Struggling with the governance of interprofessional elderly care in mandated collaboratives: a qualitative study.

BACKGROUND: Governing interprofessional elderly care requires the commitment of many different organisations connected in mandated collaboratives. Research over a decade ago showed that the governance relied on clan-based mechanisms, while lacking formal rules and incentives for collaborations. Awareness and reflection were seen as first steps towards progression. We aim to identify critical governance features of contemporary mandated collaboratives by discussing cases introduced by the healthcare professionals and managers themselves. METHODS: Semi-structured interviews (n = 24) with two regional mandated collaboratives took place from November 2019 to November 2020 in the Netherlands to learn more about critical governance features. The interviews were thematically analysed by the project team (authors) to synthesise the results and were subsequently validated during a focus group. RESULTS: Critical governance features of interorganisational activities in mandated collaboratives include the gradual formulation of shared vision and clear client-centred goals, building trust and acquaintanceship for the advancement of an open collaborative culture, establishing a non-extreme formalised governance structure through leadership, mutual trust and innovation support and facilitating information exchange and formalisation tools for optimal elderly care. CONCLUSION: Trust and leadership form the backbone of interorganisational functioning. Interorganisational functioning should be seen in light of their national embedment and resources that are (being made) available, which makes them susceptible to constant change as they struggle with balancing between critical features in a fluid and intermingled governance context. The identified critical features of (contemporary) mandated collaboratives may aid in assessing and improving interprofessional functioning within integrated elderly care. International debate on governance expectations of mandated collaboratives may further contribute to sharpening the roles of both managers and healthcare professionals.

Epistemic Injustice in Incident Investigations: A Qualitative Study.

Serious incident investigations-often conducted by means of Root Cause Analysis methodologies-are increasingly seen as platforms to learn from multiple perspectives and experiences: professionals, patients and their families alike. Underlying this principle of inclusiveness is the idea that healthcare staff and service users hold unique and valuable knowledge that can inform learning, as well as the notion that learning is a social process that involves people actively reflecting on shared knowledge. Despite initiatives to facilitate inclusiveness, research shows that embracing and learning from diverse perspectives is difficult. Using the concept of 'epistemic injustice', pointing at practices of someone's knowledge being unjustly disqualified or devalued, we analyze the way incident investigations are organized and executed with the aim to understand why it is difficult to embrace and learn from the multiple perspectives voiced in incident investigations. We draw from 73 semi-structured interviews with healthcare leaders, managers, healthcare professionals, incident investigators and inspectors, document analyses and ethnographic observations. Our analysis identified several structures in the incident investigation process, that can promote or hinder an actor's epistemic contribution in the process of incident investigations. Rather than repeat calls to 'involve more' and 'listen better', we encourage policy makers to be mindful of and address the structures that can cause epistemic injustice. This can improve the outcome of incident investigations and can help to do justice to the lived experiences of the involved actors in the aftermath of a serious incident.

Assuring data quality in investigator-initiated trials in dutch hospitals: Balancing between mentoring and monitoring.

The complexity of regulations governing investigator-initiated trials (IITs) places a great burden on hospitals. Consequently, many hospitals seek to alleviate regulatory pressures by seeking an alternative quality management system (QMS). This paper takes the Netherlands as a case. To investigate how QMSs for IITs are organized in Dutch hospitals, we adopted the theoretical concepts of mentoring and monitoring in a mixed methods study in the period 2014-2018. In clinical practice and international guidelines, monitoring is seen as the standard quality assurance for ongoing trials. However, hospitals have implemented monitoring programs that resemble mentoring. The contrast between these ideal types is less pronounced in practice as both combine elements of compliance and feedback for learning in practice. In a monitoring setting, learning is one-way, from monitor to researcher; whereas mentoring focuses on mutual support and learning. To tackle problems in each system, the authority of the Board of Directors (BoD) and the BoD's relationship with staff members are crucial. We discuss the challenges that BoD and staff face in keeping an integrated view of the various components of QMSs.

Institutional work to maintain, repair, and improve the regulatory regime: How actors respond to external challenges in the public supervision of ongoing clinical trials in the Netherlands.

