Evaluation of lived experience Peer Support intervention for mental health service consumers in Primary Care (PS-PC): study protocol for a stepped-wedge cluster randomised controlled trial.

BACKGROUND: The demand for mental health services in Australia is substantial and has grown beyond the capacity of the current workforce. As a result, it is currently difficult for many to access secondary healthcare providers. Within the secondary healthcare sector, however, peer workers who have lived experience of managing mental health conditions have been increasingly employed to intentionally use their journey of recovery in supporting others living with mental health conditions and their communities. Currently, the presence of peer workers in primary care has been limited, despite the potential benefits of providing supports in conjunction with GPs and secondary healthcare providers. METHODS: This stepped-wedge cluster randomised controlled trial (RCT) aims to evaluate a lived experience peer support intervention for accessing mental health care in primary care (PS-PC). Four medical practices across Australia will be randomly allocated to switch from control to intervention, until all practices are delivering the PS-PC intervention. The study will enrol 66 patients at each practice (total sample size of 264). Over a period of 3-4 months, 12 h of practical and emotional support provided by lived experience peer workers will be available to participants. Scale-based questionnaires will inform intervention efficacy in terms of mental health outcomes (e.g., self-efficacy) and other health outcomes (e.g., healthcare-related costs) over four time points. Other perspectives will be explored through scales completed by approximately 150 family members or carers (carer burden) and 16 peer workers (self-efficacy) pre- and post-intervention, and 20 medical practice staff members (attitudes toward peer workers) at the end of each study site's involvement in the intervention. Interviews (n = 60) and six focus groups held toward the end of each study site's involvement will further explore the views of participants, family members or carers, peer workers, and practice staff to better understand the efficacy and acceptability of the intervention. DISCUSSION: This mixed-methods, multi-centre, stepped-wedge controlled study will be the first to evaluate the implementation of peer workers in the primary care mental health care sector. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623001189617. Registered on 17 November 2023, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386715.

Capacity building for mental health services: methodology and lessons learned from the Partners in Recovery initiative.

BACKGROUND: The Partners in Recovery (PIR) program was implemented by the Australian Government Department of Health. Its overriding aim was to improve the coordination of services for people with severe and persistent mental illness, and who have complex needs that are not being met. The PIR capacity-building project (CBP) was funded to provide capacity building activities to the nationwide network of consortia that were set up in 2013 to deliver PIR over a 3-year period. The purpose of this paper is to describe the design and findings from an evaluation of the PIR CBP. METHODS: The evaluation involved collecting feedback from consenting PIR staff via an online survey and follow-up semi-structured interviews. CBP activities included: state and national meetings; a web portal; teleconferences; webinars; a support facilitator mentor program; and tailored support from the CBP team. RESULTS: The CBP made a positive contribution to the implementation and delivery of PIR. Staff highly valued activities that employed face-to-face interaction or provided informative knowledge exchange, and were appreciative of CBP staff being responsive and adaptable to their needs. CONCLUSIONS: From this evaluation, we recommend the following: identify relevant functions (e.g. prioritise networking), select the right mode of delivery (e.g. establish an online presence) and abide by key principles (e.g. be responsive to staff needs). This information is informing the mental health workforce capacity building activities that our team is currently undertaking.

National disability insurance scheme access: What evidence do you need to provide for psychosocial disability?

OBJECTIVES: The National Disability Insurance Scheme (NDIS) was introduced in 2013 and offered a new way of providing support to people with permanent and significant disabilities. Despite pilot testing, implementation of the scheme has been challenging, particularly for people with a disability arising from a mental health condition. In 2019, to address the challenge of accessing the NDIS, researchers from Flinders University worked with the National Disability Insurance Agency (NDIA) to develop a streamlined access process for psychosocial disability. The aim of this paper is to provide guidance on the evidence required to demonstrate that a person has a significant and persistent psychosocial disability to access the NDIS. CONCLUSION: Providing evidence for a psychosocial disability requires knowledge of how to address the disability requirements. The Evidence of Psychosocial Disability (EPD) form has been designed to address these requirements and offers guidance on the evidence that should be provided. A range of resources to accompany the EPD form are freely available online. These resources address a significant knowledge gap that currently exists with the implementation of the NDIS.

