Open Access

Background: The option of intentional sedation to relieve intolerable suffering from treatment-refractory symptoms may elicit a feeling of safety for patients and informal caregivers as a last resort if the situation becomes unbearable. Many health care professionals feel uncomfortable and insecure in conducting intentional sedation due to specific challenges. We developed a complex intervention to support best practice use of sedative drugs in specialist palliative care in Germany based on previously published recommendations. This article aims at reporting the development of the intervention. Methods: The development of the intervention was based on theory and existing evidence with active stakeholder participation and patient and public involvement, following the updated Medical Research Council (MRC) Framework on complex interventions. A “Theory of Change,” drawing on expert-approved best practice recommendations and applying user-centered methods, fostered the development. The process encompassed study preparation, development of the elements of the intervention, and designing the multimodal intervention. For reporting, we adhere to the Guidance for Reporting Intervention Development framework. Results: The intervention is aimed at health care professionals working in specialist palliative care (inpatient and homecare settings) and consists of several components: (1) a screening tool, (2) the individual elements of the intervention, and (3) educational material for health care professionals to support them using the intervention. Additional information material was developed for patients and informal caregivers. Despite the benefits of stakeholder involvement, we faced some barriers due to limited health care staff and time resources and reservations regarding research in general. Discussion: A pilot study is planned for testing the overall feasibility of the intervention and exploring possible benefits for health care professionals to inform a subsequent fully powered implementation study. To deal with the challenges, we stayed in contact with the health care teams, maintained transparency, and provided opportunities for active participation.

Background In palliative care, it can be challenging to distinguish between reduced consciousness related to the illness and sedation due to a potentially sedating drug (intended, or unintended). These differentiations are important because unintended sedation requires consideration of alternative treatment options, and intentional sedation demands compliance with guidelines. The aim of the study, which was part of the consortium project iSedPall, was to determine cut-off values for drugs’ doses/dosing intervals which are expected to result in defined depth of sedation/continuous effect. Methods Group Delphi conducted in Germany with prior online survey. Based on a review of the literature, statements regarding cut-off values for drugs´ doses/dosing intervals which are expected to result in a defined depth of sedation/continuous effect were developed for 11 drugs. Consensus was defined as ≥ 75% agreement. Statements with lower agreement entered the next round of discussion. Between the rounds (5 small groups, 3 – 4 participants each), the results were presented and discussed. If necessary, statements were adapted for the following round. Participating experts were physicians, pharmacists, and nurses experienced in palliative care, mostly with over 10 years of professional experience. Results 25/30 invited experts participated in the online survey, 17 in the Group Delphi. 12/33 statements were consented in the survey. The initial questionnaire for the Group Delphi comprised 22 statements on ten drugs. After three rounds, consensus was reached for all statements, determining cut-off doses/dosing intervals for lorazepam, midazolam, diazepam, levomepromazine, haloperidol, melperone, pipamperone, propofol, dexmedetomidine, and trazodone. Conclusions This study for the first time provides evidence- and expert consensus-based data to support clinical judgements regarding sedating effects of a range of potentially sedating drugs commonly used in palliative care.