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Magnesium after cardiac surgery practice change audit
Expand descriptionAtrial fibrillation (AF) is the most common complication after cardiac surgery, with an incidence ranging from 20 to 50%. It represents a potential cause of thromboembolic events, hemodynamic instability and prolonged Intensive Care Unit (ICU) stay. Maintaining a normal blood magnesium concentration may help prevent the onset of atrial fibrillation after cardiac surgery. Previously we performed an assessment of the pharmacokinetics of magnesium administration after cardiothoracic surgery from August, 2016 to April, 2017: “Assessment of Blood and Urine Magnesium Levels in Patients Admitted to the Intensive Care Unit” (HREC: LNR/15/Austin/306). We included 60 patients: 30 patients in the before period who received a bolus of 20 mmol of magnesium sulphate over 1 hour; and 30 patients in the after period who received a bolus of 10 mmol of magnesium sulphate followed by a continuous infusion at 3 mmol/h over 12 hours. In the before period, we found that the loading dose of 20 mmol increased both serum and urinary magnesium concentrations, however the serum concentration returned to pre-intervention levels within 12 hours of observation and the urinary excretion remained elevated. In the after period, the intervention of a loading dose of 10 mmol of magnesium sulphate followed by a continuous infusion was associated with an increase of both the serum and urinary concentrations of magnesium over time. The after-period protocol allowed us to achieve a sustained, safe, and moderately elevated serum magnesium concentration at twice to three times the lowest total magnesium concentration in our laboratory (1.4 to 2.0 mmol/L), which might be expected to deliver a greater chance of AF prevention. As such the management practices associated with magnesium administration in our intensive care unit has changed. The purpose of this project is to evaluate the effect of the new protocol on the incidence of atrial fibrillation in patients who undergo cardiac surgery and are admitted to the intensive care unit. Using a medical record audit design we will evaluate patients treated with the new magnesium protocol with that of a historical control.
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Clinical and economic outcomes of the Reducing the Use of Sedatives (RedUSe) project in Australian residential aged care facilities
Expand descriptionA multifaceted program (the Reducing the Use of Sedatives; RedUSe project) was implemented across 150 Australian residential aged care facilities (RACFs). The RedUSe project consisted of educational sessions supported by auditing and benchmarking of sedative prescribing. There was also a sedative review component where pharmacists, nurses and doctors work together in consultation with the resident and/or relatives to review regularly used sedative medications (predominantly antipsychotics and benzodiazepines). We aimed to review the clinical outcomes of the residents and nursing home staff, and economic outcomes for the health care system resulting from this intervention. We hypothesised that reduced use of antipsychotics and/or benzodiazepines, as a result of this project, will: - Not negatively affect behavioural and psychological symptoms - Improve resident quality of life - Decrease the rate of resident falls - Increase activities of daily living - Decrease general practitioner visits - Decrease hospitalisations - Decrease caregiver burden - Increase the job satisfaction of nursing staff - Be associated with lower costs to the health care system than 'usual' practice. Nursing staff were interviewed with validated questionnaires to assess behavioural and psychological symptoms, social engagement, activities of daily living, and caregiver burden at the start and four months of RedUSe. Additionally, nursing staff were required to record the number of falls, challenging episodes, hospitalisations, and general practitioner consultations the residents had each month for the same four month period (a minor addendum to their existing recording activities). To asses job satisfaction, an anonymous survey was made available at the start and four months of RedUSe.
