SAFE-LEAD: Details

For those who are interested in finding out more about SAFE-LEAD we have listed some details below on the following topics: Background (Quaser-guide), The SAFE-LEAD leadership guide, Aim and research questions, Methods, Work schedule, About the SAFE-LEAD intervention.

Background (Quaser-guide)

The SAFE-LEAD project builds and expands on the outcomes of a recent EU FP7 project (QUASER project). This project developed a tool for leaders in European hospitals (the QUASER-guide) to support their quality and safety improvement work. The QUASER guide is based on extensive research in five European countries funded by the European Commission’s Framework Seven Program. SAFE-LEAD will further develop the QUASER guide and adapt it to the Norwegian primary health care setting.

The SAFE-LEAD leadership guide

The leadership guide is structured around a short series of questions to stimulate reflection on quality and safety and an accompanying decision-aid menu of potential options, including strategies across macro, meso and micro system levels. Use of the guide is designed to facilitate patient safety and quality improvement in clinical practice and service delivery, by providing a means for managers to systematically identify the strengths and weaknesses of their improvement approach and reflect on what is needed to develop quality improvement and patient safety efforts tailored to their particular institution and its context.  Specifically, the guide encourages leaders to reflect on existing quality and safety improvement work according to eight essential organizational quality and safety improvement challenges:

  • Structural – organizing, planning and coordinating

  • Political – politics of change, power issues

  • Cultural – giving ‘quality’ a shared, collective meaning

  • Educational– creating learning processes

  • Emotional – enthusiasm, engaging, mobilizing people

  • Physical and technological – designing physical systems and technological infrastructure

  • Contextual – social, political and contextual factors (inner & outer)

  • Senior leadership – strategic leadership across challenges

Aim and research questions

The overall aim is to build leadership competencies in quality and safety improvement strategies among primary care leaders. SAFE-LEAD will:

  • Investigate the influence of context on the implementation of an evidence-based quality and safety leadership intervention in primary care

  • Test the effectiveness of the leadership intervention on changes in knowledge, attitudes and practices relating to quality and safety in primary care

  • Develop theory to guide implementation of future leadership interventions designed to improve the quality and safety in primary care

  • Compare the results with the results of a similar study in Netherlands

Research questions:

  • What are the key contextual factors influencing quality and safety improvement in the Norwegian primary care setting?

  • How can the SAFE LEAD Primary Care intervention best be designed to implement use of a research-based quality and safety improvement tool in primary care?

  • What contextual factors, including leadership practices and processes influence successful implementation and use of the QUASER guide in primary care?

  • How can patient and next of kin involvement be integrated into the QUASER guide and the overall SAFE LEAD Primary Care intervention?

  • What are the implications of the SAFE LEAD Primary Care research findings on the development of theoretical perspectives on links between organisational context, leadership processes and quality and safety improvement efforts in primary care settings?

  • What are the similarities and differences in factors determining successful implementation of a research-based quality and safety improvement tool in Norway and the Netherlands?

  • How and to what extent do the identified key contextual factors explain implementation, uptake, and impact of the SAFE LEAD Primary Care intervention across differing nursing homes and homecare services?


The project will use a mixed-methods design. The intervention will be evaluated through process evaluation, a survey on outcome measures (knowledge, attitudes, practices), and contextual mapping, using both qualitative (interviews, observations) and quantitative methods. At the end of the study, the results from the qualitative, quantitative, and context data will be synthezised.

Furthermore, we will use a contrasting case approach. Four nursing homes and four homecare services will be recruited to the study (from 4-8 municipalities) based on such selection criteria as size, geography, and variation between city, and rural based services. A similar study is planned in the Dutch healthcare setting, allowing for cross-country comparison.

Work schedule

The research will be organized in five work packages, described below.

Work Package 1: Guide adaptation, pilot test, and contextual mapping tool.

The aims at this stage is to:

  • Translate and adapt the QUASER guide for use in a Norwegian primary care context

  • Pilot test the Norwegian version of the QUASER guide in a primary care setting

  • Develop a web-based QUASER tool to facilitate its implementation and use

  • Develop a contextual mapping tool for use in the intervention implementation and evaluation

Work Package 2: Intervention design, pilot testing, recruitment, and contextual mapping

The aims at this stage is to:

  • Design the intervention

  • Pilot test the intervention in one nursing home and one homecare setting

  • Recruit four nursing homes and four homecare services for the intervention study

  • Conduct the contextual mapping of the recruited institutions

  • Conduct a literature review on measurement scales

Work Package 3: Testing and evaluating the SAFE-LEAD Primary Care intervention

The aims at this stage is to:

  • Test the intervention in a variety of primary care settings

  • Evaluate the broad impact of implementing a research-based quality and safety improvement tool in practice,

  • Assess which contextual factors, including leadership practices and processes influence successful implementation and use of the QUASER guide tool in nursing homes and homecare services

Work Package 4: Mixed methods synthesis, cross-country comparison, theory development

The aims at this stage is to:

  • Synthesize the evaluation results from the leadership intervention

  • Conduct a cross-country comparison

  • Develop theory on the relationship between leadership-focused interventions, contextual factors, and quality and safety improvement work

About the SAFE-LEAD intervention

The intervention will be conducted in two stages. The first stage involves all eight institutions in the sample, while stage 2 involves four of the eight institutions.

Stage 1 is a training component involving action learning workshops in which primary care managers and their teams will be able to apply the leadership guide and conduct a self-diagnosis of their current quality and safety work. A team involving experienced researchers in the project will facilitate reflexive group discussions among the teams, which will take place in four group sessions (two hours each) in all participating institutions over a six-month period. It is proposed that each group will consist of an extended management team (director of health and care services in municipality, nursing home director/director of homecare services, department managers, head nurses, nursing home physicians, and patient representatives). These sessions will act to:

  • Introduce the leadership guide to the participating institutions (rationale, concepts, web-tool, procedure)

  • Provide tools for integrating patient and next of kin experiences in quality and safety improvement work

  • Establish strategies to address the diagnosed quality and safety challenges

  • Help adjust the established strategies according to management team members’ experiences with the improvement work (across the intervention period)

This stage of the intervention will be evaluated through a KAP survey on staff and leaders before the intervention, and six months after.

Stage 2 is a more comprehensive intervention, which will involve an in-depth improvement process in closer collaboration with the researchers. At this stage, a narrow sample of two nursing homes and two homecare services (from the total sample of 8 institutions) will participate. The researchers will work with managers on the implementation of the QUASER-guide in their organization. Selection of the four study sites will be conducted according to a contrasting case approach, based on criteria related to size, geography, and variation of the participating municipalities (city, town, rural). The intervention will hence allow for pattern recognition across nursing homes and homecare services in different contextual settings. In addition to the training component described in Stage 1, the institutions in this narrow sample will be involved in three site visits à three days per institution over a period of 12 months (Stage 1 + Stage 2=12 months). Activities during site visits will involve:

  • A workshop to support existing and new learning arenas in clinical improvement work

  • Observations and feedback on quality and safety leadership strategy and practices

  • A workshop to support the use of tools

This stage of the intervention will be evaluated through qualitative process evaluation: quality and safety leadership processes and practices.