Promoting the consumer voice in palliative care: exploring the possibility of using consumer impact statements.

BACKGROUND: It can be difficult to engage consumers in health decision making. This is particularly so in the area of palliative care, where consumers are very unwell and are unlikely to become involved in long-term programmes that promote consumer input. This paper explores the possibility of using 'Consumer Impact Statements' to facilitate the inclusion of the viewpoint of people at the end of life in the process of policy and decision making, particularly in the area of subsidy of pharmaceuticals used in palliative care. SEARCH STRATEGY: A broad search was conducted to find information about the use of impact statements in any health field. The health literature and grey literature were searched to explore the use of Consumer Impact Statements to date. RESULTS: No papers were found describing the use of Consumer Impact Statements in the palliative care setting. Health impact assessment is used in the areas of environmental health and community health. Impact statements are less commonly used in other areas of health, especially policy development, and no formal description of a Consumer Impact Statement was found. DISCUSSION: There is considerable scope for developing the use of Consumer Impact Statements to promote the consumer viewpoint in health decision making, because it will allow people who are otherwise unlikely to contribute to the public debate to have their views heard by decision makers. CONCLUSION: The use of Consumer Impact Statements is particularly suited to palliative care, given that consumers are often otherwise unable to contribute to the public debate.

Delivery strategies to optimize resource utilization and performance status for patients with advanced life-limiting illness: results from the "palliative care trial" [ISRCTN 81117481].

CONTEXT: Evidence-based approaches are needed to improve the delivery of specialized palliative care. OBJECTIVES: The aim of this trial was to improve on current models of service provision. METHODS: This 2×2×2 factorial cluster randomized controlled trial was conducted at an Australian community-based palliative care service, allowing three simultaneous comparative effectiveness studies. Participating patients were newly referred adults, experiencing pain, and who were expected to live >48 hours. Patients enrolled with their general practitioners (GPs) and were randomized three times: 1) individualized interdisciplinary case conference including their GP vs. control, 2) educational outreach visiting for GPs about pain management vs. control, and 3) structured educational visiting for patients/caregivers about pain management vs. control. The control condition was current palliative care. Outcomes included Australia-modified Karnofsky Performance Status (AKPS) and pain from 60 days after randomization and hospitalizations. RESULTS: There were 461 participants: mean age 71 years, 50% male, 91% with cancer, median survival 179 days, and median baseline AKPS 60. Only 47% of individuals randomized to the case conferencing intervention received it; based on a priori-defined analyses, 32% of participants were included in final analyses. Case conferencing reduced hospitalizations by 26% (least squares means hospitalizations per patient: case conference 1.26 [SE 0.10] vs. control 1.70 [SE 0.13], P=0.0069) and better maintained performance status (AKPS case conferences 57.3 [SE 1.5] vs. control 51.7 [SE 2.3], P=0.0368). Among patients with declining function (AKPS <70), case conferencing and patient/caregiver education better maintained performance status (AKPS case conferences 55.0 [SE 2.1] vs. control 46.5 [SE 2.9], P=0.0143; patient/caregiver education 54.7 [SE 2.8] vs. control 46.8 [SE 2.1], P=0.0206). Pain was unchanged. GP education did not change outcomes. CONCLUSION: A single case conference added to current specialized community-based palliative care reduced hospitalizations and better maintained performance status. Comparatively, patient/caregiver education was less effective; GP education was not effective.

Off-label prescribing in palliative care - a cross-sectional national survey of palliative medicine doctors.

