Regulation of long-term care for older persons: a scoping review of empirical research.

OBJECTIVE: Not only care professionals are responsible for the quality of care but other stakeholders including regulators also play a role. Over the last decades, countries have increasingly invested in regulation of Long-Term Care (LTC) for older persons, raising the question of how regulation should be put into practice to guarantee or improve the quality of care. This scoping review aims to summarize the evidence on regulatory practices in LTC for older persons. It identifies empirical studies, documents the aims and findings, and describes research gaps to foster this field. DESIGN: A literature search (in PubMed, Embase, Cinahl, APA PsycInfo and Scopus) was performed from inception up to December 12th, 2022. Thirty-one studies were included. RESULTS: All included studies were from high-income countries, in particular Australia, the US and Northwestern Europe, and almost all focused on care provided in LTC facilities. The studies focused on different aspects of regulatory practice, including care users' experiences in collecting intelligence, impact of standards, regulatory systems and strategies, inspection activities and policies, perception and style of inspectors, perception and attitudes of inspectees and validity and reliability of inspection outcomes. CONCLUSION: With increasingly fragmented and networked care providers, and an increasing call for person-centred care, more flexible forms of regulatory practice in LTC are needed, organized closer to daily practice, bottom-up. We hope that this scoping review will raise awareness of the importance of regulatory practice and foster research in this field, to improve the quality of LTC for older persons, and optimize their functional ability and well-being.

Active involvement of young people with T1DM during outpatient hospital consultations: Opportunities and challenges in transitional care services.

OBJECTIVE: Little is known about active involvement of young people (YP) with type 1 diabetes (T1DM) in transitional care. This study aims to gain insight into patient-provider interactions during outpatient hospital consultations. METHODS: Semi-structured observations (n = 61) of outpatient consultations with YP with T1DM (15-25 years) treated in 12 hospitals in the Netherlands. The consultations concerned pediatric care (n = 23), adult care (n = 17), and joint consultations (n = 21). Thematic data analysis focused on whether professionals engaged in open, in-depth conversations; used motivational interviewing techniques; involved YP in shared decision-making; and addressed non-medical topics. RESULTS: Apart from some good examples, the healthcare professionals generally had difficulty interacting adequately with YP. They paid little attention to the YP's individual attitudes and priorities regarding disease management; non-medical topics remained generally underexposed. Conversations about daily life often remained shallow, as YP's cues were not taken up. Furthermore, decisions about personal and health-related goals were often not made together. CONCLUSION: By adopting a more person-centered approach, professionals could empower YP to take an active role in their diabetes management. PRACTICE IMPLICATIONS: Using a structured conversation model combined with a tool to encourage YP's agenda-setting and shared decision-making is recommended for more person-centered transitional care in T1DM.

The added value of transition programs in Dutch diabetes care: A controlled evaluation study.

PURPOSE: The desirability of evaluating transition programs is widely acknowledged. This study aimed to explore the added value of transitional care investments for young adults with type 1 diabetes mellitus. DESIGN AND METHODS: Based on qualitative data, two groups of diabetes teams were created through cluster analysis: paying more (HI-ATT) versus less attention (LO-ATT) to transitional care. Retrospective controlled evaluation included chart reviews on healthcare use and clinical outcomes; and a survey on young adults' experiences, satisfaction with care, and self-management skills. RESULTS: Data from 320 patients in fifteen diabetes teams were collected; 123 young adults (38.4%) completed a questionnaire. Self-reported outcomes showed that young adults treated by a HI-ATT team felt better prepared for transfer (p < .05). Self-management outcomes did not differ between groups. HI-ATT teams had more scheduled consultations in the year after transfer (p < .05); only 10.6% of all measurements had reached targeted HbA1c scores. CONCLUSIONS: Current transitional care investments in Dutch diabetes care did not lead to notable improvements in experiences and outcomes, except for preparation for transfer. The period after transfer, however, is just as important. Attention is required for parent involvement. PRACTICE IMPLICATIONS: Transitional care investments should extend beyond the transfer. By educating young adults about the importance of regular clinic attendance and introducing additional person-centered consultations in adult care, nurses may help ensure continuity of care. Nurses could also introduce support programs for parents to prepare for the transition and their change in role, taking into account their continuing partnership.