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A novel intervention to promote engagement in physical activity for individuals with whiplash associated disorder
Expand descriptionSix participants aged 18-60 years will be recruited for this study. Inclusion criteria includes: grade II whiplash of at least 3 months duration; living in a community setting; a neck disability index score >32% [1]; deemed medically safe to participate in moderate intensity PA; and currently insufficiently physically active for good health. Exclusion criteria includes: known or suspected serious spinal pathology; confirmed fracture or dislocation at time of injury – WAD Grade IV; nerve root compromise; and spinal surgery in the past 12 months. This study will utilise Multiple Baseline Single Subject Experimental Design with three phases: a 5, 8 or 11 week baseline period; a 16-week intervention comprised of 12 one hour sessions; and a 5-week no intervention withdraw. Primary outcome measures will be collected weekly during the baseline data collection period, fortnightly during the intervention period, and weekly during the follow-up period. Secondary outcome measures will be collected at the following time-points: week 1 of the baseline period; at the conclusion of the baseline period; at the midpoint of the intervention; at the end point of the intervention; and at the end of the follow-up period. Data collection will be completed by a researcher independent of the intervention delivery. 1. Vernon & Moir. The neck disability index: a study of reliability and validity. J Manip Physiol Ther, 1991. 14(7), 409-415.
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LIFE Study: Liver transplant recipient Initiative: Feasibility study to Enhance cardio-metabolic health
Expand descriptionWe are studying ways to improve the health of people after their liver transplant. We want to develop better ways to improve the cardio-metabolic health after liver transplant so that patients can avoid developing common conditions like obesity, diabetes and heart problems. The aim of this study is to find out if using telehealth technology (web-based appointments and educational videos) is useful to support patients in healthy eating and exercising in a way that can improve overall cardio-metabolic health after liver transplant. The information gathered from this study will be used to improve liver transplant services, and assist in developing better long term access to services that can be made available through technology.
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An imaging study of 64Cu-SARTATE using positron emission tomography in paediatric patients with high-risk neuroblastoma.
Expand descriptionThe aim of this project is to investigate if a novel tracer called 64Cu-SARTATE can be used to help accurately image neuroblastoma on PET/CT in pediatric patients. Who is it for? Paediatric patients aged 16 years or less diagnosed with high-risk neuroblastoma and life expectancy of 12 weeks or more are eligible for this study. Study details Eligible patients will be administered a single dose of 64Cu-SARTATE and undergo whole body PET scans at 4hrs & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & the visit 3 (day 8). Three blinded assessors will compare the new scans to the standard of care imaging to determine if they are superior. We hope that by testing this investigational product in paediatric patients, we can confirm that the biodistribution of 64Cu-SARTATE will facilitate specific and more sensitive identification of malignant tissues using PET/CT scanning. It is hoped that this method can then be translated into everyday clinical care.
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A Single-Center, Open-Label Pharmacokinetic (PK) Study to Assess the PK Profile of Nicotine Delivered by the Chrono Quit Smoking Solution (CQSS2)
Expand descriptionThis study is a Phase 2, open-label, PK study to assess the PK profile of nicotine over a 30 hour period in healthy Caucasian male volunteers who are smokers, using the Chrono Quit Smoking Solution (CQSS2) system. All subjects will receive the CQSS2. A strap (i.e., Comfort Band) will be the primary method used to attach the CQSS2 to the body. Subjects will be randomized in a 1:1 ratio to wear the CQSS2 in one of two application site locations, the upper arm (n = 5) or mid thigh (n = 5), for approximately 30 hours. Application site location, safety, and tolerability will be evaluated.
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Reducing the Use of Sedative medication in aged care facilities: Implementation of the ‘RedUSe’ project into everyday practice.