BACKGROUND: Regulatory bodies including the European Medicines Agency register medications (formulation, route of administration) for specific clinical indications. Once registered, prescription is at clinicians' discretion. Off-label use is beyond the registered use. While off-label prescribing may, at times, be appropriate, efficacy and toxicity data are often lacking. AIM: The aim of this study was to document off-label use policies (including disclosure and consent) in Australian palliative care units and current practices by palliative care clinicians. DESIGN: A national, cross-sectional survey was conducted online following an invitation letter. The survey asked clinicians their most frequent off-label medication/indication dyads and unit policies. Dyads were classified into unregistered, off-label and on-label, and for the latter, whether medications were nationally subsidised. SETTING/PARTICIPANTS: All Australian palliative medicine Fellows and advanced trainees. RESULTS: Overall, 105 clinicians responded (53% response rate). The majority did not have policies on off-label medications, and documented consent rarely. In all, 236 medication/indication dyads for 36 medications were noted: 45 dyads (19%) were for two unregistered medications, 118 dyads (50%) were for 26 off-label medications and 73 dyads (31%) were for 12 on-label medications. CONCLUSIONS: Off-label prescribing with its clinical, legal and ethical implications is common yet poorly recognised by clinicians. A distinction needs to be made between where quality evidence exists but registration has not been updated by the pharmaceutical sponsor and the evidence has not been generated. Further research is required to quantify any iatrogenic harm from off-label prescribing in palliative care.

Case conferences in palliative care - a substudy of a cluster randomised controlled trial.

BACKGROUND: In palliative care, case conferences have demonstrated improved maintenance of function and a significant reduction in hospitalisations. This study aimed to define the content and themes of palliative care case conferences. METHODS: This was a substudy of a cluster randomised controlled trial. Case conferences meeting the requirements for Medicare Benefits Schedule reimbursement were organised by the research officer in conjunction with the general practitioner and the participating palliative care service. All were audiotaped, coded and analysed for content and themes, using qualitative methods and interaction analysis. RESULTS: Seventeen case conferences were transcribed and coded. Physical issues were the dominant topic. Management of psychosocial concerns were rarely discussed. Lack of information was a common theme and time was spent during each conference ensuring all people were familiar with the issues and patient history. Healthcare professionals tended to respond to the content of patient concerns, but not the emotion. DISCUSSION: The discussions were complex and health professional participants rarely summarised information or checked that patients and carers had understood the information provided.

The role of ondansetron in the management of cholestatic or uremic pruritus--a systematic review.

CONTEXT: Pruritus associated with hepatic or renal failure can be a troublesome symptom, refractory to treatment and associated with significant physical and emotional distress and a reduction in quality of life for patients already burdened with chronic disease. Serotonin has been implicated as a possible pathological mediator, and, therefore, 5HT(3) antagonists have been suggested as a possible therapeutic intervention. OBJECTIVES: This review of the literature systematically explores the role of ondansetron in the management of cholestatic or uremic pruritus. METHODS: Electronic databases were systematically searched for randomized controlled trials examining the role of ondansetron in cholestatic or uremic pruritus between 1966 and 2008. RESULTS: Five randomized controlled trials were included in this systematic review: three for cholestatic pruritus and two for uremic pruritus. All trials examined ondansetron vs. placebo, with differing treatment protocols. Overall, three studies showed no benefit to ondansetron over placebo; however, two studies in cholestatic pruritus showed small reductions in pruritus with questionable clinical significance. CONCLUSION: Ondansetron was demonstrated to have negligible effect on cholestatic or uremic pruritus on the basis of a limited number of studies.

Palliative care case conferencing involving general practice: an argument for a facilitated standard process.

OBJECTIVE: To discuss the results of a qualitative analysis of the group dynamics of General Practitioner (GP)-led case conferences for palliative care patients, where the GP becomes the care coordinator. Two outcomes are sought: (1) raise the understanding of this type of case conferencing for palliative care patients; and (2) recommend improvements to this process that will positively affect its efficacy. METHODS: Original data is the qualitative component of quantitative and qualitative study of 17 GP-led case conferences for palliative care patients. Data were analysed using Carney's Ladder of Analytical Abstraction. RESULTS: Analysis produced four persistent themes: ambiguity of purpose; ambiguity of role; lack of information; and involvement of multiple interconnected and dynamic groups. These themes are a natural result of the case conferencing process that occurred during the study. CONCLUSION: Case conferences were inherently uncertain and complex. Complexity results from the range of people and groups interacting with the patient before the case conference who do not attend the conference. Uncertainty results from a lack of direction, leadership and agreed outcomes against which the conference can be structured and measured. A standard process facilitated by someone other than the GP and containing necessary information would offer a better chance of optimising this process.

