ANZCTR search results

Tobacco remains a major cause of death in Australia & NZ, with 20,000 annual deaths. Approximately 300,000 smokers have elective surgery each year in Australia & NZ. Smoking increases anaesthetic and surgical risks; particularly respiratory complications and wound infections. Stopping smoking for >4 weeks before surgery significantly reduces these risks, but there is little data on the best ways to help patients quit before surgery. Many smokers make unassisted quit attempts prior to surgery but relapse is common so most arrive in hospital having smoked that day. The use of nicotine patches and engagement with telephone Quitlines significantly increase quitting success in community settings, but have been little studied in surgical populations. Despite strong evidence in their favour, few smokers having surgery use patches and fewer have Quitline contact. There are no studies looking at using these measures at the time patients go onto the surgical wait-list. More research is important because: (1)Stopping before surgery, especially >4-weeks reduces surgical & anaesthetic complications. (2)There is often a significant period of time on the surgical waiting list to allow such quit times to be achieved (3)Surgery is recognised as a teachable moment for behaviour change; a period in one’s life when there is reflection upon health behaviours and increased motivation for positive change. (4) A significant proportion of patients quitting before surgery remain a lifelong non-smoker. Given the large numbers of smokers having surgery each year, efforts to increase abstinence may be a significant public health benefit. This is health services research to evaluate if an offer of a stop-smoking program will increase quitting before surgery. Smokers of 10 or more cigarettes per day (nicotine dependent) will be offered a free 5-week course of free nicotine patches shortly after they go onto the waiting list. The 5-week nicotine patch supply will be mailed to patients in order to make their use as easy and convenient as possible; eliminating many of the barriers to use. Patients who were smokers at time of waiting list placement will be approached on their day of surgery by a data collector and asked for verbal consent for a short interview (<4-minutes). This will ask if they have quit smoking, or made quit attempts before surgery. For those that claim to have quit (>24 hours), we will ask for written permission to confirm this by exhaled carbon monoxide testing plus to make brief telephone contact at 3 and 6 months after surgery to see if they are still quit. A comparison group of patients who smoke will not have this quit package promoted or offered to them.

The aim of this study is to examine the efficacy of an infant and family health and wellbeing short-term message service (SMS) intervention in supporting expectant and new parents both birthing at partnered Queensland Hospitals. The intervention period will be for 48 weeks from recruitment date and involves the provision of relevant and timely information on positive parenting strategies, attachment and health behaviours and support networks via an SMS program. Participants will be recruited in the antenatal period via antenatal clinics in partnered hospitals in late 2015 (600 intervention; 600 control). This study will follow a mixed methods design involving qualitative and quantitative methodologies. The researchers aim to measure the effectiveness of the project by following a mixed methods design. Study procedures will involve face-to-face and web-based surveys pre-intervention and web based and telephone surveys for the last three data collection points in the evaluation, including post-intervention. Focus group interviews with a selection of participants post project intervention. This trial follows on from the Connecting2u (C2u) pilot project conducted with families delivering at Logan Hospital between March and October 2014 which indicated the effectiveness of text messages in supporting parental confidence. Phase Two includes the dissemination of text messages in the antenatal period as research has indicated the importance of early intervention before birth in regards to health and wellbeing of the parents and child.

Background: The KneeAlign 'Registered Trademark' is an accelerometer-based, electronic, portable device which was designed for use in navigational total knee arthroplasty. There is literature which supports its efficacy and safety in achieving satisfactory knee alignment following total knee arthroplasty. However, most studies on the device has come from the designer unit and further information gathered from independent operators will be important. Its potential benefit is in the area of navigated arthroplasty as it is less-bulky than current navigation equipment and may prove important in complex surgeries where navigation is most useful. The risks are minimal and may even protect the medullary canal (as this is invaded using conventional alignment guides). The patient receives the same implant by the same surgeon and this device is to be used solely as an aid in achieving accurate bony cuts during surgery. This study will compare conventional guides and the navigation device in question. The trial will be conducted in compliance with the protocol laid out, GCP and the ethics regulations. The study will look at patients who are undergoing routine total knee replacement for osteoarthritis (the most common reason for prosthetic replacement). Trial Objectives: To prospectively compare patient-reported outcome measures and radiological results between conventionally guided and accelerometer-based navigation in patients undergoing total knee replacement surgery. Specifically, we will compare pain and functional scores together with mechanical axes correction in both sagittal and coronal planes. trial will be a prospective, patient-blinded, randomised comparative study with the end-points being patient-reported outcome measures, radiological results and duration of surgery. Patient consent and ethical approval will be obtained prior to trial commencement. Clinical outcome measures would be assessed via the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome score (KOOS) questionnaires which are both validated patient reported outcome measures following knee arthroplasty. These questionnaires will be taken at the time of standard appointments (pre-surgery & 6 months). Radiological outcomes will be assessed via CT imaging studies pre and post op using the CT Perth Protocol (To assess for mechanical & anatomical alignment). Patients will be recruited at the time when a decision to proceed with a knee arthroplasty is made during consultation.

