Ensuring high quality Oyster Care for people experiencing severe and persistent mental illness – A three-phase development of a quality monitoring tool

Ensuring high quality Oyster Care for people experiencing severe and persistent mental illness – A three-phase development of a quality monitoring tool | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Ensuring high quality Oyster Care for people experiencing severe and persistent mental illness – A three-phase development of a quality monitoring tool Caressa Van Hoe, Loïc Moureau, Kathleen Leemans, Ilse Decorte, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7545849/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 07 Mar, 2026 Read the published version in Community Mental Health Journal → Version 1 posted You are reading this latest preprint version Abstract Introduction: Oyster Care is an innovative care model designed to meet the needs of people experiencing severe and persistent mental illness—a population often overlooked by the healthcare system and at heightened risk due to caregivers either persisting with ineffective therapeutic interventions or discontinue care altogether. The model encourages caregivers to engage in creative, out-of-the-box thinking, enabling them to move beyond conventional protocol to improve the person’s sense of meaning, well-being and quality of life. In recent years, the adoption of Oyster Care’s principles has gained momentum within Flemish mental healthcare. Consequently, there is an increasing recognition of the need for an evidence-based tool that can translate the conceptual framework of Oyster Care into practice, providing caregivers with clear, actionable guidance on its core principles. Methods A mixed methods study was conducted from 2021 to 2023. The first research phase involved a literature review and a qualitative study aimed at understanding the models’ principles. The second phase focused on translating these principles into validated, operational indicators through a Delphi expert consensus process. In the final phase, experts were tasked with selecting the most relevant validated indicators for Oyster Care. Results 79 indicators of high-quality Oyster Care were developed. These indicators were grouped into 24 sub-themes, which were organized under eight overarching themes: The care process; The somatic pillar; The psychological pillar; The social pillar; The existential pillar; End-of-life care; Team vision, culture, and development; The living environment. The SCV-I demonstrated 97% for clarity and 93% for relevance. Discussion The monitoring tool is designed for use in Flemish mental health hospitals and psychiatric nursing homes. A pilot study is currently underway to evaluate the practical use of the tool. The monitor has the potential to support future research measuring the impact of Oyster Care on health outcomes. Conclusion A practical monitoring tool was developed to support the implementation of Oyster Care within mental health services in Flanders. The tool offers a structured framework that enables teams to implement the model as intended, engage in ongoing reflection and improvement of their practices, and inform resource allocation and treatment decisions. severe and persistent mental illness palliative psychiatry palliative care approach long-term mental health care quality improvement Figures Figure 1 1. Introduction Within the field of mental health care, there are groups of people at risk of being overlooked by the healthcare system, the research community and society at large. This is particularly relevant for those experiencing severe and persistent mental illness (SPMI) (Decorte et al., 2020). SPMI encompasses long-term and disabling mental health conditions, such as refractory schizophrenia, treatment-resistant depression and severe bipolar disorder (Zumstein & Riese, 2020; Woods et al., 2008). This population shares the characteristic of experiencing persistent symptoms despite undergoing evidence-based treatments, resulting in significantly impaired daily functioning and reduced quality of life (Zumstein & Riese, 2020). Simultaneously, these people face a striking reality of reduced life expectancy, which is up to 15 years shorter than the general population, mainly due to severe co-occurring somatic disorders and limited access to timely and appropriate healthcare (Butler et al., 2018; James et al., 2018; Oakley et al., 2018; Plana-Ripoll et al., 2020; Woods et al., 2008). Traditional therapeutic interventions aimed at cure often prove ineffective for SPMI, leading caregivers to either persist with futile therapeutic approaches or in some cases discontinue care altogether. Also, in this specific population with refractory symptoms, the usual approaches of recovery and psychosocial rehabilitation alone are often not sufficient to improve wellbeing (Levitt & Buchman, 2020; Trachsel et al., 2016). This group of people, described as chronic and resistant to treatment, requires less conventional, disease-focused interventions and a shift to more person-centered care (Levitt & Buchman, 2020; Moonen et al., 2016). There is growing evidence that palliative psychiatry holds promise for addressing the needs of people experiencing SPMI (Gloeckler & Trachsel, 2021; Moonen et al., 2016; Trachsel et al., 2016; Woods et al., 2008). Palliative psychiatry emphasizes a careful reassessment of care goals. Rather than striving for cure, the focus is on alleviating suffering, minimizing harm and directly enhancing quality of life, despite or in the presence of enduring psychiatric symptoms (Levitt & Buchman, 2020; Westermair et al., 2022). Based on this palliative philosophy, the innovative model of ‘Oyster Care’ was developed. Oyster Care adopts a holistic approach in caring for this group of people based on four pillars: physical care addresses somatic conditions, psychological care focuses on comfort and well-being, social care provides structure through activities and connections and existential care promotes a sense of meaningful living. As in regular palliative care, it places great value on interpersonal relationships and creative, out-of-the-box thinking by caregivers to go beyond standard protocol in caring for these people to improve their sense of meaning, well-being and quality of life. Initial feedback on the care model from both caregivers and care users has been positive. Caregivers report a heightened sense of well-being, which is also reflected in care users through reduced symptom burden and enhanced quality of life (Decorte et al., 2020). In recent years, the dissemination of the Oyster Care model's principles has accelerated within the Flemish mental healthcare landscape. An increasing number of mental health facilities are implementing the model in their care practices. While it is being adopted by residential mental health departments and psychiatric nursing homes, the concept is also being explored by nursing homes and outpatient mental health teams. To prevent unregulated variation in the interpretation and implementation of the concept, and to ensure its application is not solely dependent on clinical knowledge and skills (Mowbray et al., 2003), there is a recognized need for an evidence-based tool to translate the conceptual framework of Oyster Care into practice, providing caregivers with clear and effective guidance on its principles. A suitable instrument for this purpose is a fidelity scale or quality monitoring tool that translates the key components of the intervention into measurable categories (Mowbray et al., 2003) \(\:.