Development of the Consumer Involvement & Engagement Toolkit: a digital resource to build capacity for undertaking patient-centred clinical trials in Australia.

OBJECTIVE: This manuscript describes the novel approach to developing a toolkit to support meaningful consumer involvement in clinical trials in Australia to help guide others in considering the development of similar resources.The toolkit aims to support greater consumer involvement in shaping how clinical research is prioritised, designed and conducted. Type of program or service: A working group of researchers, research organisations and consumers was established to co-develop the Consumer Involvement and Engagement Toolkit (the 'Toolkit'), a digital resource to guide researchers and organisations regarding consumer involvement in clinical trials. FINDINGS: A literature review and international scan of best practice revealed numerous resources outlining best practice for consumer involvement in clinical research and clear evidence of its impact and value. Through a novel content-sharing process, we were able to utilise these resources to develop a comprehensive Toolkit for researchers and research organisations that provides world-class guidance. LESSONS LEARNT: There is a growing movement to ensure consumer involvement in healthcare, including in clinical research. We discovered its proponents were willing to share their tools and resources to promote international consumer involvement. Although these international tools and resources needed adaptation to suit the Australian research environment, this was achievable with far less effort than developing them from scratch.

A snapshot of consumer engagement in clinical trials in Australia: results of a national survey of clinical trial networks and research organisations.

BACKGROUND: Little is known about the extent, perceptions or experiences of consumers involved in clinical trials across Australia. The purpose of this National study was to better understand the activity and perceptions of clinical trial networks (CTNs), research co-ordinating centres and their consumers, around consumer involvement in clinical trials. METHODS: CTNs and research co-ordinating centres who were members of the Australian Clinical Trials Alliance (ACTA), and consumers involved in the activities of these organisations, were invited to participate in online surveys. Surveys were completed between April and September 2018. RESULTS: 80 respondents completed the surveys in full: 25 of 34 CTNs, 5 from 15 research co-ordinating centres, and included research investigators of 13 active trials, 10 completed trials. There were 27 consumer respondents. Consumers were involved in clinical trial activities across 19/25 (76%) of CTNs and 3/5 (60%) of research co-ordinating centres. Consumers were involved at all stages of the trial cycle. Despite this, only 8/30 (27%) of research organisations provided specific training to their employees or members on consumer involvement in research, and most did not have a specific policy or process relating to conducting consumer involvement in clinical trials. At the organisation level, barriers to consumer involvement in clinical trials included being unsure how to involve consumers effectively and systematically, difficulty in accessing consumers or lack of infrastructure and resources. At the consumer level, barriers included limited understanding of their roles, a lack of resources and training. Enablers included education, training and funding for both the research sector and for consumers. Almost all consumer respondents (25/27; 92%) would recommend the consumer role to other potential consumers, stating it was a valuable experience that led to knowledge exchange and learning about the research process. CONCLUSIONS: Over the last few years, consumer involvement in clinical trials has increased in Australia, but the scope of involvement varies across different research organisations, and therapeutic areas. Consumer involvement in clinical trials is valued by most that do it, however, there are opportunities to further foster and strengthen ongoing partnerships, for example by providing practical advice for researchers on how to best engage and involve consumers.

Consumer involvement in clinical research (including clinical trials) is considered best practice in Australia, yet it is not yet standard practice. Before doing this research, we did not know the involvement, perceptions and experiences of researchers and consumers within research networks or organisations. Surveys were used to ask Australian Clinical Trials Alliance (ACTA) member organisations including their consumers, about how consumers are being involved in clinical trials. The surveys found that consumers are involved across many clinical trials conducted in Australia, and that their input is valued by researchers and research organisations. Sometimes researchers were uncertain on how to best involve consumers in the different aspects of clinical trials so their contribution was effective and added value. Consumers also expressed at times they were uncertain as to what was expected of them, and in some instances training would have been useful to help them engage more effectively. Support and training also needs to be more appropriate for people from different populations, ethnic backgrounds and cultures, including First Nations peoples. All agreed more resources, training and funding would be needed to support consumer involvement in clinical trials.

