ANZCTR search results

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.

RCT of vitamin C versus glucosamine to improve ulcer healing in people attending the high-risk foot clinic. The hypothesis is that vitamin C will improve ulcer healing. We also predict that it will be more effective in people with diabetes, and people who are deficient in vitamin C at the beginning of the study.

Fractured neck of femur (#NOF) is a common, painful condition in the elderly for which regional nerve block (RNB) techniques provide effective and safe analgesia. Presently, RNBs are administered by doctors, usually later in the patient journey. RNB via Fascia Iliaca Nerve Block (FIB) has been demonstrated to be safe and effective when administered by trained nurses. We hypothesise that early, nurse-initiated FIB (ENI FIB) can be successfully introduced and sustained within a tertiary level Emergency Department (ED) and can be generalised to a regional ED. We aim to demonstrate that ENI FIB can be delivered to a higher proportion of eligible patients than current practice, is at least equi-analgesic and equivalently safe with standard medical RNB, and can be delivered significantly earlier than medically-initiated RNB. In the preparatory phase, data will be collected regarding current RNB/analgesic therapy whilst a core nurse FIB operator group is trained at RNSH. Subsequently the implementation phase will begin in early 2017 where ENI FIB will be introduced as the preferred RNB for #NOF. Data will be collected regarding enrollment rates, safety, pain levels and times to analgesia. Gosford ED will follow the protocol six months behind RNSH with implementation taking place in May 2017. After twelve months, ENI FIB will be re-evaluated at both sites with respect to embeddedness, safety and effective practice. The Implementation Package will be refined as indicated. Potential benefits are that significantly more patients with #NOF will have access to effective, safe and early pain relief. We aim to demonstrate that this model of care is generalisable to another ED whilst yielding similar positive clinical outcomes. Assuming adoption and sustainability of ENI FIB at both sites, there is potential to roll out a standardised, proven ENI FIB program across a large number of the State’s EDs in an economical fashion, utilising a ‘train the trainer’ model and our refined Implementation Package.

The study will assess the effects of a nutrient supplement (nutraceutical) combination in individuals with treatment-refractory obsessive-compulsive disorder. The study is a 5 month, open-label, multicentre pilot study.

Gut microbiota is highly influenced by environmental factors particularly the diet and its dietary fibre content. Dietary fibre is non-digestible polysaccharide fermented by gut bacteria, subsequently releasing short chain fatty acids, critical for health. Dietary fibre promotes beneficial gut microbiota. However, the potency of different types of fibre to reshape gut microbial population and to boost the release of short chain fatty acids is unknown. While fibre is found in grains and legumes it can be hard to evaluate which type of fibre is present and how much is consumed. The aim of the current study is to test dietary fibre supplements which are affordable and easily quantifiable to determine which type of fibre supplement might be the most beneficial for gut and overall health. 30 women aged between 35-65 years will be recruited. The study will be a randomised open crossover fibre supplementation trial. Each participant will be studied on 3 occasions, such that over the experiment they will receive all 3 fibre supplements in random order. The 3 fibre supplements will include Fibremax (New Image), Vitafiber (Myprotein) and Inulin (Myprotein). Participants will be asked to consume daily the 34g of FibreMax, 15g of Vitafiber or 12g of Inulin supplement per day during the treatment period. Participants will be requested to consume a standardised diet that excludes fibre rich foods (beans, high fibre cereals and bars), dietary supplements, pre and probiotic foods and supplements, antibiotics and anti-inflammatory drugs. Participants will attend an RPA blood collection centre where they will complete 6 x blood collections and the RPA clinic at the Charles Perkins Center on 7 occasions where they will be asked to complete 6 x stool collections and 6 x 4 d food diaries. Participants will first attend a screening interview where they will be asked to complete questionnaires on their medical history, medications, and eating behaviours. Two weeks before the start of the first supplementation period, participants will be asked to consume a standardized diet and will then to undergo 3 x 7 d fibre supplementation periods that will each be separated by 2week washout periods. The blood and stool samples will be used to measure short chain fatty acid levels, microbial diversity in response to dietary fibre supplementation.

This study is to find if one type of expander (a plate) is better at widening the upper jaw of children aged 10-16. The expander will be placed on their top teeth and will be one of the following: 1) Hyrax Expander: this is the common type of expander which requires a separate key to turn. 2) Hybrid-Hyrax Expander: this is the normal expander but it also includes two pins placed in the top of the upper jaw (palate) 3) Keles Expander: this is a new type of expander which has a built-in key to turn the expander. This new type of expander is not yet approved by Therapeutic Goods Administration. Our hypothesis is that the Keles expander will work as equally as effectively as the Hyrax, whereas the Hybrid-Hyrax will be more effective in expanding the jaw due to the use of the two palatal pins. Patients will be recruited at the Sydney Dental Hospital and will be included if they meet the inclusion criteria of having a narrow jaw and in the correct age range. Exclusion criteria include if patients have had previous orthodontic treatment and/or any serious health issues that may impact orthodontic treatment. 60 selected patients will be randomly placed into 3 groups of 20 patients each. Records of patients will be taken before treatment. The appliance will be constructed and installed on each patient. Patients will be taught to turn the expander and will continue expanding until the correct amount of expansion has been achieved. After this, the expander will be locked to prevent further turning and the patient left with the expander in-situ for 6 months to retain the changes in the expanded jaw. The expander is then removed and then new records taking. Patients are then followed up to continue with normal braces treatment as per normal. The records taken of participants will include: questionaires, photos, study casts, 3d photos, and Cone Beam CT images. The data retrieved from these records will be used to assess the dental, skeletal, facial and airyway changes as a result of the expansion. The primary outcome will be to assess the change in angulation of upper first molars relatve to the palate in cross section on Cone Beam CT images. Secondary outcomes include: easability of the difference appliances, airway changes, facial changes and skeletal changes measured on CT images..

The overall objective of this study is to pilot test the feasibility of a community and consumer engagement strategy using design thinking and EBCD methodologies in the healthcare setting. This study aims to invite consumers, carers, healthcare workers and/or visitors to the hospital to attend collaborative workshops and/or the InstaBooth (an interactive booth) to share their experiences and suggestions for improving hand hygiene practices and/or reducing hospital-acquired infections and inform the design of possible solutions to these healthcare problems. After data analysis is completed, one of the possible solutions designed in the collaborative workshops will be implemented at the study site and its impact will be evaluated.