\) This instrument can improve the quality of care by offering teams a structured approach to assess and refine their implementation practices in alignment with the principles of the Oyster Care model. By establishing a feedback loop, the tool enables teams to gain insight into their current practices, which can subsequently inform targeted improvements. This process fosters adherence to the model’s core philosophy, ensuring that care delivery remains consistent with its intended framework and ultimately leading to higher-quality Oyster Care. Furthermore, once fidelity to the model can be reliably measured, it becomes possible to evaluate the quality of care provided, predict outcomes, assess whether the expected outcomes are being achieved and facilitate comparisons of treatments (Bellg et al., 2004; Durlak & DuPre, 2008; Mowbray et al., 2003). In addition, it can promote scientific research, enhance awareness and support the broader dissemination of the model of care (Bond et al., 2011). In the Netherlands, Active Recovery Triad (ART) and Flexible Assertive Community Treatment (FACT) have already developed tools that enable teams to continuously evaluate their practices, ensuring the quality of care for people experiencing severe psychiatric disorders (Westen et al., 2019; Zomer et al., 2020). However, Oyster Care emphasizes specific aspects of quality care for this population, which necessitates the development of a distinct monitoring tool tailored to its unique focus. For this, it is essential that researchers, intervention developers and other stakeholders agree on how implementation can reliably and validly measured. At the same time, the data should not only provide an accurate assessment of the fidelity of the specific model but also be useful for the caregiver. The aim of this study is to report on the development and validation of a monitoring tool for Oyster Care to support its implementation into practice. The three underlying sub-aims are: 1) to develop a quality framework for Oyster Care by mapping its key principles 2) to translate these principles into validated, operational indicators for the Oyster Care monitor and 3) to develop a feasible monitoring tool for practical application. 2. Methodology 2.1 Design The researchers undertook a mixed methods study consisting of three phases, conducted between 2021 and 2023, to develop a quality monitoring tool for Oyster Care (Johnson et al., 2007). The first phase entailed a literature review and a qualitative study focused on understanding the principles of the care model based on the experiences of those involved, in order to develop a quality framework for Oyster Care. The second phase comprised a Delphi expert consensus process aimed at developing and validating operational indicators relevant to Oyster Care. In the final phase, experts were tasked with selecting the validated indicators most important to Oyster Care in order to establish a feasible monitoring tool for practical implementation of the model within mental health services in Flanders. By using a mixed methods approach, the study was able to develop a quality monitoring tool that was both theoretically sound and practical, adapted to the specific imperatives of Oyster Care and applicable in the real context of mental health services in Flanders. 2.2 Setting and study population The study was conducted in collaboration with eight mental health facilities across Flanders, namely three psychiatric hospitals, three psychiatric nursing homes, a walk-in centre for people with a death wish due to severe mental health problems and a psychiatric outpatient team. A ninth facility, a psychiatric nursing home, withdrew from participation prior to the start of the study, citing that they had not yet implemented the Oyster Care model in their practice and therefore felt unable to provide relevant insights regarding its use. The study population consisted of various stakeholders Oyster Care intends to reach: people experiencing severe and persistent mental illness, next of kin, and professionals, policy makers and academics who engage with people experiencing SPMI and are familiar with the Oyster Care model. 2.3 Methods Phase 1: Developing a comprehensive quality framework for Oyster Care Initially, a theoretical quality framework for Oyster Care was developed based on existing literature on the needs of people experiencing SPMI, their next of kin and professionals, as well as palliative care approaches for people experiencing SPMI to address these needs. However, recognizing the limited scope of research specifically addressing these topics, a qualitative research design was subsequently selected. This approach was deemed appropriate for addressing the identified gaps in the literature while allowing for a more focused exploration of the Oster Care model through the lens of experienced evidence. Literature review In December 2021, the researchers conducted a comprehensive literature search on palliative care approaches for people experiencing SPMI and the needs of those involved, excluding articles related to euthanasia and assisted suicide. The search yielded 18 relevant articles, which were analyzed with a focus on the needs of people experiencing SPMI, their next of kin and professionals and how palliative care approaches can meet these needs. Qualitative interviews Between January 2022 and November 2022, a qualitative study was conducted in two concurrent phases. Phase 1a explored the principles of Oyster Care from the perspectives of healthcare professionals, managers and policy makers. A total of 44 participants were interviewed through focus groups or individual interviews. Phase 1b focused on understanding the care needs of people experiencing SPMI and their next of kin, along with their experiences with Oyster Care and the extent to which the model does or does not address their needs. The researchers argue that involving people experiencing SPMI in research efforts stands as a cornerstone for empowerment - a feasible aspiration. Underscoring the importance of respectful and inclusive practices when engaging with this population, thereby enhancing the quality and relevance of research outcomes and facilitating more effective healthcare interventions tailored to their needs. Sixteen people experiencing SPMI and eight next of kin were interviewed one-on-one. A contact person at each participating facility supervised the recruitment process and additional precautions were taken during the recruitment of people experiencing SPMI to minimize participant burden (see Table 1 ). A semi-structured interview guide with open-ended questions was employed. The data were transcribed, coded using NVivo13 and analyzed according to a thematic analysis (Braun & Clarke, 2008). Table 1 Supportive measures to include people experiencing SPMI in research - Interviews with patients are conducted only in real life. - The gatekeeper, in consultation with the treating psychiatrist, assesses the patient's decision-making capacity (impact of research) and the extent to which they can provide informed consent. - Interested patients cannot directly contact the researcher. They can express their interest to the gatekeeper - Considering the patient's SPMI, the researcher contacts the local contact person on the day of the interview to discuss whether it is appropriate to proceed with the conversation. - The interview duration is limited. Conversations last a maximum of 45 minutes to reduce participant burden - Patients may choose to have a trustee to join the conversation. The trustee can offer emotional support or assist patients in articulating their experiences. Trustees cannot try to force the patient to continue the conversation. If the patient indicates a desire to end the conversation, the researcher concludes the discussion. - Care providers and departmental leaders are informed of the nature, location, and timing of the conversation to mobilize a safety net within the department. Patients are asked if the local contact person or another care provider can accompany them back to the department after the conversation to offer additional support if needed. Integration of findings Both the literature review and the qualitative research employed an inductive analysis, allowing themes to emerge organically from the data collected. This open approach facilitated the development of a theoretical quality framework that responded to new insights. Consequently, the themes identified in relation to the research questions revealed strong connections with those in the conceptual model of Oyster Care (Decorte et al., 2020), highlighting the relevance of the model while also accommodating emerging concepts. The overarching themes that emerged from both the literature review and qualitative interviews were largely consistent, although the sub-themes varied and complemented one another. This process led to the development of a quality framework, which was subsequently face-validated during an ad hoc expert meeting. Five experts from three different settings