Improving leadership skills of infection prevention and control teams by psychological empowerment: study protocol for a cluster randomised controlled trial (IP-POWER)

Introduction

Healthcare-associated infections (HAIs) occur in connection with medical treatment, thereby jeopardising patient safety while leading to additional treatment needs, prolonged inpatient stays and increased mortality.1 A recent survey estimated the point prevalence of HAIs throughout Germany to be 4.9% in acute hospitals and 5.2% when including long-term care facilities.2 Extrapolated to the entire European economic area, almost nine million nosocomial infections per year can be assumed.3 A significant proportion of HAIs are preventable if evidence-based preventive measures are implemented in medical care.4–6

Infection prevention and control (IPC) teams are essential facilitators in implementing both legal requirements and medical guidelines in order to prevent HAIs and the spread of multidrug-resistant pathogens.7 In order to fulfil the requirements for optimal IPC, these teams have to cope with a variety of tasks: they design and create IPC plans, take part in various advisory committees, conduct inspections and fulfil the legal obligation to monitor nosocomial infections and multidrug-resistant pathogens, including consulting and feedback loops. In addition, they are responsible for training courses of the hospital staff and compliance/process observations.

This professional role implies a variety of challenges. In addition to the immense variety of tasks, IPC teams as intermediaries are confronted with diverse, sometimes conflicting interests. On the one hand, guidelines must be communicated and integrated as comprehensively as possible8; on the other hand, good relationships must be built and maintained with all those involved in the processes. New or updated guidelines often go hand in hand with considerable restructuring of workflows and organisational processes; the resulting (behavioural) changes are associated with additional work, at least in the short term, until new routines are successfully established.9 This additional effort is problematic for clinical staff, as systemic factors such as staff shortage, time pressure and workload are ubiquitous.10–12 Combined with a lack of awareness of the effects of their own actions,13 this results in resistance to change. In addition, there is an inertia to change that varies from person to person but is particularly strong in insecure living and working conditions, as routines provide a form of security and relief.14 15 In the clinical context, this inertia (‘clinical inertia’) is equally well known, both in the implementation of guidelines, the taking of medication or in the adherence to behavioural recommendations.16–18 This constellation complicates the work of IPC teams and can pose significant barriers to compliance with infection prevention (IP) clinical interventions and interdisciplinary collaboration.8 19 20

While front-line clinical staff is confronted with ever-changing and increasingly challenging work environments, so, too, are IPC teams; numerous studies indicate that the work of IPC teams has become more demanding and challenging in recent decades.21 22 There is a high level of emotional stress associated with time pressure, cognitive demands and inadequate communication regarding IPC.21 Since stress is associated with reduced patient safety, a correlation with HAIs can also be assumed.23 Deficient interdisciplinary cooperation between nurses and doctors also influences the likelihood of burn-out24 and can, therefore, impair IPC. In contrast, an empowering emotional context and committed clinical leaders are associated with lower infection rates.25 It has also been shown that positive emotional contexts are associated with intrinsic motivation.11 Against this background, IPC teams are challenged in two ways: they must not only professionally deal with the additional personal burden but also absorb the burden on the part of the clinical staff, all the while taking both aspects into account when implementing IP measures.

In successfully combining both highly specialised knowledge acquisition and teaching psychosocial skills, training for a job in IPC is very heterogeneous in Germany26 27; with regard to the latter, the focus is on didactic-pedagogical knowledge, which, however, is often not applicable beyond the training context. There is currently no comprehensive support from psychologists; the situation is worsened by the fact that there are no relevant, compulsory training courses for IPC professionals. As a result, scientifically sound (psychological) training is the hospital’s or individual’s responsibility.

