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Biopatch (trademark) or Kendall (trademark) AMD Foam Disc to reduce the incidence of Central-Line-Associated Blood Stream Infection: A pilot randomized controlled trial
Expand descriptionA dressing containing chlorhexidine (Biopatch 'Trademark') has been introduced at the RBWH for all patients requiring a CVC. The dressing is expensive and the evidence for its effectiveness is contradictory. In related work we have some preliminary data showing that Biopatch may not be as effective as first thought in destroying potentially harmful bacteria. Another product, ‘Kendall 'Trademark' AMD Foam Disc’ has shown promise and we propose to compare the two antimicrobial dressings.
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Healthy Living after Cancer (HLaC) - a telephone-delivered healthy lifestyle coaching program for cancer survivors
Expand descriptionThe aim of the Healthy Living after Cancer program (HLaC) is to evaluate the integration of a telephone-delivered lifestyle intervention for cancer survivors into the existing Cancer Council 13 11 20 information and support telephone service offered by Cancer Councils New South Wales, Victoria, South Australia and Western Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have completed curative treatment for any type of localised cancer. Study details All participants will receive up to 12 telephone coaching calls over a period of six months to assist them to increase physical activity, improve their eating habits, and work towards moderate weight loss if appropriate. The calls will be delivered by Cancer Council nurses / information and support consultants trained in program recruitment, intervention and evaluation protocols. Pre- and post-program evaluation will be conducted, with a focus on program implementation (i.e., number of referrals and number of program completions) as well as assessment of patient-reported outcomes (i.e., physical activity, diet, weight, and quality of life).
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A Safety Study of Oraxol (HM30181 + oral paclitaxel) in Cancer Patients
Expand descriptionOraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-Orax-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. Once the dose of Oraxol has been confirmed in the KX-ORAX-002 study, then enrolment of patients who have not participated in the KX-ORAX-002 study will be allowed. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm that the blood levels of paclitaxel after several doses of Oraxol are similar to the levels expected. Participants in Group B (N=8) will receive the same weekly paclitaxel capsule treatment as the remainder of the subjects except for 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period) during which they will receive paclitaxel tablets and undergo PK assessments.
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Psychological Stress in intensive care survivors
Expand descriptionA significant proportion of patients who have survived admission to an Intensive Care Unit (ICU) experience long-term psychological consequences that include anxiety, depression and post-traumatic stress disorder (PTSD). A high proportion of family members of ICU patients also present with varying psychological symptoms of anxiety, depression and PTSD. Currently there are no routine follow ups of psychological well-being of patients discharged from intensive care units in Australia. There are little data from Australia about the incidence of psychological stress in the local population of ICU survivors and family members. Understanding of the incidence of the psychological stress in ICU survivors and their family members could potentially lead to routine assessment of the problem and measures to reduce the incidence. The primary aim of this multicentre study is to determine and compare the prevalence of affective symptoms in intubated and non-intubated ICU survivors and their family members by screening them for PTSD, anxiety, depression and Health Related Quality of Life (HRQoL) over a 12-month follow up period. The secondary aims of this study are to identify the risk factors for adverse psychological outcomes in ICU survivors.
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CHERISH Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital
Expand descriptionOlder people (age 65 and older) account for more than half of hospital bed days, and have longer stays and more hospital adverse events that younger people. A hospital stay is often a decisive point in an older person’s health, with hospitalisation accounting for half of newly acquired disability in elders. Geriatric syndromes (including delirium, functional decline, falls, incontinence and pressure injury) result in longer hospitalisations and greater risk of death and institutionalisation. Research clearly shows that “simple” strategies (early mobilisation, adequate oral nutrition, and meaningful cognitive activities) are effective to reduce geriatric syndromes, improve outcomes and reduce costs. While such strategies have been effectively incorporated in specialist “acute care for elders” wards, only a limited number of patients have access to these specialist services. In order to optimise care we need to embed these principles in all acute wards caring for older people. However, this requires systematic changes in acute care staff attitudes, practices and systems of care. We have piloted a programme of enabling facilitation, based on the i-PARIHS implementation framework, to embed this evidence into practice. The “Eat Walk Engage” programme supports a ward-based multidisciplinary team to identify barriers, trial solutions and embed successful strategies into practice using evidence-based quality improvement methods. In two pilot wards at the Royal Brisbane and Women’s Hospital we have shown promising reductions in length of stay, geriatric syndromes and adverse events accompanying process improvements. The CHERISH (Collaborative for Hospitalised Elders: Reducing the Impact of Stays in Hospital) study is a cluster randomised controlled trial of the “Eat Walk Engage” programme across 4 sites, and will provide robust evidence of the transferability, scalability, effectiveness and cost-effectiveness of the programme to inform further implementation. Comparing 4 intervention wards with control wards in the same hospitals to account for other sources of variation, we aim to demonstrate a reduction in hospital stay, geriatric syndromes, and discharge to a higher level of care within 12 months of implementing the “Eat Walk Engage” programme. The project is supported by a Queensland Accelerate Partnership Grant from the Department of Science, Information Technology, Innovation and the Arts, administered by Queensland University of Technology.
