Artikel
Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial
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Autoren
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Rieke Schnakenberg
- Carl von Ossietzky Universität Oldenburg, Fakultät VI - Medizin und Gesundheitswissenschaften, Ambulante Versorgung und Pharmakoepidemiologie, Oldenburg, Germany
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Katharina Silies
- University of Lübeck, Institute for Social Medicine and Epidemiology, Nursing Research Unit, Lübeck, Germany
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Almuth Berg
- Martin Luther University Halle-Wittenberg, Germany, Institute for Health and Nursing Science, Halle (Saale), Germany
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Änne Kirchner
- Martin Luther University of Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science, Halle (Saale), Germany
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Henriette Langner
- Martin Luther University of Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science, Halle (Saale), Germany
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Yuliya Chuvayaran
- University of Wuppertal, Germany, Center for Health Economics and Health Services Research, Wuppertal, Germany
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Juliane Köberlein-Neu
- University of Wuppertal, Germany, Center for Health Economics and Health Services Research, Wuppertal, Germany
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Burkhard Haastert
- mediStatistica, mediStatistica, Neuenrade, Germany
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Gabriele Meyer
- Martin Luther University Halle-Wittenberg, Germany, Institute for Health and Nursing Science, Halle (Saale), Germany
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Sascha Köpke
- University of Lübeck, Germany, Institute for Social Medicine and Epidemiology, Lübeck, Germany
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Falk Hoffmann
- Carl von Ossietzky Universität Oldenburg, Fakultät VI - Medizin und Gesundheitswissenschaften, Ambulante Versorgung und Pharmakoepidemiologie, Oldenburg, Germany
| Veröffentlicht: | 2. Oktober 2019 |
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Gliederung
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Background: In Germany, advance care planning (ACP) for residents of nursing homes and mental health care institutions were introduced by a legal act in 2015.
Objective: This study aims to evaluate the effect of an ACP program in care dependent community-dwelling older persons on patient’s activation, compared to optimised usual care. Following the UK Medical Research Council’s (MRC) guidance for development and evaluation of complex interventions, we recently adapted the program Respecting Choices to the ambulatory care setting. Due to the feasibility, the adapted version of the program is timely restricted and less extensive. Therefore it aims to raise awareness to ACP and to enable people to communicate their wishes regarding future medical treatment and care. The STADPLAN intervention is pre-tested and piloted in a temporally feasible version.
Methods, analysis and expected results: A cluster-randomised controlled trial with 12 months follow up will be conducted in 3 German study sites. Eligibility criteria for patients are: > 60 years or older, adequate German language skills, degree of care dependency > 1, DSS score of < 3 or 3-5, if a known nurse evaluates the patient as being able to participate. ACP will be delivered by two trained nurse facilitators per home care service. The ACP communication will offer inclusion of a proxy decision-maker. The primary endpoint of the study is patient activation, operationalised by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of advance directives, hospitalisation, quality of life as well as depression and anxiety. An economic evaluation as well as a comprehensive process evaluation will be conducted. The primary outcome will be assessed by blinded study assistants.
The recruitment of participants will start in June 2019 and the last follow up measurement will be finished in September 2020. We aim to allocate 32 home care services including 960 participants either to the intervention or to the control group. Group comparison will be conducted by using a mixed model with a level of significance of α = 0.05 (two-sided) adjusting for baseline values (fixed effect) and cluster effect (random effect).
Discussion and practical implications: STADPLAN is the first study in Germany that empowers nurses to deliver an ACP offer to older people being cared for at home. The results will support the improvement of understanding and communicating the patient’s will regarding future medical treatment and care, and thereby contribute to patient´s autonomy at the end of life.
Ethics and dissemination: Approved by the Ethics Committees of the Medical Faculties of the Universities of Halle-Wittenberg and Oldenburg in a joint evaluation process with the Ethics Committee at the University of Lübeck, Germany. Results will be disseminated via international journal publications as and conference contributions.
Trial registration: German Clinical Trials Register (DRKS00016886)
Funding: German Federal Ministry of Education and Research (BMBF)