participated in the four-hour live session, along with two members of the research team and one of the founders of the care model. During this session, additional content and nuance were incorporated into the quality framework and a small number of subthemes were renamed or removed if their content was covered by other subthemes. A significant change was the removal of the subtheme ‘Ethical and legal aspects of care’, as these considerations were deemed integral to all themes within the Oyster Care model. The overarching theme ‘team structure’ was removed due to insufficient content to justify its inclusion. Phase 2: Developing and validating quality indicators based on expert consensus Research phase 2 started with the research group translating the principles within the quality framework into operational indicators, enabling the measurement of high-quality Oyster Care provision (Mowbray et al., 2003). Since Oyster Care is a new intervention and scientific research on positive outcomes is lacking, collecting expert opinions through a modified Delphi study is an appropriate method for assessing face and content validity (Polit & Beck, 2021; Taherdoost, 2016). Through purposive and snowball sampling, twelve professionals and two academics experienced in working with people experiencing SPMI through the Oyster Care model, as well as one next of kin were recruited. They worked in facilities across all provinces in Flanders, with a balance between psychiatric nursing homes and psychiatric hospitals. Twelve of them had not participated in the initial research phase and the professionals had various backgrounds. Data collection took place between October 2022 and March 2023. Through an iterative process, the expert panel assessed the indicators for clarity using a dichotomous answer option of ‘clear’ or ‘not clear’, and the relevance of the indicator to the concept of Oyster Care was asked using a 5-point Likert scale. The first and third Delphi rounds were organized through the completion of an anonymous, digital questionnaire and the experts had the opportunity to explain their quantitative answers in a qualitative manner. The second Delphi round was conducted via a digital live meeting. The Item-Content Validity Index (I-CVI) was calculated to measure the extent to which experts reached consensus (Yusoff, 2019). Fifteen experts participated in the first round, while twelve participated in both the second and the third round. The threshold for consensus on the clarity and relevance of an indicator was set at 86.67%, slightly higher than the conventional 80%, due to the experts’ consistently positive scoring on the complete questionnaire in Delphi round one. Indicators that scored 86.67% or higher were retained. Those scoring between 66.67% and 86.67% were individually reviewed by the researchers, with decisions on these indicators discussed during the second and third Delphi rounds. This also applied to new indicators introduced based on qualitative feedback to address gaps in the original set. Indicators scoring below 66.66% were removed from the monitoring tool. Surveying management perspectives on the structure of Oyster Care teams : Research phase 2 also explored a potential ninth theme "team structure" for which insufficient data had been collected in research phase 1. The aim was to address the following question: What is the ideal structure of an Oyster Care team in terms of team composition and organizational framework? To investigate this, the researchers surveyed six head nurses from various Oyster Care teams within the participating facilities via e-mail. The survey focused on mapping their current team structure and an ideal team structure (e.g., disciplines, expertise, educational background, contract hours) necessary to deliver Oyster Care in a high-quality manner. These insights led to the development of fifteen new indicators, which were presented to the experts for evaluation in the third Delphi round. However, no consensus was reached and qualitative feedback from the experts revealed too much variation. Consequently, it was decided not to retain these indicators. Phase 3: Selecting key indicators for a feasible monitoring tool Following the Delphi study, approximately 160 indicators emerged as clearly described and relevant to Oyster Care. However, feedback from Delphi experts and other stakeholders suggested that this extensive set needed to be minimized to ensure its feasibility for practical implementation (Leemans et al., 2016). Consequently, the decision was made to downsize the set of indicators to make it more manageable for use in practice. This marked the third and final phase of the study, focusing on selecting the most important indicators for delivering high-quality Oyster Care. For this, experts in each of the eight overarching themes were consulted based on their specialized knowledge. For instance, a general practitioner and nurse reviewed somatic care, a psychiatrist and psychologist assessed psychological care and a head nurse and manager evaluated the care process. Each theme was reviewed independently by at least two experts who had participated in earlier phases of the study. The choices were then cross-checked with the research group, integrating both qualitative and quantitative data from the first and second research phases. Simultaneously, one of the founders of the Oyster Care model was asked to independently select the most important indicators for all themes. The selections made by the experts, a founder of the Oyster Care model and the research group were found to be consistent with one another. Enduring collaboration between the research team and expert consultants During the two-year study, regular consultations were held with the research team, consisting of individuals with expertise in various research methodologies and the development of quality monitoring tools, palliative care approaches and end-of-life care, ethical considerations within care provision, and founders of the Oyster Care model. Additional expertise was enlisted on an ad hoc basis, including ART and FACT researchers with expertise in quality management and the development of monitoring tools for similar populations. Moreover, amidst exploration of effective care modalities for people experiencing SPMI there arose a dialogue across borders. In Belgium, healthcare workers are embracing practices from Dutch partners about prioritising the integration of people experiencing SPMI into society. At the same time, Dutch partners undertake a similar effort by exploring Belgian perspectives on delivering high-quality care within residential mental health settings to their own practices. This cross-border exchange of ideas and practices highlights the dynamic interplay between community-based initiatives and the organisation of residential mental health support systems. 2.5 Ethical considerations The study adhered to the Declaration of Helsinki and European General Data Protection Regulation rules, and was approved by the Medical Ethics Committee of the Vrije Universiteit Brussel (VUB) (approval no. EC-2021-322). All participants were asked to sign an informed consent form ensuring their anonymity and confidentiality 3. Results The aim of this study is to report on the development and validation of a monitor tool for Oyster Care to support its implementation into practice. By guiding teams on the key principles that contribute to high-quality Oyster Care, the tool can support the implementation of the care model as intended, facilitate regular reviews of their practice, provide valuable insight into areas for practice improvement, and enable thorough evaluations of both improvement efforts and outcomes. The three underlying sub-aims are: 1) to develop a quality framework for Oyster Care by mapping its key principles 2) to translate these principles into validated, operational indicators for the Oyster Care monitor and 3) to develop a feasible monitoring tool for practical application An iterative process of various methods led to the development of 79 indicators of high-quality Oyster Care. The 79 indicators were grouped into 24 subthemes, which were in turn organized under eight overarching themes. The eight overarching themes are: 1. The care process, 2. The somatic pillar, 3. The psychological