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van CCT (UK)

van CCT (UK)

Helder Sturen - Veilige Zorg

- candidate number21554
- NTR NumberNTR5155
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2015
- Secondary IDs80-83200-98-025 ZonMw
- Public TitleHelder Sturen - Veilige Zorg
- Scientific TitleEffect of management team training on patient safety trough culture change.
- hypothesisBetere patientveiligheidscultuur leidt tot een betere naleving van de richtlijnen op de OK om postoperatieve wondinfecties te voorkomen.
- Healt Condition(s) or Problem(s) studiedSafety, Management, Team Practice, Administrator
- Inclusion criteriaZiekenhuizen met OK
- Exclusion criteriaGeen OK
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate31-dec-2015
- Target number of participants280
- InterventionsManagement team trainingen met sleutelfiguren uit het ziekenhuizen mbt POWI's
- Primary outcomeNaleving van de POWI-bundel.
- Secondary outcomePatientveiligheidscultuur Aantal ziekenhuisinfecties Handhygiene anesthesiepersoneel
- TimepointsNulmeting: juni 2014 Start interventie; juli 2014 Einde interventie: mei 2015 Nameting: juni 2015
- Trial web siten.v.t.
- statusopen: patient inclusion
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryIn modern health care systems, adverse events have been recognized as an important but largely avoidable threat to patients.
Culture and organisational change are essential in order to create safer health care systems and prevent adverse events, which pose a threat to public health and place a major financial burden on society. In order to improve patient safety culture on the work floor, it is imperative to include management in this process. Managers are central in the operationalisation of organisational patient safety goals, although concrete patient safety improvements are most often led by caregivers at the ward level. Combining these two worlds can lead to more successful patient safety interventions and long term improvements in patient safety.
The Dutch VMS programme stimulates hospitals to participate in various projects aimed at improving patient safety, for example a project aimed at reducing Postoperative Wound Infections (POWI) through the application of a bundle of interventions. POWI’s were chosen as one of the 10 themes hospitals should focus on, since they contribute to a large proportion of adverse events, as they are one of the most common types of complication for surgery patients. POWI’s always lead to an increased length of stay and often also to extra surgery, and therefore also to higher health care costs. Therefore, a bundle of evidence-based interventions was formulated in the POWI theme. Many hospitals are trying to implement the POWI bundle, but most encounter difficulties when trying to do so, particularly since the POWI bundle requires cooperation from several departments, disciplines, investment of time and energy and priorities. Stimulating and sustaining progress in the Dutch VMS programme could greatly benefit from interventions aimed at improving safety culture, and these interventions should primarily be targeted at the hospital management This study aims to evaluate the effectiveness of a previously developed team training intervention, which will be adapted to target hospital managers. The original team training intervention is based on the results and experiences of three ZonMw funded projects (330020056, 94517101 and 125030015). The team training intervention was successful in increasing the compliance with hand hygiene guidelines, which is considered a patient safety priority. Although the team training approach has so far been used to target specific patient safety behaviours of health care workers, it can also be applied at a management level to set culture norms and targets, identify barriers, stimulate successful leadership and employee empowerment and formulate management activities to improve patient safety. The proposed study will test the effects of this intervention on the adherence to patient safety measures (POWI bundle), on the occurrence of infections (POWI) and on the patient safety culture in the hospital. Furthermore in this study the factors leading to an effect will be investigated in detail in a process evaluation focussing on the determinants in innovation. In accordance to the Agency for Healthcare Research and Quality (AHRQ) report,, we will investigate the effectiveness and implementation experiences at both the individual organisations and as a group.
The effectiveness of the intervention will be investigated in four hospitals, in a pre-post design with repeated measurements.
The primary outcome measure will be the adherence to the POWI bundle, as defined by the VMS programme. This will be collected before, and 3, 6, 9 and 12 months after start of the intervention. The secondary outcome variables will be the occurrence of infections (POWI) and the patient safety culture, as measured by the Dutch ComPaz survey. These will be collected before and six and twelve months after the intervention. Process of the intervention at all levels (from intervention to organisation) will be collected pre and post intervention. Process indicators at the team level will be collected after each training session and six months after the last training session. Other process indicators identifying possible infection prevention activities outside the intervention package will be collected during the entire intervention.
This intervention, aimed at managers of different levels within the organisation, will stimulate participation in the various VMS themes and aid managers in translating the general VMS plans into implementation of concrete patient safety improvements within the hospital. It is this link which is essential for successful dissemination within the institution and sustainable progress in patient safety. In the current study proposal we will investigate the effectiveness of this intervention on the implementation of the POWI bundle, although the intervention could be applied to any of the other themes as well.
- Main changes (audit trail)
- RECORD12-jan-2015 - 31-mei-2015

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