BACKGROUND: National regulatory regimes for supervising ongoing clinical trials are affected by external challenges, both international, such as harmonization of EU legislation, and national, such as critical reviews of incidents. This study examines how supervisory bodies dealing with ongoing trials respond to external challenges of the past two decades and engage in institutional work to maintain, repair, or improve the Dutch regulatory regime. METHODS: International and national regulatory documents were analyzed and interviews (n = 27) were conducted with various actors, including public supervisory bodies, hospital staff, and boards of directors. FINDINGS: In the Netherlands, EU harmonization directed at centralizing and coordinating the regulatory regime for good clinical trial practice in Member States has paradoxically led to further fragmentation. The resulting ambiguity and inefficiency remained largely unresolved until a serious incident in a university hospital became a catalyst to clarify both the interconnected responsibilities and working relationships of various supervisory bodies. New legislation and regulatory methods were implemented, and actors outside the legislative framework became active in the field in order to strengthen supervision of ongoing trials, further multiplying yet also aligning with existing regulatory regimes. CONCLUSIONS: Public supervision of ongoing trials is fragmented in the Netherlands because the responsibilities and resources are unevenly distributed. In countries like the Netherlands, public supervisory bodies must do a great deal of institutional work to align with new EU regulations and still safeguard their traditional regulatory mechanisms that protect human safety. However, national regulatory traditions also offer new opportunities to strengthen the quality assurance of clinical trials.

How incident reporting systems can stimulate social and participative learning: A mixed-methods study.

Incident reporting systems (IRSs) have been widely adopted in healthcare, calling for the investigation of serious incidents to understand what causes patient harm. In this article, we study how the Dutch IRS contributed to social and participative learning from incidents. We integrate quantitative and qualitative data in a mixed-methods design. Between 1 July 2013 and 31 March 2019, Dutch hospitals reported and investigated 4667 incidents. Healthcare inspectors scored all investigations to assess hospitals' learning process following incidents. We analysed if and on what aspects hospitals improved over time. Additionally, we draw from semi-structured interviews with incident investigators, quality managers, healthcare inspectors and healthcare professionals. Healthcare inspectors score incident investigation reports better over time, suggesting that hospitals conduct better investigations or have become adept at writing reports in line with inspectors' expectations. Our qualitative data suggests the IRS contributed to practices that support social and participative learning-the professionalisation of incident investigation teams, the increased involvement of patients and families in investigations-and practices that do not-not linking learning from the investigation teams to that of professionals, not consistently monitoring the recommendations that investigations identify. The IRS both hits and misses the mark. We learned that IRSs need to be responsive to the (developing) capabilities of healthcare providers to investigate and learn from incidents, if the IRS is to stimulate social and participative learning from incidents.

Effects of EU harmonization policies on national public supervision of clinical trials: A dynamic cycle of institutional change and institutional work.

BACKGROUND: The EU Clinical Trials Directive (EUCTD) and the EU Clinical Trials Regulation aim to harmonize good clinical practice (GCP) of clinical trials across Member States. Using the Netherlands as a case study, this paper analyzes how endeavours to implement the EUCTD set in motion a dynamic process of institutional change and institutional work. This process lead to substantial differences between policy and actual practice; therefore, it is important to learn more about the implementation of harmonization policies. METHODS: Relevant documents, such as legal texts and previous research, were analyzed. Interviews were conducted with stakeholders in clinical trials and inspectors from (inter)national supervisory bodies (n=33), and Dutch Health Care Inspectorate inspections were observed (n=4). RESULTS: Dutch legislators' efforts to implement the EUCTD created a new level of governance in an already multilevel legislative framework. Institutional layering caused a complex and fragmented organizational structure in public supervision, leading to difficulties in achieving GCP. This instigated institutional work by actors, which set in motion further incremental institutional change, principally drift and conversion. CONCLUSIONS: Harmonization processes can create dynamic cycles between institutional change and institutional work, leading to significant divergence from the intended effects of legislation. If legislation intended to strengthen harmonization is not carefully implemented, it can become counterproductive to its aims.

Making Markets in Long-Term Care: Or How a Market Can Work by Being Invisible.