pillar, 4. The social pillar, 5. The existential pillar, 6. End-of-life care, 7. Team vision, culture and development and 8. The living environment. The corresponding scale-level content validity index for these indicators shows 97% for clarity, meaning 97% of the items were found easy to understand, and 93% for relevance, meaning 93% of the items were found relevant for the concept of Oyster Care. At the end of the results sections provides Fig. 1 a flowchart outlining the research phases and key findings. Each overarching theme in the monitoring tool begins with an introduction that delineates the care needs and challenges encountered by people experiencing SPMI, their next of kin and healthcare professionals in relation to that theme. It provides the theoretical context for the indicators, ensuring a comprehensive understanding of the framework’s foundation and elucidating how adherence to these indicators supports the delivery of high-quality Oyster Care. Each overarching thema consists of one to four subthemes, for which clear guidelines are provided for interpreting and measuring the indicators associated with that subtheme, ensuring they can be applied accurately and effectively in practice. Best practices collected throughout the study are also incorporated into the descriptions of each subtheme. Although some of these practices were not directly translated into operational indicators or selected during the third research phase, they are included as supplementary examples to support the practical implementation of quality care. At the conclusion of each subtheme, teams are presented with a 4-point Likert scale to evaluate their level of implementation for that specific subtheme. This scale ranges from ‘not visible’ to ‘in development,’ ‘embedded,’ and ‘pearl’. The latter draws upon the shell metaphor, which serves as the central metaphor of the Oyster Care model. ‘Pearl’ can be interpreted as ‘exemplary’ or representing excellence in implementation. The subtheme is scored as a whole, with the associated indicators providing an indication of the extent to which that subtheme has been integrated into their Oyster Care practice. For illustration, see Table 2 . Table 2 Overarching theme 2. Physical pillar – Subtheme 5. Physical health Subtheme 5. Physical health Not visible In development Embedded Pearl Comments • The team timely assesses the care user's physical (pain) symptoms to understand and, if necessary, treat them • The team acts as a liaison between the care user and practitioner, providing support to the care user during a medical examination if needed • The team encourages care users to adopt a healthy lifestyle, provides tailored advice and support, and mediates when lifestyle choices are detrimental to health A description of each overarching theme’s content is provided below. The complete monitor can be found in Appendix 1. ( 1 ) During the care process , the focus is on promoting the well-being and quality of life of the care user. To this end, the care user, next of kin and the team work together to develop a care plan that responds to the care user's unique needs and values, and a care process marked by trial-and-error and the continual adaptation of care and treatment plans. For this, the team has an important role in interpreting verbal and nonverbal cues to understand and respect the care user's deeper desires, using the life story as a valuable guide. To provide personalized care and adapt the intensity of care to the changing needs of the care user, a balance between preparedness and flexibility is needed. Predefined strategies for care intensification help ensure a coordinated responsiveness, while pragmatism and adaptability are essential because standard protocols are not always appropriate. The care process consists of four subthemes: the acquaintance, the personal support plan, the support discussion, the upscaling and downscaling of care intensity. ( 2 ) In the physical pillar , physical symptoms are detected early and assessed holistically, taking into account somatic, psychological, social and existential factors. When lifestyle choices are harmful to health, the team discusses the underlying needs of the unhealthy behavior and formulates an approach to mediate. In addition, the team focuses on restoring contact with the body, and medication policy balances between symptom relief and minimizing side effects. An indicator related to healthcare users having a voice in meal choice was considered less important by the experts. However, it was retained because this insight emerged as highly significant in qualitative interviews with people experiencing SPMI. For many, it served as a motivation to get out of bed, participate in cooking activities (due to the ability to choose what they ate, aligning with their preferences), or to venture outside as outings often concluded with a visit to a bistro (which in turn contributed to feeling connected to the broader community). The physical pillar comprises four subthemes: physical health, the eating environment, contact with the body and medication policy. ( 3 ) The care relationship is a cornerstone of the psychological pillar and serves as the foundation for further interventions, such as exploring, understanding and effectively treating psychiatric and psychological symptoms and behaviors. Understanding the care user's personal history and unique communication style facilitates this process, and the team explores creative ways to address these symptoms, intervening only when the care user or their environment are truly affected. Therapy and activities aim to create the right conditions for connection, relieve suffering and improve feelings of well-being by providing a measured amount of stimulation. The team recognizes early signs of overstimulation and creates an emotionally safe and structured environment by “closing the shell” to offer security. As the need for care decreases and the behavior and decisions of the care user become less harmful, “the shell reopens”. For example, a care user with chronic suicidal ideation and frequent impulsive suicide attempts experienced heightened emotional distress following the sudden death of his uncle. To ensure his safety, particularly given his impulsivity, the care team, in consultation with the care user, implemented a plan requiring him to travel only with accompaniment to reduce the risk of a suicide attempt. As his grief subsided and his social network provided strong support, the team gradually allowed him more autonomy, permitting occasional solo outings under structured agreements. Moving forward, the team will continue to evaluate his progress and collaboratively explore increasing his independence as his emotional stability improves. This approach addresses the dynamic nature of autonomy, which is influenced by the care user's often fluctuating levels of decision-making capacity. Four subthemes cover the psychological pillar, namely: the care relationship, therapy and activities, coping with symptoms and dealing with crisis and coercive measures. ( 4 ) Within the social pillar , the team identifies people important to the care user from the past and investigates why contact with them was lost or broken. Together with the care user, they consider whether restoring these relationships makes sense and/or look for ways to maintain the meaning of these relationships without direct contact. In addition, the team supports care users in nurturing existing relationships and building reciprocal ties, providing the network with practical and emotional support. A tailored, predictable structure of activities and interactions supports care users in leading an active and as independent life as possible. Hereby participating together in daily social life and regular contact with volunteers helps to feel connected to the outside world. In addition, the team tackles institutionalization and stigma to help care users integrate into society and take on roles beyond those of a care user. The social pillar is structured around three subthemes: family and next of kin, activation, and social participation and inclusion. ( 5 ) Shedding light on the existential dimensions associated with experiencing SPMI the existential pillar is described. To foster a sense of connection, meaning and identity, the team (re)recognizes and understands in the care user feelings of hopeless existential suffering and grief arising from the loss of life dreams, relationships, health and self-worth. They provide an external structure within which care users can (re)discover values important to them, experience meaning in their daily functioning and reconnect with themselves, others, nature and the transcendent. These elements are covered in the sub-theme ‘Connection, meaning and identity’. In addition, the team recognizes and responds to care users' spiritual and religious needs by creating an open and respectful environment for such questions. They collaborate with experts to ensure that care users’ spiritual and religious concerns are addressed. This focus on the journey towards reclaiming their humanity and sense of self is captured in the subtheme ‘Spirituality, worldview and religion’. ( 6 ) Due to the prolonged stay of people experiencing SPMI in Oyster Care units, these facilities are equipped to accommodate the possibility of reaching the end stage of life. High quality end-of-life care for care users in the last phase of life requires a careful and coordinated team approach so that efforts can be made to maintain and/or improve quality of life, quality of care and autonomy. To implement this, the theme of end-of-life care outlines indicators that can be divided into three subthemes, namely advance care planning, end-of-life care and post-death care. Decisions regarding end-of-life care hinge upon regular discussions held with the person and next of kin regarding their needs and preferences. Providing palliative care requires a lot from a team. Ethical consultation can help increase a team's ability to provide care and assist in end-of-life decisions. The team should have the opportunity to employ additional staff for one-on-one care when needed. Continual training in palliative care and the addition of a specialist or collaboration with a palliative home care service improve the quality of care. ( 7 ) The team vision, culture and development theme focuses on the importance of a shared mission and values within a healthcare team, the importance of a positive team culture and how continuous growth and collaboration improve the quality of care. A number of key competencies are essential for an Oyster care team, these include demonstrating flexibility and creativity, being respectful and understanding of each other and of care users, and having sufficient professional knowledge. Providing Oyster Care can place significant demands on caregivers, therefore it is essential to create an environment of resilience, self-care and mutual support. The seventh domain is divided into three subthemes, namely attitude; professionalization, innovation and quality of care; and leadership. ( 8 ) The eighth and final theme the living environment focuses on creating an appropriate living and housing space and designing infrastructure that meets the needs of care users, next of kin and the care team. This theme first addresses the opportunities and challenges inherent in communal living, where the coexistence of diverse personalities and individuals with severe illnesses can present some difficulties. To mitigate these challenges, the infrastructure must meet several specific requirements: it should be age-appropriate and provide structure, feature small living units and smaller living groups, offer single rooms, and include multipurpose rooms and low-stimulation rooms. Additionally, a pleasant garden and other supportive environmental features are essential to create a therapeutic and accommodating living environment. The living environment has one subtheme: living space and environment. The analyses showed a lack of definitive answers as to how an Oyster Care team should be structured because of the different needs in different care settings. This could have constituted a potential ninth theme in the study. However, the findings underscored the crucial need for sufficient staff, especially for responding promptly to peaks in intensity of care, depending on the non-stable condition of this population, and providing one-on-one support. The importance of therapists from various professional backgrounds was also stressed. This inclusiveness ensures that every care user can access and participate in therapies and activities that appeal to them personally. Moreover, the presence of psychiatrists and psychologists was considered essential for understanding symptoms, particularly through the lens of the person's life story, which may provide insight into coping mechanisms. Collaboration with general practitioners and sufficient hours for social workers and existential care professionals were also considered necessary to meet care users' somatic, social and existential needs, enabling holistic care delivery. This need is exacerbated by the various ethical and existential dilemmas and needs (e.g., dynamics around giving autonomy and providing structure; or dealing with various loss experiences) present in this population. 4. Discussion In this study, a quality monitoring tool for Oyster Care was developed through a comprehensive literature review and qualitative research involving various stakeholders of the care model. These insights were translated into measurable indicators of high-quality Oyster Care and validated through a Delphi procedure. Following this, the most significant indicators important for high-quality Oyster Care were selected, resulting in a practical monitoring tool comprising 79 indicators across 8 overarching themes. The resulting practice monitor is designed for use in Flemish psychiatric hospitals and psychiatric nursing homes, as a tool to guide and assess the implementation of the Oyster Care model. By evaluating their practices, teams have the opportunity to gain objective insights into their own performance and identify areas for improvement. In line with the Oyster Care model and an expanding body of evidence, the researchers emphasized the importance of inclusivity and meaningful engagement with people experiencing SPMI in both research endeavors and healthcare development (Carlsson et al., 2017; Dempsey et al., 2016; Kars et al., 2016). A strength of this study lies in the extensive interviews conducted with people experiencing SPMI. The interviews were conducted in accordance with established standards, albeit with a deliberate embrace of non-conventional approaches while advocating an attitude of critical, ethical reflection to reach the most vulnerable people within this population. However, over the course of the study, a critical stance toward the role of gatekeepers remained imperative, especially given the tendency to overprotect these individuals. The researchers ensured that the selection of participants was not biased in favour of those who were most articulate or had positive experiences of treatment and care. Despite using a qualitative research methodology, efforts were made to include a diverse range of voices and certainly those of the hardest-to-reach. This was facilitated by gatekeepers who were highly committed to addressing the needs of this population—with all its subgroups—and their recognition of the potential positive impact that inclusion in research could have on practical outcomes (Van Hoe et al., 2024). The researchers were able to interview only a limited number of next of kin, which reflects the reality that people experiencing SPMI often have a limited social network (Moonen et al., 2016; Woods et al., 2008). This limitation highlights not only the challenges posed by the individual's condition but also issues within the mental healthcare system, such as the insufficient involvement of next of kin in treatment decisions. This is unfortunate, as the family member who participated in the second phase of the study provided valuable insights that differed from those of the professional experts. Their perspectives offered important nuances that the experts had not considered, enriching the overall understanding of the care experience and, consequently, what should constitute high-quality Oyster Care for them. This highlights the importance of collaboration between the care user, their network, and professionals, aligning with the principle of "nothing about them, without them." The absence