Outcome after polytrauma in a certified trauma network: comparing standard vs. maximum care facilities concept of the study and study protocol (POLYQUALY)

Michael Koller, Antonio Ernstberger, Florian Zeman, Julika Loss, Michael Nerlich, on behalf of the Trauma Network Eastern Bavaria (TNO)

The aim of this study is to evaluate the performance of the first certified regional trauma network in Germany, the Trauma Network Eastern Bavaria (TNO) addressing the following specific research questions: Do standard and maximum care facilities produce comparable (risk-adjusted) levels of patient outcome? Does TNO outperform reference data provided by the German Trauma Register 2008? Does TNO comply with selected benchmarks derived from the S3 practice guideline? Which barriers and facilitators can be identified in the health care delivery processes for polytrauma patients? The design is based on a prospective multicenter cohort study comparing two cohorts of polytrauma patients: those treated in maximum care facilities and those treated in standard care facilities. Patient recruitment will take place in the 25 TNO clinics. It is estimated that n = 1.100 patients will be assessed for eligibility within a two-year period and n = 800 will be included into the study and analysed. Main outcome measures include the TraumaRegisterQM form, which has been implemented in the clinical routine since 2009 and is filled in via a web-based data management system in participating hospitals on a mandatory basis. Furthermore, patient-reported outcome is assessed using the EQ-5D at 6, 12 and 24 months after trauma. Comparisons will be drawn between the two cohorts. Further standards of comparisons are secondary data derived from German Trauma Registry as well as benchmarks from German S3 guideline on polytrauma. The qualitative part of the study will be based on semi-standardized interviews and focus group discussions with health care providers within TNO. The goal of the qualitative analysis is to elucidate which facilitating and inhibiting forces influence cooperation and performance within the network. This is the first study to evaluate a certified trauma network within the German health care system using a unique combination of a quantitative (prospective cohort study) and a qualitative (in-depth facilitator/barrier analysis) approach. The information generated by this project will be used in two ways. Firstly, within the region the results of the study will help to optimize the pre-hospital and clinical management of polytrauma patients. Secondly, on a nationwide scale, influential decision-making bodies, such as the Ministries of Health, the Hospital Associations, sickness funds, insurance companies and professional societies, will be addressed. The results will not only be applicable to the region of Eastern Bavaria, but also in most other parts of Germany with a comparable infrastructure. VfD_Polyqualy_12_001978 , 10.Jan.2013; German Clinical Trials Register DRKS00010039 , 18.02.2016.