ANZCTR search results

Patients referred to hospital chest pain clinics are often found to have non-cardiac (non threatening) symptoms, but have been found to have a high prevalence of risk factors (eg high cholesterol, smoking) for subsequent cardiovascular events (eg heart attack, stroke). These risk factors are not often formally addressed within a traditional chest pain clinic or cardiology clinic. The chest pain clinic provides an opportunity to identify patients at higher risk of subsequent cardiovascular events. We hypothesize that initiating strategies to modify individual risk factors during this initial visit will assist patients to develop a more favourable cardiovascular risk profile.

A small number of patients who are brought to the emergency department need a general anaesthetic. This lets us help them by keeping their airway open and breathing for them, and allows us to perform tests and provide further treatment. In very rare cases, the breathing tube cannot be passed through the mouth. This is a life threatening emergency, and an emergency procedure called a cricothyroidotomy then has to be performed. This involves making a cut in the front of the neck, directly into the windpipe, so that the breathing tube can be put directly into the airway. This is similar to a tracheostomy. The area of the neck where the cut is made is called the cricothyroid membrane, and it is usually identified by feeling the front of the neck with a finger. Recently, it has become clear that ultrasound scans can be used to locate the membrane, but it is not clear if this is more or less accurate than locating it by feel, and whether using an ultrasound takes more or less time. The study aims to compare two groups of patients. One group will have their cricothyroid membrane identified by touch, and the other group will have it identified by ultrasound. The participants in the study, will be randomly assigned (like tossing a coin) into one of these two groups. Immediately before having a CT scan, a doctor will try and locate the patients’ cricothyroid membrane using either touch or ultrasound (depending on the group they are randomised to), and then place a marker (a small metal cross) on the neck, which will be held in place with adhesive tape. After the CT scan, an x-ray specialist will then be able to see whether or not the marker has been placed accurately. We will then compare whether one method is more accurate than the other, as well as how long it took to place the marker. With the exception of (1) the attempt of cricothyroid membrane localisation, via ultrasound or landmark palpation and (2) placing a marker on their neck, the rest of the participants’ care will be carried out as normal.

This study aims to examine the effects of probiotics on immune system function. 120 healthy adults will take part and we will investigate the immune effects of six commercially available probiotics (20 participants in each probiotic group). Participants will take a probiotic for 2 weeks and provide a blood sample on Day 1, Day 8 and Day 15 (the day after their last probiotic dose). We will examine immune system function using the three blood samples provided. This study will provide important information on whether taking probiotics improves the function of the immune system.

Using the PICO format (participants, intervention, comparison, outcome): P: In babies greater than or equal to 28 weeks gestational age at birth I: can umbilical cord clamping be delayed for 60 seconds after newborn end-tidal carbon dioxide levels exceed >15 mmHg (baby-directed umbilical cord clamping)? C: no comparator O: The primary outcome is adherence to study protocol and evaluation of protocol safety. The purpose of this non-randomized feasibility study is to gain experience providing baby-directed umbilical cord clamping (BABY-DUCC) in newborn infants born at 28 weeks or later immediately after birth. BABY-DUCC is delaying umbilical cord clamping after birth to maintain placental circulation and gas exchange and provide respiratory support (if indicated) until lung aeration and pulmonary gas exchange has begun indicating successful neonatal adaption after delivery. This will be a single centre non-randomized feasibility study in babies born at a gestational age of 28 weeks or later at the Royal Women’s Hospital. We plan to provide respiratory support to the newborn infant with the umbilical cord intact. The umbilical cord will then be clamped after physiologic changes indicating a successful neonatal adaption has begun, based on end tidal carbon dioxide monitoring. Specifically, umbilical cord clamping will be delayed for 60 seconds after the newborn’s end-tidal carbon dioxide is measured at >15 mmHg. The clinical team in charge of the care for the baby will use a portable BABY-DUCC warming mattress allowing the evaluation and initiation of respiratory support to occur next to the mother. Specifically, the portable BABY-DUCC warming mattress will be equipped to provide heat to the newborn (chemical heating packs or electric warming mattress) and a dedicated study “respiratory support pole” with the ability to provide blended oxygen, CPAP, positive pressure ventilation, heated and humidified gas, and suction. We will monitor and record end tidal carbon dioxide, tidal volume, pulse, and saturation of peripheral oxygenation using the NM3 Respiratory Monitor, heart rate via electrocardiographic electrodes or portable ultrasound machine, and a high definition audio/video recording of the events. All physiologic information will be converted from analog to digital signal and recorded at 100 Hz using a custom built software program called the BABY-DUCC Data Acquisition System which presents the data in graphical and table form for analysis. In addition to the standard medical staff attending the deliveries, two dedicated members of the research team will be present at each delivery to review the study protocol with all the clinical staff in the delivery room (including staff looking after the mother), confirm with the clinical teams that there are no increased risks to the mother’s or baby’s health that would preclude attempting the BABY-DUCC protocol, set up the study materials, and carry out the study protocol.