Barriers to employment of Australian cancer survivors living with geographic or socio-economic disadvantage: A qualitative study.

BACKGROUND: Opportunities for cancer survivors' employment can both reflect and perpetuate health inequities, as employment is an important social determinant of health. Socio-economic and geographic disadvantage is associated with greater difficulty finding work, but little is known about work needs of Australian cancer survivors living with disadvantage. OBJECTIVE: This study examined survivor and health-care professional (HCP) perspectives on barriers experienced by Australian cancer survivors experiencing disadvantage when attempting to remain at or return to work. METHOD: Focus groups and individual interviews were held with cancer survivors (N = 15) and oncology and primary HCPs (N = 41), focusing on communities at risk of disadvantage. Participants were asked about employment barriers and facilitators in general and in the context of disadvantage. Themes were identified using framework analysis. RESULTS: Geographic and socio-economic disadvantage resulted in specific individual- and system-level barriers. These related to distance from treatment and support services and limited availability and suitability of work for survivors living with geographic disadvantage, and limited availability, security, and flexibility of work and previous unemployment for survivors living with socio-economic disadvantage. Identified needs included system-level changes such as public and workplace-level education, legislative and policy changes, and better access to resources. CONCLUSIONS: Cancer survivors living with disadvantage experience limited access to flexible employment opportunities and resources, further perpetuating their disadvantage. Promotion of health equity for cancer survivors living with disadvantage requires systemic changes to support attempts to remain at/return to work. PATIENT OR PUBLIC CONTRIBUTION: This study included cancer survivors and HCPs as investigators, authors and participants.

General practice nurses and physicians and end of life: a systematic review of models of care.

BACKGROUND: General practitioners (GPs) and general practice nurses (GPNs) face increasing demands to provide palliative care (PC) or end-of-life care (EoLC) as the population ages. In order to maximise the impact of GPs and GPNs, the impact of different models of care that have been developed to support their practice of EoLC needs to be understood. OBJECTIVE: To examine published models of EoLC that incorporate or support GP and GPN practice, and their impact on patients, families and the health system. METHOD: Systematic literature review. Data included papers (2000 to 2017) sought from Medline, Psychinfo, Embase, Joanna Briggs Institute and Cochrane databases. RESULTS: From 6209 journal articles, 13 papers reported models of care supporting the GP and GPN's role in EoLC or PC practice. Services and guidelines for clinical issues have mixed impact on improving symptoms, but improved adherence to clinical guidelines. National Frameworks facilitated patients being able to die in their preferred place. A single specialist PC-GP case conference reduced hospitalisations, better maintained functional capacity and improved quality of life parameters in both patients with cancer and without cancer. No studies examined models of care aimed at supporting GPNs. CONCLUSIONS: Primary care practitioners have a natural role to play in EoLC, and most patient and health system outcomes are substantially improved with their involvement. Successful integrative models need to be tested, particularly in non-malignant diseases. Such models need to be explored further. More work is required on the role of GPNs and how to support them in this role.

Facilitators and barriers to general practitioner and general practice nurse participation in end-of-life care: systematic review.