Publication of inspection frameworks: a qualitative study exploring the impact on quality improvement and regulation in three healthcare settings.

BACKGROUND: The Dutch healthcare inspectorate publishes its inspection frameworks to inform both the public and healthcare providers about regulatory procedures and in the hope that publication will motivate healthcare providers to improve quality and comply with standards. This study explores the consequences of publishing these frameworks for the regulation of quality and safety in healthcare. METHODS: We selected recently published inspection frameworks used in three healthcare settings: nursing home care, dental care and hospital care. We conducted 37 interviews with 39 respondents (healthcare professionals, managers, quality officers, policy advisers and inspectors) and explored their awareness of and experiences with these frameworks. We held a group interview with three inspectors to reflect on our findings. All data underwent thematic content analysis. RESULTS: We found that the institutional infrastructure of a sector plays an important role in how an inspection framework is used after publication; particularly the presence and maturity of quality improvement work in the sector and the inspectorate's grip on a sector matter. Respondents mentioned differences in framework use in organisational contexts, particularly relating to scale. In some organisations, the framework served as an accountability mechanism to check if quality meets basic standards, while in other organisations professionals adopted it to stimulate discussion and learning across teams. CONCLUSION: Publication of inspection frameworks might result in quality improvement work, and in particular contexts could be used as a regulatory strategy to target quality improvement in a healthcare sector. For this, it is important that regulators consider the capabilities and possibilities for learning and improving within a sector.

Developing process measures in value-based healthcare: the case of aortic valve disease.

Background: As process measures can be means to change practices, this article presents process measures that impact on outcome measures for surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) within value-based healthcare. Methods: Desk research and observations of patient trajectories were performed to map the processes involved in TAVR and SAVR. Semistructured interviews were conducted with healthcare professionals (n=8) and patients (n=2) to explore which processes were most important in relation to a standard set of outcome measures that was already monitored. Additionally, open interviews (n=2) were held to prioritise results. A focus group was performed for validation of the formulated process measures. Numerical data for these measures was not collected. Results: Process maps of the full cycle of care of TAVR and SAVR treatments in theory and in practice were developed. 28 processes were found important by interview participants due to their expected impact on patient-relevant outcomes. Seven processes were prioritised to be most important and were formulated into 12 process measures for both TAVR and SAVR: 'Number of times that deficient information provision to SAVR patients causes negative outcomes', 'Type of TAVR/SAVR prosthesis', 'Brand of TAVR prosthesis', 'Number of times the frailty score of a TAVR/SAVR patient >75 years is measured', 'Time between TAVR/SAVR surgery indication and surgery', 'Number of times that anticoagulants are stopped within 3 days before surgery', 'Time in hours between TAVR/SAVR surgery and permanent pacemaker implantation' and 'Percentage of standardised pain measurements'. Conclusion: This study proposes an addition of select process measures to standard sets of outcome measures to improve healthcare quality. It illustrates a clear method for identifying process measures with impact on health outcomes in the future.

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.

Diabetic retinopathy care--an international quality comparison.

PURPOSE: The purpose of this paper is to study the quality indicator appropriateness and use it for international quality comparison on diabetic retinopathy (DR) patient care process in one American and one Dutch eye hospital. DESIGN/METHODOLOGY/APPROACH: A 17-item DR quality indicator set was composed based on a literature review and systematically applied in two hospitals. Qualitative analysis entailed document study and 12 semi-structured face-to-face interviews with ophthalmologists, managers, and board members of the two hospitals. FINDINGS: While the medical-clinical approach to DR treatment in both hospitals was similar, differences were found in quality of care perception and operationalization. Neither hospital systematically used outcome indicators for DR care. On the process level, the authors found larger differences. Similarities and differences were found in the structure of both hospitals. The hospitals' particular contexts influenced the interpretation and use of quality indicators. PRACTICAL IMPLICATIONS: Although quality indicators and quality comparison between hospitals are increasingly used in international settings, important local differences influence their application. Context should be taken into account. Since that context is locally bound and directly linked to hospital setting, caution should be used interpreting the results of quality comparison studies. ORIGINALITY/VALUE: International quality comparison is increasingly suggested as a useful way to improve healthcare. Little is known, however, about the appropriateness and use of quality indicators in local hospital care practices.

