Contemporary Clinical Trials Communications (Sep 2021)
Evidence of the medical and economic benefits of implementing hygiene measures by a prevention link physician in trauma surgery: Study protocol for a biphasic multicenter prospective interventional pre-post cohort study using a structured intervention bundle development and tools of behavior change management
Abstract
Introduction: The German Commission for Hospital Hygiene and Infection Prevention recommends nominating one authorized medical specialist in every medical department as an infection prevention link physician (PLP). It has been roughly described that a PLP serves as a link between the infection prevention team and the respective clinical departments. No detailed evidence about the contribution made by PLPs to the decrease of infection rates is available in Germany. The “HygArzt” project aims to demonstrate the medical and economic benefits of the implementation of hygiene measures by PLP in trauma surgery/orthopedics. Methods: A multicenter interventional pre/post cohort study design was chosen. The study will run for a three-year period, including a pre-, post-, and an intervention phase, in four different hospitals, one of which will serve as pilot. A complex intervention containing evidence-based infection control measures will be developed and implemented by a PLP to proof efficacy. After the successful implementation of the preventive measures in the pilot hospital, the concept will be transposed to the three remaining trauma and orthopedic departments to confirm the transferability and generalizability. To enable the PLPs of the non-pilot departments, a subject-specific training program will be developed based on the study results of the pilot hospital and offered to the PLPs. Discussion: Data are intended to provide evidence that and, if so, to which extent the implementation of specific preventive measures by a medical department-specific PLP is possible and results in a reduction of nosocomial infections in orthopedic surgery and traumatology. Contribution to the literature: The present study describes a novel complex study design to prove the effectiveness of intervention measures for infection prevention. The study design and newly developed methodological approach could serve as a model for similar studies on infection prevention in the future. For the first time, the presented research project “HygArzt” focuses on the implementation of hygiene measures by an infection prevention link physician (PLP) and investigates whether nosocomial infections, especially surgical site infections, can be reduced by the measures implemented. Trial registration: German clinical Trials register DRKS-ID:00013,296. Registered on March 5, 2018, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013296.