of people experiencing SPMI—despite efforts to include them—and the underrepresentation of next of kin in the expert panel might have had an impact on the consensus scores during the second phase of the study. It could be argued that incorporating indicators scoring less than 80% might compromise the validity of the research and should be approached with extreme caution. Nonetheless, these lower scoring indicators emerged as highly important during discussions with those not present in the expert panel. For example, while the experts rated ‘involvement in meal choices’ as only moderately relevant, it was a recurring theme in conversations with people experiencing SPMI. Similarly, family meetings that provided opportunities for peer contact among family members were rated lower by the expert panel, yet in discussions with families, these meetings were highlighted as having significant added value. This discrepancy may be a result of the underrepresentation of these stakeholders in the panel, again highlighting the need for continued dialogue with them, both in care provision and in the development of policy and research, rather than making decisions on their behalf. The inclusion of lower-scoring indicators was therefore a deliberate decision to mitigate potential bias. One of the essential resources is sufficient staffing to implement Oyster Care as it is intended, which relies on providing one-on-one care when needed, adjusting care intensity to the care user’s needs, conducting activities in small groups and delivering personalized care that meets the complex needs of the individual (Decorte et al., 2020). This need is further intensified by the ethical and existential dilemmas and needs present in this population, such as balancing autonomy with structure and addressing various loss experiences, as well as providing end-of-life care and managing its associated challenges (Liégeois & Moureau, 2023; Moureau et al., 2023). Although this study provides some insights, future research will be required to determine the optimal team structure for implementing Oyster Care interventions effectively in practice, assisting policymakers in allocating resources efficiently and ensuring the delivery of high-quality care. In the development of a practical monitoring tool, the third phase of the study focused on reducing the number of indicators to retain only the most crucial ones for delivering Oyster Care. Although an additional Delphi round could have been conducted to finalize these selections, the experts were already heavily burdened by extensive questionnaires and had put significant effort into providing qualitative responses for each indicator. To maintain their engagement and avoid overburdening them, it was decided to select the most important items within each theme with the experts related to that theme. These choices were reviewed with all experts from the second phase of the study, and no substantial objections were received. This strategy aimed to balance the need for expert input with the practical constraints of their involvement, ensuring that their feedback remained an integral part of the entire Oyster Care development process. Influenced by discussions with FACT and ART experts, the scoring system in the monitoring tool prioritizes emphasizes the strengths of an Oyster Care team during an assessment, rather than merely checking off items (Westen et al., 2019). In this approach, the indicators for each subtheme will constitute a significant portion of the score. However, if a team applies a different, yet responsible, approach to the subtheme that deviates from the prescribed method, they can still receive a positive score for the subtheme. This allows for an emphasis on best practices while ensuring that less successful elements do not dominate the overall assessment. Consequently, the evaluation process becomes more flexible and nuanced, providing recommendations that are better tailored to the specific context and casemix of each team. This encourages innovation and creativity and empowers teams to explore what strategies work best in supporting and caring for people with SPMI within an offered quality framework that underscores Oyster Care's core principles. Furthermore, quality indicators can be adapted and refined to align them with the (evolving) needs of the target population, the social context, available societal resources and new insights into factors that influence healthcare outcomes (Durlak & DuPre, 2008). It is recommended to carefully document what changes – to adapt indicators to their specific context – are made to facilitate measurement of their impact on outcomes. This need for contextual flexibility also partly explains why no definitive answer could be drawn about the team structure required to implement Oyster Care. Different settings, such as psychiatric hospitals versus psychiatric nursing homes, and varying case mixes require different resources and approaches. In future studies, efforts will be made to translate and adapt the indicators for use in other care contexts, including general nursing homes and outpatient psychiatric teams. A pilot study will capture the experiences of end-users – professionals who utilize the monitor – and to evaluate the implementation process of Oyster Care using the monitoring tool. This would assist in refining the process based on their feedback and experiences, given the complexity and variability inherent in Oyster Care ensuring consistent implementation is challenging. The pilot study will be conducted from April 2024 to April 2025 in four mental health facilities. The primary aim of this study is to evaluate and optimize the implementation of Oyster Care through a comprehensive approach, including validating the monitor – to ensure that detailed measurements are feasible – developing review protocols and implementing coach-led improvement processes (Meyers et al., 2012). In parallel, another study will be conducted to assess the effects of Oyster Care on health outcomes. These measurements can provide insight into health changes, inform treatment decisions and are crucial for evaluating cost-effectiveness and improving resource allocation (Gayes et al., 2015). 5. Conclusion During a three-phase study, a quality monitoring tool was developed to ensure high-quality Oyster Care for people experiencing severe and persistent mental illness was developed. The tool is both theoretically sound and practically based, adapted to the specific imperatives of Oyster Care and applicable in the real context of mental health hospitals and psychiatric nursing homes in Flanders. It offers a structured framework that enables teams to implement the model as intended, engage in ongoing reflection and improvement of their practices, and inform resource allocation and treatment decisions. Declarations This work was supported by Onderzoeksfonds KU Leuven (BOF) (grantnumber: ebc7b31d-c18d-4d94-9639-cfdb561abcdf) and Congregation of the Sisters of Bermhertigheid Jesu The authors have no competing interests to declare that are relevant to the content of this article. Author Contribution CVH, LM, KL, ID, YV and KC contributed to the study conception and design. CVH and LB conducted the data collection and data analysis with input from all authors. All authors contributed to the content of this article, derived from discussions held in various meetings. KC and LM supervised the project and provided guidance throughout the study. CVH wrote the first draft of the manuscript. CVH, LM, KL, KC, AL, LB and YV critically revised the manuscript. All authors approved the final version. Acknowledgement The authors would like to thank Dr. Verfaillie for the insightful discussions on the concept of Oyster Care, which greatly contributed to the conceptual strengthening of this study. 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Supplementary Files supplement1.docx Cite Share Download PDF Status: Published Journal Publication published 07 Mar, 2026 Read the published version in Community Mental Health Journal → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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16:07:25","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":906277,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7545849/v1/448d58c1-2966-4571-981e-07187f69d1ae.pdf"},{"id":93483395,"identity":"6093f25d-04ce-4f6d-b677-e548a79a55ff","added_by":"auto","created_at":"2025-10-14 10:32:16","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":92874,"visible":true,"origin":"","legend":"","description":"","filename":"supplement1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7545849/v1/0df9c761d64533f22d74c8cb.