ANZCTR search results

Fast and irregular heart rhythms coming from the bottom chambers of the heart are called ventricular tachycardia (VT). VT is caused by electrical short circuits in the heart, usually as a result of a previous heart attack. 'VT storm' is a medical emergency which occurs when multiple episodes of VT occur within a short period of time. This can be life-threatening because it can stop your heart from pumping enough blood around the body, which may lead to dizziness, fainting or even death. VT can be treated with either anti-arrhythmic drugs (AADs) or catheter ablation. Catheter ablation involves navigating soft wires from the groin into the heart, to find and deliver controlled burns to the short circuits causing the VT, in an attempt to eliminate the VT. We hypothesise that in patients with VT storm, catheter ablation, compared to the current standard of care with AADs, will reduce VT recurrence, mortality, rates of hospitalisation and adverse events.

Transcatheter aortic valve implantation (TAVI) is a less-invasive, non-surgical approach for the treatment of severe aortic stenosis. With each successive generation of the transcatheter heart valve, combined with increasing experience of the proceduralists/heart teams, the outcomes have been more successful, and the risk of complications have been decreasing. One of the commonest complications of the TAVI procedure is the associated conduction abnormality (atrioventricular and intraventricular conduction blocks) which may require insertion of a Permanent Pacemaker (PPM). This is often performed post TAVI procedure, however certain patients undergo prophylactic insertion of PPM pre-TAVI. We will compare the follow up outcomes for each of these groups to assess differences in their heart rhythm following TAVI and associated requirement for PPM.

Depression is common following stroke, affecting one in three stroke survivors (Hackett et al., 2009), and it is considered one of the strongest predictors of reduced quality of life (Kim et al., 1999; King, 1996). Studies investigating treatments for post-stroke depression have mainly examined pharmacological treatments (Hackett et al., 2009), and only a small number of studies have examined psychological treatments. In a series of case studies, Rasquin et al. (2009) found that four of five stroke patients who completed cognitive-behavioural therapy (CBT) reported reduced depressive symptoms. Aphasia refers to a communication impairment caused by damage to the language centres of the brain and can include difficulties with expressive language (e.g., speaking/writing), receptive language (i.e., comprehension of what is said or what is read) or both. Stroke survivors with aphasia are at a further increased risk of experiencing depression (De Ryck et al., 2013; Hilari, 2011; Kauhanen et al., 2000). Furthermore, it is unclear whether CBT, which is predominantly a talking-based psychological therapy, can be successfully modified and tailored for feasible and effective delivery to stroke patients with depression and aphasia. In consideration of this evidence, this study aims to investigate the feasibility and efficacy of a CBT intervention in reducing depressive symptoms in individuals with aphasia secondary to stroke. A series of nine case studies will be conducted to evaluate the efficacy of a modified and individually tailored CBT program. This study will help inform future research and clinical practice, and will contribute to best practice standards in stroke rehabilitation and care.

Older adults admitted to acute care hospitals often experience frailty and pain which can impact patient outcomes. Our study will implement interventions comprising volunteer support and pain assessment to minimise the progression of frailty. The aim is to evaluate the effectiveness of using volunteer support interventions and a technology driven pain assessment (PainChek Universal®) compared with standard care, on changes in frailty and specific clinical outcomes of older adults during hospitalisation, at discharge and at 30 days after discharge, utilising a cluster randomized control trial design. Data collected will include demographic data, clinical data, measures of frailty, pain and other assessments, in patients aged 65 years and over with an anticipated length of stay 48 hours or longer. Findings will provide insight into care delivery for older adults with frailty and pain admitted to acute care hospital settings.

This study is an open label single arm trial coordinated by the Investigators at the Princess Alexandra Hospital (PAH) in Woolloongabba (Queensland, Australia), the Australian Centre for Complex Integrated Surgical Solutions at the Translational Research Institute (Queensland, Australia) and the Centre for Regenerative Medicine at the Institute of Health and Biomedical Innovation in Kelvin Grove (Queensland, Australia). The primary purpose of this study is to assess the feasibility of surgical placement of a new protein scaffold in conjunction with free tissue transfer for bone reconstruction in patients who have an acquired skull defect secondary to trauma, malignancy or infection. Experimental data suggests augmented bone regeneration of this new protein scaffold when combined with autologous vascularised free tissue from the subject. It is hypothesised that this method of reconstruction will result in superior regeneration of skull bone with improved cosmesis at a reduced cost to hospital and patient. This will be assessed through pre-and post-operative CT imaging to quantify bone regeneration. This will be compared to previous types of skull reconstruction in terms of functionality (i.e. cosmesis and patient satisfaction) and financial implications (i.e. costs associated with operation(s) and complications). Patients will be followed up at 4weeks, 3, 6, 12 and 24 months to assess to adequate bony union (through CT and clinical exam) as well as completed surveys of their experience and physical, mental, emotional and social outcomes.

The diagnosis of anterior cruciate ligament (ACL) injury and reconstruction (ACLR) in skeletally immature patients is climbing at a rate significantly higher than adults. The increased incidence has been attributed to several factors including rise in competitive sport participation, decreased incidental activity, increased clinical awareness of a potential for ACL tear in this population, more comprehensive diagnosis and evaluation with Magnetic Resonance Imaging (MRI) and a shift in clinical practice to provide early intervention. The weight of available evidence now supports reconstruction over conservative management with minimal complications. Nonetheless, evidence regarding the ideal surgical technique for the skeletally immature patient is still lacking. Two commonly implemented surgical methods are reconstruction using single or double hamstring tendon autograft. The primary aim of this single blind randomized controlled trial is to determine whether a single or double hamstring tendon graft ACLR leads to superior clinical outcomes post-surgery in paediatric patients with ACL injury.

