ANZCTR search results

This project aims to determine the clinical effect of intra-articular multiple PRP injections compared to single PRP injection into the symptomatic early arthritic knee. The objective is to determine the effectiveness of PRP injections for early knee arthritis and if multiple injections give a better clinical response at up to 12 months following treatment. This study is designed as a double blinded, randomised placebo-controlled trial with three groups. All groups receive 3 injections 1 week apart. • Group 1 receives 3 placebo injections (Normal Saline). • Group 2 receives one PRP injection followed by two placebo injections. Group 3 receives 3 PRP injections

To collect patient outcome data into a database that allows research to be generated. This occurs by identifying trends, systematically recognising unexpected outcomes from surgical techniques and allowing hypothesis generation to be tested in a retrospective manner.

The main evidence-practice gaps in emergency departments for patients presenting with acute low back pain include overuse of imaging, liberal use of opioids, and inappropriate admission to hospital. These practices are wasteful of scarce health resources and lead to worse patient outcomes. The Sydney Health Partners Emergency Department (SHaPED) trial will address these problems by improving clinical pathways through implementation of the ACI model of care for acute low back pain. The ACI model of care promotes best practice and collaboration across the care continuum. The SHaPED trial uses routinely collected measures of healthcare to judge success of the implementation of the model of care. We will use these same measures to monitor whether the improved outcomes are sustained at the SHaPED trial sites and also at other sites when we scale up the project. The SHaPED trial will implement the ACI model of care for acute low back pain at three urban and one rural emergency department in NSW: Royal Prince Alfred Hospital, Concord Repatriation General Hospital, Canterbury Hospital, and Dubbo Base Hospital. After a retrospective control period of 12 months, where the emergency departments are not exposed to the intervention, each emergency department will randomly and sequentially crossover from control to intervention periods, until all emergency departments are exposed to the intervention. This study design, known as a stepped wedge cluster randomised controlled trial, is particularly suited for the evaluation of policy interventions and healthcare service delivery. Participants are emergency department clinicians (such as medical doctors, nurses, and physiotherapists). The 4-week initial intervention period, targeting emergency clinicians, comprises of printed and electronic educational materials, weekly educational meetings, and an audit and feedback approach focussed on the outcomes of the study. Outcomes are routinely collected measures of imaging referrals (primary outcome), opioid prescription, and inpatient admission. Data will be extracted directly from participating hospitals’ electronic record systems, such as the Sydney Local Health District Targeted Activity and Reporting System (STARS).

The behavioural and psychological symptoms of dementia (BPSD) are a constellation of distressing non-cognitive symptoms that frequently accompany dementia, affecting up to 82% of nursing home residents with the disorder. Agitation is a commonly reported BPSD, as are aggression, delusions, anxiety and depression. These symptoms can be distressing to the person with dementia and their carer, and can significantly increase the burden of care. BPSD has also been shown to increase the total annual cost of dementia care in the community by more than 30%, with 2002 estimates indicating an increase in both direct and indirect care costs of dementia care by 25% and 35%, respectively. Antipsychotic medication continues to be the primary mode of treatment for BPSD; this is despite reservations about the clinical effectiveness and safety of these agents for BPSD. A 7-tiered BPSD management model was proposed in 2003 in an attempt to improve the management of BSPD, and to reduce antipsychotic use. In the lower tiers of the model, non-pharmacological treatment is recommended as first-line management, with antipsychotics only indicated as a `last resort' if symptoms cause severe distress or an immediate risk of harm to the patient or others. In light of these recommendations, as well as concerns regarding the cost, safety and effectiveness of antipsychotic medication for the management of BPSD, many carers and health providers are turning to the use of non-pharmacological therapies to manage agitation and other BPSD. One such approach that is receiving increasing attention in the literature because of its purported safety, low-cost, high level of acceptance and ease of implementation, is aromatherapy. Aromatherapy is the therapeutic administration of plant essential oils via inhalation or topical application. Empirical evidence suggests that essential oils may assist in the management of agitation and BPSD by acting on the neurolimbic system, and by upregulating neurotransmitter synthesis to generate antidepressant, anxiolytic and sedative effects. Despite essential oils being a biologically plausible, low-cost and well-tolerated treatment for BPSD, current evidence of effectiveness is conflicting, with some calling for higher-quality, longer-term trials. In response to these recommendations, researchers at the University of South Australia Department of Rural Health will be conducting a cluster-randomised, placebo-controlled feasibility trial to explore whether topically-administered, individualised essential oil preparations are effective in alleviating agitation in persons with dementia. The 10-week trial will be implemented across two residential aged care facilities in regional South Australia, and is hoping to recruit at least 30 residents with dementia. Findings from this trial will determine the feasibility of conducting a large effectiveness trial of essential oils for agitation in dementia.

