Sentinel fall presenting to the emergency department (SeFallED) - protocol of a complex study including long-term observation of functional trajectories after a fall, exploration of specific fall risk factors, and patients' views on falls prevention.

BACKGROUND: Falls are a leading cause for emergency department (ED) visits in older adults. As a fall is associated with a high risk of functional decline and further falls and many falls do not receive medical attention, the ED is ideal to initiate secondary prevention, an opportunity generally not taken. Data on trajectories to identify patients, who would profit the most form early intervention and to examine the impact of a fall event, are lacking. To tailor interventions to the individual's needs and preferences, and to address the whole scope of fall risks, we developed this longitudinal study using an extensive assessment battery including dynamic balance and aerobic fitness, but also sensor-based data. Additionally, participative research will contribute valuable qualitative data, and machine learning will be used to identify trips, slips, and falls in sensor data during daily life. METHODS: This is a mixed-methods study consisting of four parts: (1) an observational prospective study, (2) a randomized controlled trial (RCT) to explore whether a diagnostic to measure reactive dynamic balance influences fall risk, (3) machine learning approaches and (4) a qualitative study to explore patients' and their caregivers' views. We will target a sample size of 450 adults of 60 years and older, who presented to the ED of the Klinikum Oldenburg after a fall and are not hospitalized. The participants will be followed up over 24 months (within four weeks after the ED, after 6, 12 and 24 months). We will assess functional abilities, fall risk factors, participation, quality of life, falls incidence, and physical activity using validated instruments, including sensor-data. Additionally, two thirds of the patients will undergo intensive testing in the gait laboratory and 72 participants will partake in focus group interviews. DISCUSSION: The results of the SeFallED study will be used to identify risk factors with high predictive value for functional outcome after a sentinel fall. This will help to (1) establish a protocol adapted to the situation in the ED to identify patients at risk and (2) to initiate an appropriate care pathway, which will be developed based on the results of this study. TRIAL REGISTRATION: DRKS (Deutsches Register für klinische Studien, DRKS00025949 ). Prospectively registered on 4th November, 2021.

Moving towards patient-centered care and shared decision-making in Germany.

The main focus of this paper is to describe the development and current state of policy, research and implementation of patient-centered care (PCC) and shared decision-making (SDM) in Germany. What is the current state in health policy? Since 2013, the Law on Patients' Rights has standardized all rights and responsibilities regarding medical care for patients in Germany. This comprises the right to informed decisions, comprehensive and comprehensible information, and decisions based on a clinician-patient partnership. In addition, reports and action plans such as the German Ethics Council's report on patient well-being, the National Health Literacy Action Plan, or the National Cancer Plan emphasize and foster PCC and SDM on a policy level. There are a number of public organizations in Germany that support PCC and SDM. How are patients and the public involved in health policy and research? Publishers and funding agencies increasingly demand patient and public involvement. Numerous initiatives and organizations are involved in publicizing ways to engage patients and the public. Also, an increasing number of public and research institutions have established patient advisory boards. How is PCC and SDM taught? Great progress has been made in introducing SDM into the curricula of medical schools and other health care providers' (HCPs) schools (e.g., nursing, physical therapy). What is the German research agenda? The German government and other public institutions have constantly funded research programs in which PCC and SDM are important topics. This yielded several large-scale funding initiatives and helped to develop SDM training programs for HCPs in different fields of health care and information materials. Recently, two implementation studies on SDM have been conducted. What is the current uptake of PCC and SDM in routine care, and what implementation efforts are underway? Compared to the last country report from 2017, PCC and SDM efforts in policy, research and education have been intensified. However, many steps are still needed to reliably implement SDM in routine care in Germany. Specifically, the further development and uptake of decision tools and countrywide SDM trainings for HCPs require further efforts. Nevertheless, an increasing number of decision support tools - primarily with support from health insurance funds and other public agencies - are to be implemented in routine care. Also, recent implementation efforts are promising. For example, reimbursement by health insurance companies of hospital-wide SDM implementation is being piloted. A necessary next step is to nationally coordinate the gathering and provision of the many PCC and SDM resources available.