The use of multiple medicines (polypharmacy) is associated with poor clinical outcomes. It has been reported that more than a third (36.1%) of older Australians (aged 70 years or older) living in the community were affected by polypharmacy. There has been a move towards deprescribing (the process of withdrawing an inappropriate medication that is supervised by a health care professional with the goal of managing polypharmacy and improving outcomes). However, there are many barriers to deprescribing from the perspectives of both the patients and prescribers. The Team Approach to Polypharmacy Evaluation and Reduction (TAPER) medication review process has been developed to directly address these barriers. The focus is on maintaining essential drugs while supporting reduction in medicines with known associations with adverse effects, some of which could lead to emergency presentations and/or unplanned admissions to hospital, and those in which risks outweighs benefits. Participants attend sequential linked consultations with a pharmacist and their GP to collaboratively stop/reduce potentially inappropriate medications (in the context of their personal preferences and goals of care), using a structured ‘pause and monitor’ period. This randomised control trial will compare the TAPER intervention to usual care in older adults living in the community to determine the effect of TAPER in participants taking 5 or more medicines on the participants' medication use, wellbeing and health system utilisation including emergency presentations and/or unplanned admission to hospital. Addressing polypharmacy in older people may reduce adverse events and save money. There is evidence to suggest that there will be cost benefits by both reduced medicines costs, and reduced adverse events leading to reduced health service utilisation.

A randomised, single-blinded, controlled, non-inferiority clinical trial comparing a technology-based, remotely delivered ("Telehealth group") TKR rehabilitation program to usual, in-person care ("Clinic group"). 150 participants who are scheduled to undergo primary elective total knee replacement will be recruited over a period of 10 months with 75 participants randomly allocated to each arm of the study. Participants allocated to both arms of the study will complete 6 weeks of post-surgery exercise rehabilitation (twice per week for three weeks, then once per week for the next three weeks). Primary outcome measures are 'knee flexion range of motion' (ROM) and the 'Knee Injury and Osteoarthritis Outcome Score' (KOOS). Secondary patient reported outcomes include Visual Analogue Scale, Short Form Health Survey (Sf-36), Global Rating of Change, Patient Satisfaction and the Telehealth Digital Literacy Questionnaire. Secondary functional assessments include 40meter Fast Paced Walk Test, 30 Second Sit to Stand Test, Stair Climb Test (9 stairs) and the Timed Up and Go Test. Participants from both groups will have outcome measures collected in an in-person assessment: pre-surgery, 7 weeks post-surgery (+7 weeks), and at 12 months post-surgery (+12 months). Online questionnaires only will be send at 6 months post-surgery (+6 months). This study aims to: 1. Determine if short- and medium-term outcomes for TKR patients are similar following a 6-week rehabilitation delivered either via telehealth or within a clinic setting (in-person). 2. Assess the economic costs of rehabilitation delivered in each of these modes. 3. Determine whether knee joint range of motion (ROM) can be assessed both practically and accurately via telehealth.

During the COVID-19 Pandemic a number of medical and allied health consultations has been changed from face-to-face to telehealth, using either telephone or video. This study would like to understand the level of satisfaction melanoma patients and their clinicians had with telehealth. Learning about the satisfaction may lead to improvement of this service in the future, as telehealth may be able to bridge geographical gaps many patients experience who do not live in large urban areas. Who is this study for? Patients: This study may be suitable for you if you are: at least 18 years of age, able to read and understand English and respond to survey questions, are able to provide informed consent, you have been diagnosed with melanoma, you have had at least one consultation via telehealth since March 2020, you are receiving services from healthcare professionals at Melanoma Institute Australia, or Melanoma and Surgical Oncology at Royal Prince Alfred Hospital Clinicians: This study may be suitable for you if you are: a healthcare professional (e.g. doctor, nurse, allied health) involved in providing care, support, and management of patients with melanoma, providing services at Melanoma Institute Australia and Royal Prince Alfred Hospital, you have provided at least one telehealth consultation in relation to melanoma management since March 2020. Study details: Participants enrolled in this study will be asked to complete ONE survey. Melanoma patients will be able to complete this survey online or in paper form. This survey will take about 20 minutes to complete and will contain questions about general demographic and melanoma information, satisfaction with telehealth, emotional and physical functioning, Clinicians will, be asked to complete a 10 minute survey containing questions about their general demographic information, their career stage, opinion about adequacy of Medicare items for telehealth as well as their own perception of telehealth they provided. Clinician survey will be available online. It is hoped that this study will highlight the benefits of telehealth, as well as some areas where improvements may be needed. This may lead to implementation of the strategies to address areas of low satisfaction in both clinical practice as well as research.

This study will be a placebo-controlled, double-blind, randomised Phase 2b/3 study in participants with established cardiovascular disease to evaluate the impact of statin therapy on changes in plaque burden and composition in participants with different polygenic risk scores using CT coronary angiogram. The study will take place at ten sites in Australia.