BACKGROUND: General practitioners (GPs) and general practice nurses (GPNs) face increasing demands to provide palliative care (PC) or end-of-life care (EoLC) as the population ages. To enhance primary EoLC, the facilitators and barriers to their provision need to be understood. OBJECTIVE: To provide a comprehensive description of the facilitators and barriers to GP and GPN provision of PC or EoLC. METHOD: Systematic literature review. Data included papers (2000 to 2017) sought from Medline, PsycInfo, Embase, Joanna Briggs Institute and Cochrane databases. RESULTS: From 6209 journal articles, 62 reviewed papers reported the GP's and GPN's role in EoLC or PC practice. Six themes emerged: patient factors; personal GP factors; general practice factors; relational factors; co-ordination of care; availability of services. Four specific settings were identified: aged care facilities, out-of-hours care and resource-constrained settings (rural, and low-income and middle-income countries). Most GPs provide EoLC to some extent, with greater professional experience leading to increased comfort in performing this form of care. The organisation of primary care at practice, local and national level impose numerous structural barriers that impede more significant involvement. There are potential gaps in service provision where GPNs may provide significant input, but there is a paucity of studies describing GPN routine involvement in EoLC. CONCLUSIONS: While primary care practitioners have a natural role to play in EoLC, significant barriers exist to improved GP and GPN involvement in PC. More work is required on the role of GPNs.

General practice physicians' and nurses' self-reported multidisciplinary end-of-life care: a systematic review.

BACKGROUND: General practitioners (GPs) and general practice nurses (GPNs) face increasing demands to provide end-of-life care (EoLC) as the population ages. To enhance primary palliative care (PC), the care they provide needs to be understood to inform best practice models of care. OBJECTIVE: To provide a comprehensive description of the self-reported role and performance of GPs and GPNs in (1) specific medical/nursing roles, (2) communication, (3) care co-ordination, (4) access and out-of-hours care, and (5) multidisciplinary care. METHOD: Systematic literature review. Data included papers (2000 to 2017) sought from Medline, Psychinfo, Embase, Joanna Briggs Institute and Cochrane databases. RESULTS: From 6209 journal articles, 29 reviewed papers reported the GPs' and GPNs' role in EoLC or PC practice. GPs report a central role in symptom management, treatment withdrawal, non-malignant disease management and terminal sedation. Information provision included breaking bad news, prognosis and place of death. Psychosocial concerns were often addressed. Quality of communication depended on GP-patient relationships and GP skills. Challenges were unrealistic patient and family expectations, family conflict and lack of advance care planning. GPs often delayed end-of-life discussions until 3 months before death. Home visits were common, but less so for urban, female and part-time GPs. GPs co-ordinated care with secondary care, but in some cases parallel care occurred. Trust in, and availability of, the GP was critical for shared care. There was minimal reference to GPNs' roles. CONCLUSIONS: GPs play a critical role in palliative care. More work is required on the role of GPNs, case finding and models to promote shared care, home visits and out-of-hours services.

General practice palliative care: patient and carer expectations, advance care plans and place of death-a systematic review.

BACKGROUND: With an increasing ageing population in most countries, the role of general practitioners (GPs) and general practice nurses (GPNs) in providing optimal end of life (EoL) care is increasingly important. OBJECTIVE: To explore: (1) patient and carer expectations of the role of GPs and GPNs at EoL; (2) GPs' and GPNs' contribution to advance care planning (ACP) and (3) if primary care involvement allows people to die in the place of preference. METHOD: Systematic literature review. DATA SOURCES: Papers from 2000 to 2017 were sought from Medline, Psychinfo, Embase, Joanna Briggs Institute and Cochrane databases. RESULTS: From 6209 journal articles, 51 papers were relevant. Patients and carers expect their GPs to be competent in all aspects of palliative care. They valued easy access to their GP, a multidisciplinary approach to care and well-coordinated and informed care. They also wanted their care team to communicate openly, honestly and empathically, particularly as the patient deteriorated. ACP and the involvement of GPs were important factors which contributed to patients being cared for and dying in their preferred place. There was no reference to GPNs in any paper identified. CONCLUSIONS: Patients and carers prefer a holistic approach to care. This review shows that GPs have an important role in ACP and that their involvement facilitates dying in the place of preference. Proactive identification of people approaching EoL is likely to improve all aspects of care, including planning and communicating about EoL. More work outlining the role of GPNs in end of life care is required.

Systematic review of general practice end-of-life symptom control.