Restorative care to date has focused on physical and daily function but not considered social engagement and quality of life. This highlights the need to develop a restorative care program focusing on quality of life which specifically includes those with cognitive impairment. The significance of this research is that if we show that Lifeful is feasible we will apply for funding to conduct a well-powered randomized controlled trial. This larger trial will add to a growing body of literature on restorative residential aged care, and is timely given the increasing focus of the Australian Aged Care Quality Agency and Department of Health on quality of life. The pilot study aims are to examine: 1. To investigate the feasibility of a delivering and evaluating restorative care program (Lifeful), 2. To investigate staff behavior change and obstacles experienced in adhering to the program 3. To investigate the suitability of the outcome measures. The hypotheses are: 1. It will be feasible to deliver the Lifeful training program to at least 80% of staff working on study units and it will be feasible to recruit at least 80% of residents to participate in the evaluation of the program 2. Care staff will improve engagement with residents as demonstrated by the person-centred assessment tool, as reported in focus groups and through an audit of resident care plans and progress notes. 3. The outcome measures chosen will be suitable i.e. residents can answer the questions, there are no floor or ceiling effects, they capture the changes on outcomes reported by staff in focus groups

This study aims to investigate whether palm oil and cocoa butter that are high in saturated fat, but contains primarily monounsaturated fat in the sn-2 position of triglycerides, have similar effects on blood lipid profiles than monounsaturated fat olive oil in normal healthy Australian participants.

The project will explore the efficacy of an occupational therapy intervention in common use clinically with young children with autism, provided in the home to address a problematic behaviour indentified by the family. Two different interventions will be provided to each child in random order, one a sensory based intervention and the other is a relationship based intervention, Being Responsive. Ten participants will be included in a single case experimental design study, undergoing intervention and baseline phases over a 14 week period with daily behaviour ratings and parent stress levels monitored on a visual analogue scale. Each participant acts as their own comparison across phases. This study will help to understand the responses to each intervention. A follow up data collection will occur for two weeks, 6 months after the completion of the intervention. Intervention sessions will be audio recorded to allow for checking of the application of the intervention.

This proposal aims to use new technology to aid the management of women after gestational diabetes (GDM), to improve lifestyle behaviours and adherence to recommendations in the postpartum period. If successful, this model would support diabetes prevention programs for women following GDM, particularly those in remote or regional settings. This randomised controlled trial will recruit women during a GDM pregnancy, with the intervention being conducted in the 6 months postpartum. The intervention will include the use of interactive mobile phone messaging, the use of an activity monitor, supported by individual consultations with a health counsellor. Control subjects will receive standard care. The main outcomes to be analysed are the proportion of women meeting dietary and physical activity guidelines.

The primary purpose of our study is to determine whether home exercise programs delivered via an App have greater adherence rates than usual methods of prescription used by physiotherapists. We will conduct an assessor- blinded, randomised controlled trial, with a sample size of 80. Subjects will be deemed eligible for inclusion if they meet the following criteria: * have sustained an upper or lower limb fracture, injury or other musculoskeletal condition * have been prescribed a set of exercises for the next 4 weeks (or longer) by their treating physiotherapist * have been advised to complete their exercises at least 3 times per week * have access to a smart phone, tablet device or computer * are over 18 years of age and are able to provide informed consent * are willing to participate in the trial * are not expected to require surgery or be readmitted to hospital during the trial Subjects will be excluded if they: * are unlikely or unwilling to co-operate (e.g. serious medical condition, cognitive impairment, drug dependency, psychiatric illness, behavioural problems) * are scheduled to receive face- to- face physiotherapy for their condition or injury within the next 4 weeks * have limited English This trial will be undertaken in patients who have been prescribed a home exercise program by physiotherapists based on the orthopaedic ward or short stay surgical unit of Royal North Shore Hospital (RNSH); or from the outpatient department or hand therapy clinic of Royal North Shore Hospital (RNSH). Participants will be randomised to receive their home exercise program delivered via either the current paper-based method alone, or via our App with supplementary follow-up phone calls. The primary outcome will be self-rated exercise adherence in the first 4 weeks following prescription of exercises by a physiotherapist. The secondary outcomes will include functional status, degree of disability, perceptions of treatment effectiveness, satisfaction with healthcare service delivery and assessor-rated exercise adherence. Baseline assessments will be conducted just prior to randomisation by treating physiotherapists. Follow up assessments will be conducted 4 weeks after randomisation by a blinded assessor via telephone interview and online survey.

The project aims to develop a customised falls prevention plan in hospital settings using local data by improving staff knowledge and perceptions of falls prevention strategies and embedding improved clinical practice in participating wards of two metropolitan hospitals. This will inform a model that can be used to reduce the rates of falls, recurrent falls and injurious falls. The project will involve comprehensive collection and detailed analysis of specific local (geographic and demographic) data to determine the most appropriate evidence based interventions to be implemented at each particular site. The content of the specific interventions will be informed by the local context. The wards to be will be those nominated by each hospital. The initial phase will include a patient survey, a staff survey and data collection of historical and current falls prevention programmes and falls data. We will also collect information about the demographics of each ward, details on falls prevention activities have been or are being undertaken by the ward and which ones have been successful. We will then collect falls data for a 10 week period including number of falls and number of injurious falls per occupied bed days, circumstances and risk factors associated with each fall, and an environmental audit following each fall and of the ward in general. The data will be analysed to determine local patterns in falls predictors, risk factors and causes of falls. Interventions will be developed based on the findings of the analyses.

The purpose of this study is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo trademark Aortic Bioprosthesis, hereafter referred to as the ACURATE neo trademark, and ACURATE TF trademark Transfemoral Delivery System. The ACURATE neo trademark and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in study participants presenting with severe aortic valve stenosis. Note, the ACURATE neo trademark and its Transfemoral Delivery System has been CE Marked and approved for sale in Europe. This study protocol is being implemented in Australia and is equivalent to the post market clinical follow-up plan study protocol developed by Symetis post European certification.