Search

Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented. Discussion This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012. Trial registration ISRCTN58683841

Abstract Background Evidence demonstrates that measures are needed to optimise therapy and improve administration of medicines in care homes for older people. The aim of this study is to determine the clinical and cost effectiveness of a novel model of multi-professional medication review. Methods A cluster randomised controlled trial design, involving thirty care homes. In line with current practice in medication reviews, recruitment and consent will be sought from general practitioners and care homes, rather than individual residents. Care homes will be segmented according to size and resident mix and allocated to the intervention arm (15 homes) or control arm (15 homes) sequentially using minimisation. Intervention homes will receive a multi-professional medication review at baseline and at 6 months, with follow-up at 12 months. Control homes will receive usual care (support they currently receive from the National Health Service), with data collection at baseline and 12 months. The novelty of the intervention is a review of medications by a multi-disciplinary team. Primary outcome measures are number of falls and potentially inappropriate prescribing. Secondary outcome measures include medication costs, health care resource use, hospitalisations and mortality. The null hypothesis proposes no difference in primary outcomes between intervention and control patients. The primary outcome variable (number of falls) will be analysed using a linear mixed model, with the intervention specified as a fixed effect and care homes included as a random effect. Analyses will be at the level of the care home. The economic evaluation will estimate the cost-effectiveness of the intervention compared to usual care from a National Health Service and personal social services perspective. The study is not measuring the impact of the intervention on professional working relationships, the medicines culture in care homes or the generic health-related quality of life of residents. Discussion This study will establish the effectiveness of a new model of multi-professional clinical medication reviews in care homes, using novel approaches to recruitment and consent. It is the first study to undertake an examination of direct patient outcomes, together with an economic analysis. Trial Registration ISRCTN: ISRCTN90761620

Abstract Background Falls in hospitals are common, resulting in injury and anxiety to patients, and large costs to NHS organisations. More than half of all in-patient falls in elderly people in acute care settings occur at the bedside, during transfers or whilst getting up to go to the toilet. In the majority of cases these falls are unwitnessed. There is insufficient evidence underpinning the effectiveness of interventions to guide clinical staff regarding the reduction of falls in the elderly inpatient. New patient monitoring technologies have the potential to offer advances in falls prevention. Bedside sensor equipment can alert staff, not in the immediate vicinity, to a potential problem and avert a fall. However no studies utilizing this assistive technology have demonstrated a significant reduction in falls rates in a randomised controlled trial setting. Methods/Design The research design is an individual patient randomised controlled trial of bedside chair and bed pressure sensors, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, across five acute elderly care wards in Nottingham University Hospitals NHS Trust. Participants will be randomised to bedside chair and bed sensors or to usual care (without the use of sensors). The primary outcome is the number of bedside in-patient falls. Discussion The REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff. Trial Registration ISRCTN trial number: ISRCTN44972300.

Abstract Background Dysphagia occurs in up to 50% of patients admitted to hospital with acute strokes with up to 27% remaining by seven days. Up to 8% continue to have swallowing problems six months after their stroke with 1.7% still requiring enteral feeding. Nasogastric tubes (NGT) are the most commonly used method for providing enteral nutrition in early stroke, however they are easily and frequently removed leading to inadequate nutrition, early PEG (Percutaneous Endoscopic Gastrostomy) insertion or abandoning of feeding attempts. Looped nasogastric tube feeding may improve the delivery of nutrition to such patients. Methods Three centre, two arm randomised controlled trial, with 50 participants in each arm comparing loop (the intervention) versus conventional nasogastric tube feeding. The primary outcome measure is proportion of intended feed delivered in the first 2 weeks. The study is designed to show a mean increase of feed delivery of 16% in the intervention group as compared with the control group, with 90% power at a 5% significance level. Secondary outcomes are treatment failures, mean volume of feed received, adverse events, cost-effectiveness, number of chest x-rays, number of nasogastric tubes and tolerability. Trial Registration ISRCTN Number: ISRCTN61174381

