BEVOR – Planning patient-relevant effects of treatment in advance: cluster-randomized intervention study in senior care facilities.
Despite the legal anchoring of living wills (2009), under- or overtreatment occurs in health crises with incapacity to consent, with far-reaching consequences for all parties involved, as living wills are often not meaningful, valid or traceable. The concept of advance care planning (APP) aims to ensure that people are treated the way they want to be treated, even if they are no longer able to express their own wishes. This requires fundamental changes at the systemic and individual level in the sense of patient-centeredness.
Project goals and hypothesis
The aim of the study is to examine whether the introduction of the BVP program of the German interprofessional association Behandlung im Voraus Planen e.V. (www.div-bvp.de) leads to persons in inpatient care facilities being increasingly treated according to their wishes. The study will examine whether the intervention results in the following:
- a higher rate of individuals whose treatment wishes are (a) known and (b) heeded,
- an increased perception of this compliance,
- a reduction in unintentional hospital admissions (primary endpoint),
- reduced rates of involuntary invasive treatments
- more frequent use of home as the place of death
Study design and methodology
Multi-center cluster-randomized intervention study.
After randomization, half of the 40 facilities will receive a multimodal intervention (intervention group), the remaining facilities will receive usual care (as well as a delayed intervention after the observation phase) (control group). 21 months after the start of the intervention, a group comparison is made over the previous 12 months. In addition, a process evaluation and a health economic evaluation will be conducted according to the MRC.
Intervention
The multimodal complex BVP intervention includes:
- Qualification of BVP discussion facilitators and subsequent discussion facilitation in accordance with § 132g SGB V.
- Institutional and regional implementation of BVP: e.g. qualification of general practitioners, hospital and ambulance staff, and other regional actors, support in the respective institutional organizational development).
Participating institutions
- Consortium management and study center Düsseldorf: Institute of General Medicine, Centre for Health and Society (chs), Faculty of Medicine, Heinrich Heine University
- Study Center Göttingen: Institute of General Medicine & Clinic for Palliative Medicine, University Medical Center Göttingen
- Study Center Halle: Institute for Health and Nursing Science & Institute for History and Ethics in Medicine, Martin Luther University Halle
- Study Center Munich: Clinic for Palliative Medicine, University Hospital Munich & Institute for Ethics, History and Theory of Medicine, LMU Munich.
- Methodology and analysis: Institute of Medical Biometry and Epidemiology, UKE Hamburg
- Data management and monitoring: Coordination Center for Clinical Studies (KKS), HHU Düsseldorf
- Health economics: Institute for Health Services Research and Health Economics, Centre for Health and Society (chs), Faculty of Medicine, Heinrich Heine University, Düsseldorf
- Consulting (transfer to standard care): BARMER Ersatzkasse
Study registration
Clinical trials 01VSF18004
Ethics vote:
- First vote: 02/14/2020 (University Hospital Düsseldorf, 2019-761).
- Secondary votes: 20.03.2020 (Munich: 20-154), 23.03.20 (Göttingen: 12/3/20Ü), 23.04.20: (Halle/Saale: 2020-048).
Project funding
Innovation Committee at the Federal Joint Committee (Innovation Fund)
Contact
contact information
- telephone: +49 551 3965302
- fax: +49 551 3929530
- e-mail address: evelyn.kleinert(at)med.uni-goettingen.de