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eEnsuring high quality Oyster Care for people experiencing severe and persistent mental illness – A three-phase development of a quality monitoring tool\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eWithin the field of mental health care, there are groups of people at risk of being overlooked by the healthcare system, the research community and society at large. This is particularly relevant for those experiencing severe and persistent mental illness (SPMI) (Decorte et al., 2020). SPMI encompasses long-term and disabling mental health conditions, such as refractory schizophrenia, treatment-resistant depression and severe bipolar disorder (Zumstein \u0026amp; Riese, 2020; Woods et al., 2008). This population shares the characteristic of experiencing persistent symptoms despite undergoing evidence-based treatments, resulting in significantly impaired daily functioning and reduced quality of life (Zumstein \u0026amp; Riese, 2020). Simultaneously, these people face a striking reality of reduced life expectancy, which is up to 15 years shorter than the general population, mainly due to severe co-occurring somatic disorders and limited access to timely and appropriate healthcare (Butler et al., 2018; James et al., 2018; Oakley et al., 2018; Plana-Ripoll et al., 2020; Woods et al., 2008). Traditional therapeutic interventions aimed at cure often prove ineffective for SPMI, leading caregivers to either persist with futile therapeutic approaches or in some cases discontinue care altogether. Also, in this specific population with refractory symptoms, the usual approaches of recovery and psychosocial rehabilitation alone are often not sufficient to improve wellbeing (Levitt \u0026amp; Buchman, 2020; Trachsel et al., 2016). This group of people, described as chronic and resistant to treatment, requires less conventional, disease-focused interventions and a shift to more person-centered care (Levitt \u0026amp; Buchman, 2020; Moonen et al., 2016).\u003c/p\u003e\u003cp\u003eThere is growing evidence that palliative psychiatry holds promise for addressing the needs of people experiencing SPMI (Gloeckler \u0026amp; Trachsel, 2021; Moonen et al., 2016; Trachsel et al., 2016; Woods et al., 2008). Palliative psychiatry emphasizes a careful reassessment of care goals. Rather than striving for cure, the focus is on alleviating suffering, minimizing harm and directly enhancing quality of life, despite or in the presence of enduring psychiatric symptoms (Levitt \u0026amp; Buchman, 2020; Westermair et al., 2022). Based on this palliative philosophy, the innovative model of \u0026lsquo;Oyster Care\u0026rsquo; was developed. Oyster Care adopts a holistic approach in caring for this group of people based on four pillars: physical care addresses somatic conditions, psychological care focuses on comfort and well-being, social care provides structure through activities and connections and existential care promotes a sense of meaningful living. As in regular palliative care, it places great value on interpersonal relationships and creative, out-of-the-box thinking by caregivers to go beyond standard protocol in caring for these people to improve their sense of meaning, well-being and quality of life. Initial feedback on the care model from both caregivers and care users has been positive. Caregivers report a heightened sense of well-being, which is also reflected in care users through reduced symptom burden and enhanced quality of life (Decorte et al., 2020).\u003c/p\u003e\u003cp\u003eIn recent years, the dissemination of the Oyster Care model's principles has accelerated within the Flemish mental healthcare landscape. An increasing number of mental health facilities are implementing the model in their care practices. While it is being adopted by residential mental health departments and psychiatric nursing homes, the concept is also being explored by nursing homes and outpatient mental health teams. To prevent unregulated variation in the interpretation and implementation of the concept, and to ensure its application is not solely dependent on clinical knowledge and skills (Mowbray et al., 2003), there is a recognized need for an evidence-based tool to translate the conceptual framework of Oyster Care into practice, providing caregivers with clear and effective guidance on its principles. A suitable instrument for this purpose is a fidelity scale or quality monitoring tool that translates the key components of the intervention into measurable categories (Mowbray et al., 2003)\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\:.\\)\u003c/span\u003e\u003c/span\u003e This instrument can improve the quality of care by offering teams a structured approach to assess and refine their implementation practices in alignment with the principles of the Oyster Care model. By establishing a feedback loop, the tool enables teams to gain insight into their current practices, which can subsequently inform targeted improvements. This process fosters adherence to the model\u0026rsquo;s core philosophy, ensuring that care delivery remains consistent with its intended framework and ultimately leading to higher-quality Oyster Care. Furthermore, once fidelity to the model can be reliably measured, it becomes possible to evaluate the quality of care provided, predict outcomes, assess whether the expected outcomes are being achieved and facilitate comparisons of treatments (Bellg et al., 2004; Durlak \u0026amp; DuPre, 2008; Mowbray et al., 2003). In addition, it can promote scientific research, enhance awareness and support the broader dissemination of the model of care (Bond et al., 2011).\u003c/p\u003e\u003cp\u003eIn the Netherlands, Active Recovery Triad (ART) and Flexible Assertive Community Treatment (FACT) have already developed tools that enable teams to continuously evaluate their practices, ensuring the quality of care for people experiencing severe psychiatric disorders (Westen et al., 2019; Zomer et al., 2020). However, Oyster Care emphasizes specific aspects of quality care for this population, which necessitates the development of a distinct monitoring tool tailored to its unique focus. For this, it is essential that researchers, intervention developers and other stakeholders agree on how implementation can reliably and validly measured. At the same time, the data should not only provide an accurate assessment of the fidelity of the specific model but also be useful for the caregiver.\u003c/p\u003e\u003cp\u003eThe aim of this study is to report on the development and validation of a monitoring tool for Oyster Care to support its implementation into practice. The three underlying sub-aims are: 1) to develop a quality framework for Oyster Care by mapping its key principles 2) to translate these principles into validated, operational indicators for the Oyster Care monitor and 3) to develop a feasible monitoring tool for practical application.\u003c/p\u003e"},{"header":"2. Methodology","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Design\u003c/h2\u003e\u003cp\u003eThe researchers undertook a mixed methods study consisting of three phases, conducted between 2021 and 2023, to develop a quality monitoring tool for Oyster Care (Johnson et al., 2007). The first phase entailed a literature review and a qualitative study focused on understanding the principles of the care model based on the experiences of those involved, in order to develop a quality framework for Oyster Care. The second phase comprised a Delphi expert consensus process aimed at developing and validating operational indicators relevant to Oyster Care. In the final phase, experts were tasked with selecting the validated indicators most important to Oyster Care in order to establish a feasible monitoring tool for practical implementation of the model within mental health services in Flanders. By using a mixed methods approach, the study was able to develop a quality monitoring tool that was both theoretically sound and practical, adapted to the specific imperatives of Oyster Care and applicable in the real context of mental health services in Flanders.