Abstract Falls in older people are a major public health concern in terms of morbidity, mortality and cost. Previous studies suggest that multifactorial interventions can reduce falls, and many geriatric day hospitals are now offering falls intervention programmes. However, no studies have investigated whether these programmes, based in the day hospital are effective, nor whether they can be successfully applied to high-risk older people screened in primary care. The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling. This will be tested by a pragmatic parallel-group randomised controlled trial in which the participants, identified as at high risk of falling, will be randomised into either the intervention Day hospital arm or to a control (current practice) arm. Those participants preferring not to enter the full randomised study will be offered the opportunity to complete brief diaries only at monthly intervals. This data will be used to validate the screening questionnaire. Three day hospitals (2 Nottingham, 1 Derby) will provide the interventions, and the University of Nottingham's Departments of Primary Care, the Division of Rehabilitation and Ageing Unit, and the Trent Institute for Health Service Research will provide the methodological and statistical expertise. Four hundred subjects will be randomised into the two arms. The primary outcome measure will be the rate of falls over one year. Secondary outcome measures will include the proportion of people experiencing at least one fall, the proportion of people experiencing recurrent falls (>1), injuries, fear of falling, quality of life, institutionalisation rates, and use of health services. Cost-effectiveness analyses will be performed to inform health commissioners about resource allocation issues. The importance of this trial is that the results may be applicable to any UK day hospital setting. Sites General practices across Nottinghamshire and Derbyshire. Day hospitals: Derbyshire Royal Infirmary (Southern Derbyshire Acute Hospitals NHS Trust) Sherwood Day Service (Nottingham City Hospital Trust) Leengate Day Hospital (Queen's Medical Centre Nottingham University Hospital NHS Trust)

Background: Falls in hospitals are common, resulting in injury and anxiety to patients, and large costs to NHS organisations. More than half of all in-patient falls in elderly people in acute care settings occur at the bedside, during transfers or whilst getting up to go to the toilet. In the majority of cases these falls are unwitnessed. There is insufficient evidence underpinning the effectiveness of interventions to guide clinical staff regarding the reduction of falls in the elderly inpatient. New patient monitoring technologies have the potential to offer advances in falls prevention. Bedside sensor equipment can alert staff, not in the immediate vicinity, to a potential problem and avert a fall. However no studies utilizing this assistive technology have demonstrated a significant reduction in falls rates in a randomised controlled trial setting.Methods/design: The research design is an individual patient randomised controlled trial of bedside chair and bed pressure sensors, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, across five acute elderly care wards in Nottingham University Hospitals NHS Trust. Participants will be randomised to bedside chair and bed sensors or to usual care (without the use of sensors). The primary outcome is the number of bedside in-patient falls.Discussion: The REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff. [ABSTRACT FROM AUTHOR]

Background: Older people represent a significant proportion of patients admitted to hospital. Their care compared to younger patients is more challenging, length of stay is longer, risk of hospital-acquired problems higher and the risk of being re-admitted within 28 days greater. This study aims to compare a Community In-Reach and Care Transition (CIRACT) service with Traditional Hospital Based rehabilitation (THB-Rehab) provided to the older person. The CIRACT service differs from the THB-rehab service in that they are able to provide more intensive hospital rehabilitation, visiting patients daily, and are able to continue with the patient's rehabilitation following discharge allowing a seamless, integrated discharge working alongside community providers. A pilot comparing the two services showed that the CIRACT service demonstrated reduced length of stay and reduced re-admission rates when analysed over a four-month period., Methods/design: This trial will evaluate the clinical and cost-effectiveness of the CIRACT service, conducted as a randomised controlled trial (RCT) with an integral qualitative mechanism and action study designed to provide the explanatory and theoretical components on how the CIRACT service compares to current practice. The RCT element consists of 240 patients over 70 years of age, being randomised to either the THB therapy group or the CIRACT service following an unplanned hospital admission. The primary outcome will be hospital length of stay from admission to discharge from the general medical elderly care ward. Additional outcome measures including the Barthel Index, Charlson Co-morbidity Scale, EuroQoL-5D and the modified Client Service Receipt Inventory will be assessed at the time of recruitment and repeated at 91 days post-discharge. The qualitative mechanism and action study will involve a systematic programme of organisational profiling, observations of work processes, interviews with key informants and care providers and tracking of participants. In addition, a within-trial economic evaluation will be undertaken comparing the CIRACT and THB-rehab services to determine cost-effectiveness., Discussion: The outcome of the study will inform clinical decision-making, with respect to allocation of resources linked to hospital discharge planning and re-admissions, in a resource intensive and growing group of patients., Trial Registration: Registered with the ISRCTN registry ( ISCRCTN94393315 ) on 25 April 2013 (version 3.1, 11 September 2014).

