Patient navigation in German emergency care (NODE). Study protocol of a multi-center mixed-methods trial.

Background & objective: The objective of the study is to explore and to evaluate existing patient navigation models between emergency departments (ED) and alternative outpatient emergency care providers. Therefore, three different patient navigation models in emergency care in Berlin, Germany will be evaluated regarding their efficiency, quality of care, patient safety, patient satisfaction, costs and cost-effectiveness: (1) a hospital-owned separate outpatient care model within the ED premises or on the hospital grounds, (2) an urgent care practice of the Regional Association of Statutory Health Insurance (SHI) Physicians at the ED location, and (3) a standard care ED with prospective assessment of patient-care and urgency levels by ED doctors.

Methods: In a convergent, parallel, mixed-methods, multi-center study design, patients' and health care providers' perspectives assessed by qualitative methods will be triangulated with the results of a quantitative prospective cohort study at six EDs in Berlin, Germany. This study includes four working modules: (1) a systematic literature review; (2) qualitative semi-structured interviews with patients (n∼15-20), as well as four focus group interviews with health care providers (n∼5); (3) a prospective multi-centre cohort study in adult, self-referred emergency patients at two time points (t0: n = 1,031; t1: n = 344), primary endpoint: proportion of patients treated other than standard emergency care, secondary endpoints: secondary efficiency, patient-reported outcome measures (PROMs), patient safety, quality of care, clinical outcomes, and cost-effectiveness; participant observation of patients' treatment trajectories and organizational processes at three different patient navigation models (n∼10-15), an online provider survey; and (4) data triangulation and recommendations for practice and policy.

Discussion: This is the first study to compare different patient navigation and cooperation models to standard ED care in Germany and evaluate their effectiveness. Results will provide deep insights into the efficiency, patient satisfaction, quality of care, patient safety and cost-effectiveness. This will help providers and policymakers organise future emergency care in Germany. The study is expected to contribute to health services and systems research.

Trial registration: DRKS00030398.