In the presence of a critical illness a child may require mechanical ventilation to support their breathing. In the intensive care unit this is achieved through the insertion of an endotracheal tube. This tube serves as the child’s airway and is cared for by a nurse. The nurse removes mucous from the tube by performing an endotracheal suction (ETS). Saline is often used with ETS. Saline use is thought to help loosen dried mucous and prevent it from blocking the tube. Researchers have shown suction is important to prevent complications which arise from retained airway mucous, however, there is no quality research regarding saline use with suction to help guide nurses ETS practice. ETS is associated with a number of complications including pulmonary derecruitment. Collapsed alveolar negatively impair gas exchange and may be colonised by bacteria leading to nosocomial infection and ventilator associated pneumonia. The use of lung recruitment following ETS may help to restore pulmonary volumes and prevent harmful, accumulative atelectasis. We will compare ETS in mechanically ventilated children with i) normal saline instillation (NSI) and no NSI and ii) lung recruitment (LR) and no LR. The primary outcome is trial feasibility as determined by a composite analysis of recruitment, retention, protocol adherance and missing data. Secondary outcomes include measures of gas exchange, respiratory mechanics and ventilator associated pneumonia. Research examining ETS best nursing practice is lacking. Leaving nurses to make ETS related decisions in a vacuum of evidence. These decisions can influence the outcomes of critically ill children. Conducting research in paediatric populations is challenging and piloting trial protocols prior to committing the resources needed for a definitive trial helps maximise the efficiency of the trial and processes.

Major depressive disorder ranks second amongst the most important causes of disability in Australia. Anxiety disorders also rank in the top ten causes of disability. One problem is that the benefits of antidepressant medication, the most widely used remedy for both these disorders, are small and the harms are significant. There is a swing towards the use of psychological treatments, of which cognitive behaviour therapy (CBT) is the best researched. However CBT has many out of pocket costs (average >$60 per visit), quality is not assured, and therapy is not widely available outside major city centres. Internet delivered automated cognitive behaviour therapy (iCBT) on the other hand, produces the same benefit and freedom from harms as face to face CBT, but has advantages of low cost, high fidelity and wide distribution at levels comparable to medication. In iCBT studies, however, adherence varies markedly according to the amount of encouragement or clinical guidance provided. In our research, adherence varied from 33% for a group who received no support, to 68% for those who received automated reminders, to 81% for the group who received telephone reminders from a technician. A later comparison of technician reminders with coaching by a clinician showed no difference in adherence or efficacy. The two levels of support were therefore comparable but the costs to the health system were not. The primary purpose of this trial is to examine the efficacy and adherence of iCBT for anxiety and depression (6 lessons + homework + automated reminders) across five varying levels of support plus usual care, compared with usual care alone. Eligible participants will be randomly allocated to one of six groups with varying levels of support: 1) Self-help only; 2) Technician contact upon request; 3) Scheduled technician contact after each lesson; 4) Clinician contact upon request; 5) Scheduled clinician contact after each lesson; or 6) Treatment as usual (TAU) control group. The main hypotheses to be tested are: 1. iCBT at all 5 levels of support will significantly reduce symptoms of anxiety, depression, distress and disability compared to a TAU control group. 2. The efficacy will be related to the frequency of support. 3. The adherence rate will be related to frequency of support. 4. The most cost effective (staff cost per unit of health gain) will be technician support on request. It is hoped that the findings of this trial will provide further information regarding (1) the adherence rates and treatment effects that are associated with various levels of clinician or technician support, (2) the cost effectiveness that is characteristic of each level of intervention, (3) whether certain levels of intervention are not sufficiently effective to be attractive to a health service, and (4) whether there are levels of intervention that are not sufficiently more cost effective than a lower cost intervention to be attractive to a health service.

