The end of life care phase (EoL), being defined when curative treatment is not possible and disease is likely to cause death within 12 months, can be traumatic for the patient and care giver. Indeed, EoL symptoms dominate the clinical picture and contribute to impaired quality of life. Even when people do not experience significant psychological distress, they may still struggle to adjust to the social, emotional, and personal changes brought on by the EoL. From this perspective, supporting caregivers’ and healthcare providers’ well-being is an important contributor to patients’ experiences and to the health of the healthcare system, both in terms of informal and formal care. For example, research evidence suggests that care giver and healthcare provider resilience, compassion and reduced psychological distress may lead to better patient outcomes and a more healthy and productive workplace[1, 2].
Mindfulness – attention and acceptance
There are many psychotherapies that have been applied to improve resilience, compassion and psychological distress [3, 4], but the simplest and possibly an effective approach is mindfulness [3, 5, 6]. The elements of mindfulness, namely awareness and nonjudgmental acceptance of one's moment-to-moment experience, are regarded as effective antidotes against common forms of psychological distress — rumination, anxiety, worry, fear, anger, and so on — many of which involve the maladaptive tendencies to avoid, suppress, or overengage with one's distressing thoughts and emotions [7, 8]. Also, mindfulness has been found to enhance self-compassion in healthcare professionals . Clinicians and caregivers have been studied in models using mindfulness to improve the caregivers’ well-being and the patient outcomes [1, 6, 10]. The success of mindfulness has seen it implemented as part of the education and training of students in medical and nursing schools . Patients in the end of life care phase, their caregivers and associated healthcare providers represent an area of considerable research interest in the mindfulness space [10-14]. Mindfulness-based group approach is a rapidly growing psychological therapy embedded within the concept of acceptance to help people adjust to chronic illness and manage unpleasant symptoms [5, 15]. Furthermore, mindfulness has potential cost advantages as programs are delivered to groups requiring less clinical/expert time per participant. Mindfulness courses have clear time boundaries, and once the techniques have been taught, participants can continue practising without additional supervision.
The relationship between mindfulness and self-compassion is explored in the health care literature, with a corollary emphasis on reducing stress in health care workers and providing compassionate patient care. Health care professionals are particularly vulnerable to stress overload and compassion fatigue due to an emotionally exhausting environment. Compassion fatigue among caregivers in turn has been associated with less effective delivery of care  Having compassion for others entails self-compassion. In Kristin Neff's research self-compassion includes self-kindness, a sense of common humanity, and mindfulness. Both mindfulness and self-compassion involve promoting an attitude of curiosity and non-judgement towards one's experiences . Research suggests that mindfulness interventions, particularly those with an added loving-kindness component, have the potential to increase self-compassion among health care professionals. Enhancing focus on cultivating self-compassion using mindfulness interventions for healthcare workers holds promise for reducing perceived stress and increasing effectiveness of clinical care .
The present project proposal is an experimental study involving patients, caregivers and healthcare providers testing a novel self-facilitated mindfulness approach called MindHealth Circles (MHC). This proposal is nested within a collaborative research program led by ACT Health called the End of Life Care Research Translation Project: Using Experiences to Deliver Better Care (ERT Project). The ERT Project is an implementation science framework and performance management approach underpinned by AI data science-driven technology. It represents a flagship research collaboration to significantly improve patients’ end of life experiences, while establishing a research infrastructure and methodology for knowledge discovery.
The focus is on patients who are predicted to have less than 12 months of life diagnosed with an advanced disease in cancer, congestive heart failure or other advanced cardiac conditions, chronic pulmonary disease, or dementia. The common goals include improving patient and carer experiences; creating new models of care that are patient-carer focused across the health system; encouraging compassion, empathy and enhancing resilience of patients, carers and healthcare staff through well-being programs; discovering new treatments that limit symptom severity; and establishing whole of healthcare funding models that better reflect best practice and optimise health outcomes.