Overall, IP-POWER aims to better understand the diverse and demanding profession of IPC while strengthening IP in their work. In order to empirically record the extent of burdens and support needs within the field, our research group initiated a nationwide needs assessment in the run-up to the cluster-randomised controlled trial (C-RCT) described hereafter. IPC teams’ specific burdens, support needs and resources were assessed. In addition, the extent to which psychological input was addressed during IPC training in terms of competencies in behavioural change and communicative skills was evaluated. Analyses show a lack in self-efficacy in dealing with resistance as a risk factor for work strain, and support needs regarding resistance-related and emotion-related communication; major deficits in this area were reported during professional training.28

Given that IPC interventions differ according to the target group, the IPC-CASCADE model8 was used to design an intervention that focuses on the IPC professional’s role as both a multiplier (for clinical staff) and intermediary (functioning on a level between hospital management and front-line staff).29 In designing a tailor-made concept using both this approach and the results obtained via the nationwide survey, it is assumed that positive change among higher levels of the model (in this case, IPC professionals) can be transferred to the lower levels of the model (in this case, clinical staff), thereby reducing rates of HAIs.

By including interpersonal and emotion-related factors into the training concept, not only social and communicative competences in dealing with emotionally challenging situations are to be trained but also interdisciplinary as well as interprofessional cooperation is to be improved, which in the long run should enable an optimisation of IP. The innovative linking of behavioural psychology and relationship management imparts not only new competencies but also a different approach to well-known and well-established difficulties within the field of IPC. The intervention concept combines the three main topics: motivation, resistance and feedback.

In focusing on these aspects, IPC teams cannot only be given competencies and skills but will develop a solution-oriented attitude that enables them to handle complex situations while encouraging sustainable and proactive structures. In this vein, a consistent promotion of attitudes and competencies will succeed in building an environment that hardly needs any external control or support. Translated to IPC, this means that empowered IPC teams succeed in establishing optimal compliance among clinical staff and in creating an environment in which self-regulatory mechanisms maintain a high level of compliance. IP-POWER’s specific aims are as follows: (1) to improve leadership competencies of IPC teams members by psychological empowerment interventions (primary aim), (2) to improve their self-efficacy in dealing with resistance and emotions as well as their perceived level of goal attainment, and as an indirect effect (3) to improve clinicians’ hand hygiene capabilities, motivation, planning skills and compliance (secondary aims).

Methods and analysis

Trial design

IP-POWER is a multicentre, two-arm, non-blinded, parallel-group, C-RCT with one usual practice waiting control group. The intervention consists of a 2-day, on-site workshop with IPC teams and a 12-week supervision period in order to psychologically empower them and hone their leadership skills (see figure 1).

Figure 1
Figure 1

Flow chart diagram showing the steps of baseline assessments, intervention strategies in the two study arms (intervention group: psychological empowerment versus waiting control group: usual practice) and follow-up data assessments.

Baseline levels of outcomes will be assessed in the period between the kick-off event and the start of the intervention. The participating IPC teams will be sent a link to an online questionnaire after attending the kick-off event. At the same time, a link to an online questionnaire addressing the respective hospital’s front-line staff will be provided; the link will be passed on to the clinical staff by a member of the IPC team. Both questionnaires should be completed by the start of the intervention. In the course of the data processing, each participant is assigned a personal code that enables a pseudonymised evaluation of the data.

In addition to the online questionnaires, hospitals will be asked to provide hand hygiene compliance data for the period between 1 April 2022 and 30 September 2024 (before the intervention).

Once the baseline data are available, the intervention will take place at the respective hospital site(s). The 2-day workshop will be conducted on-site by the study team’s medical and psychological specialists. Afterwards, the IPC teams have the opportunity to apply and test the findings from the intervention in their usual working environment over a period of 12 weeks. During this time, a monthly consultation (online and/or by phone) will be offered by the study team to clarify questions and reflect on progress. If necessary, a maximum of two further consultation occasions will be granted, so that a maximum of five exchange opportunities per hospital will be made possible.

The follow-up measurement will be carried out after the 12-week implementation period. The outcomes recorded in the baseline measurement will be collected again via online questionnaires in order to check the extent to which changes have occurred in the observed measured variables.

After the end of the intervention, the respective hospital’s current hand hygiene compliance data will be requested. After completion of the C-RCT phase, the hospitals in the waiting control group will be offered an optimised and therefore shorter workshop based on the project experience, which, as in the intervention group, should contribute to an ‘empowered’ practice in the sense of the project approach.