Designing and conducting randomized controlled trials in palliative care: A summary of discussions from the 2010 clinical research forum of the Australian Palliative Care Clinical Studies Collaborative.

Rigorous clinical research in palliative care is challenging but achievable. Trial participants are likely to have deteriorating performance status, co-morbidities and progressive disease. It is difficult to recruit patients, and attrition unrelated to the intervention being trialled is high. The aim of this paper is to highlight practical considerations from a forum held to discuss these issues by active palliative care clinical researchers. To date, the Australian Palliative Care Clinical Studies Collaborative (PaCCSC) has randomized more than 500 participants across 12 sites in 8 Phase III studies. Insights from the 2010 clinical research forum of the PaCCSC are reported. All active Australian researchers in palliative care were invited to present their current research and address three specific questions: (1) What has worked well? (2) What didn't work well? and (3) How should the research be done differently next time? Fourteen studies were presented, including six double-blind, randomized, controlled, multi-site trials run by the PaCCSC. Key recommendations are reported, including guidance on design; methodologies; and strategies for maximizing recruitment and retention. These recommendations will help to inform future trial design and conduct in palliative care.

Palliative care clinical trials: how nurses are contributing to integrated, evidence-based care.

The aim of this paper is to describe the emerging role of the palliative care clinical trials nurse in an era of evidence-based practice and increasing clinical trial activity in palliative care settings across Australia. An overview of the current clinical trials work is provided, with a focus on three aspects of clinical trials nursing practice that have significant implications for patients: managing the consent process, integrating clinical trials into multidisciplinary care, and establishing and building the evidence base to inform practice in palliative care settings. Clinical trials roles provide palliative care nurses with an opportunity to contribute to clinical research, help expand palliative care's evidence base, and develop their own research capabilities.

Aggregating single patient (n-of-1) trials in populations where recruitment and retention was difficult: the case of palliative care.

Randomized controlled trials (RCTs) are the gold standard for evaluating new interventions. Different RCT designs apply depending on the patient population, clinical setting, and intervention being evaluated. A design that may help to generate evidence in some clinical areas where recruitment is a challenge is aggregated n-of-1 trials. N-of-1 trials are randomized, double-blind, and multiple crossover comparisons of an intervention and a control treatment. Methodologically robust n-of-1 trials provide an objective means of testing the effectiveness of treatments within individual participants. Aggregation of multiple cycle identically conducted n-of-1 trials yield a population estimate of effect, which potentially commensurate with that derived from other RCT designs. Trial participants contribute data for both intervention and control treatments creating matched data sets while using generally smaller sample sizes than conventional RCT trials. Careful choice of symptoms and medications are required for n-of-1 trials to be feasible. A validated and reliable outcome measure sensitive to change is still required. This article reviews the utility and limitations of aggregated n-of-1 trials to gather evidence in populations where conducting formal RCTs is difficult because of the low prevalence of the underlying condition or the clinical condition making recruitment and retention difficult. The article examines a proposed palliative care trial as a test case.

Planning phase III multi-site clinical trials in palliative care: the role of consecutive cohort audits to identify potential participant populations.

