Background antipsychotic drugs are regularly prescribed as first-line treatment for neuropsychiatric symptoms in persons with dementia although guidelines clearly prioritise non-pharmacological interventions. Objective we investigated a person-centred care approach, which has been successfully evaluated in nursing homes in the UK, and adapted it to German conditions. Design a 2-armed 12-month cluster-randomised controlled trial. Setting nursing homes in East, North and West Germany. Methods all prescribing physicians from both study arms received medication reviews for individual patients and were offered access to 2 h of continuing medical education. Nursing homes in the intervention group received educational interventions on person-centred care and a continuous supervision programme. Primary outcome: proportion of residents receiving at least one antipsychotic prescription after 12 months of follow-up. Secondary outcomes: quality of life, agitated behaviour, falls and fall-related medical attention, a health economics evaluation and a process evaluation. Results the study was conducted in 37 nursing homes with n = 1,153 residents (intervention group: n = 493; control group: n = 660). The proportion of residents with at least one antipsychotic medication changed after 12 months from 44.6% to 44.8% in the intervention group and from 39.8 to 33.3% in the control group. After 12 months, the difference in the prevalence was 11.4% between the intervention and control groups (95% confidence interval: 0.9–21.9; P = 0.033); odds ratio: 1.621 (95% confidence interval: 1.038–2.532). Conclusions the implementation of a proven person-centred care approach adapted to national conditions did not reduce antipsychotic prescriptions in German nursing homes. Trial registration ClinicalTrials.gov NCT02295462.

Background: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. Methods: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. Discussion: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. Trial registration: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

Background: Process evaluation addresses the implementation, mechanisms of impact, and context of participants in complex interventions. The STADPLAN study assesses the effects of conversations on advance care planning (ACP) led by trained nurse facilitators. The complex intervention consists of several components that may lead to various changes in attitude and behavior regarding personal ACP activities. With the process evaluation, we aim to assess how changes were achieved in the STADPLAN intervention. Methods: The planned process evaluation study will be conducted alongside a cluster-randomized controlled trial on ACP in home care services (HCS). Trained nurse facilitators will deliver the ACP intervention consisting of an information brochure and two ACP conversations. A logic model depicts the assumed change processes of the intervention: the educational program enables nurses to conduct ACP conversations with patients and their caregivers. Patients gain knowledge and reflect upon and engage in their own ACP. Caregivers better understand patients' wishes and feel reassured in their role as surrogates. Designation of a surrogate and communication on ACP are facilitated. We will assess the effects of the educational program with questionnaires and a focus group including all participating nurses. We will measure ACP engagement, and prevalence of advance directives in patients, and ask for their experiences with the intervention. We will conduct semi-structured interviews with caregivers about their expectations and experiences regarding ACP in general and the intervention. We will address context factors, e.g., basic characteristics of the HCS (such as ownership, number of clients, staff and qualification). Analysis will be based upon the logic model, integrating qualitative and quantitative data.

Background The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process. Methods The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere. Results Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients’ varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident. Conclusions The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people’s ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients’ choice for or against any ACP intervention. Ethics and trial registration Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019–045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019–024), and University of Lübeck (Ref.-No. 19–080). German Clinical Trials Register: DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.

BackgroundAdvance care planning (ACP) is a communication process about a person’s values, life goals and preferences for current and future treatment and care. It can improve end-of-life care experiences for care recipients as well as for family caregivers. Knowledge about caregivers’ needs might support implementation of ACP interventions suitable to both care recipients and their caregivers.ObjectiveTo explore the experiences and attitudes of informal family caregivers, and their knowledge, regarding ACP.MethodsA systematic literature search was conducted (participants: family caregivers; intervention: advance care planning; databases: MEDLINE, PsycINFO, CINAHL, Cochrane Library). Thematic synthesis was applied to qualitative and mixed methods studies; quantitative studies were described in relation to the themes of the meta-synthesis.Results57 studies were included, of these 51 in the meta-synthesis. Three themes emerged: (1) caregiver’s individual conceptualisation of ACP, (2) caregiver’s relationships and (3) ACP process. These themes were incorporated into a longitudinal perspective on the caregiver’s ACP trajectory, encompassing the phases (A) life before, (B) ACP process, (C) utilisation of ACP and (D) life after. The implications for ACP activities are described according to each phase.ConclusionFor the benefit of care recipients, healthcare professionals should carefully consider caregivers’ conceptualisations of ACP as well as the relationships within the family. They need to be skilled communicators, sensitive to individual needs and equipped with sufficient time resources to tailor ACP interventions to their clients’ unique situation. Thus, they will support decision-making according to care recipients’ wishes, caregivers’ end-of-life experience and their life after bereavement.PROSPERO registration numberCRD42018082492.