Organ donation as transition work: Policy discourse and clinical practice in The Netherlands.

An increasing number of patients become eligible for organ transplants. In the Netherlands, at the level of policy discourse, growing waiting lists are often referred to as a persistent "shortage" of organs, producing a "public health crisis." In this way, organ donation is presented as an ethical, social, and medical necessity. Likewise, policy discourse offers a range of seemingly unambiguous solutions: improving logistical infrastructure at the level of hospitals, developing organizational and legal protocols, as well as public information campaigns. Instead of taking these problem and solution definitions as given, we critically examine the relationship between policy discourse and clinical practice. Based on a historical review, first, we trace the key moments of transformation where organ donation became naturalized in Dutch policy discourse, particularly in its altruistic connotation. Second, based on in-depth interviews with medical professionals, we show how those involved in organ donation continue to struggle with the controversial nature of their clinical practice. More specifically, we highlight their use of different forms of knowledge that underlie clinicians' "transition work": from losing a patient to "gaining" a donor.

A framework and a measurement instrument for sustainability of work practices in long-term care.

BACKGROUND: In health care, many organizations are working on quality improvement and/or innovation of their care practices. Although the effectiveness of improvement processes has been studied extensively, little attention has been given to sustainability of the changed work practices after implementation. The objective of this study is to develop a theoretical framework and measurement instrument for sustainability. To this end sustainability is conceptualized with two dimensions: routinization and institutionalization. METHODS: The exploratory methodological design consisted of three phases: a) framework development; b) instrument development; and c) field testing in former improvement teams in a quality improvement program for health care (N teams = 63, N individual = 112). Data were collected not until at least one year had passed after implementation.Underlying constructs and their interrelations were explored using Structural Equation Modeling and Principal Component Analyses. Internal consistency was computed with Cronbach's alpha coefficient. A long and a short version of the instrument are proposed. RESULTS: The χ2- difference test of the -2 Log Likelihood estimates demonstrated that the hierarchical two factor model with routinization and institutionalization as separate constructs showed a better fit than the one factor model (p < .01). Secondly, construct validity of the instrument was strong as indicated by the high factor loadings of the items. Finally, the internal consistency of the subscales was good. CONCLUSIONS: The theoretical framework offers a valuable starting point for the analysis of sustainability on the level of actual changed work practices. Even though the two dimensions routinization and institutionalization are related, they are clearly distinguishable and each has distinct value in the discussion of sustainability. Finally, the subscales conformed to psychometric properties defined in literature. The instrument can be used in the evaluation of improvement projects.

Creating effective quality-improvement collaboratives: a multiple case study.

OBJECTIVE: To explore whether differences between collaboratives with respect to type of topic, type of targets, measures (systems) are also reflected in the degree of effectiveness. STUDY SETTING: 182 teams from long-term healthcare organisation developed improvement initiatives in seven quality-improvement collaboratives (QICs) focusing on patient safety and autonomy. STUDY DESIGN: Multiple case before-after study. DATA COLLECTION: 75 team leaders completed a written questionnaire at the end of each QIC on achievability and degree of challenge of targets and measurability of progress. Main outcome indicators were collaborative-specific measures (such as prevalence of pressure ulcers). PRINCIPAL FINDINGS: The degree of effectiveness and percentage of teams realising targets varied between collaboratives. Collaboratives also varied widely in perceived measurability (F=6.798 and p=0.000) and with respect to formulating achievable targets (F=6.566 and p=0.000). The Problem Behaviour collaborative scored significantly lower than all other collaboratives on both dimensions. The collaborative on Autonomy and control scored significantly lower on measurability than the other collaboratives. Topics for which there are best practices and evidence of effective interventions do not necessarily score higher on effectiveness, measurability, achievable and challenging targets. CONCLUSIONS: The effectiveness of a QIC is associated with the efforts of programme managers to create conditions that provide insight into which changes in processes of care and in client outcomes have been made. Measurability is not an inherent property of the improvement topic. Rather, creating measurability and formulating challenging and achievable targets is one of the crucial tasks for programme managers of QICs.

