ANZCTR search results

Key Research question(s) 1. Will the proposed MMMP model, using a risk tool to stratify patients (The Intervention) increase access to medication management services post discharge compared with those receiving usual care? 2. Will the proposed MMMP model using a risk tool to identify “at-risk” patients (The Intervention) reduce the hospital health utilisation (emergency department visits, hospital admission and length-of-stay) at 30 or 90 days post discharge compared with those receiving usual care? This project aims to reduce the risk of medication misadventure across care transitions by increasing identification of patients at-risk, and hence referral to pharmacist led medication management services. Hypothesis: The routine application of an easy to use, bedside tool can facilitate identification of at-risk patients and trigger referral to an appropriate medication management pathway in the community following hospital discharge. Improving medication management across the continuum continues to be one of the greatest challenges in modern health care. A report to Government on the Home Medicines Review (HMR) declared strong ‘widespread’ unconditional support for hospital-initiated medication review (HIMR) early post-discharge, acknowledging this gap in care. Yet nearly a decade on, there is no nationally accepted pathway for HIMRs to ensure our most vulnerable patients are supported following a hospital admission. A recent Australian systematic review highlighted those most in need of medication review remain underserved, including indigenous and Culturally and Linguistically Diverse populations, and those recently discharged from hospital. Application of the risk tool will facilitate identification of “at-risk” patients and ensure handover to a community medication management service most suited to the individual patient. ‘Risk Stratification’ uses a process to identify people likely to suffer an unplanned hospital admission. There are currently no international or national risk stratification solutions, focused on medication misadventure that can be readily applied to the Australian context. By identifying patients at risk, appropriate coordinated care can be provided to them. The period 7-10 days after hospital discharge is a particularly vulnerable time, and associated with a significant risk of medication related problems. Studies have shown about half of the patients discharged from hospital experience a medical error, with 19% - 23% suffering an adverse event, most commonly an adverse drug event. Through use of a structured framework, actively assessing risk, hospital staff will identify and triage high-risk patients for pharmacist-led medication management services in the community setting. This should improve identification of those at risk and improve care across the continuum.

Knee osteoarthritis (KOA) is a leading contributor to burden of disease in Australia. Pain and impaired function are characteristic symptoms leading to physical disability, inactivity and reduced quality of life all of which further perpetuate functional decline. Guidance to facilitate self-management is key in the treatment of KOA with physical activity and exercise advocated by all clinical guidelines as the cornerstone of conservative management irrespective of disease severity. Unfortunately, many people suffering with KOA are not receiving the advice or behaviour change support required to incorporate regular exercise and physical activity into their daily routines. A combination of factors may be responsible including financial, geographical, and personal barriers. To overcome these barriers innovative, novel and cost-effective approaches to exercise education, prescription and exercise behaviour change are needed to increase exercise uptake and reduce physical inactivity in the KOA population and ultimately reduce both the individual and societal burden of OA in Australia. Electronically delivered physical activity and exercise interventions may be one solutions. Several OA specific internet resources already exist within Australia. These resources provide only general exercise and physical activity advice to people with KOA, with minimal evidence supporting their positive effect on clinical outcomes. It can be speculated that the effectiveness of such resources may be enhanced by the addition of higher quality, detailed and specific physical activity and exercise instruction and guidance. This trial will, therefore, investigate whether the addition of “My Knee Exercise” (an Internet delivered 24-week exercise program with mobile phone text message exercise adherence support) to Internet delivered exercise education enhances clinical outcomes at 24-weeks in people with KOA. Participants will be randomly assigned to one of two groups; i) My Knee Education (control condition): participants will be provided access to “My Knee Education”, a website containing information about KOA and exercise benefits plus general exercise and physical activity recommendations, similar to those provided in current Australian OA consumers resources. ii) My Knee Exercise (intervention): participants will be provided access to “My Knee Exercise”, a website containing the same information provided to the control condition in addition to a 24-week Internet delivered exercise program, supported by mobile phone text message exercise adherence support and detailed physical activity guidance. Data collection will be self-reported questionnaires relating to knee pain, physical function, global rating of change, health-related quality of life, physical activity levels, self-efficacy and satisfaction, collected at baseline and 24-weeks after commencement of the intervention.

