Strengthening the role of hospital leadership in infection control (LEAD-IC) – a multimodal educational intervention in German acute care hospitals

Background The effect of leadership support for adherence to infection control and prevention (IPC) measures has been demonstrated. To expand this support, a target group-specific educational study for chief medical officers (CMO) was implemented and its influence on IPC indicators was investigated. Methods A controlled cohort study was conducted between 2018 and 2019. The intervention based on an initial workshop, an e-learning course, and a final meeting. Participants’ activities involving IPC management were surveyed. Consumption of alcohol hand rub (AHR) and incidence density of hospital-associated (HA) Clostridioides difficile-associated infections (CDI) were analyzed. Results Eight percent of 360 CMOs invited participated in the initial workshop; 70% of those participants registered for the online course. Overall, 43% completed the post-intervention questionnaire, in which 85% of respondents reported increased collaboration with relevant stakeholders. The pre-intervention median AHR consumption was higher in the intervention group than in the control group. Both groups showed an increase (38.6 (interquartile range (IQR) 33.6; 45.0) to 41.9 ml/patient day (PD) (IQR 35.0; 56.6) and 33.4 (IQR 28.3; 40.8) to 35.8 ml/ PD (IQR 31.6; 43.2), respectively). Pre-intervention median HA CDI cases were lower in the intervention group than in the control group. Both groups reported a decrease (0.22 (IQR 0.17; 0.33) to 0.19 cases/1000 PD (IQR 0.15; 0.26) and 0.32 (IQR 0.2; 0.48) to 0.22 cases/1000 PD (IQR 0.11; 0.33), respectively). Conclusion Multimodal IPC training of CMOs is worthwhile and can lead to changes in IPC-relevant cooperation in hospitals. IPC training of hospital management should be further intensified. Supplementary Information The online version contains supplementary material available at 10.1186/s12909-023-04709-z.


Background
Effective measures which are known to prevent nosocomial infections and reduce antibiotic resistance are not always fully implemented in German hospitals.Since 2011 the Infection Prevention Act (Infektionsschutzgesetz, IfSG) and state hygiene ordinances have made hospital management responsible for compliance with infection prevention measures.
This task is usually assigned by the management of a hospital to its chief medical officer (CMO).In most cases, however, these medical officers do not have the appropriate professional background to perform this task.Expertise in the field of infection prevention and control (IPC) is found mainly in the hospital hygienist and hygiene specialists.However, when it comes to implementing prevention measures-measures that as yet have not been successfully implemented-these staff members often do not have sufficient authority or influence to carry out the necessary changes.The fact that support from hospital management has a positive effect on compliance with prevention measures has been demonstrated in several studies (Brannignan et al, Frankel et al, Siant et al, Sinkowitz-Cochran et al).Within the framework of support, barriers can be identified and reduced and employees motivated to implement prevention measures.Active support on the part of management (leadership) is thus an important contribution to the culture of safety in hospitals.
Up to now, the cooperation of the above-mentioned individuals, which is urgently needed for infection prevention, has been concentrated in most hospitals on the hygiene commission meetings required by the IfSG and which have to be held regularly.These commission meetings are an important forum for analysing the current status of infection prevention, identifying priorities for further work, and discussing the introduction of further measures.However, the interaction between the CMO and a hospital's IPC staff at IPC commission meetings is usually not adequate in the long term for successfully implementing the measures necessary.
In a 2014 survey of 534 KISS hospitals, 79% of the senior IPC staff reported that the hospital management was involved in the IPC commission.However, concrete objectives with regard to specific IPC-relevant process indicators were only set in 13% of the hospitals.Only 47% of the senior IPC staff felt they were actively supported by hospital management in implementing IPC measures, and in only 25% of the hospitals did the hospital management offer "rounds" (so-called "WalkRounds") (Hansen et al., Bundesgesundheitsblatt 2016).
Within the framework of standardized, multicentre training courses on sepsis prevention in intensive care units (ISEP, Hansen et al.) and neonatal intensive care units (NEO-ISEP, Salm et al., both within the framework of the Hospital Infection Surveillance System (KISS)) and the "Clean Hands Campaign," it has been shown that there is great interest to do more in the field of infection prevention in many hospitals.In the ISEP and NEO-ISEP projects, a significant reduction in bloodstream infections was achieved within the framework of such training materials.