Impairment in the ability to recall detailed autobiographical memories (AM) of in one’s life is a factor in the onset and maintenance of clinical depression. This is due to the critical role that specific AM play in healthy psychological functioning. For example, an impaired ability to retrieve specific AM is associated with poorer problem-solving, imagining, planning, and prediction, inaccurate appraisals of past events, and faulty decision-making. Without the ability to draw on our experiences in a detailed way, our capacity to adapt in the world is clearly impaired. Interventions designed to improve AM specificity involve training in retrieving memories. Preliminary studies of a face-to-face training program indicate it can produce significant improvement in AM specificity and depressive symptoms. Improving AM specificity appears to be a promising means by which to reduce depressive symptoms. Further, such interventions need not be delivered by a clinician, which provides the opportunity to test its delivery via the internet. Online mental health interventions are clinically- and cost-effective, with good equity of access given the majority of Australians use the internet regularly (83%), and almost all from home (97%). As over 1.1 million Australians meet criteria for a Major Depressive Episode, yet approximately 50% do not access services and 30% do not respond to current first-line treatments, there is clear scope for more accessible and effective interventions. The objective of this project will be to conduct the first randomised controlled trial of this online memory specificity training intervention to treat clinical depression. The study will also examine the mechanisms of change of this intervention, with implications for its broader use It is hypothesised that: - Individuals that receive the intervention, relative to those that don't, will report a lower incidence of depressive disorders at post-intervention and follow-up, and reductions in depressive symptoms; - the intervention group, relative to the non-intervention group, will report improvements in psychological resources at post-intervention and follow-up.

The effects of simethicone added to the rinse solution during colonoscopies as antifoaming agent with regard to polyp detection rates is poorly studied. We thus aim to quantitate the effects of simethicone during a cohort study when for a defined time period the practice to routinely add simethicone to the rinse solution was discontinued and later re-introduced. Since this change was not communicated to endoscopists they were blinded with regard to this change.

This study aims to evaluate the short- and mid-term effects of a brief web-based intervention to increase emergency department staff’s knowledge of paediatric medical traumatic stress. This training program is designed to educate emergency department staff on peadiatric medical traumatic stress following childhood injuries and detail trauma-informed care principles and strategies that can be used by emergency department staff to minimise distress and facilitate social support for these children and families. Additionally, this study aims to assess the feasibility and acceptability of this web-based training program for ED staff. All participants who complete participation receive a $30 gift voucher.

Rationale: Constraint Induced Movement Therapy (CIMT) is an effective intervention for upper limb recovery following stroke and traumatic brain injury (TBI) that produces significant improvements in upper limb function compared to usual therapy, after only 2 weeks (Stevenson, Thalman, Christie, & Poluha, 2012). Despite the robust body of evidence for CIMT, there is a knowledge translation gap between research and use in clinical practice (Fleet et al., 2014; Viana & Teasell, 2012). Lack of therapist knowledge of the CIMT protocol has been identified as one key barrier (Fleet et al., 2014) – one that is amenable to change with training. Aim: To establish if a 2-week publicly funded CIMT program can be translated into practice and sustained over 2 years across multiple health services in SWSLHD. Design: The proposed research will use a before and after study design. Mixed methods will be used to evaluate the impact of a CIMT implementation package on changes to clinician/team behaviour and practice in rehabilitation services at 5 sites in SWSLHD. Sample: The sample will include occupational therapists and physiotherapists at 5 sites across SWSLHD and their patient participants in CIMT programs (n=100). Data collection methods: Baseline data of CIMT delivery will be gathered via file audit. A barrier analysis will be conducted at baseline prior to delivery of the CIMT Implementation package and post project to investigate CIMT knowledge, attitudes and organisational challenges using in-depth staff interviews. Team outcomes at all sites will be measured at baseline, and at 3-month intervals following delivery of a CIMT implementation package by an assessor up to 15 months post intervention. For people with stroke and brain injury participating in CIMT programs at the sites, upper limb outcomes will be measured at baseline, at the completion of CIMT intervention (i.e. 2 weeks) and 6 weeks later. Intervention: Following collection of baseline data, therapy teams will receive a CIMT Implementation package. The package will include a) identification of local CIMT champions, b) 2 day training workshop to increase skills and knowledge, c) a community of practice via telephone d) onsite support during CIMT program implementation. Outcome measures: Primary outcome: The proportion of eligible people with stroke and traumatic brain injury who are offered CIMT as a component of their rehabilitation program. Secondary outcome: CIMT participant outcomes will be obtained at baseline, 2 weeks and 6 weeks following CIMT intervention including: a) Action Research Arm Test b) Motor Activity Log c) 9 hole Peg test d) Canadian Occupational Performance Measure The RE-AIM framework will also be used to evaluate program transferability. Discussion: Occupational therapists, physiotherapists, allied health assistants and managers within NSW Health will overcome an evidence-practice gap through routine delivery of a recommended, highly effective intervention.