Expand descriptionFor over thirty years research has consistently shown that the use of sedatives (predominantly antipsychotic and benzodiazepine medication) in many residential aged care facilities (RACFs) is excessively high. These agents only offer modest effects, yet are associated with significant adverse effects such as falls, confusion and daytime drowsiness, and they increase the risk of stroke and death. Many strategies have been adopted to reduce sedative prescribing in aged care. The most effective interventions involve audit and feedback, health practitioner training and medication review. Combinations of these strategies appear to offer the most success. The strategies of audit cycles, nursing staff training and ACF medication review are currently promoted and funded by the Australian government; however, there has been limited training for pharmacists to effectively deliver them. Further, there are no coordinated audit/training/medication review packages that specifically target sedative prescribing. The initial ‘Reducing the Use of Sedatives’ (RedUSe) project was a 6-month controlled trial conducted in 25 Tasmanian ACFs during 2008/2009. RedUSe was pharmacy-led and involved a computerised clinical audit of sedative use. This information was then presented to each facility alongside an educational session on the appropriate use of these medications. The final component of the RedUSe project was a dedicated sedative review process which involved nursing staff, the GP and the reviewing pharmacist. The initial RedUSe project resulted in a significant decrease in the utilisation of sedative medication, an overall reduction in sedative doses used and the project was well received by participants. This study involves a significant expansion of the RedUSe project to a national sample of 150 RACFs, and is funded by the Australian Government as part of the second round of the ‘the Aged Care Service Improvement and Healthy Ageing’ grants fund. In this expanded RedUSe project the same format of sedative audit and feedback, an educational program for ACF nurses and carers, and a dedicated interdisciplinary sedative review will be followed. The overall RedUSe program will be enhanced by the involvement of collaborators; the National Prescribing Service MedicineWise, and the Pharmaceutical Society of Australia. The ultimate benefits for residents in ACFs following successful reduction in rates of sedative use should include increased mobility and alertness, decreased fall rate and an enhanced quality of life. Other interventions have also shown an increase in the level of staff satisfaction when sedative use is minimalised and we aim to evaluate these outcomes in the expanded RedUSe project.
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The Description of Lung Ultrasound From Initial Neonatal Transition in Very Preterm Infants
Expand descriptionThe aim of this prospective, non-randomised, observational study is to characterise changes in lung ultrasound images from birth in preterm infants born at less than 29 weeks. We believe that lung ultrasound images obtained in the delivery room, in the first 20 minutes after birth, may be able to predict the level of respiratory support babies born at less than 29 weeks gestation will receive in the first 72 hours after birth. This will be a single centre observational study at the Royal Women’s Hospital. We plan to obtain serial lung ultrasound images in premature infants born at less than 29 weeks starting with in the delivery room in order to investigate if early lung ultrasound can predict the level of respiratory support the infant will need in the first 72 hours after birth. We plan to obtain 3 second lung ultrasound video clips of the right and left side of the chest between birth and 10 minutes after birth, between 10-20 minutes after birth, at 1-3 hours after birth (after being stabilized in the NICU) and at 24-48 hours after birth. Additionally, if the baby is intubated for surfactant delivery, we plan to obtain images immediately prior to surfactant delivery and after surfactant delivery (targeting 30 minutes to 3 hours depending timing of cares and infant wellbeing) and immediately prior to the first extubation attempt as well as after extubation (targeting 30 minutes to 3 hours depending on timing with cares and infant wellbeing). Lung ultrasound examinations are brief, requiring minimal handling and less than 1 minute of patient contact to obtain the two images for each exam. Images can be obtained with the patient in either supine or prone position. Each lung ultrasound exam (birth to 10 minutes, 10-20 minutes, 1-3 hours after birth, at 24-48 hours, and if intubated, pre and post surfactant administration and pre and post the first extubation attempt) will only be performed after discussion with the treating clinician or bedside nurse.
