• Addressing Behaviours of Concern in the Bush: Sustainable evidence-based practice in rural and regional residential aged care
  
• A double-blind, dose-ranging study to determine the optimal dose of oral morphine or oxycodone needed to treat breakthrough pain for people  on regular opioid in the palliative care setting
• A prospective, randomised, placebo-controlled, double-blind, cross- over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea due to maximally treated primary pulmonary hypertension in opioid naive participants.
  
• A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction in people with advanced cancer.
  
• A randomised, double-blind placebo controlled study of subcutaneous ketamine in the management of cancer pain. 
• Cancer Trials Australia – OnLine: A tool for cancer patients to find open clinical trials and consider trial participation. 
• Can the needs of caregivers of patients with advanced cancer be met using a General Practice Caregiver Needs Toolkit?
  
• CareSearch palliative care knowledge network
• Finding the Evidence in Indigenous Health 
• Improving the welfare and end of life experience for residents, families and staff: A case conferencing approach for older people living with advanced dementia or mental illness.
  
• Palliative Care Clinical Studies Collaborative (PaCCSC) 
• Palliative Care for People with Dementia: building capacity in rural residential aged care facilities
  
• Palliative Care Curriculum for Undergraduates (PCC4U)
• Palliative Care Outcomes Collaboration (PCOC)
• Palliative Extended and Care at Home Packages
• Randomised control trial of oral risperidone, oral haloperidol, and oral placebo with rescue subcutaneous midazolam in the management of delirium in palliative care inpatients. 
• Systematic expansion of the clinical evidence base in opioid prescribing for refractory dyspnoea at the end of life.
• Using single patient trials to determine the effectiveness of psychostimulants in fatigue in advanced cancer patients.
  

Addressing Behaviours of Concern in the Bush: Sustainable evidence-based practice in rural and regional residential aged care.

To support residential aged care facilities improve the quality of care, the Australian government has developed a program to implement evidence-based practice – “Encouraging Best Practice in Residential Aged Care” (EBPRAC). With funding from this program, Dr Sam Davis is leading a consortium comprising McCarthy Psychology Services (RTO), Bendigo-Loddon Primary Care Partnership, a Multi-purpose Service and ten residential aged care facilities (RACFs) in seven locations across rural northwest Victoria, to implement evidence-based best practice non-pharmacological behaviour assessment and management based on the creation of dementia friendly physical and social environments. This work is funded for 24 months and is to be completed by December 2010.

Implementation strategies will recognise that steps to assess and respond to behaviours of concern are most productive when undertaken in environments that acknowledge the influence of the organisational culture, the residents’ life and social history, family supports, staff skills and the environment and care practices. Therefore, the Rural consortium activities will include:

• assessing current practice;
• identifying barriers to and facilitators of quality dementia care;
• promoting organisational engagement in improved behaviour management;
• providing education and training;
• providing on-site practice support, and 
• undertaking an evaluation of effectiveness.

The all inclusive approach means that management, staff, family and residents will be involved across the spectrum of consortium activities. Other consortium members will provide a wide range of expertise, support and assistance to ensure that RACFs can achieve positive, sustainable improvements to care. Audits of relevant policy, observations, surveys, education in small groups, RACF designated staff on-site support, specialist consortium on-site individual training and practice support and environmental audits are some of the activities that will contribute to the development of dementia friendly environments to address behaviours of concern.

Consortium activities will produce educational resources, training materials, policy and procedural documentation and support tools that will become a kit for ongoing use and as a resource to guide the implementation in other aged care facilities across Australia.

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A double-blind, dose-ranging study to determine the optimal dose of oral morphine or oxycodone needed to treat breakthrough pain for people  on regular opioid in the palliative care setting.

People who take regular strong pain relieving medications such as morphine or oxycodone (opioids) to treat pain frequently experience episodes of pain between their regular doses of medication. This is called breakthrough pain. Usually, extra doses of morphine or oxycodone are prescribed to treat this pain. These doses are usually a short acting form of the regular medication. The challenge for doctors is to decide how to determine the ideal dose of these medications in order to maximise pain relief and minimise side effects. The dose is determined by calculating the total daily dose of regular medication taken by the participant, and then prescribing a fraction of this dose. Some doctors prescribe a dose of 1/6th of the total daily dose, while others prescribe 1/8th or 1/12th.. There is currently no published literature based on research to guide doctors as to which dose, if any, is best to prescribe. The aim of this study is to determine the breakthrough dose of the commonly used opioids (morphine or oxycodone) that best help breakthrough pain and causes the least side effects.