Cognitive Remediation Therapy (CRT) and social cognition remediation (SCRT) are treatments that have evidence for their immediate efficacy in remediating the social and neurocognitive deficits of schizophrenia and other severe mental illness. However, there is a lack of information as to whether these treatments are effective for young people, whether the combination of these two treatment approaches adds increased benefit and if so, whether the combination’s effect is lasting and contributes to improved function and outcome. We propose a randomised controlled trial to address the following aims:- 1. Does a combined program of CRT and SCRT speed reintegration into work or educational? 2. Is there an advantage to combining these treatments over and above being treated by cognitive remediation alone? 3. Is there a clinical group that is particularly advantaged by combining CRT and SCRT

This study will determine the prevalence and incidence of thiamine deficiency in patients admitted to the intensive care unit with sepsis and septic shock, and measure association with peak lactate concentrations at admission, and within 24, 48 and 72 hours of admission. As a pilot epidemiological study, this project will help inform future studies of the role of thiamine and other nutritional deficiencies in the pathogenesis and management of septic shock, and will provide useful data for hypothesis generation and calculation of sample size for future studies.

As the ageing population increases, so has the number of colorectal cancer surgeries performed. Despite clear consensus on the treatment, the elderly are known to be undertreated. This study aims to interrogate age-related morbidity, mortality and long-term survival in elderly colorectal cancer patients.

Sleep problems in the preschool years represent a transdiagnostic risk factor for numerous child mental health and academic problems, in the short- and long-term. Given that sleep problems are modifiable, successful treatment before children begin primary school will reduce child sleep and mental health problems, improve the transition to primary school, and enhance academic outcomes. We aim to conduct a large-scale, multi-site study through a randomised controlled trial (RCT) investigating the efficacy of a parent-focused, group-based behavioural sleep program (BSP) delivered BEFORE children begin primary school targeting preschool sleep problems. Relative to care-as-usual (CAU), we expect the BSP will reduce child sleep and mental health problems, and improve school transition and academic outcomes. Participants in both conditions will be assessed before and after the treatment phase, as well as at the end of terms 1 and 2 of the first year of primary school. The following hypotheses are proposed: 1. Compared to children in the CAU condition, children whose parents participate in the BSP program will exhibit a significantly greater reduction in sleep problems at post-assessment, and terms 1 and 2 of Prep/Reception; 2. Compared to children in the CAU condition, children whose parents participate in the BSP program will exhibit a significantly greater reduction in emotional and behavioural mental health outcomes (i.e., anxiety symptoms, depression symptoms, somatic complaints, rule breaking behaviour, attention problems, aggression, and oppositional behaviour) at post-assessment, term 1 and term 2 of Prep/Reception. 3. Sleep outcomes will mediate the effect of treatment arm on mental health outcomes. That is, improvements in child sleep problems (measured at post-assessment) will lead to improvements in mental health outcomes for the BSP relative to the CAU group at post-assessment, term1 and term 2 assessment points. 4. Sleep outcomes will also mediate the effect of treatment arm on child school transition and academic outcomes. That is, improvements in child sleep problems (measured at post-assessment) will lead to improvements in school transition and academic outcomes for the BSP condition relative to the CAU group at term 1 and term 2 assessment points. During this three-year project, two cohorts will be recruited in Years 1 and 2 of the study. In the final quarter of the year prior to commencement of primary school, parents of preschool children with sleep problems will be randomised to BSP and CAU conditions and those in the BSP condition will receive treatment. Outcomes from this study will provide new directions for improving sleep, mental health problems, and preparedness for early major life transitions in young Australians.