GOALS OF WORK: Multiple sites enable more successful completion of adequately powered phase III studies in palliative care. Audits of the frequency and distribution of the symptoms of interest can better inform research planning by determining realistic recruitment goals for each site. The proposed studies are to improve the evidence-base for registration and subsidy applications for frequently encountered symptoms where current pharmacological interventions are being used 'off-licence'. METHODS: Six services participated in a standardised, retrospective, consecutive cohort audit of five symptoms of their inpatient populations to inform the design of double blind randomised controlled phase III studies to which each site would recruit simultaneously. The audit covered all deaths in a 3-month period for people who were referred to a specialist palliative care service who had at least one inpatient admission between referral and death, regardless of when the person was referred to the service. The audits were based around inclusion and exclusion criteria for the proposed studies. MAIN RESULTS: Of the 468 people whose medical records were reviewed, potential study participant rates varied by symptom having accounted for general and specific inclusion and exclusion criteria: pain 17.7%; delirium 5.8%; anorexia 5.1%; bowel obstruction 2.8% and cholestatic itch 0%. For those people with a symptom of interest, it was noted at the beginning of the inpatient admission more than half the time. Of all inpatients, fewer than one third would be eligible to participate in at least one study. CONCLUSIONS: These data provide a baseline estimate of potential people to approach about clinical trials in supportive care but do not account for clinician 'gate-keeping', lack of interest in participating nor withdrawal from the study once initiated. The data are retrospective and therefore, limited by clinical documentation. The audit directly informed an increase in the number of participating sites.

Creating a research culture in a palliative care service environment: a qualitative study of the evolution of staff attitudes to research during a large longitudinal controlled trial (ISRCTN81117481).

This study investigated the impact of a three-year randomized control trial of different models of service provision on palliative care staff associated with the hospice where the trial was being conducted. Eleven open access de-identified qualitative focus groups were held over a period of three years: three months into the trial, one year after its inception, and at the end of the trial. Four staff groups were involved: inpatient hospice nurses, palliative care outreach nurses, medical palliative specialists, and administrative staff and social workers. Initially the impact of the trial produced high levels of staff stress which largely diminished over time, to be replaced by enthusiasm for the changes achieved and sadness that post trial the perceived benefits gained would be lost. When attempting to change a clinical culture to incorporate research, and in particular where increased staff workload is involved, highly interactive levels of communication and valuing of staff input are required to minimize the stress and burden of this imposition.

Multidisciplinary care planning and teamwork in primary care.

OBJECTIVE: To examine policy and implementation issues around multidisciplinary care planning (MDP) as a means of improving outcomes for patients with chronic disease and/or complex care needs. METHODS: We conducted a series of five systematic reviews of the literature from 1990 to 2006, sampling a spectrum of issues associated with chronic disease and complex health care needs, with a focus on planning and provision of multidisciplinary care. RESULTS: Our review showed that MDP does improve many functional outcomes in the areas studied. Analysis of MDP programs involves examination of two groups of variables - the multidisciplinary components (a range of clinical perspectives and specialist knowledge) and team components (eg, communication and support). Implementing MDP requires changing patterns of interaction between care providers, alignment of roles and work practices, and changes to organisational arrangements. CONCLUSION: While MDP improves many functional outcomes, widespread implementation of MDP in standard practice will require complex and targeted strategies. Devising and testing such strategies is a prerequisite for widespread, routine use of MPD in chronic disease management.

Promoting patient centred palliative care through case conferencing.

BACKGROUND: What are the characteristics of case conferences between general practitioners and specialised palliative care services (SPCS)? METHODS: Study participants were adults (N=461) with pain in the preceding 3 months who were referred to a SPCS and their GPs (N=230). Patients were randomised to case conferences or routine care by SPCS. RESULTS: One hundred and sixty-seven conferences were held; 46 patients withdrew and 142 died before the conference could be conducted. Medicare payment was requested for 72 (43%) conferences. Median time from randomisation to case conference was 52 days (SD: 55), and from case conference to death/end of study was 79 days (SD: 166). Twenty-five percent of conferences had over three health professionals participant; patients and/or their caregivers participated in 91%. Average conference duration was 39 minutes (SD: 13). Mean conference length did not increase when more health professionals were present (3 vs. >3, 39 [SD: 14] vs. 42 [SD 11] minutes, p=0.274), nor when patients/caregivers were present (present vs. absent, 39 [SD: 13] vs. 44 [SD: 14] minutes, p=0.159). DISCUSSION: Case conferencing involving SPCS, the GP, other health professionals and the patient can be an efficient part of routine care.