UC is a destructive chronic inflammatory disorder of the gastrointestinal tract. Children have a 30 to 40% colectomy rate at 10 years (1). Paediatric onset UC accounts for 15 to 20% of all UC patients (1). Disease is extensive, pancolitis in 60-80% of children occurs twice as frequent as in adults (1). Currently, the pathogenesis of UC is unknown. It is thought that a complex dysregulated immune response to gut microflora plays a major role. Different phenotypes of UC appear to respond to different medical therapies. In particular, two phenotypes, that of moderate-severe UC and PSC-UC, have demonstrated response to newer "biologic agents" like anti-Tumour Necrosis Factor-alpha antibodies and oral vancomycin respectively. Biologics are considered for children with Acute severe presentations not responding to steroids and for chronic refractory UC, uncontrolled by aminosalicylates and thiopurines(1). Indeed, 5-10% of patients with UC require acute surgical intervention because of fulminant colitis refractory to medical therapy (1). Similarly, Antibiotics have gained interest in the management of Colitis, and in small study reported by our group, Vancomycin has shown significant improvement, even complete mucosal healing of the colitis associated with Primary Sclerosing Cholangitis, PSC-UC. There has also been improvement in blood tests of liver inflammation although the significance of these liver improvements remain to be determined.(2). PSC in conjunction with UC, whilst associated with milder bowel disease can lead to to liver cirrhosis, colorectal cancer and cholangiocarcinoma (1. However, these two therapies are new and the mechanisms and impact on mucosal healing and regain of liver function is not yet quantified. We propose to study these evolving treatment modalities in an open label study of patients with UC, including those with PSC-UC who are failing conventional therapies (5-ASA and/or immunosuppression). Children with UC considered for biologics and children with PSC-UC and considering oral Vancomycin will be considered for this study. Consistent with our current clinical practice, at initial enrolment and after 3 months therapy we will systematically assess: patients clinical characteristics, inflammatory markers (CRP, fecal calprotectin), mucosal healing by endoscopy and colonoscopy and features of PSC on Magnetic Resonance Cholangio Pancteatography (MRCP) in those with PSC-UC. We will also collect an additional 10 biopsies at each colonoscopy, each 1-2mm (consistent with our other Ethically approved biopsy study in Crohn's Disease with no additional risk) to assess activity of populations of white blood cells and microflora. Under GA, blood will be obtained to assess IBD genetic mutations. Stool for microbiome will be collected at same time as for faecal calprotectin, a clinical disease marker.

This local-multicentre, prospective, randomised control study will aim to assess the impact of an intentional weight loss and a prescribed exercise program in overweight and obese patients with heart failure and reduced ejection fraction (HF-REF). The impact of the program will be assessed by the measurement at 12 months of the change in exercise capacity (as measured by peak VO2 on CPET), and the change in KCCQ score compared with baseline measurements. These two parameters will be the composite endpoints. A number of secondary endpoints will be collected to assess the prognostic significance (including mortality, rate of hospitalisations, changes in New York Heart Association Classification (NYHA)), cardiac structural, functional, mood and cardiac biomarker effects of this program. This study aims to assist in clarifying the degree of controversy and uncertainty about the appropriateness of advice to patients with obesity and established HF-REF. This is a result of a recurrently observed, but somewhat controversial ‘obesity paradox’ in a number of heart failure (HF) studies where patients with HF and higher body mass index (BMI) appear to have improved outcomes including less deterioration of functional class and lower mortality rates compared with those who have HF and a lower BMI. There is a paucity of published clinical studies that have assessed the combined effects of an intentional weight loss and prescribed exercise program on heart failure outcomes including functional measures, hospitalisations, mortality, and cardiac structural changes along with measured serum biomarkers. This study will evaluate the effects of a structured lifestyle interventional program compared with standard of care in overweight and obese patients with heart failure and reduced ejection fraction.