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Clinical Observation, Management, and Function Of low back pain Relief Therapies (COMFORT)
This study evaluates the effect of an educational outreach visit promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids on general practitioner prescribing of opioids dispensed to their patient-participants with low back pain over 1 year from index visit. We hypothesise the intervention will reduce opioid medicines dispensed, harms (adverse events, poisonings, hospitalisations) and result in no worse clinical outcomes such as pain, disability, mental health, and quality of life, and be cost-effective. Methods: At least 40 General Practices will be recruited and randomly assigned to receive training in the opioid stewardship intervention or assigned to the usual care they provide (no outreach visit). Patient-participants will be provided with a Consumer Medicines Information leaflet for the opioid medicine(s) prescribed at the enrolment visit either electronically or via post. This will be determined during the baseline follow-up between the researcher and the patient-participant and provided by the study team
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Solving Unknown Primary cancER Earlier Diagnosis (SUPER-ED): A stepped wedge cluster randomised controlled trial implementing a Model of Care to support earlier diagnosis
Cancer of unknown primary (CUP) encompasses a diverse range of cancer types, whereby a metastatic lesion is identified but a primary tumour evades clinical detection. This study aims to develop and test a standardised model of care for patients with cancer of unknown primary. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a malignancy (cancer) of undefined primary origin and you are able to undergo diagnostic testing (as agreed by your doctor). Study details Participants who choose to enrol in this study will either receive the newly developed standardised model of care, or the current standard treatment pathway that is employed by most hospitals. This will depend upon the timing of their consent to participate and whether their specific hospital has been allocated to the new model or is continuing with the current treatment pathway. The newly developed standardised model of care will involve a standardised diagnostic workup supported by a virtual CUP-dedicated Multi-Disciplinary Meeting (MDM), embedding a CUP care coordinator in local health services, and developing a CUP educational interactive website to enhance education and engagement of treating clinicians and consumers. The current treatment pathway also provides support to patients, however these options are less personalised, e.g. patients are provided with a copy of the Cancer Council booklet ‘Understanding Cancer of Unknown Primary and access to a Cancer Council phone Helpline. It is hoped this research will demonstrate that provision of a new standardised model of care is feasible and that implementation of the new model of care may lead to faster diagnosis times and consequently better provision of care to patients with cancer of unknown primary.
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The efficacy of caffeine in restoring cognitive declines across 24 hours of sustained wakefulness
This research project is investigating how caffeine consumption effects cognitive performance across 24 consecutive hours of being awake. The project will involve four separate overnight trials. Across this time, a series of cognitive tests will be completed and a low (100 mg), moderate (200 mg), and high (400 mg) dose of caffeine will be administered to assess whether there are improvements in these tests. The next-day sleep will be measured to investigate if the caffeine consumed overnight causes changes in recovery sleep. Given caffeine is a stimulant, it is expected that it will improve cognitive performance overnight but may have a negative effect on next-day sleep. By investigating different doses, we are aiming to determine if there is an optimal dose of caffeine to help overnight performance.
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Investigating the effect of smartphone-based cognitive training completed at home on sustained changes in appetite and food cravings: A randomised controlled trial
Cognitive Bias Modification has elicited some intriguing results in studies of substance addiction or appetite pathology. Training in an experimental setting has been shown to reduce alcohol consumption in binge drinkers, smoking frequency, and decrease preference and intake of palatable foods in people with overweight/obesity. Moreover, they do not require some of the onerous demands of time, energy, and commitment required by traditional obesity prevention-oriented interventions. Response inhibition training, a form of Cognitive Bias Modification, has seen some success in reducing snack food preference and intake, and even weight, although significant results were only seen in short-term, laboratory-based studies. However, the results vary conspicuously based on methodology and training parameters. Additional testing in natural settings was considered beneficial to discern the clinical and real world utility of this type of intervention. The inclusion of a follow up measurement provided the opportunity to detect how long potential changes in appetite control are maintained after training. The primary aim of this study was to investigate whether response inhibition training delivered by smartphone can produce sustained changes in preferences and cravings for energy-dense foods, as well as reward-driven eating in a free-living setting. It was expected that the response inhibition training intervention would lead to a significant reduction in all primary outcomes relative to the control group from baseline to post-training. Although it was expected that all primary outcomes would increase over the 1-week follow-up period, we posited that they would remain significantly different from baseline.