Background: Evidence demonstrates that measures are needed to optimise therapy and improve administration of medicines in care homes for older people. The aim of this study is to determine the clinical and cost effectiveness of a novel model of multi-professional medication review., Methods: A cluster randomised controlled trial design, involving thirty care homes. In line with current practice in medication reviews, recruitment and consent will be sought from general practitioners and care homes, rather than individual residents. Care homes will be segmented according to size and resident mix and allocated to the intervention arm (15 homes) or control arm (15 homes) sequentially using minimisation. Intervention homes will receive a multi-professional medication review at baseline and at 6 months, with follow-up at 12 months. Control homes will receive usual care (support they currently receive from the National Health Service), with data collection at baseline and 12 months. The novelty of the intervention is a review of medications by a multi-disciplinary team. Primary outcome measures are number of falls and potentially inappropriate prescribing. Secondary outcome measures include medication costs, health care resource use, hospitalisations and mortality. The null hypothesis proposes no difference in primary outcomes between intervention and control patients. The primary outcome variable (number of falls) will be analysed using a linear mixed model, with the intervention specified as a fixed effect and care homes included as a random effect. Analyses will be at the level of the care home. The economic evaluation will estimate the cost-effectiveness of the intervention compared to usual care from a National Health Service and personal social services perspective.The study is not measuring the impact of the intervention on professional working relationships, the medicines culture in care homes or the generic health-related quality of life of residents., Discussion: This study will establish the effectiveness of a new model of multi-professional clinical medication reviews in care homes, using novel approaches to recruitment and consent. It is the first study to undertake an examination of direct patient outcomes, together with an economic analysis., Trial Registration: ISRCTN: ISRCTN90761620.

Background: Dysphagia occurs in up to 50% of patients admitted to hospital with acute strokes with up to 27% remaining by seven days. Up to 8% continue to have swallowing problems six months after their stroke with 1.7% still requiring enteral feeding. Nasogastric tubes (NGT) are the most commonly used method for providing enteral nutrition in early stroke, however they are easily and frequently removed leading to inadequate nutrition, early PEG (Percutaneous Endoscopic Gastrostomy) insertion or abandoning of feeding attempts. Looped nasogastric tube feeding may improve the delivery of nutrition to such patients., Methods: Three centre, two arm randomised controlled trial, with 50 participants in each arm comparing loop (the intervention) versus conventional nasogastric tube feeding. The primary outcome measure is proportion of intended feed delivered in the first 2 weeks. The study is designed to show a mean increase of feed delivery of 16% in the intervention group as compared with the control group, with 90% power at a 5% significance level. Secondary outcomes are treatment failures, mean volume of feed received, adverse events, cost-effectiveness, number of chest x-rays, number of nasogastric tubes and tolerability., Trial Registration: ISRCTN Number: ISRCTN61174381.

Falls in older people are a major public health concern in terms of morbidity, mortality and cost. Previous studies suggest that multifactorial interventions can reduce falls, and many geriatric day hospitals are now offering falls intervention programmes. However, no studies have investigated whether these programmes, based in the day hospital are effective, nor whether they can be successfully applied to high-risk older people screened in primary care. The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling. This will be tested by a pragmatic parallel-group randomised controlled trial in which the participants, identified as at high risk of falling, will be randomised into either the intervention Day hospital arm or to a control (current practice) arm. Those participants preferring not to enter the full randomised study will be offered the opportunity to complete brief diaries only at monthly intervals. This data will be used to validate the screening questionnaire. Three day hospitals (2 Nottingham, 1 Derby) will provide the interventions, and the University of Nottingham's Departments of Primary Care, the Division of Rehabilitation and Ageing Unit, and the Trent Institute for Health Service Research will provide the methodological and statistical expertise. Four hundred subjects will be randomised into the two arms. The primary outcome measure will be the rate of falls over one year. Secondary outcome measures will include the proportion of people experiencing at least one fall, the proportion of people experiencing recurrent falls (>1), injuries, fear of falling, quality of life, institutionalisation rates, and use of health services. Cost-effectiveness analyses will be performed to inform health commissioners about resource allocation issues. The importance of this trial is that the results may be applicable to any UK day hospital setting. SITES: General practices across Nottinghamshire and Derbyshire. Day hospitals:Derbyshire Royal Infirmary (Southern Derbyshire Acute Hospitals NHS Trust)Sherwood Day Service (Nottingham City Hospital Trust)Leengate Day Hospital (Queen's Medical Centre Nottingham University Hospital NHS Trust).