Use of sedative drugs in specialist palliative care (iSedPall): a multi-modal intervention pilot study protocol

The use of sedative drugs in specialist palliative care is common but presents challenges due to specific medical, ethical, and legal considerations. There is little to no assistance for administering adequate sedative drug doses, ensuring accurate documentation before and during sedation, or managing ethically and legally challenging situations. In 2021, the SedPall study group published recommendations on the use of sedative drugs in palliative care. The German Association for Palliative Medicine endorsed the dissemination of the recommendations nationwide. However, disseminating recommendations alone does not necessarily lead to changes in clinical practice. In the project "Development and piloting of a multi-modal intervention for the use of sedative drugs in specialist palliative care (iSedPall)", we will develop a multi-modal intervention that implements these national recommendations into practical tools for healthcare professionals in specialist inpatient and home care settings. In the pilot study described below, we aim to test the feasibility of the multi-modal intervention, its appropriateness, and acceptability as primary feasibility outcomes of the multi-modal intervention. Additionally, we aim to assess the feasibility of measuring healthcare professionals´ confidence in using sedative drugs as an outcome indicator for a possible subsequent study.

We will use a mixed-methods approach to develop and pilot a multi-modal intervention. The primary feasibility outcomes and formative evaluation of the implementation process will be explored using quantitative (retrospective cohort study, survey) and qualitative elements (focus groups, interviews). Additionally, we will pilot the measurement of healthcare professionals´ confidence in using sedative drugs as an outcome indicator through a pre-post survey. Four specialist palliative care services will pilot the complex intervention for nine months. Due to the complexity of the intervention, we will follow the principles of the MRC framework for complex interventions and will apply a Theory of Change approach. The intervention will include different elements to be used throughout the patients' treatment in inpatient and home specialist palliative care considering medical, ethical, and legal aspects for the use of sedative drugs and intentional sedation. The evaluation of the overall feasibility and the decision about proceeding to an implementation study will be based on the integration of quantitative and qualitative data, according to our mixed-methods approach.

This project is the first attempt to translate national recommendations on best practices for sedative drug use into a multi-modal intervention and tests its feasibility. The study group identified potential risks and challenges related to the intervention´s feasibility, acceptability, and appropriateness in advance. To mitigate these risks, the study protocol is based on a theoretical framework, developed through a Theory of Change approach. Participatory elements and the involvement of different stakeholders are expected to enhance user acceptance and feasibility, potentially improving the development of supporting materials for sedative drug use in specialist palliative care while considering the interests of non-professionals.

Registered in the German Clinical Trials Register, DRKS-ID: DRKS00027241; Registered: 10/12/2021; https://www.drks.de/drks_web/setLocale_EN.do .