Objective
Building on these experiences, the project "LEAD-IC" ("Leadership in Infection Control" or "The Role of Hospital Management in Infection Prevention") is to be developed.The LEAD-IC project is intended to support hospital management (usually the CMOs) with a structured approach that will better prepare them for their tasks, as specified by the IfSG, and to improve the implementation of IPC measures through the competence and commitment they get from the project.This is a first in Germany.
Important starting points for effective design of infection prevention in hospitals are to be conveyed within the framework of a structured multimodal training program.This is also intended to establish synergies between the hospital management and the hygiene team of a hospital for overcoming barriers and to improve IPC.

Primary study objective
Can structured multimodal training of hospital management reduce the incidence of bloodstream infections (BSI) in hospitals?

Secondary study objectives
Can a change in the following indicators be achieved through structured, multimodal training of hospital management?i.) A reduction in the incidence of bloodstream infections by multidrug-resistant organisms (MDRO) and/or ii.) a reduction in the incidence of nosocomial Clostridium difficile infections (CDI) iii.) an increase in the hospital-wide consumption of alcohol-based hand disinfectant.

Study design and inclusion criteria
LEAD-IC will be conducted as a prospective, cluster-randomised, controlled intervention These hospitals are to be randomly divided into 2 groups: Group 1 hospitals will have the opportunity to participate in the intervention during the first intervention period (year 2018), while Group 2 hospitals will have the opportunity to participate in the intervention during the second intervention period (year 2019).The control group will be (i) the respective intervention group before the start of the intervention, (ii) in 2018, intervention group 2 will serve as a control for intervention group 1.Before the intervention and after the end of the intervention period, IPC structures of the hospital will be surveyed by means of a structured questionnaire.

Recruitment
The CMOs of all 402 hospitals will be contacted by post and invited to participate in the study.Doctors (or their deputies) who agree in writing to participate will be invited to an introductory event and later will be given training online over a 5-6 week period (see below).

Randomization and blinding
All participants who have given their written consent to participate will be randomly assigned to one of the two intervention groups.A later change of this assignment (e.g.due to scheduling difficulties of the participants) will not be possible.Participants will be instructed in the introductory session not to inform their co-workers about the study.This is to avoid the intervention (training of the doctors) being influenced by knowledge of the study by other hospital staff.Blinding of the participants with regard to the endpoints is not planned.

Primary endpoint:
The rate of bloodstream infections per hospital per year, measured as number (n) of all positive blood cultures (BC) per 1000 patient days/ number (n) of all BK per 1000 patient days.Since data on blood cultures taken is not routinely collected for the entire hospital in the KISS system, the hospitals must request this data from the department responsible for the data or the responsible microbiological laboratory and transmit it to the study center.The methodological approach of using BC at hospital level as an has already been carried out in other studies (Rock et al, 2016;Leekha et al, 2013).

Study period
The intervention will take place over 12 months in 2018 (group 1) and over 12 months 2019 (group 2) and will begin with an introductory event in the first quarter.Data collection will take place at the beginning of the study and at the end of the intervention phase.Online training will start for both groups in the first quarter of the intervention and run for a period of 5-6 weeks.In the 2nd quarter, 2 reminders will be sent to the participants.

Sample size calculation
The calculation of the sample size is based on an expected decrease of 15% in the primary endpoint (nosocomial BSI).
Based on studies in R-net (network of the DZIF), a median BSI incidence of 0.5 per 100 patients can be assumed.Assuming an alpha error of 0.05, a power of 80%, an expected reduction effect by the intervention of 15%, and a design effect (which was estimated on the basis of KISS ICU data on catheter-associated bloodstream infections with an intra-cluster correlation of 0.13), the sample size will be approx.130,200 patients per group.
On average, approx.15,000 patients per hospital and per year are to be expected.
Accordingly, at least nine hospitals per group are to be included.Taking into account possible "dropouts," it is planned to include 15 hospitals per group (calculated by Christin Schröder on 25.07.17).