The study will ask the participants to take 6 doses of opioids (2 each of 1/12, 1/8 and 1/6 of the total daily dose of opioid) as a breakthrough for the first breakthrough dose of medication taken on any 6 days in a 28 day period. The participant will know that they will take a dose of medication each time, but will not know which specific dose is being taken. Participants will be encouraged to take these extra doses of medications as they normally would. For the rest of the day, participants would take their normal breakthrough medications as prescribed by their doctor. Participants will be asked to complete a pain information form after taking each dose of the study medication and to keep a simple daily diary noting their pain, the medications taken and the pain relief obtained. The participant will finish the study when all 6 doses have been taken or when 28 days have elapsed. Study contact will include a 2 day run-in period using the twice daily diary, and then a weekly visit by the study nurse and a mid-week phone call. Objectives: To improve the evidence base for pain management in clinical practice by defining the optimal dose of breakthrough opioid, based on background analgesia, by identifying the dose that produces rapid and effective analgesia with the fewest side effects and to better understand the side-effect profile of immediate release opioids in the setting of breakthrough pain.

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A prospective, randomised, placebo-controlled, double-blind, cross- over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea due to maximally treated primary pulmonary hypertension in opioid naive participants.

A prospective, randomised, placebo-controlled, double-blind, cross- over study of the efficacy of sustained-release low dose morphine in the subjective sensation of dyspnoea due to maximally treated primary pulmonary hypertension in opioid naive participants.

Dyspnoea is a source of physical and psychological distress. By definition, people with severe primary pulmonary hypertension have breathlessness despite maximal therapy with new therapies for primary pulmonary hypertension. Opioids have been studied for the relief of breathlessness predominantly in people with chronic obstructive pulmonary disease although people with cancer and heart failure have been included.

This study specifically studies people with primary pulmonary hypertension for whom breathlessness is a significant symptomatic problem, to establish whether there is benefit from sustained release morphine, and if so, what magnitude of benefit, and the clinical characteristics of those who are most likely to respond to this intervention.

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A randomised double blind placebo controlled trial of infusional subcutaneous octreotide in the management of malignant bowel obstruction in people with advanced cancer.

Bowel obstruction in the setting of advanced cancer is frequently encountered however there is limited evidence in the understanding of the pathophysiological processes involved and no adequately powered randomised evidence to guide pharmaco-therapeutic options to minimise gastrointestinal secretions and reduce the frequency and volume of vomiting and reduce pain, especially colicky pain caused by continuing peristalsis.

Current management options include combinations of surgery where this is clinically feasible, nil by mouth, nasogastric decompression or continuous suction, analgesia (opioids, anti-spasmotics), and medications that reduce sectretions. None of these interventions have been the subject of an adequately powered study to determine the net clinical benefit, and more aggressive interventions such as surgery may not be technically possible or best practice for someone close to the end of life.
Octreotide is a somatostatin analogue that has specific effects including the potential to inhibit the release of vasoactive intestinal peptide, gastrin, secretin, motilin and other peptide hormones. Three placebo controlled double-blind RCTs of octreotide for malignant bowel obstruction all showed a benefit favouring the use of octreotide. Other published data have been from small, underpowered studies with significant methodological limitations. Additional data are required to further define the efficacy of octreotide in the treatment of bowel obstruction in the palliative care setting. Octreotide is currently not approved for use for this indication despite widespread clinical use.

A phase III randomised, double blind, placebo controlled trial of octreotide delivered by subcutaneous infusion used in conjunction with bolus daily parenteral (subcutaneous or intravenous) dexamethasone, ranitidine by subcutaneous infusion and parenteral hydration (10mls/kg/24hours) over a maximum of 72 hours is proposed. Hospital in-patients >18 years of age with a bowel obstruction with vomiting that precipitates a hospital admission or change in clinical care while in hospital will be included.