The underlying theoretical focus of the ERT Project is a wellness model of healthcare. This emphasis has the potential to create a paradigm shift in the medicalisation of care grounded in the realm of positive psychology , and more broadly a “systems” perspective . The theoretical drivers of well-being comprise a series of centric inter-dependant circles each contained in a broader dimension, starting with the individual expanding to the community or society through a series of inter-connected levels (see Figure 1). This allows an inclusive approach to existing theories – from physiological explanations to social networks to cultural values. Compassionate healthcare is critical for humanity from the perspective of the individual, socially and culturally [20-23]. An ecological perspective on health emphasises both individual and contextual systems and the interdependent relationships between the two .
In summary developing a theoretical framework to add to our knowledge of how Individual wellbeing  positioned within groups, give meaning to their lives, expanding this into the wider context, workplace settings, community and society. A paradigm shift toward a compassionate society, where individuals are making decisions and choices based on interdependent relationships, with collaborations and collective wisdom. A key principle of ecological psychology is the reciprocal relationship between people and their environments. Explicit emphasis on the importance of developing theory, research and interventions that situate individuals, settings, and communities within culture and context, and focuses on the interdependence of these things. It acknowledges multiple levels of influence on behaviour and appreciates human diversity on dimensions of culture and resources .
The specific aims and hypotheses are: For the health-care professional Aim - To increase their resilience, reduce compassion fatigue, improve job satisfaction, and improved social support Research Hypothesis 1a - Health care professionals participating in the MindHealth Circles will have a significantly important benefit in terms of improved resilience, reduced compassion fatigue and overall job satisfaction. Research Hypothesis 1b - Health care professionals participating in the Zoom MindHealth Circles will have an equivalent benefit in terms of improved resilience, reduced compassionate fatigue and overall job satisfaction when compare to face-toface MindHealth Circles. Research Hypothesis 1c - Online Zoom has a greater “acceptance of use” than face-toface intervention. For the Care Giver Aim - To reduce psychological distress, improve resilience, reduce compassionate fatigue and improve social support. Research Hypothesis 2 – Care givers participating in the MindHealth Circles will have a significantly important benefit in terms of quality of life, improved resilience and reduced compassionate fatigue and improved social support For the Patient Aim - To reduce psychological distress and to improve the quality of dying Research Hypothesis 3 - Patients participating in the MindHealth program will have a significantly important benefit in terms of quality of life and patient experiences. Methods
A parallel randomised controlled design sequenced by subject type (caregiver or healthcare provider) is the main approached to be used. To minimise contamination between the experimental arms of the care giver and healthcare providers in MHCs and Treatment as Usual (TAU) a phased approach will be adopted (4 phases). The first phase will be a feasibility assessment based on data collected from a prospective cohort of patients, care givers and healthcare providers. Participants will provide valuable information on process and outcome that will be used to determine practical issues on the study design and delivery of the MHCs (including online feasibility), and statistical requirements. 1. Assessing time and resource problems, for example whether it is feasible for patients to answer all the questionnaires and the time taken to do so, the flow of participants entering the study, the use of equipment to set up Zoom, and other resources needed 2. Determine data management issues, by monitoring levels of missing data and data variability 3. Evaluate the potential for detecting a change in each of the proposed outcome measures (anxiety, depression, pain, fatigue, insomnia, quality of life, subjective wellbeing) 4. Understand the mechanisms of change (mindfulness skills, acceptance, selfcompassion, decentering, tolerance of uncertainty) 5. Assess the qualitative experiences of receiving the mindfulness intervention and people’s views and experiences of using Zoom as a mode of delivery as well as people’s feedback on the questionnaires used The second phase is the caregiver randomised control trial testing the well-being benefits of MHCs to care givers and associated patients. In this phase, patients are not part of the MHC but are given materials to read and the caregiver is encouraged to engage the patient in mindfulness activities. These materials are only provided to a patient if the caregiver is part of MHC experimental arm. At the end of an 8-week intervention cycle, the care givers in the MHCs are encouraged to continue the “circles”. Both experimental arms of the trial are continued to be assessed over the remaining phases of the study. The TAU arm is not crossed over to the MHC because carergivers’ and patients’ outcomes are measured over the course of the healthcare providers experiment.