Evaluation of a large scale implementation of disease management programmes in various Dutch regions: a study protocol.

BACKGROUND: Disease management programmes (DMPs) have been developed to improve effectiveness and economic efficiency within chronic care delivery by combining patient-related, professional-directed, and organisational interventions. The benefits of DMPs within different settings, patient groups, and versions remain unclear. In this article we propose a protocol to evaluate a range of current DMPs by capturing them in a single conceptual framework, employing comparable structure, process, and outcome measures, and combining qualitative and quantitative research methods. METHODS: To assess DMP effectiveness a practical clinical trial will be conducted. Twenty-two disease management experiments will be studied in various Dutch regions consisting of a variety of collaborations between organisations and/or professionals. Patient cohorts include those with cardiovascular diseases, chronic obstructive pulmonary disease, diabetes, stroke, depression, psychotic diseases, and eating disorders. Our methodological approach combines qualitative and quantitative research methods to enable a comprehensive evaluation of complex programmes. Process indicators will be collected from health care providers' data registries and measured via physician and staff questionnaires. Patient questionnaires include health care experiences, health care utilisation, and quality of life. Qualitative data will be gathered by means of interviews and document analysis for an in depth description of project interventions and the contexts in which DMPs are embedded, and an ethnographic process evaluation in five DMPs. Such a design will provide insight into ongoing DMPs and demonstrate which elements of the intervention are potentially (cost)-effective for which patient populations. It will also enable sound comparison of the results of the different programmes. DISCUSSION: The study will lead to a better understanding of (1) the mechanisms of disease management, (2) the feasibility, and cost-effectiveness of a disease management approach to improving health care, and (3) the factors that determine success and failure of DMPs. Our study results will be relevant to decision makers and managers who confront the challenge of implementing and integrating DMPs into the health care system. Moreover, it will contribute to the search for methods to evaluate complex healthcare interventions.

Quest for client autonomy in improving long-term mental health care.

The objective of the present study was to explore how mental health-care professionals initiate, improve, and maintain client autonomy while improving other aspects of quality of care. We studied the different ways in which they approach autonomy and the dilemmas associated with them. As a methodology, we used the insights of actor-network theory, where concepts cannot be predefined, but are formed within specific situations, and therefore, should be studied by addressing the actors involved. Data were gathered by conducting ethnographic observations of national conferences of a quality-improvement collaborative and by interviewing actors involved in the improvement practices. In a bottom-up analysis, four approaches to autonomy emerged: (i) professionals removed constraints to autonomy and passed initiative to clients; (ii) professionals made an active effort to learn and support client preferences; (iii) clients were given opportunities towards independent lifestyles; and (iv) professionals tried to 'normalize' their relationship with clients to encourage roles other than those of client. The study showed that autonomy is an important issue throughout the process of quality improvement. Articulating the different approaches to autonomy and the dilemmas in these approaches contributed to reflection on the concept and highlighted the limits of the concept within a mental health-care setting.

Opening the black box of quality improvement collaboratives: an Actor-Network theory approach.

BACKGROUND: Quality improvement collaboratives are often labeled as black boxes because effect studies usually do not describe exactly how the results were obtained. In this article we propose a way of opening such a black box, by taking up a dynamic perspective based on Actor-Network Theory. We thereby analyze how the problematisation process and the measurement practices are constructed. Findings from this analysis may have consequences for future evaluation studies of collaboratives. METHODS: In an ethnographic design we probed two projects within a larger quality improvement collaborative on long term mental health care and care for the intellectually disabled. Ethnographic observations were made at nine national conferences. Furthermore we conducted six case studies involving participating teams. Additionally, we interviewed the two program leaders of the overall projects. RESULTS: In one project the problematisation seemed to undergo a shift of focus away from the one suggested by the project leaders. In the other we observed multiple roles of the measurement instrument used. The instrument did not only measure effects of the improvement actions but also changed these actions and affected the actors involved. CONCLUSIONS: Effectiveness statistics ideally should be complemented with an analysis of the construction of the collaborative and the improvement practices. Effect studies of collaboratives could benefit from a mixed methods research design that combines quantitative and qualitative methods.