Study setting, eligibility criteria, sampling and participants

Based on a query of data from the Federal Statistical Office (as of 31 December 2020), all German hospitals with >400 beds were addressed; this selection was supplemented with contacts and distribution lists of the German Hospital Association (DKG). In total, 250 hospitals across Germany were addressed directly and its IPC staff was asked to participate in the needs assessment survey; forwarding of the survey to additional hospitals was achieved via distribution lists and various professional associations. At the end of the survey, there was a call to get in touch with the study coordinator if the hospital was interested in participating in the intervention study, that is, the C-RCT. Twenty-five interested hospitals responded and were contacted via telephone by the study team to evaluate the inclusion and exclusion criteria (see table 1).

Table 1

Eligibility criteria for the IP-POWER trial

Interventions

In the study‘s intervention arm, the 2-day on-site workshop will include psychological empowerment modules regarding the following components: motivation, dealing with resistance and emotions, and feedback. Both knowledge transfer and practical, experiential skills training elements will be integral parts of the workshop. All workshops will be held both by a certified specialist in hospital epidemiology and a certified psychologist from the IP-POWER project team. To foster the relevance of the workshop to the participating teams’ IPC practice, they will be invited to provide the IP-POWER team with examples of challenging situations and issues prior to the workshop, which will then be taken up. Following the workshop, each IPC team will have the opportunity to receive supervision for 12 weeks. As a rule, the project team will offer three to a maximum of five digital consultations per month. This part of the intervention aims to support implementation of the approaches develop in the workshop. Discontinuation of this part of the interventions is left to the discretion of the participants.

Prior to interventions, the kick-off meeting (see figure 1) will be used to inform the IPC teams in the study hospitals about details of the project, including both assessments of outcomes and the application of the interventions, in order to both clarify uncertainties, overcome ambiguities and eventually improve the participants’ adherence to the protocol.

Primary outcomes

The leadership competencies of IPC teams are measured by adapted versions of three subscales of the validated German ‘Leadership Effectiveness and Development’ questionnaire,30 31 namely ‘Environmental Design’, ‘Personal Influence’ and ‘Staff Development’ (see table 2). Approved by the authors30 31 and the publisher (Hogrefe), the language and content have been adapted to align with the IPC context. The instruments allow both self-assessment and external (=peer) assessment of competencies, both of which will be measured. Self-assessment is done by all members of the IPC team participating in the trial, whereas the external assessment will be performed by the respective study hospital’s clinical staff; no restriction will be made with regard to ward type or medical specialisation. The assessment will be carried out twice: before the start of the intervention and after the intervention (figure 1).

Table 2

Presentation of outcome measure, method of data collection, data source and time of assessment

Secondary outcomes

Secondary outcomes will be the following (see table 2):

  • Perceived work strain is measured using questions from the initial needs assessment, including items on distancing ability, emotional competence, self-efficacy and dealing with resistance. These measurements are taken both before and after the intervention.

  • Based on KRINKO (Commission for Hospital Hygiene and Infection Prevention at RKI) recommendations,6 a grouping of typical IPC activities was created; it is assumed that the quantitative distribution of the different activities is dynamic in nature. This measurement is carried out both before and after the intervention.

  • The Goal Attainment Scale32 33 is used to assess the extent to which personal perceptions of success in implementing infection control activities change. The measurement is carried out both before and after the intervention.

  • Capabilities, motivation and planning skills with regard to hand hygiene as an infection-preventive activity are measured with scales based on.34

  • Compliance with hygienic hand disinfection on normal and intensive care units before and after intervention, as recorded by the hospitals according to the protocol of the German Clean Care is Safer Care Campaign,35 will be compared.

Sample size and recruitment

Based on the inclusion criteria and the variable size of the IPC teams, and depending on the size of the hospital, a sample size of N=85–125 staff members is assumed for the primary outcome on the side of the IPC team. For the primary outcome of the IPC teams’ leadership skills as assessed by the clinical staff, a sample size of N=310 clinical staff per study arm is assumed, based on previous experience in earlier studies.36–38 Based on calculations with the tool G*Power and with regard to the significance level starting from an α-error probability of p<0.05, this corresponds to an effect size of 0.2 and a test strength of 0.8.

Accordingly, the survey of clinical staff can be considered completed when at least 310 persons per study arm have documented data on baseline and follow-up. If necessary, an increase to compensate for the drop-out should be targeted by further reminders to participate in the survey. The planned start and end dates for the trial are 1 February 2024 and 30 November 2024, respectively.