At the end of the Healthcare Provider experiment (8 week intervention) we implement a healthcare provider led MHC model (Phase 4) to undertake a translation evaluation of the approach where healthcare providers supervise carer-facilitated MHCs, and healthcare providers are part of their own healthcare provider facilitated MHCs. This phase is somewhat dependant on the analysis of the primary hypotheses in Phases 2 and 3. If the findings indicate null results than a decision will need to be made about proceeding to Phase 4. In addition to the effectiveness of the MHCs the final phase, we are interested in the long-term sustainability of the model. Healthcare providers, care givers and patients who were part of the TAU arms of earlier phases will be part of the MHCs or associated materials in the final phase, where relevant. Psychologists do the initial training of participants in a short course then the circles use this training to progressively apply mindfulness within the groups facilitated by a rotating circle leader.
At this stage, patients to be included in this study are those who are predicted to have less than 12 months of life, and have been diagnosed with an advanced disease in the area of cancer, congestive heart failure or other advanced cardiac conditions, chronic pulmonary disease, or dementia. Caregivers are those who are associated with the selected patients. Patients and Caregivers are excluded if the Caregiver: • Has severe cognitive impairment that would make participation in the mindfulness sessions and home practice of mindful meditation problematic or distressing; • Has a serious psychiatric condition (e.g. psychosis, drug/alcohol abuse) that can potentially risk failure in the intervention or limit participation in the course; • Has severe hearing impairment; • Is currently participating in other psychological therapies; or • Has prior formal training in mindfulness methods or current meditation practice. Health care professionals include those working within the outpatient and inpatient locations where patients will be recruited. These professions include: • Enrolled registered nurses • Allied Health professionals Excluded from the selection of Health professionals for the MHC are: • Doctors because there is an expectation that it will be difficult to engage them in this activity (this may be reviewed during the feasibility phase); • Are those currently participating in other psychological therapies; and • Those who have prior formal training in mindfulness methods or current meditation practice. Proposed Main Outcome measures
Mental health measures Sample types: patients, caregivers, and health professionals Dimensions: Depression and anxiety Instrument name: Depression Anxiety and Stress Scales – short-form (DASS-21). Self-Compassion Sample types: caregivers, and health professionals Dimensions: Self-compassion Instrument name: Self-Compassion Scale—Short Form (SCS-SF Kristin Neff)  Research has shown that self-compassion is associated with psychological well-being and suggests that self-compassion might be an important protective factor, fostering emotional resilience . Resilience Sample type: Healthcare professionals and caregivers Dimensions: Resilience Instrument name: Connor-Davidson Resilience scale (CD-RISC) . Quality of Life Sample type: Patients Dimensions: Fatigue, weakness and physical functioning Instrument name: to be determined Sample type: Caregivers and healthcare professionals Dimensions: Instrument to be used: The Quality of Life Inventory (QOLI;) Quality of death and dying Sample type: Patients and Caregivers Dimensions: Perception of wishes being met, burden of care, location choice for dying Instrument name: Quality of death and dying questionnaire QDDQ. Job Satisfaction Sample type: Healthcare Professionals Dimensions: Satisfaction with job, perception of support Instrument name: Job satisfaction among health professionals  Mindfulness Sample type: Caregivers and healthcare professionals Dimensions: Awareness and acceptance Instrument name: Philadelphia Mindfulness Scale (PHLMS)  Social Support Sample type: Caregivers and healthcare professionals Dimensions: Meaningful relationships, significant others Instrument name: to be determined The Outcome measure is independent of the intervention for work. For example ‘Do health professionals perceive they are being supported by their workplace’. Technology Assessment Dimensions: Overall satisfaction with online conference call; Audio and visual quality; Ease of accessing technology; and Attendance Instrument name: to be determined Statistical Analysis As part of the hypotheses, the project will be focused on detecting change in the outcomes each of the outcome measures listed above. A statistical analysis plan will be developed with the statisticians from the ERT Project support group. The plan will outline the analysis of each phase of the study, including the descriptive and hypothesis testing parts. Significance The proposed Compassionate Healthcare Study on MindHealth Circles is a pivotal step towards the next generation of healthcare focused on wellness. The proposed study is utilising sound scientific evidence on a journey to the implementation of sustainable, translatable and cost-effective wellness models in the end of life care that enhance mental and physical health.
