ANZCTR search results

Our preliminary work demonstrates a strong need for a DIVA identification process which accurately highlights those patients who have DIVA; and links to an insertion escalation pathway, incorporating the use of ultrasound if needed, so that DIVA patients have a better chance of having a PIVC successfully inserted on the first attempt. The three-phased project will develop, implement and evaluate the clinical and cost-effectiveness of DIVA identification and escalation pathways. The Difficult Access Requires Thought, Training and Technology (DART3) project aims: (1) To understand and describe the budget and funding mechanisms for PIVC insertion procedures in Australian hospitals; (2) To develop and pilot test sustainable DIVA identification and escalation pathways and associated implementation strategies suitable for the Australian care context; and, (3) To test the effect of the DIVA identification and escalation pathways on clinical, cost and implementation outcomes

We seek to determine whether the use of a multimedia video can enhance consent for patients undergoing a total laparoscopic hysterectomy. In the era of increasingly complex surgical procedures and focus on patient-centred decision-making, the responsibility on clinicians to provide quality informed consent has never been more critical. In the current surgical climate, the Coronavirus pandemic has meant less face-to-face appointments and further delays from the initial booking appointment to surgery. Various media sources are often informally accessed by patients but these risk misinformation and further confusion. The addition of multimedia videos to routine consent has been shown to increase patient understanding and recall which optimizes informed consent and healthcare outcomes. This is a randomised controlled trial. Participants will be patients currently on the waitlist for a total laparoscopic hysterectomy at the Mercy Hospital for Women who have already received routine consent with their doctor. Participants will be assessed on their baseline understanding of the procedure, baseline anxiety levels and health literacy. They will be randomised into two groups. Group 1 will receive additional routine verbal consent. Group 2 will receive additional routine verbal consent and then watch an 11 minute multimedia video. Both groups will complete a questionnaire afterwards to evaluate their understanding of their procedure, anxiety and satisfaction levels which is repeated at 4 weeks. The multimedia video uses animations and text to describe the procedure of a total laparoscopic hysterectomy as well as complications and post-operative recovery. Our hypothesis is that patients who watch the multimedia video will have a better understanding of their procedure which will be reflected in a higher score in the questionnaire, without a negative impact on their anxiety level.

People who live in rural areas of Australia have higher rates of heart disease. Nutrition impacts on many of the risk factors for heart disease, making it a key lifestyle factor to focus on. However, access to qualified health professionals with the skills and knowledge assist with this can be limited in these areas. This randomised controlled trial will test the effectiveness of five telehealth consultations with a specially trained Accredited Practising Dietitian (APD) for rural people who are at moderate to high risk of heart disease. The study participants will also get the usual care they would normally receive from their General Practitioner (GP). The control group in this instance will receive usual care, as offered by their GP. Both groups will also receive personalised feedback on their nutrition via the Australian Eating Survey - Heart Version. Study participants must be categorised as living in an area classed as 3-7 by the Modified Monash Model, a measure of rurality, and receive a letter of invitation from their GP. Our study will look at the changes in blood cholesterol over 12 months, and will compare the results of those who had consultations with APDs against those who did not. We shall also investigate blood pressure, weight and waist circumference. We believe that the series of five consultations with health professionals with specialised training in nutrition will be cost effective in reducing the risk of heart disease in rural adults.

Diabetes-related foot ulcers (DFU) are a common and burdensome condition. Established interventions to promote DFU healing include local wound care, debridement, pressure offloading, management of infection and revascularisation. Despite this, the condition still accounts for significant morbidity and mortality in the community and further improvements in ulcer healing and overall outcomes in patients is essential. Recent studies have suggested that patients with type 2 diabetes mellitus are at risk of nutritional deficiencies due to high calorie yet low quality diets, poor food choices and/or restrictive eating (2). Nutrients such as Vitamin C (VitC), Vitamin A (VitA) and zinc are essential in wound healing by stimulating epithelialisation and cellular proliferation. Deficiencies in these micronutrients are common amongst people with diabetes and DFU but data regarding the effect of supplementation is limited . In this pilot randomised controlled trial, we aim to recruit 100 adult patients at Fiona Stanley Hospital or Fremantle Hospital with a DFU present for >4 weeks, without healing. Subjects can be either hospitalised under the inpatient Multidisciplinary Diabetes Foot Ulcer (MDFU) service or attending the outpatient MDFU clinic. We will then compare 28 days of oral supplementation of VitC, VitA and zinc with placebo in a pilot randomised controlled trial. Subjects will be followed up at 4 and 12 weeks to assess wound healing, as measured using ARANZ Medical Silhouette™ wound measurement camera. Our primary outcome is to prove that micronutrient supplementation with VitC, VitA and zinc will result in greater reduction in wound area from baseline to 12 weeks (ie percentage change in wound area measured by Silhouette wound camera at 12 weeks). Secondary outcomes include: i) the percentage of completely healed DFUs at 12 weeks (ie percentage of patients with completely healed DFU at 12 weeks in intervention vs control group) ii) minor or major lower limb amputation or death at 12 weeks and iii) wound healing trajectory over 12 weeks (measured using total % area change from baseline). The following are not prespecified secondary outcomes but will also be reported i) baseline prevalence of VitC, VitA and zinc deficiencies in people with DFU, ii) VitC, VitA and zinc levels after 28 days of supplementation iii) adverse effects associated with micronutrient supplementation and placebo iv) baseline prevalence of anaemia, absolute iron deficiency and functional iron deficiency.

