News on the SIMoN study

SIMoN – ‘Stopping the isolation of patients with multi-resistant, gram-negative pathogens (3MRGN) in German intensive care units’ is a project in the field of healthcare research. It serves to develop and evaluate strategies for the care of patients with 3MRGN who are treated in German intensive care units.

The study is funded by the Joint Federal Committee (GBA) as part of the Innovation Fund.

Note for interested parties

The recruitment phase ended on 30 April 2023.

It is no longer possible to join the SIMoN study!

If you have any questions or require additional information, please contact the study director (PD Dr Rasmus Leistner), Dr Beate Schlosser (project manager) or Mrs Elke Lemke (specialist nurse for anaesthesia and intensive care medicine, study nurse).

Tel.: 030-450570233 oder 030-450577612

Fax: 030-450577920

Email: simon-studie-2021@charite.de

Dear SIMoN participants,

You can access the study materials (educational film, study videos, link for MOOC training video, patient information ...) at the top right of this page.

1. Why are we conducting the SIMoN study?

There have been no high-quality studies confirming the benefits of vertical prevention strategies (screening with subsequent isolation of positively tested patients) for MRP to date. According to KRINKO recommendations, the following 3MRGN species should currently be isolated: E. coli, K.pneumoniae (KP), P. aeruginosa (PA), A. baumanii (AB). Several studies have shown that horizontal prevention measures (including hand disinfection and continuous training programmes for infection prevention) are effective in preventing the spread of MRP.

The end of contact isolation would benefit staff, patients and their families and save time. With the Simon study, we want to show that the elimination of contact isolation on the study wards does not lead to an increase in the new acquisition rates of 3MRGN if, in return, the horizontal measures are intensified. In addition, our bundle of measures is effective in preventing infection from many pathogens and increases the contentment of staff, patients and relatives in everyday ward life.

2. What are our goals?

The aim of the SIMoN study is to show that the replacement of vertical prevention strategies (isolation) is effective in reducing the spread of multidrug-resistant Gram-negative pathogens (3MRGN). As a replacement for the lifting of contact isolation, a package of measures is being implemented to optimise horizontal infection prevention measures: twice-a-year measurement of hand hygiene compliance with feedback events and further training on infection prevention in German intensive care units. The SIMoN study will show that the planned interventions do not lead to an increase in 3MRGN on the study wards and that the interventions are beneficial to ward staff, patients and their relatives.

3. How do we proceed?

Participating intensive care units implement the planned interventions for at least 6 months. These include lifting contact isolation, measuring hand hygiene compliance every six months and further training courses on infection prevention for medical staff on the study wards. In a short survey to determine point prevalence, we regularly assess the compliance of application of the interventions. Furthermore, the Institute of Medical Sociology and Rehabilitation Sciences is conducting a survey of employees on their satisfaction in their day-to-day work. This survey is conducted anonymously and digitally in both study phases.

4. Who can participate?

German intensive care units that are willing to implement the planned interventions (lifting of contact isolation, six-monthly compliance measurements of hand hygiene plus feedback events; further training on infection prevention) are eligible to participate. The minimum participation period is 6 months. Participants must isolate at least the following 3MRGN species before the clinical trial starts: E. coli, K. pneumoniae, P. aeruginosa, A. baumanii

Preference will be given to ICUs that are already experienced participants in ITS-KISS surveillance (at least for MRGN). Newcomers to ITS-KISS pathogen surveillance can also take part in SIMoN. In this case, please contact us by telephone so that we can discuss the best approach for your case.