ANZCTR search results

The MOHMQuit trial aims to support maternity services to help women stop smoking in pregnancy. It comprises of an evidence-based intervention that includes smoking cessation support (SCS) training for maternity service leaders (leaders), and clinicians (midwives, obstetricians, Aboriginal health workers), and changes to the way SCS is recorded in the electronic medical records. It will be trialled at nine public maternity services in New South Wales (NSW). The MOHMQuit trial tests whether the intervention will increase (1) the number of women able to quit smoking in pregnancy (2) the amount of SCS offered to pregnant women who smoke (3) the amount of SCS clinicians report that they offer to women. The MOHMQuit trial also tests whether over time, pregnant women who smoke report increases in the SCS offered to them including (4) receiving advice on quitting smoking in pregnancy (5) being referred to a quitting program (e.g., NSW Quitline) (6) being given written self-help resources. The MQ trial will also test: (7) The cost-effectiveness of MOHMQuit using an economic evaluation. Finally, maternity service leaders will also be interviewed and complete questionnaires to assess how well the MOHMQuit trial has worked at each site.

Negative pressure wound therapy (NPWT) is a wound dressing system that provides sub-atmospheric pressure within a closed dressing. Evidence demonstrates that, when compared to standard treatment, the early application of NPWT to paediatric burns results in significant improvement in time to re-epithelialisation, with corresponding reduction sin the need for scar management and operating theatre time. Moreover, the total healthcare costs for treatment with NPWT were significantly lower (mean $903.69) per child when compared to standard silver dressings alone (mean $1,669.01). The demonstrated clinical and cost efficacy of NPWT calls for widespread implementation. Despite the demonstrated clinical efficacy and cost-effectiveness of NPWT, evidence-based guidelines for its incorporation into acute paediatric burn care have not yet been devised. We propose to facilitate the early implementation of NPWT into Emergency Department (ED) burn care practice to provide Australian children access to evidence-based treatment that may improve clinical outcomes and reduce healthcare costs. Partnering with Australia’s four major paediatric burns centres (The Children’s Hospital at Westmead, Perth Children’s Hospital, Queensland Children’s Hospital and Royal Children’s Hospital, Melbourne), we will co-design implementation strategies tailored to the complex acute burn care setting and evaluate the effectiveness of implementation. We hypothesise that the facilitated implementation will result in better adherence to early NPWT application in acute burn care settings (ED/burns centres). Leveraging previous, successful collaborations and international expertise of the CI team, results from this study will transform policy and practice to improve outcomes for Australian children.

Diabetic foot ulcer (DFU) is a common complication of diabetes with high rates for ulcer recurrence. We hypothesize that monthly Extracorporeal shockwave therapy (ESWT) and Electromagnetic stimulation therapy (EMST) will reduce the ulcer recurrence rates compared to the standard of care in a 12 month period.. We aim to test the hypothesis by determining the effect of monthly treatment on ulcer recurrence using Extracorporeal shockwave therapy (ESWT) and Electromagnetic stimulation therapy (EMST) along with standard of care and compared against standard of care in a 12 month randomized clinical trial.

Evidence suggests that fragmented REM sleep may serve as a likely mechanism by which insomnia increases the risk for PTSD. To test this, project ARISE examines the role of REM sleep in trauma recovery mechanisms in individuals with insomnia disorder. The study aims to: 1) examine the relationship between REM sleep and fear inhibition (extinction and safety signal recall) in insomnia disorder; and 2) test whether improving REM sleep through treatment of insomnia, subsequently improves measures of fear inhibition. This study will be the first to examine REM fragmentation as a potential mechanism underlying insomnia's contribution to PTSD. It will have potential significant implications for the prevention of PTSD, as well as other disorders characterised by impaired fear inhibition (i.e., most anxiety disorders), in populations at risk for trauma exposure (e.g., emergency service workers) and/or REM fragmentation (e.g., other sleep disorders, shift work etc.).

The research aims to help prevent anxiety and depression in children aged 9-12 years. We are looking for children who might already be experiencing some symptoms of anxiety or depression. Two programs will be compared: MBCT-C (mindfulness-based cognitive therapy for children) and CBT (cognitive behavioural therapy). MBCT-C is newer and showing promise. CBT is well-established. Both programs start out by helping children become more aware of links between thoughts, feelings, and behaviour, and aim to help children manage “big” feelings like anxiety. • CBT does this by teaching skills like problem solving, and learning to be brave, to build confidence. The style of CBT is like classroom teaching. • MBCT-C has mindfulness activities based around the 5 senses (smell, sound, taste, touch, and sight). Children are taught to spend more time paying attention to the present moment, which can help them to worry less, make wise choices, and better able to concentrate. Primary Aims *Test whether MBCT-C can be strengthened by adding a parent module *Establish the relative effectiveness of MBCT-C, including the parent module, compared to traditional CBT (with parent module) over a follow-up period of up to 15 months, for prevention of internalizing difficulties in children who are at-risk of anxiety and depression, within lower SES upper primary schools Hypotheses: *MBCT-C will be equivalent to CBT in reducing anxiety and depressive symptoms, from pre- to post-intervention *Exploratory research question: determine whether MBCT-C and CBT continue to be equivalent over an 15-month follow-up period (i.e. at 3, 6, 12, and 18-month follow up intervals)