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A randomised, double-blind placebo controlled study of subcutaneous ketamine in the management of cancer pain

Ketamine is a parenteral general anaesthetic agent, indicated for the induction and maintenance of anaesthesia. Ketamine at low or sub anaesthetic doses has been used for the provision of analgesia in a wide range of clinical situations and also as an adjuvant medication with analgesics, particularly opioids. The evidence available through a wide range of clinical audits and case reports supports a role for low dose ketamine in the management of refractory or neuropathic pain. The published evidence to date is generally of low level however and is subject to bias. It is apparent that additional clinical studies would be necessary to support a palliative care indication for access to ketamine on the Pharmaceutical Benefits Scheme. This study will assess the benefits of ketamine within the context of a randomised controlled trial.

A phase III randomised, double blind, placebo controlled trial of ketamine delivered by subcutaneous infusion over a maximum of 5 days. Hospital in-patients >18 years of age with chronic pain secondary to cancer and/or its treatment with a Brief Pain Inventory average pain score of ≥3 despite adequate treatment with opioids and co-analgesics for at least 5 days will be included.

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Cancer Trials Australia – OnLine: A tool for cancer patients to find open clinical trials and consider trial participation.

The internet is commonly used by cancer consumers to access information. There has been a growing need in Australia to provide a website which contains consumer friendly information about cancer clinical trials. Such sites already exist worldwide with the best known examples being the National Cancer Institute website from the United States www.cancer.gov and the Cancer Research United Kingdom website www.cancerhelp.uk . In Australia most trials are registered with the Australian New Zealand Clinical Trials Registry (ANZCTR). This is an ideal source of data for an Australian consumer website, which will be called Australian Cancer Trials Online.

The initial stage of the project was to build a website interface with the ANZCTR about cancer clinical trials. The aims of the Australian Cancer Trials Online website are to:

a)    Enable consumers and doctors to easily search for cancer clinical trials that are open (recruiting),

b)    Provide information about these trials (eg cancer type, extent, treatments being tested) and

c)    Provide a decision support tool to help cancer consumers consider the pros and cons of clinical trial participation, and with their doctor, decide whether to join a clinical trial.

The next stage of the project is to evaluate the impact of use of the Australian Cancer Trials Online website and decision support tool, using a cluster randomised controlled trial on:

a)    Discussions between doctors and patients about possible participation in clinical trials,

b)    The numbers of patients who are invited to participate in a trial and the numbers of patients who ultimately enrol in a clinical trial and the

c)    Quality of consumers' understanding of the pros and cons of clinical trial participation and quality of decision making about whether to join a clinical trial.

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Can the needs of caregivers of patients with advanced cancer be met using a General Practice Caregiver Needs Toolkit?

During advanced cancer, health professionals and family members focus primarily on the patients’ needs. Most wish to die at home, which largely depends on the family caregiver’s capacity to manage as the patient approaches death. Caregivers’ own needs often receive little attention in the face of overwhelming patient needs. This project will develop and evaluate a General Practitioner (GP) Caregiver Needs Toolkit to enable caregivers’ needs to be systematically identified and met in a general practice setting. The Toolkit will include: an evidence based review of caregiver needs, a brief Caregiver Needs Assessment Tool that can be completed by caregivers or with their GP’s help to identify their levels of unmet informational, practical, health, relational and spiritual needs and to communicate these to their GP; and a full manual and ready reference of resources to help GPs to develop care plans to meet those needs. These resources are being developed and pilot-tested in Phase 1 to ensure they are suitable and acceptable to GPs and caregivers. In Phase 2, a randomised controlled trial will evaluate the extent to which caregiver needs are better met with the systematic use of the Toolkit compared to current usual care. Evidence-based academic detailing methods will be used to train GPs whose caregiving patients are allocated to receive the intervention. Members of the research team have already developed Palliative Care Needs Assessment Guidelines and a Palliative Care Needs Assessment Tool for health professionals to identify and address patient needs. The GP Caregiver Needs Toolkit will complement these resources and enhance caregivers’ access to more timely and needs-based care in the general practice setting. A strategy to disseminate the Toolkit nationally will be devised in Phase 3, if it is shown to improve caregiver outcomes.

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CareSearch palliative care knowledge network

CareSearch palliative care knowledge network (or more simply CareSearch) is a suite of palliative care information and resources available at www.caresearch.com.au. The website is designed to support health professionals involved in providing palliative care and those needing palliative care and their families and friends.

The project that created CareSearch palliative care knowledge network began in July 2006 and has been funded by the Australian Government as part of the National Palliative Care Program.