Intervention (multimodal training of hospital management)
The intervention starts in both groups with a one-day introductory event at the beginning of the intervention period.Here, an introduction to the study will be presented and preliminary knowledge provided about the organization of the IPC team and procedures in the event of outbreaks (topics 1 & 2, see below).During the next 5-6 weeks, the participants will be trained online in five additional topic complexes to be structured as follows (topics 3-7):

Implementation of the online training
The online training courses will take place in the form of MOOCs (Massive Open Online Courses) in 5 weekly blocks.Participants must register one time on the corresponding internet platform with an email address and a password and will then receive an email at the beginning of each week reminding them to participate.The content of MOOCs is conveyed primarily in the form of video sequences.Learning materials can also be downloaded from the platform, and participants can exchange information on forums.After each weekly block, there will be a multiple-choice test that checks individual knowledge.The results of the multiple-choice test will be reported back to the participants individually; the study center will receive the results anonymously.The weekly blocks consist of 3-5 video sequences, each 5-10 minutes long.The total weekly training time should not exceed 60 minutes.A hotline to the study center, which is active at pre-determined times, will give participants an opportunity to ask questions when uncertainties arise.

Data protection and ethics
No personal data of patients will be collected or transmitted.A data protection vote and a positive vote by the ethics committee have been obtained for the anonymized collection and evaluation of the cumulative KISS data.For the current project, a data protection application and an ethics application will be submitted to the Charité, and the study will begin only after a positive vote.The data of the hospitals and the responsible hospital management will be evaluated pseudonymously, aggregated in the study center, and published.The heads of the participating hospitals must give their consent for participation in the study.

Cooperations
Within the framework of the study, cooperation is to be entered into with the following institutions: -German Hospital Association (DKG) Support in the recruitment of participating hospitals -Association of Hospital Directors in Germany (Verband der Krankenhausdirektoren Deutschlands eV), requested Support in recruiting the participating hospitals Support in the design of the training materials with regard to their target group-specific applicability study of stepped-wedge design.Eligible participatants are the EDs or their deputies of those hospitals in Germany that have been participating in Hand-KISS (Surveillance of Hand Disinfectant Use (HDMV)), MRSA-KISS and CDAD-KISS (Surveillance of Clostridium difficileassociated diarrhea) modules of the National Reference Centre for Surveillance of Nosocomial Infections (NRZ) since 2016 and for at least 18 months (n=402, as of 04/2017).
Analogous to the study byRock et al., the collection of data on the primary endpoint should be uncomplicated and only the absolute values of BC or positive BC per year should be requested.The possibility of multiple collections from a single patient or possible contamination of the BCs with coagulase-negative staphylococci should not be taken into account primarily as it is assumed that this figure will not be influenced by the intervention.For the secondary endpoints: In order to calculate the rate of bloodstream infections by multi-resistant pathogens (MRE) per hospital per year (number (n) of all positive blood cultures (BC) per 1000 patient days/ number (n) of all BC with evidence of MRE per 1000 patient days), the pathogen type will also be recorded when a BC is positive and transmitted to the study center.The determination of resistance will be carried out by the respective hospital laboratory, whereby the participating hospitals must specify the methodology used for testing resistance (EUCAST, DIN 58940 or CLSI (Clinical & Laboratory Standards Institute)).The other secondary endpoints (incidence of nosocomial Clostridium difficile infections and the consumption of alcohol-based hand disinfectant per hospital per year) are recorded directly via KISS.

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What is the optimal organization of the hygiene team and the liaison staff to the wards (doctors responsible for hygiene, nursing staff responsible for hygiene) based on the type and size of the hospital?What aspects must be considered when outsourcing important services related to infection prevention (microbiological laboratory, central sterilization, cleaning, etc.)?  What must be considered when establishing antibiotic stewardship (ABS) concepts?Face-to-face meeting 2  How do you organise good crisis management during outbreaks?Face-to-face meeting 3  How is a good overview of infection rates, resistance rates, and the implementation of processes obtained, based on conditions in each hospital?What is the best way to support the hygiene staff in terms of How should hygiene committee meetings be organised so that they improve the implementation of prevention measures?Is it useful to define hospital-wide prevention targets, From a hospital hygiene point of view, what should one be aware of in hospital management "