The current provisional or emergency use approvals of COVID-19 vaccines are based on interim phase 3 clinical trial results indicating that these vaccines have an acceptable safety profile, are immunogenic and protect against symptomatic COVID-19. To date, it has not been possible to obtain robust safety and immunogenicity data for pregnant women or the very elderly; two groups at increased risk of developing severe COVID-19, because the initial trials focused on healthy adults. It is probable that the elderly will have less robust responses to COVID-19 vaccination, whereas pregnant women may or may not respond similarly to non-pregnant adults. We propose to conduct COVID-19 vaccination studies in these vulnerable groups and compare vaccine-specific antibody and T cell responses to those induced in young healthy non-pregnant individuals. The COVID-19 pandemic has seen the rapid development of multiple candidate COVID-19 vaccines, many using new platforms never before used for licensed human vaccines, including mRNA and viral vectors vaccines. While we know that they elicit SARS-CoV-2 specific antibody and T cell responses, we have no information about their broad effects on the immune system. Systems vaccinology is a newly emerging approach to studying vaccine effects by utilising various ‘omics’ platforms such as transcriptomics and metabolomics to provide unique insights into mechanisms of adverse events, reactogenicity and immunogenicity of vaccines. We will therefore use an exploratory systems vaccinology approach to interrogate the broad immunological effects of COVID-19 vaccination on the immune system of participants, providing important data for their future deployment and development. The interrogation of responses in those more vulnerable to the serious outcomes of COVID-19, and also more likely to have suboptimal immune responses, may identify mechanisms and strategies to optimise COVID-19 vaccines for vulnerable populations. Given the well-established links between nutrition, microbiome, mood and the immune system, there is a strong rationale and urgent need to conduct multidisciplinary studies that include both molecular and lifestyle factors. Standard questionnaires will therefore be administered prior to each blood collection (pre- and post-vaccination) to assess mood, nutrition and lifestyle. The results will be correlated with the key molecular findings from the immunological analyses.

ABI can be defined as damage to the brain sustained after birth which is not of a congenital or genetic nature. It is a leading cause of death and disability in children and adolescents, with a global incidence rate of ~ 47-280 per 100,000 children. In Victoria alone, more than 1000 children a year present with an ABI, with the most common causes including traumatic brain injury (TBI) (from falls, sports, vehicular accidents), child stroke and cancer, infection and hypoxicischaemic events. Bierbaum et al reported that, in Australia over a 10-year period, ABI related hospitalisations of children aged 16 years or younger have cost the health system close to half a billion dollars, with life-long health implications for the child and their family. Injury to the brain in childhood has significant consequences, primarily impaired cognition, communication, behaviour, social skills and overall quality of life. Despite the consequences of childhood ABI, implementation of robust childhood ABI treatments to improve social skills is currently hindered by imprecise understanding of the mechanisms underpinning the social domain, a lack of high quality evidence and a focus on generic approaches, treating only a single domain, despite children‘s varied behavioural impairment profiles. Disappointingly, the exciting potential for applying a targeted approach addressing modifiable factors unique to the individual‘s social profile has not been attempted. ITSS will address this gap and improve child outcomes after ABI by delivering evidence-based individualised treatment (ITSS), tailored to the child’s needs. Cognition. The Amsterdam Memory and Attention Training for Children (AMAT-C) is a treatment for deficits in children‘s attention, memory and executive skills commonly associated with impaired social skills following ABI. Social cognition. The Program for the Education and Enrichment of Relational Skills (PEERS) is an evidence-based treatment that has shown efficacy in improving social cognition and social competence in children with neurodevelopmental and socio-emotional disorders, with improvements observed in social knowledge, peer-engagement, and friendships. Mental Health: Anxiety/depression. The Cool Kids Anxiety Program (COOL KIDS is an evidence based structured Cognitive Behavioural Therapy (CBT) treatment, with a focus on anxiety. Parenting. The Signposts Program for Building Better Behaviour (Signposts) is an evidence-based parent education CBT treatment program that assists parents to identify and manage their child‘s challenging behaviours. Parental mental health. Take a Breath is a treatment on Acceptance Commitment Therapy aimed to reduce persisting parent anxiety and stress in the context of child illness/injury.