A series of concepts have driven the development of the CareSearch project:

• The role of evidence from creation to application, " the knowledge translation cycle"
• The multidisciplinary nature of palliative care
• The concept of a palliative care community, that is, both those providing palliative care and those affected by the need for palliative care
• Granularity, or the idea of the size and scale of components and their relationships within a system, that enables users to find and use specific information within a website

Quality processes to ensure trustworthiness and relevance of content
The project has an active research program in a number of areas relating to literature identification, eHealth literacy, knowledge translation and online resource development.

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Finding the Evidence in Indigenous Health

Being able find literature and evidence is an important part of providing the best possible health care. For Aboriginal and Torres Strait Islander people, being able to retrieve relevant information is important in building the knowledge base to support researchers, health workers and policy makers in improving care planning and provision. This study will provide pilot data relating to the issues and difficulties of searching in this field. 

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Improving the welfare and end of life experience for residents, families and staff: A case conferencing approach for older people living with advanced dementia or mental illness.

This project seeks to implement and evaluate a systematic case conferencing  model of intervention to improve the care and quality of life for people with advanced dementia and other mental illnesses in residential aged care facilities (RACF). Case conferencing is a framework to combine systematic multidisciplinary assessment, planning and desired outcomes informed by the individual's advance care plan. This collaborative, interdisciplinary multi-centred project: increase general practitioner (GP) involvement with the persons' family; and introducing an integrated approach to advance care planning. Systematic steps in this process will involve: integrating specialist palliative care and specialist aged care psychiatry involvement where appropriate in RACF; facilitating care communicating and coordination; increasing uptake of symptom management strategies and decreasing unnecessary hospitalisations; and facilitating transitions in care if hospital admissions are necessary (communicating care planning to new care environment using a standardised protocol). 

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Palliative Care Clinical Studies Collaborative (PaCCSC)

The Palliative Care Clinical Studies Collaborative (PaCCSC) is a research group that consists of a Coordinating Agency (Flinders University), a governance structure including a Management Advisory Board (MAB), and a number of organisations that will be collaboratively involved in Phase 3 and Phase 4 clinical medication studies.

Phase 3 clinical studies will verify the effectiveness of individual medication in symptom management for palliative care patients, and Phase 4 (or pharmacovigilance studies) will provide additional data on the benefit to risk balance for individual medication including the use of medication in a normal clinical setting and in comparison with current practice.

The aims of the PaCCSC are to:

• develop an efficient and effective method of generating research data that will support the listing of palliative care medicines on the ARTG;
• to build the research capacity of the palliative care sector so that ongoing clinical medication studies can occur; and
• to build the evidence base to support the ongoing implementation of studies on medicine use and quality practice in palliative care.

Palliative Care Curriculum for Undergraduates (PCC4U)

The PCC4U Project is an initiative of the Department of Health and Ageing through the National Palliative Care Program that aims to promote inclusion of palliative care education as an integral part of all medical, nursing and allied health undergraduate training.

• The first stage of this project developed resources to enable palliative care approaches and techniques to be incorporated into medical, nursing and allied health undergraduate curriculum
• The second stage provided national support to several tertiary institutions to implement and promote the use of the following palliative care undergraduate curriculum resources
• The third stage involves the national roll-out of the developed resources to all universities which offer medical, nursing and allied health undergraduate training.

The PCC4U Implementation Project is being led by a multidisciplinary team of nursing, medical and allied health professionals from the Queensland University of Technology, Flinders University, Charles Darwin University and the Centre for Palliative Care Research and Education.

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Palliative Care for People with Dementia: building capacity in rural residential aged care facilities

The project will develop and trial a unique interactive e-resource specifically designed for rural and remote residential aged care facilities to educate staff on how to recognise when a person with dementia may need palliative care and ways in which to provide it. The lessons learned from the trial of both small group and individual learning experiences will provide valuable information for others to implement the training in-house with little or no additional resources. 

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Palliative Care Outcomes Collaboration (PCOC)

PCOC is a national, voluntary, quality initiative established to assist palliative care providers across Australia to improve practice and meet the ‘Australian National Standards for the Provision of Palliative Care’.

With funding from the Department of Health and Ageing, PCOC is supporting specialist palliative care services to collect an agreed set of data items to measure outcomes for palliative care, and to establish national benchmarking activities that will contribute to improving the quality of care for palliative care patients.

PCOC is a collaboration of 4 Australian universities, including Flinders University, led by a group from the Centre for Health Services Development at Wollongong University.