This study aims to determine if an Omega-3 powder, rich in docosahexaenoic acid (DHA), can improve cognitive function and mood in healthy male participants aged between 40-60 years. A total of 30 participants will be recruited to take part in this trial. Previous clinical trials have demonstrated improvements in cognitive function and mood after supplementation with long-chain omega-3 fatty acids. This will be the first clinical trial to investigate the specific supplement at this dosage, however, the supplement is currently used as a food additive by a number of companies. The benefits of omega-3 supplements on health is well established, and has led to an increase in use, as well as the addition of omega-3 fatty acids in dietary supplements. Despite this, only a small number of controlled trials have directly investigated the acute (short-term) cognitive benefits associated with omega-3 supplementation. The current study therefore aims to investigate the acute effects of a DHA-rich omega-3 supplement on cognitive function. We will be measuring the effects of the omega-3 supplement compared to a placebo using assessments of mental fatigue, cognition, memory and mood.

Approximately 250 volunteers will be required for this study. The study will test whether a 6-month multicomponent intervention (involving health coaching, sit-stand workstations at work, and a smartphone behavioural promoting tool) can reduce daily sitting time and improve blood glucose control as well as risk markers for cardiovascular disease (blood pressure and blood vessel health). The results of this trial will build on our understanding of the cardiometabolic consequences (i.e. high risk of developing heart disease) of too much sitting in individuals with type 2 diabetes and will help design intervention strategies in the community to reduce the risk of developing complications associated with diabetes.

Low blood pressure (hypotension) that does not improve with administration of fluids is a common reason for admission to intensive care. These patients usually require drugs that tighten blood vessels (vasopressor) to be given by continuous drip into a vein (intravenous infusion) to support the circulation and maintain a sage blood pressure for a period of time until the patient improves. Underlying causes of this hypotension may relate to sepsis, inflammatory conditions such as pancreatitis, use of medications and inflammation as sometimes seen in patients after surgery. Midodrine is a drug that tightens blood vessels that can be taken by mouth and has been successfully used in many patients with diseases that cause low blood pressure and faintness when standing (orthostatic hypotension). It can be given as a tablet and is well tolerated. Recent studies have focused on its use in patients with other causes of hypotension and suggest it may be safely used in critically unwell patients already receiving vasopressor infusions for hypotension to shorten the length of time requiring such infusions. This may have additional patient benefits with shorter length of time of invasive monitoring and shorter length of ICU and hospital stay. There are, however, no randomised controlled trials assessing this effect, making it unclear whether reports published so far are correct. We aim to compare the effect of midodrine added to usual care against usual care in critically ill patients on low dose vasopressor infusions for fluid-unresponsive hypotension. We plan to enrol a total of thirty patients who have required a vasopressor infusion for more than 24 hours and remain on an infusion due to continuing hypotension. These thirty patients will be randomly (like the toss of coin) assigned to receive either midodrine in three divided doses of 10 mg each per day or usual care. To understand the effect of the midodrine administration, we will record routinely recorded patient demographic data, circulation data (such as blood pressure, heart rate, central venous pressure and cardiac output), baseline laboratory data (haemoglobin, white cell count, alanine aminotransferase, international normalised ratio, bilirubin, urea, creatinine, troponin, lactate), urine output and fluid balance and dose of intravenous vasopressor. The primary outcome measure will be time in hours from initial administration of Midodrine to cessation of intravenous vasopressor. Secondary outcome measures, such as length of ICU and hospital stay, will also be recorded. The results of this study will provide insight into the effects of midodrine in attenuating duration of vasopressor infusions in intensive care patients with fluid resistant hypotension and, if positive, will allow our patients to be able to stop their infusion and return to the ward and home more quickly.

The aim of the trial is to evaluate the safety and pharmacokinetics of ACP-015 in healthy male subjects. Such data will be descriptive rather than based on a statistical approach. ACP-015 is designed to provide long-term CNP exposure with the goal of optimizing efficacy with a well-tolerated and convenient once weekly dose. No identified or potential risks for use of ACP-015 in humans have been established as no data is available regarding the use of ACP-015 in humans.