Many Western countries have introduced market principles in healthcare. The newly introduced financial instrument of "care-intensity packages" in the Dutch long-term care sector fit this development since they have some characteristics of a market device. However, policy makers and care providers positioned these instruments as explicitly not belonging to the general trend of marketisation in healthcare. Using a qualitative case study approach, we study the work that the two providers have done to fit these instruments to their organisations and how that enables and legitimatises market development. Both providers have done various types of work that could be classified as market development, including creating accounting systems suitable for markets, redefining public values in the context of markets, and starting commercial initiatives. Paradoxically, denying the existence of markets for long-term care and thus avoiding ideological debates on the marketisation of healthcare has made the use of market devices all the more likely. Making the market invisible seems to be an operative element in making the market work. Our findings suggest that Dutch long-term care reform points to the need to study the 'making' rather than the 'liberalising' of markets and that the study of healthcare markets should not be confined to those practices that explicitly label themselves as such.

Voice and choice by delegation.

In many Western countries, options for citizens to influence public services are increased to improve the quality of services and democratize decision making. Possibilities to influence are often cast into Albert Hirschman's taxonomy of exit (choice), voice, and loyalty. In this article we identify delegation as an important addition to this framework. Delegation gives individuals the chance to practice exit/choice or voice without all the hard work that is usually involved in these options. Empirical research shows that not many people use their individual options of exit and voice, which could lead to inequality between users and nonusers. We identify delegation as a possible solution to this problem, using Dutch health care as a case study to explore this option. Notwithstanding various advantages, we show that voice and choice by delegation also entail problems of inequality and representativeness.

Access to health care for undocumented migrants: a comparative policy analysis of England and the Netherlands.

The presence of undocumented migrants is increasing in many Western countries despite wide-ranging attempts by governments to increase border security. Measures taken to control the influx of immigrants include policies that restrict access to publicly funded health care for undocumented migrants. These restrictions to health care access are controversial, and evidence suggests they do not always have the intended effect. This study provides a comparative analysis of institutional, actor-related, and contextual factors that have influenced health care policy development on undocumented migrants in England and the Netherlands. For undocumented migrants, England restricts its access to care at the point of service, while the Netherlands restricts through the payment system for services. The study includes an analysis of policy papers and semistructured, in-depth interviews with various actors in both countries. Findings confirm the influence of such contextual factors as immigration considerations and cost concerns on health care policy making in this area. However, these factors cannot explain the differences between the two countries. Previously enacted policies, especially the organization of the health care system, affected the kind of restrictions for undocumented migrants. Concerns about the side effects of generous treatment of undocumented migrants on other groups played a substantial role in formulating restrictive policies in both countries. Evidently, policy development and implementation is critically affected by institutional rules, which govern the degree of influence that doctors and professional medical associations have on the policy process.

Patient participation in collective healthcare decision making: the Dutch model.

OBJECTIVE: To study whether the Dutch participation model is a good model of participation. BACKGROUND: Patient participation is on the agenda, both on the individual and the collective level. In this study, we focus on the latter by looking at the Dutch model in which patient organizations are involved in many formal decision-making processes. This model can be described as neo-corporatist. DESIGN: We did 52 interviews with actors in the healthcare field, 35 of which were interviews with representatives of patient organizations and 17 with actors that involved patient organizations in their decision making. RESULTS: Dutch patient organizations have many opportunities to participate in formal healthcare decision making and, as a result, have become institutionalized. Although there were several examples identified in which patient organizations were able to influence decision making, patient organizations remain in a dependent position, which they try to overcome through professionalization. DISCUSSION: Although this model of participation gives patient organizations many opportunities to participate, it also causes important tensions. Many organizations cannot cope with all the participation possibilities attributed to them. This participation abundance can therefore cause redistribution effects. Furthermore, their dependent position leads to the danger of being put to instrumental use. Moreover, professionalization causes tensions concerning empowerment possibilities and representativeness. Conclusion Although the Dutch model tries to make patient organizations an equal party in healthcare decision making, this goal is not reached in practice. It is therefore important to study more closely which subjects patients can and should contribute to, and in what way.