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Palliative Extended and Care at Home Packages - evaluation project

This project aims to evaluate individual care packages compared with usual care for complex and unstable symptom management and high care needs atients wishing to return home earlier from hospital or Palliative Care nits AND for those requiring high level End of Life Care who wish to remain at home. This may include patients who have cancer or non-cancer diagnoses. Care packages at home could include nursing, domestic support, and equipment provision as well as more expeditious access to Specialist Palliative Care MDT services and General Practitioners. The evaluation project will explore the net incremental effect on patients and caregivers outcomes and associated net incremental costs relative to usual care.

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Randomised control trial of oral risperidone, oral haloperidol, and oral placebo with rescue subcutaneous midazolam in the management of delirium in palliative care inpatients.

Delirium is prevalent in patients with advanced cancer and in the palliative care setting, and is associated with significant and distressing symptomatology and poor prognosis. Antipsychotics are considered by most clinicians as first line pharmacotherapeutic agents for delirium despite limited level 2 evidence for management of delirium in any health care setting, including palliative care. The few studies that exist explore post treatment efficacy in relation to total delirium score reduction, and do not guide management of target symptomatology. There has been no systematic evaluation of toxicity profile in relation to delirium management with typical or atypical antipsychotics, in particular extrapyramidal toxicity and degree of sedation. There is need for randomized control trial evidence of the efficacy of antipsychotics to control targeted delirium symptoms, and also to consider broader implications on caregiver and patient distress.

A randomised double blind placebo controlled phase III study to compare the effectiveness and toxicity of oral risperidone, oral haloperidol, and oral placebo with rescue subcutaneous midazolam in the management of palliative care patients with “Diagnostic and Statistical Manual of Mental Disorders – IV edition revised” (DSM IV – R) defined Delirium.

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Systematic expansion of the clinical evidence base in opioid prescribing for refractory dyspnoea at the end of life.

Evidence demonstrates that morphine is efficacious in the management of refractory dyspnoea in the palliative setting. We now need to determine:

• the minimum effective dose reflecting the net benefit that incorporates response balanced with any adverse effects; and
• whether the benefits reflected in short term use are maintained over the long term.

When these first two questions have been adequately answered, the next clinically relevant question is whether all opioids offer the same benefits as morphine for dyspnoea. Given that there are different opioid receptors targeted by different opioids, we cannot assume that different opioids provide the same benefit or side effect profile.  An equivalence study comparing the most commonly used opioids, morphine and oxycodone, is needed.

There are no good population prevalence data on symptomatic dyspnoea. Given the large number of life-limiting illnesses and co morbidities that can cause or contribute to truly refractory dyspnoea, it is imperative to understand the level of refractory dyspnoea that is prevalent in the community. Although palliative care services can reflect the level of dyspnoea of people referred, only 50% of people with life-limiting illnesses in Australia are referred to specialised palliative care services. Population-based methods are required to establish the true burden of refractory dyspnoea across the whole eligible population.

Currently no medication is registered nor subsidised for the relief of refractory dyspnoea. These data are needed if clinicians and industry are to support changes in registration and subsidy of opioids. Service planners need better data on the prevalence of dyspnoea if current evidence-based therapies are to be made available to all Australians who have dyspnoea affecting their day-to-day lives despite optimal therapy for the underlying causes.

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Using single patient trials to determine the effectiveness of psychostimulants in fatigue in advanced cancer patients.

Australia’s population is ageing. The proportion of people aged over 65 was 12.5% in 2001 and is estimated to rise to 25% by 2052 (4). It is estimated that 20% of deaths in Australia are caused by malignant disease each year. In advanced cancer, the prevalence of fatigue is very high at 60-90% and can be related to the treatment or the disease itself. The impact of fatigue on function (physical, mental, social and spiritual) and hence quality of life (QOL) is very significant for many palliative patients as well as their families/carers.  Any decrease in fatigue should provide a positive benefit for both patients and their families/carers’ QOL

Study design: Single patient (n-of-1) trials (SPTs) of methylphenidate (MPH) vs placebo as a treatment for fatigue, with a population estimate of the benefit following the combination of multiple SPTs.  Any patient meeting inclusion criteria will be asked to participate in a n of 1 trial (single patient trial) of methylphenidate as a treatment for fatigue.  Study drug will be discontinued if:

1. unacceptable toxicity
2. non-compliance with treatment or study procedures
3. development of any of the exclusion criteria during the trial.