The aim of this study is to determine whether an SMS-text message follow-up intervention for deliberate self-harm (DSH) is more effective in reducing DSH re-presentation to hospital, than treatment-as-usual hospital follow-up. Method This study will be conducted at Blacktown, Westmead and Nepean Hospitals as a Randomised Controlled Trial (RCT). Individuals will be eligible for study inclusion if they present with DSH to a hospital Emergency Department during the recruitment period, have access to a mobile phone for personal use and are aged 16 years and over. Eligible study participants will be randomly assigned to either hospital follow-up treatment as usual (TAU) or TAU plus SMS-text message follow-up. The study will have a two year recruitment phase with participants in the intervention condition receiving a supportive SMS text message at 1, 2, 3, 4, 5, 6, 8, 10 and 12 months after their index admission/randomisation. The outcomes of interest are i) the number of DSH re-presentations in each group, ii) median time to first re-presentation in each group and, iii) deaths within each group, within 12 months following recruitment. Benefits Repetition of self-harm within 12 months of an index episode occurs at a median rate of 15% (interquartile range 12-25%). This has a strong association with subsequent completed suicide and significant ongoing resource implications for the health care system. We have demonstrated in our previous ’Postcards from the EDge’ study (Carter et al, 2005, 2007, 2013, Milner and Carter, 2015) that, in individuals with a prior admission for deliberate self-poisoning (DSP), a simple postcard follow-up significantly reduces hospital re-presentation rates and associated costs. SMS text messaging has been demonstrated to be an effective method of communication with vulnerable people. Determining whether electronic communication is more effective than current practice in preventing DSH re-presentation is of the utmost importance, since DSH accounts for 5% of all general hospital admissions in Australia and mobile phone ownership is becoming almost universal, particularly among young people who are more at risk of self-harm. Should text messaging prove more effective, it allows for a vastly more flexible, direct and deliverable medical follow-up system than has ever existed under traditional models of care for DSH patients.

Increasingly recognised within the clinical disciplines of Medicine and Public Heath over the past four decades, dysfunctional sleep continues to impose incremental costs to the community due to declining quality of life and vocational productivity. The adverse effects of sleepiness and sleeplessness are confounded by the associated burden of co-existing non-communicable diseases (NCDs) such as chronic pain, obesity, diabetes, obstructive sleep apnoea and obstructive coronary artery disease. The primary aim of the Eastern Australian Sleep and Health Livingness Study is to describe and quantify the multi-faceted interrelationship between the diverse manifestation of impaired sleep and individual variations in physical activity, daytime cognitive function, emotional well-being and other lifestyle characteristics following adjunctive treatments for sleep rhythm maintenance. ‘Adjunctive’ treatments include a broad range of environmental modification, physical activity, sedatives, exogenous hormonal replacements, dietary supplements and/or emerging trend of adjunctive Complementary Medicine modalities in addition to conventional medical treatments. The study is a prospective observational cohort study of adults in Eastern Australian rural and urban centres who report of impaired sleep with or without chronic bodily symptom(s). Interviewer-assisted survey and stratified sampling over a five-year period will stratified participants into case-control study for their exposure to important risk factors of impaired sleep and/or chronic bodily symptoms, pattern of health care utilisation, pattern and quality of sleep, persistence and/or development of bodily symptoms such as pain(s), tiredness and fatigability in addition to task-specific cognitive impairment and emotional well-being. The matched case-control study design of comparison of participants living in rural and urban centres offers an efficient method of testing the study hypotheses within a relatively shorter period of follow up time. It also allows testing of multiple study outcomes, different case-control scenario such as patterns of health care utilisation, calculation of time-dependent or exposure-dependent risk and minimise selection bias as compared to a large-scale population study which is most costly to implement. The currently available estimated prevalence of impaired sleep, chronic bodily symptom(s) and ‘adjunctive’ treatment is significant to reduce potential bias of risk factor exposure. Given the etiological importance of regular physical activity and adverse lifestyle factors, the study will confirm supportive sleep rhythm(s) is/are represented by a consistent pattern(s) of ‘livingness’ which is readily identifiable and reproducible. The implication of the study proposes the reorientation of our Public Health policy in practical lifestyle modification which are necessary in improving productivity and preventing the long-term complications of sleep-related disorders.

Globally children's intake of unhealthy foods and beverages is excessive, contributing to weight gain and risk of obesity. Parents’ attitudes and beliefs influencing food provision provide a promising new avenue for obesity prevention through reducing children’s intake of unhealthy foods and beverages. There is a need to understand the relative importance of different parental attitudes and beliefs in influencing their provision, starting with the home setting. The aim of this study is to understand the relationships between, and relative importance of, parents’ attitudes and beliefs and children’s intake of unhealthy foods and beverages. This aim will be achieved by an online cross-sectional survey of parents of 3-7 year olds to measure parental attitudes and beliefs influencing their provision of unhealthy foods. The data will be examined using Structural Equation Modelling analyses to determine the predictive ability of attitudes and beliefs on parents’ provision of unhealthy foods to 3-7 year old children. Findings from this study can then be used to develop evidence-based interventions to support parents’ to limit provision of unhealthy foods and beverages, hence improve energy balance and prevent obesity from an early age.

An active break intervention targeting improving academic and physical activity related outcomes will be implemented in selected Victorian Government primary schools. Our findings will determine the feasibility and potential efficacy of active breaks for improving academic and physical activity related outcomes.