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The efficacy of the application of Self-Determination Theory to an online cognitive rehabilitation intervention in remediating cognitive dysfunction associated with cancer and its treatment.
Expand descriptionThe primary purpose of this study is to determine whether a web-based version of the ReCog program has a greater impact on cognitive function and other wellness measures than standard care in cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 or over, have experienced adult-onset cancer of any type other than a cancer affecting the central nervous system, have completed treatment at least 6 months ago (and not more than 5 years ago) and have complaints of cognitive function. Study details: On enrolling in this study, participants will be allocated to one of two groups. The first group will receive access to the ReCog online program. You will be required to complete 4 modules, each lasting approximately 60 minutes, plus weekly homework activities taking approximately 30-60 minutes each. Activities will include relaxation training, goal-setting, problem-solving and the learning of new strategies to improve areas of cognitive function, such as memory, fatigue, attention and emotions. Participants will have 4 weeks to complete the modules, and are expected to complete one module per week. The second group will have access to the ReCog program 4.5 months after group 1. All participants will be asked to fill out a series of questionnaires at four timepoints up to 3 months after the end of the intervention period. It is hoped that the findings of this trial will establish the efficacy of the web-based ReCog program to aid cognitive function in cancer survivors.
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In Total Hip Replacement, do ceramic-ceramic or highly-cross-linked plastic bearing surfaces have less migration and wear at 12 years?
Expand descriptionWe propose to follow up 61 participants from a previous randomized controlled trial conducted in 2001-2002 at SCGH and Hollywood Private Hospital, which randomized participants for total hip replacement to either a ceramic-ceramic or metal-highly-crosslinked-plastic bearing surface. The 12-year outcomes, in terms of radiographically measured wear rate and implant migration, and clinical findings will be determined and presented for each group.
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Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomised Control Trial
Expand descriptionIntensive care admissions, particularly for prolonged periods are often associated with muscle weakness, deconditioning, malnutrition and impaired long-term functional status. Nutrition is a potential modifiable factor to attenuate this deterioration. However defining what optimal nutrition is for critically ill patients in order to improve their outcomes remains controversial and needs further investigation. Despite feeding protocols, internationally and at the Royal Melbourne Hospital (RMH), patients continue to receive inadequate energy and protein compared to recommended targets. Results from our recently completed observational study in Intensive Care at RMH showed that accumulating an energy debt over an Intensive Care Unit (ICU) admission is associated with decreased muscle strength, physical function and the diagnosis of ICU Acquired Weakness (ICUAW). Patients with poorer strength and suboptimal physical function had a longer ICU length of stay and a higher requirement for inpatient rehabilitation, which is associated with increased health costs. This pilot randomised controlled trial aims to determine if a feeding protocol based on energy and protein targets, using a volume approach decreases muscle wastage and improves muscle strength and functional outcomes at discharge from the ICU compared to standard care. Patients will be randomised to standard care or the targeted feeding protocol which aims to provide 25kcal per kilogram and 1.5g protein per kilogram, which is in line with international best practice guidelines. The study period is from day of enrolment until ICU day 15 or discharge from ICU. Data collection will be the same for both groups and will include demographic data, the amount of energy and protein delivered, nutritional markers; such as weight and nutritional status and outcome such as length of stay and length of mechanical ventilation. Muscle strength and physical function will be assessed by the physiotherapist using standardised methods, which have been validated in the ICU. Muscle mass will be measured using ultrasound, which is a non-invasive technique, which has been safely used in the ICU. Data from this study will assist in informing future research studies to answer important clinical questions, including; should higher protein recommendations be targeted and what are the effects of improved calorie and protein delivery on functional outcomes for patients. This study will provide feasibility data to inform large multicentre randomised control trials.
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Non-invasive diagnosis and monitoring of non-alcoholic fatty liver disease in bariatric surgical patients
Expand descriptionThis is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate efficacy of non-invasive tests in diagnosing and monitoring NAFLD. Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited to undergo an intraoperative liver and adipose tissue biopsy. Each participant will be required to attend regular follow-up appointments (0, 1, 3, and 12 months), blood tests (0, 1, 3 and 12 months), FibroScan (0, 3 and 12 months) and MRS (0 and 12 months) over a 12-month study period. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4, any fibrosis, any inflammation or greater than 33% steatosis) will be offered a follow-up liver biopsy at 12-months post-operatively. Liver tissues and serum will be investigated for markers that may indicate disease presence and prognosis.
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Pathophysiology and treatment of nonalcoholic fatty liver disease (NAFLD): Effects of bariatric surgery
Expand descriptionThis is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate the impact of surgical weight loss on the liver. Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited from The Alfred Hospital, to undergo an intraoperative liver and adipose tissue biopsy. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4 or fibrosis score greater than F1) will be offered a follow-up liver biopsy at 12-months post-operatively. Liver tissues will be investigated for markers that may indicate disease prognosis and underlying pathophysiology, particularly immune cell markers.