Assessing the implementation and effectiveness of early integrated palliative care in long-term care facilities in France: an interventional mixed-methods study protocol

Abstract

Background: Majority of residents in long-term care facilities (LTCF) have limited and delayed access to palliative care even though many suffer from incurable chronic illnesses that will likely require the provision of palliative care. We present the study protocol of "PADI-Palli", an intervention aims to advance early integrated palliative care into standard care delivered in LTCF. This study will assess the effectiveness of early integrated palliative care on palliative care accessibility for older persons in LTCF, and identify the key factors for the successful implementation of early integrated palliative care and its sustainability in the LTCF context.

Methods: This multicentre interventional study utilises a pragmatic research design with a convergent parallel mixed-methods approach. The qualitative study will use a case study design and the quantitative study will use a stepped wedge cluster randomised trial. In total, 21 participating LTCF from three French regions will be randomly allocated to one of seven clusters. The clusters will cross over from the usual care to the active intervention condition over the course of the study. The primary outcome relates to the accurate identification of palliative care needs and early access to palliative care for LTCF residents. Secondary outcomes are quality of care, quality of life for residents and their families, and quality of life at work for professionals. Measurements will be performed before and after the intervention. Implementation and evaluation of PADI-Palli intervention is grounded in the Consolidated Framework for Implementation Research.

Discussion: Existing evidence demonstrates that early integrated palliative care in cancer care leads to a significant improvement in patient outcomes and processes of care. Little is known, however, about early integrated palliative care in the context of LTCF for older persons. This study has the potential to fill this gap in the literature by providing evidence on the effectiveness of early integrated palliative care for older persons in LTCF. Moreover, this study will provide a better understanding of the relevant contextual elements that facilitate or hinder early integrated palliative care implementation and transferability. If proven effective, this intervention can be scaled to other care settings in which older persons require palliative care.

Trial registration: ClinicalTrials.gov ID: NCT04708002; National registration: ID-RCB number: 2020-A01832-37.

Keywords: Early palliative care; Implementation; Interventional research; Long-term care; Older persons; Quality improvement; Stepped wedge cluster randomised trial.

Fig. 1

Flowchart representing the research design with a convergent parallel mixed-method

Fig. 2

Stepped wedge with seven cluster groups and periods of measurements. The clusters were randomly assigned to seven groups (One Cluster = 1 LTCF) that crossover to receive the intervention after pre-intervention measurements (one to two measurements).