BACKGROUND: End of life care (EoLC) is a fundamental role of general practice, which will become more important as the population ages. It is essential that general practice's role and performance of at the end of life is understood in order to maximise the skills of the entire workforce. OBJECTIVE: To provide a comprehensive description of the role and performance of general practitioners (GPs) and general practice nurses (GPNs) in EoLC symptom control. METHOD: Systematic literature review of papers from 2000 to 2017 were sought from Medline, PsycINFO, Embase, Joanna Briggs Institute and Cochrane databases. RESULTS: From 6209 journal articles, 46 papers reported GP performance in symptom management. There was no reference to the performance of GPNs in any paper identified. Most GPs expressed confidence in identifying EoLC symptoms. However, they reported lack of confidence in providing EoLC at the beginning of their careers, and improvements with time in practice. They perceived emotional support as being the most important aspect of EoLC that they provide, but there were barriers to its provision. GPs felt most comfortable treating pain, and least confident with dyspnoea and depression. Observed pain management was sometimes not optimal. More formal training, particularly in the use of opioids was considered important to improve management of both pain and dyspnoea. CONCLUSIONS: It is essential that GPs receive regular education and training, and exposure to EoLC from an early stage in their careers to ensure skill and confidence. Research into the role of GPNs in symptom control needs to occur.

Shared care involving cancer specialists and primary care providers - What do cancer survivors want?

BACKGROUND: Cancer survivors are living longer, prompting greater focus on managing cancer as a chronic condition. Shared care between primary care providers (PCPs) and cancer specialists, involving explicit partnership in how care is communicated, could ensure effective transitions between services. However, little is known about cancer patients' and survivors' preferences regarding shared care. OBJECTIVE: To explore Australian cancer survivors' views on shared care: what cancer survivors need from shared care; enablers and barriers to advancing shared care; and what successful shared care looks like. SETTING AND PARTICIPANTS: Community forum held in Adelaide, Australia, in 2015 with 21 participants: 11 cancer survivors, 2 family caregivers, and 8 clinicians and researchers (members of PC4-Primary Care Collaborative Cancer Clinical Trials Group). INTERVENTION: Qualitative data from group discussion of the objectives. RESULTS: Participants stressed that successful shared care required patients being at the centre, ensuring accurate communication, ownership, and access to their medical records. PCPs were perceived to lack skills and confidence to lead complex cancer care. Patients expressed burden in being responsible for navigating information sharing and communication processes between health professionals and services. Effective shared care should include: shared electronic health records, key individuals as care coordinators; case conferences; shared decision making; preparing patients for self-management; building general practitioners' skills; and measuring outcomes. DISCUSSION AND CONCLUSIONS: There was clear support for shared care but a lack of good examples to help guide it for this population. Recognizing cancer as a chronic condition requires a shift in how care is provided to these patients.

The role of primary care in early detection and follow-up of cancer.

Primary care providers have important roles across the cancer continuum, from encouraging screening and accurate diagnosis to providing care during and after treatment for both the cancer and any comorbid conditions. Evidence shows that higher cancer screening participation rates are associated with greater involvement of primary care. Primary care providers are pivotal in reducing diagnostic delay, particularly in health systems that have long waiting times for outpatient diagnostic services. However, so-called fast-track systems designed to speed up hospital referrals are weakened by significant variation in their use by general practitioners (GPs), and affect the associated conversion and detection rates. Several randomized controlled trials have shown primary care-led follow-up care to be equivalent to hospital-led care in terms of patient wellbeing, recurrence rates and survival, and might be less costly. For primary care-led follow-up to be successful, appropriate guidelines must be incorporated, clear communication must be provided and specialist care must be accessible if required. Finally, models of long-term cancer follow-up are needed that provide holistic care and incorporate management of co-morbid conditions. We discuss all these aspects of primary care, focusing on the most common cancers managed at the GP office-breast, colorectal, prostate, lung and cervical cancers.