Allocation and blinding

Cluster randomisation of the participating hospitals will occur after both the kick-off meeting and the acquisition of the baseline data. It will be handled by the Clinical Trial Centre (ZKS) Leipzig. An intervention group and a waiting control group will be formed, both with an N of 5. Block randomisation will be conducted using R/Excel; hospitals will be randomised in blocks of two according to their size, with two tertiary university centres being treated as a separate block. Due to the psychological-educational qualities of the interventions, blinding has been considered unfeasible both by the peer reviewers involved in the funding decision, the Ethics Committee of the University of Leipzig, the consulting Clinical Trial Centre (ZKS) Leipzig, and the project team.

Data collection and management, and statistical methods

Duplicate measurements in the primary outcome will be prevented by use of a pseudonym approved by data protection officers and the ethics committee for each participant. Questionnaire measures will come to participants as an online survey designed by the project team (LimeSurvey) and distributed within each of the participating hospitals. Training of hand hygiene compliance assessors is ensured by the inclusion criterion ‘quality level of in-house hand hygiene monitoring’. Further details of study instruments are available in Primary outcomes and Secondary outcomes sections or from the corresponding author. Promotion of retention and complete follow-up of participants in control group is aimed-at by the intervention after follow-up (waiting control).

Data files will be stored on the Leipzig University Hospital’s file server. Access to the network drive and related files will be available to study team members only. All relevant data will be backed up daily throughout the course of the study. In order to conduct the biometric analysis of the project, the collected data must be transmitted to the Hannover Medical School (MHH). The data will be transferred from the IP-POWER team to the MHH server in Hanover via a web interface and transport-secured transmission. Access to the MHH data network is only possible with personalised access, which must first be requested from the MHH Information Technology Centre. Access to the data by third parties is not possible.

The statistical analyses are the following (primarily using IBM SPSS Statistics 29 or later):

  • Primary outcome: The IPC teams’ leadership competence as assessed by the clinical staff is modelled using multiple linear regressions (general linear model) with the regressor ‘study arm’ as a dummy variable. In the process, adjustments will be made for relevant confounders (especially sociodemographic parameters).

  • Secondary outcome: ‘Perceived burden on the part of the IPC team members’: The facets of this outcome will be analysed descriptively.

  • Secondary outcome: ‘Typical activities of the IPC teams’: This outcome will be analysed descriptively.

  • Secondary outcome: ‘Personal perception of success of the IPC team members’ (Goal Attainment Scale32 33: This outcome will be analysed descriptively.

  • Secondary outcomes: ‘Capabilities, motivation and planning skills of clinical staff with regard to IP activities (scales following34)’: These outcomes will be analysed by regression analysis in analogy to the primary outcome (see above) in order to test for differences according to study arm.

  • Secondary outcome: ‘Hand hygiene compliance’: Estimates of confidence intervals of compliance rates and their differences by study arm, Breslow-Day tests for interactions of compliance differences between study arms and χ² tests will be performed.

The results of the descriptive analyses, confidence estimates, significance tests and regression models will be prepared and presented according to clinical-epidemiological standards. The preparation of a statistical analysis plan is not included. Multiple imputation is not planned. The assessment of protocol violations and intervention discontinuations due to missing or uncertain data or data that was not collected according to the protocol will be carried out in cooperation between the study management and the project management. The study management reserves the right to terminate the study in the event of non-compliance or impracticability.

Monitoring

Since safety concerns were voiced neither by the peer reviewers involved in the funding decision nor by the ethics committee, and IP-POWER is not a clinical trial with a sponsor, no data monitoring committee was established. Interim analyses will be conducted exclusively for purposes of data quality management. There are no stopping guidelines other than unexpected non-achievability of the trial’s primary aim (main criterion: achievement of at least 310 measurement points per study arm regarding the primary outcome). The project team and funder will have access to information in these contexts. Teams in the participating hospitals will be encouraged to report any adverse events and other unintended effects of trial interventions or trial conduct.

Patient and public involvement

Patients and the public were not involved because the trial addresses the professional interaction between IPC teams and clinical staff, and no interactions with patients or the public.

This post was originally published on https://bmjopen.bmj.com