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Implementing Pulmonary Rehabilitation in Primary care: Feasibility, acceptability, and safety
This study aims to investigate whether pulmonary rehabilitation (PR) can be conducted in private physiotherapy and exercise physiology practices. The study consists of two parts, part one involves training clinician participants in PR and part two involves provision of PR by those clinicians upskilled in part one to provide PR to patient participants. In part one, clinician participants will undertake a training program in PR. This will be evaluated using short questionnaires and practical assessment of skills, knowledge and confidence before, after and 3-month following the training program. In part two, people with COPD will be randomly allocated to either an 8-week private practice PR program or usual care. We will measure the feasibility to provide PR in this setting as well as measuring clinical outcomes such as exercise capacity and health-related quality of life. Both patient and clinician participants will be invited to complete semi-structured interviews.
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Use of mobile phone TEXT messages to increase the adherence of SGLT2 Inhibitors: a MULti-country Effectiveness-Implementation trial (TEXT-STIMULI)
The medications known as sodium-glucose co-transporter-2 inhibitors (SGLT2i) provide major benefits to important patient outcomes including a reduced likelihood of cardiovascular events or hospitalisations for heart failure, and a reduced risk of advanced kidney disease or kidney failure, in addition to helping to prevent or manage diabetes, to lower blood pressure, and to facilitate weight loss. Despite their many benefits, at least a third of people discontinue taking these agents within 12 months. Stakeholder engagement and external research suggests that improving patient education about the many benefits of the agents, teaching strategies to prevent side effects and providing advice about ways to remember to take medications consistently could significantly boost adherence. Text messaging provides an innovative way to deliver education and support using ubiquitous technology, and text message interventions have been used to significantly improve adherence for people with other chronic diseases. The TEXT-STIMULI trial is a randomised control trial which investigates the effectiveness of a text messaging program to improve adherence to SGLT2i, while simultaneously assessing the feasibility of implementing the intervention on a wider scale.
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Validating the Health Literacy Survey (HLS)-Child-Q15 tool in English to assess paediatric health Literacy
Health literacy is recognised by the WHO as “a critical determinant of health”, and is defined by the Australian Commission on Safety and Quality in Health Care as “the skills, knowledge, motivation and capacity of a person to access, understand, appraise and apply information to make effective decisions about health and health care and take appropriate action.” Poor health literacy is known to be associated with a wide range of adverse outcomes, including increased hospitalisation and emergency presentations, lower uptake of vaccination, and poor health and higher risk of death among older people. The promotion of health literacy in children offers to empower them to make informed decisions around their own health, and to promote the skills required to life into adulthood and beyond. The assessment of health literacy is of use to guide clinical practice and in health research – to guide interventions in health literacy itself, to assist clinicians to target the need for additional specific health education, to assist with pitching that education at an appropriate level, and to ensure research captures a broad sample of our population. The HLS-Child-Q15 is a health literacy tool for use in children which consists of 15 short questions and has advantages in respect of having been developed specifically for children, being relatively short, simple and quick to complete, and not relying on significant numerical abilities. Each item in the tool addresses how difficult or easy the child finds a particular health task (e.g. “find out which food is healthy for you?”) and assigned a score from 1 to 4 for “very difficult” to “very easy” respectively. The tool is currently only validated in its German (ages 8 to 12, but 92.8% age 9 to 10) and Dutch (ages 8 to 11) versions, both of which demonstrated high internal consistency. While an English translation of the items has been published with the initial German version and has also been used in English in one published study, this version of the tool has however not been validated. Validating this tool can provide greater confidence for the tool’s use in English-speaking populations. We therefore intend to validate the HLS-Child-Q15 in English, with the expected benefits of providing a child-specific health literacy assessment tool that is applicable to both clinical and research uses.
