMI z scores in primary-school-aged children in China. Future research should identify strategies to enhance beneficial effects among boys and investigate the transferability of the intervention to other provinces in China and countries that share the same language and cultures. TRIAL REGISTRATION:ISRCTN Identifier ISRCTN11867516.

Project description:BACKGROUND:Transfer of residential aged-care facility (RACF) residents to Emergency Departments (ED) is common, risky and expensive. RACF residents who present to ED are more likely to have hospital readmissions, longer stays and face major risks related to hospital acquired complications. Aged Care Emergency services (ACE) is a nurse led, protocol- guided, telephone RACF/ED outreach model that has been shown to be effective in reducing hospitalisation and length of hospital stay for RACF residents in the Hunter New England Local Health District, New South Wales (NSW). The Partnerships in Aged-Care Emergency services using Interactive Telehealth (PACE-IT) project enhances ACE by incorporating interactive video assessment and consultation. The PACE-IT project's primary aim is to assess whether augmentation of ACE services through the addition of protocol-guided interactive Visual Telehealth Consultation (VTC) for clinical decision-making, plus telephone follow-up, reduces RACF resident transfers to ED. METHODS:A stepped-wedge cluster randomised controlled trial will be conducted. The intervention will be delivered sequentially to 8 clusters; each cluster comprises one ED and two RACFs in NSW, Australia. The 16 RACFs in the study will be selected for order of implementation using a computer-generated randomisation sequence. A 2-step randomisation process will be undertaken, randomising the hospital EDs first and then randomising the RACFs aligned with each hospital. The PACE-IT intervention comprises: an initial phone call by RACFs to the ACE service in the ED; the ACE service in ED responds with a protocol-guided VTC, a management plan agreed between all participants; an automated consultation summary letter to the General Practitioner and the RACF; a post VTC 24?h follow-up phone call to the RACF. DISCUSSION:If shown to be effective, the intervention has the potential to improve the clinical care and quality of life for residents. Findings will provide high level evidence that will inform sustainable change and broad translation into practice across NSW. It will show how the change has been achieved and highlight success factors for scalability and sustainability. It will inform review of processes, the development of policy and guidelines that will integrate PACE-IT into existing service models in NSW. TRIAL REGISTRATION:The trial is registered with the Australian New Zealand Clinical Trials Registry (Trial ID ACTR N12619001692123 ) 02/12/2020.).

Project description:BackgroundObesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.Methods and findingsWe conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters) randomised using a computer-generated randomisation list for intervention (n = 21) or control (n = 20). Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her) consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7) and BMI of 28.8 kg/m(2) (+/- SD 6.9) with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97) and in the intervention group -0.48 kg (95% CI -0.99 to 0.03) with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16) or -0.87 kg (95% CI -1.62 to -0.13) adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.ConclusionsA low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included community integration, nonprescriptive simple health messages, small changes to behaviour, low participant burden, self-weighing, and delivery including a mix of group, phone, and SMS text reminders. The findings support population strategies to halt the rise in obesity prevalence.

Project description:IntroductionThe UK government recommends that at least 75% of people aged under 64 with certain conditions receive an annual influenza vaccination. Primary care practices often fall short of this target and strategies to increase vaccine uptake are required. Text messaging reminders are already used in 30% of practices to remind patients about vaccination, but there has been no trial addressing their effectiveness in increasing influenza vaccine uptake in the UK. The aims of the study are (1) to develop the methodology for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records and (2) to assess the effectiveness of using a text messaging influenza vaccine reminder in achieving an increase in influenza vaccine uptake in patients aged 18-64 with chronic conditions, compared with standard care.Methods and analysisThis cluster randomised trial will recruit general practices across three settings in English primary care (Clinical Practice Research Datalink, ResearchOne and London iPLATO text messaging software users) and randomise them to either standard care or a text messaging campaign to eligible patients. Flu vaccine uptake will be ascertained using routinely collected, anonymised electronic patient records. This protocol outlines the proposed study design and analysis methods.Ethics and disseminationThis study will determine the effectiveness of text messaging vaccine reminders in primary care in increasing influenza vaccine uptake, and will strengthen the methodology for using electronic health records in cluster randomised trials of text messaging interventions. This trial was approved by the Surrey Borders Ethics Committee (13/LO/0872). The trial results will be disseminated at national conferences and published in a peer-reviewed medical journal. The results will also be distributed to the Primary Care Research Network and to all participating general practices.Trial registration numberThis study is registered at controlled-trials.com ISRCTN48840025, July 2013.