Neurological Impairment (NI) in children is often caused by conditions such as cerebral palsy and other neuromuscular conditions. Many children with NI are prone to chest infections which can lead to long stays in hospital, additional impairment and even premature death. Despite the suffering caused to children and their families by these infections and the high cost to health services, there is very little information on how best to prevent them. Some doctors prescribe long-term antibiotics but we don't really know whether this treatment makes any difference to the numbers of chest infections children suffer from, or whether these antibiotics can cause long term harm. The trial (PARROT-Junior) is a sub-study of a parent study (PARROT). In PARROT-Junior, we will recruit children aged 0.3-3 years, with NI who are at risk of chest infections, along with their parents/primary care giver to take part. Children included in the trial will be given either azithromycin or a placebo for 6 months to evaluate whether regular azithromycin reduces the frequency of chest infections. For the analysis, results from PARROT-Junior will be combined with data from the children recruited from Brisbane/Darwin in the parent study (PARROT). Our target sample size thus includes the subset of Brisbane/Darwin-enrolled children from PARROT.

The purpose of this study is to evaluate the effectiveness of an 8-week intervention program on mental health and wellbeing of Year 6 students transitioning to Year 7. The project will involve 300 Year 6 students; from primary schools located within 2 km radius from the ACU Strathfield Psychology Clinic, who will participate in an 8 week, school based transition program "I'll be Ok in Year 7" and 300 Year 6 students, who will attend a one-off information session. This project is being conducted by Ms Ewa Geba MAPS and will form the basis for her Doctor of Philosophy degree (PhD) at the Institute for Positive Psychology and Education, Australian Catholic University, under the supervision of Dr Baljinder K. Sahdra and Dr. Philip Parker. The results will inform future research and service delivery of ACU Strathfield Psychology Clinic; and will be published in a scientific journal.

An intensive care unit (ICU) stay is associated with significant muscle wasting in up to 80% of critically ill patients. This muscle wasting results in ‘ICU-acquired weakness’ that is associated with slower weaning from ventilator support, longer time to discharge alive from ICU and hospital, higher in-hospital costs which persist well after discharge from the acute care setting. Nutrition therapy, delivered as liquid nutrition via a tube into the stomach, forms usual care for critically ill patients. The provision of additional protein has the potential to attenuate muscle atrophy, and hence improve outcomes following critical illness. Current international guidelines recommend delivery of protein prescription of 1.2 - 2.0 g/kg/day or higher, but this is based on very low quality of evidence, and there is observational evidence to support both benefit and harm of augmented protein prescription. Therefore, there is a need for a high-quality randomised controlled trial of differing protein prescriptions. We propose a cluster randomised clinical trial with the aim of evaluating the effect of higher dietary protein delivery on outcomes of critically ill adult patients when compared to usual care. In this study each ICU will be randomised to one of the two study formulae for 3 months and then crosses over to the other study formulae for 3 months, which is then repeated, with each site participating for 12 months. Each eligible patient admitted to the ICU during these 3-month periods will receive the same study formula.

People with Parkinson’s disease (PD) experience cognitive dysfunction, limiting their occupational performance. Establishing an effective intervention to address the impact of cognition on daily life is a research priority. Interventions that comprehensively address cognitive and physical performance skills in people with PD have not previously been explored. The Cognitive Orientation to Daily Occupational Performance (CO-OP) treatment approach is effective for improving occupational performance, improving self-efficacy and participation in other adult populations. The proposed clinical trial will evaluate the efficacy of a CO-OP approach for people with PD. This study has four research questions: 1. Is the CO-OP approach feasible for people with PD? 2. Do people with PD benefit from CO-OP? 3. What CO-OP intervention intensity achieves optimum outcomes? 4. What do people with PD think and feel about the CO-OP approach? A parallel-group assessor blinded randomized controlled feasibility trial with long term follow-up will investigate the effectiveness of the CO-OP treatment approach for adults with PD. This will be the first study to evaluate the impact of CO-OP with people with Parkinson’s disease. This research aims to improve quality of life, confidence and reduce the impact of cognitive decline on the lives of people with PD. Significantly, this research will empower older people with PD to manage their symptoms and rate of progression. This research will lead to new, evidence-based services for older people with PD, based on their preferences and priorities and wide dissemination of findings to clinicians will increase access to new treatment options.