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Examining anxiety and experiences of children, parents and staff in the perioperative environment through qualitative interviews.
Millions of children undergo anaesthesia for surgical procedures around the world every year. Medical encounters can be an anxiety inducing experience for children, particularly when invasive procedures are performed, as happens for anaesthetic induction. Children can find the induction experience unpleasant because they are in an unfamiliar environment, with unfamiliar people and/or they have an aversion to needles or because they may find the anaesthetic gas mask intrusive and frightening. Preoperative anxiety is a common and unfavourable manifestation in children and has been reported in 50 – 80% of children and can be characterised by feelings of apprehension, tension and worry and can stem from reasons including fear of the unknown, anticipation of separation from parents, fear of potential pain and fear of loss of control. High levels of preoperative anxiety are associated with both physiological and psychological adverse outcomes in children such as significantly higher postoperative pain, increased anaesthetic use, a higher incidence of emergence delirium, prolonged recovery, and lengthened hospitalisations. These outcomes have detrimental effects on patients. Moreover, negative postoperative impacts of preoperative anxiety include maladaptive behaviours, such as nightmares, separation anxiety, increased fear of doctors and eating disorders. Pharmacological interventions are currently the most common approach used to manage preoperative anxiety. However, there are some limitations to this method. Virtual-reality and video-based technology has been demonstrated to be acceptable and effective in minimising anxiety through both acting as a distraction and as an interactive means to acclimatise to the perioperative setting. Paediatric anaesthetists often use distraction techniques such as conversation or humour to mediate anxiety. Maintaining parental presence during the induction of anaesthesia is another regularly used approach to help support paediatric patients. These social support methods have their benefits and challenges, but with limited overall anxiolysis. The objectives of this project are to identify key themes related to children’s, parent’s, staff and volunteer lived experiences of and views regarding anxiety in acute settings, particularly in the perioperative environment at Perth Children’s Hospital. The ANTELOPE study will improve our understanding of children’s’ anxiety in the perioperative setting to inform the adaptation and implementation of the perioperative Magic Coat program for use at Perth Children’s Hospital.
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Assessment of the usefulness of phosphatidylethanol (PEth) measurements to detect alcohol consumption in Emergency Department patients who are being treated for suspected alcohol-related injury.
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Music therapy for chemotherapy induced nausea and vomiting
Chemotherapy induced nausea and vomiting is a well-recognised problem for patients undergoing cancer treatment. While significant progress has been made over the last few years, nausea remains a debilitating issue for some people and therefore newer treatment interventions are required. Among the non-drug interventions, music therapy intervention appears promising based on its previously demonstrated health benefits. Therefore, the aim of the study is to evaluate the feasibility and acceptability of a novel music therapy intervention for the prevention and treatment of chemotherapy induced nausea and vomiting. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and are planned to undergo systemic chemotherapy for your cancer that is known to be associated with nausea and vomiting. Study details All participants will be provided with a music listening device with preloaded music that was recorded using music therapy principles designed to promote relaxation. The device will be given to participants at the beginning of their first and second chemotherapy cycles. Participants will be asked to listen to a minimum of 5-15 minutes of music through using the device during each day chemotherapy cycles. Before and after the first and second cycle, the participant will complete questionnaires using the device regarding chemotherapy induced symptoms, symptoms of nausea and vomiting, and sleep quality. It is hoped that this study will show that music therapy is feasible, acceptable, and effective for the prevention and treatment of chemotherapy induced nausea and vomiting in cancer patients undergoing chemotherapy.