Periodic Reporting for period 3 - PD_Pal (Palliative care in Parkinson’s disease)
Reporting period: 2021-07-01 to 2022-12-31
Parkinson’s Disease (PD) is the second most common neurodegenerative disorder and is characterized in its advanced stages by motor and non-motor complications causing progressive loss of autonomy in activities of daily living, poor quality of life, marked caregiver distress, and high utilization of medical services. Similar to cancer patients, albeit for much longer duration, PD patients have considerable and mounting unmet physical, psychosocial and spiritual needs, and experience great problems with continuity of care.The overall ambition of PD_Pal is to validate a new model of palliative care which might be integrated with traditional management when disability limits mobility and independence, providing an added layer of support to patients, their loved ones, and treating clinicians.PD_Pal randomized controlled trial will provide evidence on the effectiveness of specialized, multidisciplinary, outpatient palliative care intervention and Advance Care Planning (ACP), in improving family satisfaction, symptom management and quality of life. PD_Pal will also further prove the feasibility and economic sustainability of this approach by the active involvement of patients lay associations as well relevant medical societies.PD_Pal team includes leading experts in neurology and palliative care with key-roles in both national and international PD working groups. PD_Pal has developed a new set of evidence-based Guidelines (Clinical recommendations) and a Massive Online Course (MOOC) for Palliative Care in PD involving in the process experts from the European Association for Palliative Care, the European Academy of Neurology (EAN) and the Movement Disorders Society (MDS). Thus, PD_Pal is best positioned to transfer this knowledge to all European countries and ensure that “PD_Pal Guidelines'' will translate into best practice. The PD_Pal MOOC will be integrated into the WHO supported interdisciplinary postgraduate palliative care curriculum.
Guidelines and recommendations development activities have been carried out starting with a systematic review of literature on relevant topics to clinicians, caregivers and patients.This work aimed to highlight and provide an evidence-based view of barriers and enablers of the currently implemented palliative care pathways, to identify opportunities for early thinking as well as clinical indicators and prognostic factors for palliative care referral. Concomitantly, qualitative interviews and a quantitative retrospective study were conducted with the aim of identifying indicators for timely access to palliative care and prognostic factors that could alert the clinician to ACP and palliative care referral, allowing the identification of two set of indicators of clinical progression.The systematic review was complemented by a practice review addressed to health care professionals (HCPs), with the scope to provide consensus based clinical recommendations to enable better care for people with PD. The design of the PD_Pal Clinical Study was aimed at studying the best tools of intervention and data collection for the identification of prognostic factors. A training program for the PD_Pal nurses was developed and implemented; the workbook was pretested with patients. The PD_Pal clinical trial is almost completed, after facing significant challenges related to the COVID-19 pandemic.Regarding the Health Technology Assessment (HTA) entailing the use of PDmonitor®, PDNeurotechnology also conducted collateral clinical trials in order to evaluate the cost effectiveness of a telemonitoring solution and the improvement in QoL for patients and caregivers, supporting the evidence of the system as a continuous, easy-to-use telemonitoring device to facilitate decision-making for the treatment of PwPs and communication with their physicians. The data collected during the PD_Pal clinical trial will be presented after trial’s conclusion. An ancillary qualitative study was performed to gain an overview of the possibilities of telemedicine to support care for PwPs in the palliative phase. The PD_Pal clinical trial data will be used for economic analysis from a health and social care cost, informal carer and societal perspective. The MOOC has been designed, developed and tested as an advanced Palliative Care training module related to PD as a part of wider interdisciplinary graduate and post-graduate palliative care curriculum. An intense networking activity has been done during the entire project duration to create a diverse and rich environment of experts around the PD_Pal project. In order to receive the endorsement of guidelines from the MDS task force, we have contacted and formally invited them for support and contributions since project start. Although the results of the clinical trial have not yet been presented, the dissemination of the PD_Pal ambition and the objectives accomplished has continued throughout the duration of the project with numerous congresses, workshops and conferences. Finally, the adoption to a significant extent of the PD_Pal approach as well as the knowledge it generated in the clinical practice of the partners involved (who are key opinion leaders) ensures the longevity, scale and the wider embracing of the produced results.
Timely identification of PD patients and fully understanding of palliative care needs are the keys the intervention’s success. The PD_Pal Clinical recommendations will guide the need and timing of clinical and hospice referrals and define the role of the specialists and of the multidisciplinary palliative care team members with emphasis on Social Sciences and Humanities. Moreover, given the interaction with the EAN, the new approach will be easily transmitted to all European National neurological societies to be translated into best clinical practice. The connection of PD_Pal members with the MDS Task Force on Palliative Care will provide international validity to the new formulated recommendations and therefore increased chances of integration in different healthcare systems. Prognostic risk factors and indicators for palliative care referral have been investigated, identified and will be validated within the clinical study. Interventions similar to PD_Pal are gaining interest and providing evidence on the high satisfaction and retention in the program. PD_Pal will assess person-centered outcomes, the quality of life of patients and caregiver, the effect of using telemedicine on sustainability, and cost effectiveness and societal perspective.The objective of the PD_Pal intervention is to improve health and quality of life of both patients and caregivers as well as revalidate the provision of long-term care and the effectiveness of the proposed procedures and organizational or supportive system. The HTA will be a multidisciplinary process that will summarize information about the medical, social, economic and ethical issues related to the use of PDMonitor in a systematic, transparent, unbiased, robust manner. In the PD_Pal approach information, education, and an open debate with PwPs, caregivers and HCPs are the cornerstones of the palliative care intervention. The dissemination of the MOOC course will contribute to the training and information of HCPs dealing with PD, while being able to be benefited by PwPs and caregivers. Furthermore, it will provide knowledge about the motor status and complications, and address the specific needs of patients in need of palliative care.