Nurses have a critical role in preventing patient harm through proactive assessment and communication of clinical findings to the multidisciplinary team. Poor patient outcomes occur because of delayed detection and response to inpatient deterioration, falls, pressure injuries, and inadequate communication of clinical deterioration to the multidisciplinary team with an over-reliance on ‘medical rescue’ processes. The aim of the ACCELERATE Plus trial is to remotely facilitate and evaluate implementation of a new nurse-led model of care based on a core physical assessment and structured multidisciplinary communication to transform nursing practice. We hypothesise that this will reduce medical emergency team calls, unplanned Intensive Care Unit (ICU) admissions, pressure injuries and falls; and be cost-effective. The ACCELERATE Plus intervention requires nurses to: 1) Complete a core physical assessment for all allocated patients at the start of each nursing shift. 2) Perform a nurse-to-nurse and multidisciplinary team, structured patient and family centred bedside nursing handover using: ISBAR (Introduction, Identify, Situation, Background, Assessment / Actions, Recommendations / Readback); and CARE (Connect, Ask, Respond, Empathise). 3) ‘Speak up’ by communicating and escalating assessment finding concerns early to the multidisciplinary team using ISBAR. We will evaluate a ‘train the trainer’ implementation strategy to enable ‘upscale and spread’ using existing hospital personnel and resources. Evidence-based strategies will be used to implement the ACCELERATE Plus intervention, include: education; barriers and enabler analysis; use of multidisciplinary ward clinical champions, Executive support; external facilitation; and reminders. The research team will provide regular follow-up site support through emails, and telephone calls.

The aim of this study is to examine the influence of probiotic use on absenteeism due to illnesses such as gastrointestinal tract infections (GITIs), respiratory tract infections (RTIs), while also examining the physical and psychological development among children aged 2-5-years attending childcare centres in Victoria, Australia. The study is using Biome Daily kids as a probiotic intervention and placebo prepared in similar packaging by Biome Australia Trading Ltd. The study assumes that probiotic use will improve the immune system of the children and will support them to reach their optimum development.

The clinical trial is testing the use of a novel method to grow new tissue within the breast injecting fat tissue harvested from patient's own fat deposits. A scaffold implant acts as a resorbable frame to support this growth of cells. The scaffold will be resorbed within at least 3 years. The main assumption of this clinical trial is that the method used is safe and effective for treatment of women requiring a silicone implant and /or correction of breast defect and/or deformity. The other assumption is that this method is applicable to a wider range of tissue defects, such as breast reconstruction after breast tissue removal. The new method is called '3D printed scaffold-based soft tissue regeneration', and uses a combination of own fat cells (called adipocytes) with a 3D printed scaffold to support soft tissue regeneration using the natural healing processes in their body. This substance is resorbable and is similar to the substance used for sutures and stitches that are dissolvable or resorbable in the body. The substance used for the scaffold is already TGA approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the their own tissue in its place. The combination of scaffold implantation and their own fat cells is the novel method in this trial. Conventional liposuction techniques are used from another site on the patients body to harvest their fat cells.

Oral language development in the early years of school is a developmental measure that is strongly linked to a broad range of outcomes including literacy, social skills, friendships, prosocial problem solving and conflict resolution skills, self-esteem, school attachment and subsequently mental health. In addition, students who do not master the basics of literacy in the early years of school struggle academically and may face a range of behavioural, social, vocational, and social-emotional difficulties into adolescence and adulthood. Focused efforts to improve oral language skills in the early years of school should lead to gains in literacy skills, social and emotional wellbeing, and academic trajectories. The single most important ’in-school’ factor impacting on student outcomes is the quality of teaching. Therefore, to improve oral language skills for children and confer the benefits for child social development and mental health, there needs to a paralleled improved quality of teaching. Response to intervention (RTI) is a model that can provide universal access to high quality classroom instruction in language and reading for all students, while providing intensive intervention for those students identified as at-risk (i.e. the intensity is proportional to the needs of individual students). The aim of this study is to use a RTI approach to improve oral language and reading instruction targeted to the early years of school, with a focus on: - Tier 1, addressing the whole of class, universal provision of quality instruction; and - Tier 2 interventions, addressing the needs of students most at-risk regarding their language and reading progress. This study is not designed to test the effectiveness of each component of the intervention separately. Rather, we propose testing the processes and impact of implementation of an intervention system in the ‘real world’ and how that can improve oral language competency. The mixed methods research design will innovatively combine: (1) a staged roll-out to determine impact, (2) a detailed implementation methodology to ensure that the interventions are implemented and sustained within a school system over time, and (3) qualitative data to investigate the barriers and facilitators to success.

This project addresses a significant unmet need: recovery of arm and hand function in people with tetraplegia (loss of use of the arms and legs). This issue is ranked by survivors as being of the highest importance, more important than the ability to walk. A novel non-invasive method of spinal cord stimulation (transcutaneous spinal cord neuromodulation – TESCoN) will be trialled for the first time in Australia, and in both subacute and chronic tetraplegia. Electrodes on the skin at the back of the neck will deliver a unique form of stimulation to the spinal cord without causing discomfort. This will modulate (alter the activity of) spared but non-functional pathways as well as the spinal circuitry below the injury level. When combined with intensive rehabilitation of the arm and hand, TESCoN leads to altered connections within the spinal cord, resulting in improved function. TESCoN enhances the effect of intensive rehabilitation and is not a replacement for it. This study will be an open-label trial using an adaptive design, with a combined efficacy and safety endpoint and clear rules for stopping the trial if the intervention is shown to be ineffective and/or unsafe. TESCoN is expected to lead to improvements in function that are superior to those obtained with current best practice rehabilitation. Such recovery of function may have a substantial impact on independence, potential for employment, and quality of life..