Prescribing in palliative care as death approaches.

OBJECTIVES: To determine how prescribing for comorbid illnesses and symptom control changes during the palliative phase of a terminal illness. DESIGN: This prospective cohort study explores the relative contribution to prescribing of symptom-specific medications (SSMs) and long-term medications for comorbid medical conditions. SETTING: Regional consultative palliative care program, Adelaide, South Australia. PARTICIPANTS: Two hundred sixty consecutive patients, 96% of whom had cancer, who enrolled and subsequently died in a larger randomized trial exploring palliative service delivery. MEASUREMENTS: Medication and performance data were collected monthly from referral until death (mean 107 days, median 93 days, standard deviation (SD) 103 days, range 11-752 days). Prespecified subgroup analyses of age, performance status, and the baseline use of medications for comorbid medical conditions were performed. RESULTS: At baseline, the mean total number of medications+/-SD was 4.9+/-2.8 (range 0-16), SSMs was 2.3+/-1.5 (range 0-7), and medications for comorbid medical conditions was 2.6+/-2.4 (range 0-13). As death approached, the total number of medications increased because of SSM prescribing (2.5 more medications, 95% confidence interval (CI)=2.2-2.9; P<.001) with a decrease in medications for comorbid medical conditions (1.1 fewer medications, 95% CI=0.8-1.3; P<.001). There was an increase in the number of medications meeting Beers' criteria for high-risk inappropriate medication use for SSMs (29% to 48%). More SSMs were prescribed in people with better performance status, and older participants took more medications for comorbid medical conditions. CONCLUSION: Prescribing changes as life-limiting illnesses progress, with older people taking more medications. Medications for comorbid medical conditions should be reviewed in the context of their original therapeutic goals.

Handheld computers for data entry: high tech has its problems too.

BACKGROUND: The use of handheld computers in medicine has increased in the last decade, they are now used in a variety of clinical settings. There is an underlying assumption that electronic data capture is more accurate that paper-based data methods have been rarely tested. This report documents a study to compare the accuracy of hand held computer data capture versus more traditional paper-based methods. METHODS: Clinical nurses involved in a randomised controlled trial collected patient information on a hand held computer in parallel with a paper-based data form. Both sets of data were entered into an access database and the hand held computer data compared to the paper-based data for discrepancies. RESULTS: Error rates from the handheld computers were 67.5 error per 1000 fields, compared to the accepted error rate of 10 per 10,000 field for paper-based double data entry. Error rates were highest in field containing a default value. CONCLUSION: While popular with staff, unacceptable high error rates occurred with hand held computers. Training and ongoing monitoring are needed if hand held computers are to be used for clinical data collection.

The impact of conducting a regional palliative care clinical study.

End-of-life care must be informed by methodologically rigorous, high-quality research, but well-documented barriers make the conduct of palliative care clinical trials difficult. With careful consideration to study design and procedures, these barriers are surmountable. This paper discusses the approach used in a large scale, randomised, controlled trial of service-based interventions in a regional palliative care service in South Australia, and the impact of this trial on palliative care research more broadly, the changes to the service in which it was conducted, and on health policy beyond palliative care. The Palliative Care Trial evaluated three interventions in a 2 x 2 x 2 factorial cluster randomised design: case conferences, general practitioner education, and patient education. Main outcomes were performance status, pain intensity, and resource utilisation. A total of 461 patients were enrolled in the study. Pre-study planning and piloting is crucial, and accurately estimated withdrawal and death rates in the study. Other study design elements that facilitated this research included assessment of three interventions at one time, a dedicated recruitment role, a single clinical triage point, embedding data collection into routine clinical assessments, and meaningful outcome measures. Recruitment and retention of participants is possible if barriers are systematically identified and addressed. This study challenged and developed the research culture within our clinical team and subsequently translated into further research.