Although the burden of a cancer diagnosis for patients is profound, healthcare systems often fail to address patients' and families' psychosocial, information and care coordination needs. The Oncology Nurse Navigator Education Program (ONNEP) was initiated to address these missing links in the healthcare system in a pro-active way. The nurse navigator’s roles are clinical roles held by experienced nurses with expert clinical knowledge and in-depth understanding of the health system. Therefore, further education for health care professionals as oncology nurse navigators is urgently needed. The goal of the education program is to further train and qualify the nursing staff in a comprehensive training program comprising 130 teaching units (e.g. in case management, psycho-oncology, coaching and conversational skills, decision support and problem solution, physical activity and nutrition in cancer).
Despite the growing interest among health policy decision makers, there remains hesitation in widespread adoption of nurse navigation services for German cancer patients or for providing reimbursement due to a lack of data regarding value and resource use. Here we describe the study design implemented to evaluate the effect of nurse navigation on hospitalization, health outcomes, health care utilization and health care costs in the German health care system.
A prospective evaluation design using a randomized longitudinal and cross-sectional multi-center design will be used. The program will be implemented at three hospitals and will include their network-partners (outpatient physicians). Approximately of 350 patients will be randomized at study center level, using a stratified 1:1 randomization into intervention (IG) and control group (CG). Patients with breast cancer or melanoma will be randomized according to disease stage, age group and gender (melanoma only). The planned study duration is 12 months. Data will be collected from the patients of the IG and the CG after receiving informed consent of the patients during their hospital stay (t1), as well as 3 months (t2) and 12 month later (t3). Furthermore, data will be collected from their treating in- and outpatient physicians, patients´ relatives, and the oncology nurse navigator (only IG).
For primary endpoint, the difference in numbers of hospitalizations is chosen. For testing the differences between the IG and CG in a cross-sectional way, student t-tests will be calculated at each measuring time point (t1, t2, t3) with a p-value < 0.05 as the criterion for statistical significance. Changes in the numbers of hospitalizations will be calculated compared to t1 and compared to patients in the CG at t1, t2 and t3.
The secondary endpoint is defined as the change of the psychological burden of the patients. Descriptive statistics will be calculated on HADS-D scores at t1, t2 and t3, for the IG and the CG. Changes of the psychological burden will be calculated and compared to t1 as well as in the CG at t1, t2 and t3.
The exploratory analyses will provide insights into the impact of the Oncology Nurse Navigator Education Program on different variables: The quality of life of patients as measured by EORTC QLQ-C30, quality of life of relatives (EQ-5D), psychological burden of relatives (HADS), health status/ general perceived health (WHO). Measures of social support / resources of patients, patients´ health literacy, shared decision making , days of incapacity for work, waiting time for necessary treatments, adherence to treatment, duplicate examinations, satisfaction with intervention, workflow/ operational procedures, pharmacotherapy, use of health care services, and health care costs will also be collected and analyzed.
RESULTS & DISCUSSION:
To better allocate the resources in the German health care system, further information on the economic impact and sustainability of new interventions is needed.
Patient navigation is a promising intervention for cancer patients. Implementation of such programs in other health care systems, such as the US, is rather advanced. Evaluation of the ONNEP is complex since other patient navigation services are not completely comparable. Also, settings in which such a service is offered may differ. Nevertheless, initial investigations in the US have shown significant increases in several components of quality of life and satisfaction with care. Moreover, it has been shown that hospital stay days can be reduced compared to the control group through such programs.
Oncology nurse navigation programs can be easily integrated in physicians’ routines and thus may be effective outside the framework of clinical research. However, there is a paucity of economic and value information related to establishing, sustaining, or determining the viability of an ONNEP in Germany. The design of the prospective randomized evaluation described aims to allow for informed decision making.