Project description:IntroductionAntimicrobial resistance is a growing global health threat, driven by increasing inappropriate use of antimicrobials. High prevalence of unnecessary use of antimicrobials in residential aged care facilities (RACFs) has driven demand for the development and implementation of antimicrobial stewardship (AMS) programmes. The Stepped-wedge Trial to increase antibiotic Appropriateness in Residential aged care facilities and model Transmission of antimicrobial resistance (START) will implement and evaluate the impact of a nurse-led AMS programme on antimicrobial use in 12 RACFs.Methods and analysisThe START trial will implement and evaluate a nurse-led AMS programme via a stepped-wedge cluster randomised controlled trial design in 12 RACFs over 16 months. The AMS programme will incorporate education, aged care-specific treatment guidelines, documentation forms, and audit and feedback strategies that will target aged care staff, general practitioners, pharmacists, and residents and their families. The intervention will primarily focus on urinary tract infections, lower respiratory tract infections, and skin and soft tissue infections. RACFs will transition from control to intervention phases in random order, two at a time, every 2 months, with a 2-month transition, wash-in period. The primary outcome is the cumulative proportion of residents within each facility prescribed an antibiotic during each month and total days of antibiotic use per 1000 occupied bed days. Secondary outcomes include the number of courses of systemic antimicrobial therapy, antimicrobial appropriateness, antimicrobial resistant organisms, Clostridioides difficile infection, change in antimicrobial susceptibility profiles, hospitalisations and all-cause mortality. Analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/591). Research findings will be disseminated through peer-reviewed publications, conferences and summarised reports provided to participating RACFs.Trial registration numberNCT03941509.

Project description:BackgroundDemographic changes, with an increasing number and proportion of older people with multimorbidity and frailty, will put more pressure on home care services in municipalities. Frail multimorbid people receiving home care services are at high risk of developing crises, defined as critical challenges and symptoms, which demand immediate and new actions. The crises often result in adverse events, coercive measures, and acute institutionalisation. There is a lack of evidence-based interventions to prevent and resolve crises in community settings.MethodsThis is a participatory action research design (PAR) in a 6-month cluster randomised controlled trial (RCT). The trial will be conducted in 30 municipalities, including 150 frail community-dwelling participants receiving home care services judged by the services to be at risk of developing crisis. Each municipality (cluster) will be randomised to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a manual-based, multicomponent programme that includes a rigorous assessment of the crisis, one or more interdisciplinary case conferences, and the testing and evaluation of customised treatment measures. PAR in combination with an RCT will enhance adaptations of the intervention to the local context and needs. The primary outcome is as follows: difference in change between the intervention and control groups in individual goal achievement to resolve or reduce the challenges of the crises between baseline and 3 months using the PRACTIC Goal Setting Interview (PGSI). Among the secondary outcomes are the difference in change in the PGSI scale at 6 months and in neuropsychiatric symptoms (NPSs), quality of life, distress perceived by professional carers and next of kin, and institutionalisation at 3 and 6 months.DiscussionThrough customised interventions that involve patients, the next of kin, the social context, and health care services, crises may be prevented and resolved. The PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC) study will enhance innovation for health professionals, management, and users in the development of new knowledge and a new adapted approach towards crises.Trial registrationClinicalTrials.gov identifier: NCT05651659. Registered 15.12.22.

Project description:BackgroundThis protocol describes an ongoing study of the impact of befriending on depression, anxiety and loneliness in older people living in residential aged care facilities in Australia. While systematic reviews of befriending have indicated positive benefits of befriending for people in a range of ages and settings, there have been no randomised controlled trials (RCTs) of befriending for older people living in residential aged care with depression and no studies of the cost effectiveness of befriending in residential aged care facilities (RACFs) in Australia.Methods and analysisWe are conducting a single blind pragmatic RCT comparing two groups of older people living in RACFs, one receiving an intervention consisting of weekly befriending for 4 months from a trained volunteer and the other receiving treatment as usual. Participants undergo eligibility screening for depression (GDS-15 ≥ 4) and cognitive impairment (GPCog ≥ 4) and assessments at three measurement time points: baseline prior to randomisation, 2 months post-baseline and 4 months post-baseline. The primary outcome measure is depression, and secondary outcome measures are anxiety, loneliness, social isolation and quality of life. The economic evaluation will take the form of a cost-utility analysis based on the outcome of quality of life. The primary and secondary outcomes will be analysed using negative binomial and logistic regressions utilizing the Generalised Estimating Equations approach.DiscussionTo our knowledge, this is the first RCT evaluating the effectiveness of befriending on older people with depression living in residential aged care. It is expected that the befriending intervention will reduce the severity of depression symptoms experienced by older people living in residential aged care. If the intervention proves effective it may be incorporated into volunteer training programs and adopted as a way of supporting older people's mental health.Trial registrationTrial registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR) Number: ACTRN12619000676112 , registered 06/05/2019 - retrospectively registered.

Dataset Information

Treating and preventing influenza in aged care facilities: a cluster randomised controlled trial.

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Treating and preventing influenza in aged care facilities: a cluster randomised controlled trial.

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