The proposed study is part of the End of Life Care Research & Translation (ERT) Project. The ERT Project represents a flagship research collaboration between ACT Health and its academic partners to significantly improve patients’ end of life care experiences, while establishing a research infrastructure and methodology that significantly directs and validates the formulation of ACT Health’s Research Strategy. The ERT Project draws on a novel implementation science model of questioning, testing and translation into a “knowledge bank” overlaid on cutting-edge artificially intelligent “on-the-cloud” data science technology. Funding
The End of Life Care Research & Translation (ERT) Project is seeking funding from ACT Health, ANU and other academic partners to establish the ERT framework, hire support staff to run the framework, and implement the MindHealth trial interventions. To date there has been close to $4m pledged to the project over 4 years. Team
Principal investigator of the MindHealth Study is Simonette Vaja (seeking PhD candidature). Simonette is a registered psychologist, authorised primary supervisor with AHPRA with over 27 years of experience as a clinician with concurrent experience as a mental health care and trauma-critical incident senior consultant to Corporate and Government Departments. Simonette is the Director and Principal Psychologist of MindHealth Harmony Solutions. Having designed and delivered her Resilience and Wellbeing programs to major corporations, government agencies and health care providers to include best practice, evidence based mental health and wellbeing interventions. The MindHealth Solutions program in its current form is derived from many years of application to a diverse range of high risk working environments. The ERT Project’s chief investigator is A/Professor Bruce Shadbolt. He is one of Australia’s leading data scientist/biostatistician and clinical epidemiologist in scientific methodology and the translation of clinical research into practice. He pioneered the establishment of health outcomes research in Australia, co-convening the Australian Health Outcomes Conference series over 14 years from1997-2010. ACT Health Professor Imogen Mitchell (Dean ANU Med School/ICU) A/Professor Paul Craft (Oncology) Professor Walter Abhayaratna (Cardiology/Med Services/CTU) Dr Michael Chapman (Pall Care/Aged Care/Dementia) Dr James D’Rozario (Haematology) A/Professor Bruce Shadbolt (Project Lead/Epidemiology/Biostatistics) Professor Ross Hannan (The Office of Research/Cancer Research) Professor Kirsty Douglas (GP research) Professor Matthew Cook (Immuniology/Translation) Dr Carol Huang (Respiratory Medicine) Professor Paul Kelly (Population Health) Karen Murphy (Allied Health) Calvary Hospital Professor Liz Forbat (Palliative care/Psychology) Dr Geoff Ding (ICU) Australian National University Professor Simon Foote (JCSMR) Professor Archie Clements (RSPH) Professor Nick Glasgow (Health Services Research, RSPH) Dr Ian McRae/Professor Jane Hall (Health Economics) Dr Emmalene Bartlett (JCSMR) Professor Kaarin Anstey (CRAHW) Professor Catherine Waldby (RSSS) A/Professor Rhonda Brown (RSP) University of Canberra Professor Brenda Happell (SYNERGY, NMRC: UC and ACT Health) Dr Holly Northham Primary Healthcare Network (Capital Health Network) Vlad Aleksandric (GM Strategy and Planning) Palliative Care Clinical Studies Collaborative Professor David Currow (Director) Linda Deville (Executive Manager) Consumer Representative Palliative Care Australia References 1. Escuriex, B., Labbé, EE Health Care Providers’ Mindfulness and Treatment Outcomes: A Critical Review of the Research Literature. 2011.
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