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Pilot study to assess the feasibility of hospital alcohol screening and brief intervention with referral to general practice
Expand descriptionBackground: Both ‘at-risk’ and clinical levels (abuse/dependence) of alcohol use are major causes of morbidity and mortality in Australia and are involved in many hospital presentations. However, few hospitals have instigated routine screening and brief interventions with referral to treatment (SBIRT), an approach that has been widely recommended. Objectives: To investigate the effectiveness of SBI with referral to general practicians (GP) in an Australian setting. Design: Eligible participants will be randomised to either 1) SBI with referral to their GP, or 2) SBI with no GP referral. Outcomes: Primary outcomes relate to measures of feasibility and implementation. The secondary outcomes related to changes in alcohol use and the tertiary outcomes will assess change is the use of hospital services. (Additional time and funds are required to evaluate tertiary outcomes via the WA Data Linkage System.) Participants: All people aged 18 or older entering the Fiona Stanley Hospital emergency short stay unit (ESSU) are eligible for screening (with the AUDIT-C). Those classified as ‘at-risk’ with receive a BI. Those classified as high-risk will receive a BI plus intervention by the hospital alcohol and other drug team. Those who consent will then be randomised. Sample size: Target sample per group 291. (Note we estimate that 146 will not have a GP and thus cannot be randomised). Follow-up: Telephone interviews will be conducted at 1 and 3 months to collect information on change in alcohol consumption and attendance at a GP for alcohol related treatment. At 6 months, data on FSH events (ED and admissions) will be extracted from the hospital databases including Bossnet, EDIS, Webpas. Analysis: The main analyses are descriptive. However, we will use multi-level mixed effect models to assess the interaction term of study group (GP referral vs no referral) by time (6 months pre vs 6 months post) for change in rate of presentations. We also plan two sub-studies. Firstly, validation of self-reports of contact with GPs will be conducted in three groups. From the GP referral arm of the study we will randomly select from those who: 1) report no GP contact (estimate n=10), 2) report GP contact from the moderate risk participants (n=20) and, 3) report GP contact in the high risk group (n=10). At three months we will contact the nominated GP to confirm if the patient has been seen in the interim period and if any information or treatment was provided and obtain GP feedback on the referral process. This is included in the main HREC application but is not an outcome measure for the study. Secondly, feasibility will be tested at Rockingham General Hospital emergency department, where alcohol screening and brief intervention will be introduced without additional research support. A clinical audit will be used to document the proportion of patients screened and receiving appropriate brief intervention. This clinical audit process does not require HREC approva
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Protective Vaccine Responses in Infants after Maternal Pertussis Vaccination
Expand descriptionBordetella pertussis is bacteria infecting the respiratory tract and leading to a range of symptoms from mild cough, to clinically typical whooping cough, to death. Antibiotic treatment is ineffective after the cough develops, so prevention by effective vaccines is essential to protect the most vulnerable. Maternal pertussis (whooping cough) immunisation is an effective way of reducing severe disease in young infants. In Australia, vaccinating pregnant mothers with adult formulation diphtheria-tetanus-acellular pertussis vaccine (dTap) is recommended for every pregnancy with ~50% uptake. However, dTap is not licensed for use in pregnancy and in a number of countries it has been found that infants whose mothers received pertussis immunisation during pregnancy had lower antibody responses to their infant vaccinations, although they remain protected. It is not known how long maternal immunity lasts after immunisation in pregnancy or if repeated doses have any effect on infant vaccine responses. This study involving 400 mothers and babies (mother and infant pairs) will be conducted in Western Australian and New South Wales. It will evaluate maternal immunity and the effect of pertussis vaccination in pregnancy on infant antibody responses to the routine vaccinations given at 6 weeks and 4, 6, 12 and 18 months of age. Infants will have a blood sample at 6 to10 weeks of age prior to their routine infant vaccines, Infanrix-hexa (DTaP-IPB-HBV/Hib), Prevenar13 (PCV13) and rotavirus vaccine with subsequent doses at 4 and 6 months of age. Blood samples will also be taken at 7 months, 18 months and 19 months of age to measure antibody responses to pertussis antigens, diphtheria and tetanus toxoids, Haemophilus influenzae type b (Hib) and pneumococcal serotypes contained in PCV13. Responses will be compared between children whose mothers received a pertussis vaccine during pregnancy with those whose mothers were not vaccinated. We will also evaluate the frequency of local and generalised reactions to vaccination and the development of allergies, eczema and asthma. Infant participants will have a swab collected from the inside of their nose (nasal swab) at 7, 12 and 19 months of age Mother’s will have their blood collected to measure their antibody levels 6 weeks and 18 months after giving birth. Responses will be compared between mothers who received a pertussis vaccine during pregnancy with who were not vaccinated. We will also compare antibody responses between mothers who received their first pertussis immunisation during pregnancy with those who received their second or subsequent dose. This study will provide important information to inform providers, parents and national policy and will be relevant to other countries using maternal pertussis immunisation and potentially future vaccine development.