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Setting and study population\u003c/h2\u003e\u003cp\u003eThe study was conducted in collaboration with eight mental health facilities across Flanders, namely three psychiatric hospitals, three psychiatric nursing homes, a walk-in centre for people with a death wish due to severe mental health problems and a psychiatric outpatient team. A ninth facility, a psychiatric nursing home, withdrew from participation prior to the start of the study, citing that they had not yet implemented the Oyster Care model in their practice and therefore felt unable to provide relevant insights regarding its use. The study population consisted of various stakeholders Oyster Care intends to reach: people experiencing severe and persistent mental illness, next of kin, and professionals, policy makers and academics who engage with people experiencing SPMI and are familiar with the Oyster Care model.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Methods\u003c/h2\u003e\u003cp\u003e\u003cb\u003ePhase 1: Developing a comprehensive quality framework for Oyster Care\u003c/b\u003e\u003c/p\u003e\u003cp\u003eInitially, a theoretical quality framework for Oyster Care was developed based on existing literature on the needs of people experiencing SPMI, their next of kin and professionals, as well as palliative care approaches for people experiencing SPMI to address these needs. However, recognizing the limited scope of research specifically addressing these topics, a qualitative research design was subsequently selected. This approach was deemed appropriate for addressing the identified gaps in the literature while allowing for a more focused exploration of the Oster Care model through the lens of experienced evidence.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eLiterature review\u003c/strong\u003e\u003cp\u003eIn December 2021, the researchers conducted a comprehensive literature search on palliative care approaches for people experiencing SPMI and the needs of those involved, excluding articles related to euthanasia and assisted suicide. The search yielded 18 relevant articles, which were analyzed with a focus on the needs of people experiencing SPMI, their next of kin and professionals and how palliative care approaches can meet these needs.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eQualitative interviews\u003c/strong\u003e\u003cp\u003eBetween January 2022 and November 2022, a qualitative study was conducted in two concurrent phases. Phase 1a explored the principles of Oyster Care from the perspectives of healthcare professionals, managers and policy makers. A total of 44 participants were interviewed through focus groups or individual interviews. Phase 1b focused on understanding the care needs of people experiencing SPMI and their next of kin, along with their experiences with Oyster Care and the extent to which the model does or does not address their needs. The researchers argue that involving people experiencing SPMI in research efforts stands as a cornerstone for empowerment - a feasible aspiration. Underscoring the importance of respectful and inclusive practices when engaging with this population, thereby enhancing the quality and relevance of research outcomes and facilitating more effective healthcare interventions tailored to their needs. Sixteen people experiencing SPMI and eight next of kin were interviewed one-on-one. A contact person at each participating facility supervised the recruitment process and additional precautions were taken during the recruitment of people experiencing SPMI to minimize participant burden (see Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). A semi-structured interview guide with open-ended questions was employed. The data were transcribed, coded using NVivo13 and analyzed according to a thematic analysis (Braun \u0026amp; Clarke, 2008).\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eSupportive measures to include people experiencing SPMI in research\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"1\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e- Interviews with patients are conducted only in real life.\u003c/p\u003e\u003cp\u003e- The gatekeeper, in consultation with the treating psychiatrist, assesses the patient's decision-making capacity (impact of research) and the extent to which they can provide informed consent.\u003c/p\u003e\u003cp\u003e- Interested patients cannot directly contact the researcher. They can express their interest to the gatekeeper\u003c/p\u003e\u003cp\u003e- Considering the patient's SPMI, the researcher contacts the local contact person on the day of the interview to discuss whether it is appropriate to proceed with the conversation.\u003c/p\u003e\u003cp\u003e- The interview duration is limited. Conversations last a maximum of 45 minutes to reduce participant burden\u003c/p\u003e\u003cp\u003e- Patients may choose to have a trustee to join the conversation. The trustee can offer emotional support or assist patients in articulating their experiences. Trustees cannot try to force the patient to continue the conversation. If the patient indicates a desire to end the conversation, the researcher concludes the discussion.\u003c/p\u003e\u003cp\u003e- Care providers and departmental leaders are informed of the nature, location, and timing of the conversation to mobilize a safety net within the department. Patients are asked if the local contact person or another care provider can accompany them back to the department after the conversation to offer additional support if needed.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eIntegration of findings\u003c/strong\u003e\u003cp\u003eBoth the literature review and the qualitative research employed an inductive analysis, allowing themes to emerge organically from the data collected. This open approach facilitated the development of a theoretical quality framework that responded to new insights. Consequently, the themes identified in relation to the research questions revealed strong connections with those in the conceptual model of Oyster Care (Decorte et al., 2020), highlighting the relevance of the model while also accommodating emerging concepts. The overarching themes that emerged from both the literature review and qualitative interviews were largely consistent, although the sub-themes varied and complemented one another. This process led to the development of a quality framework, which was subsequently face-validated during an ad hoc expert meeting. Five experts from three different settings participated in the four-hour live session, along with two members of the research team and one of the founders of the care model. During this session, additional content and nuance were incorporated into the quality framework and a small number of subthemes were renamed or removed if their content was covered by other subthemes. A significant change was the removal of the subtheme \u0026lsquo;Ethical and legal aspects of care\u0026rsquo;, as these considerations were deemed integral to all themes within the Oyster Care model. The overarching theme \u0026lsquo;team structure\u0026rsquo; was removed due to insufficient content to justify its inclusion.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003ePhase 2: Developing and validating quality indicators based on expert consensus\u003c/b\u003e\u003c/p\u003e\u003cp\u003eResearch phase 2 started with the research group translating the principles within the quality framework into operational indicators, enabling the measurement of high-quality Oyster Care provision (Mowbray et al., 2003). Since Oyster Care is a new intervention and scientific research on positive outcomes is lacking, collecting expert opinions through a modified Delphi study is an appropriate method for assessing face and content validity (Polit \u0026amp; Beck, 2021; Taherdoost, 2016). Through purposive and snowball sampling, twelve professionals and two academics experienced in working with people experiencing SPMI through the Oyster Care model, as well as one next of kin were recruited. They worked in facilities across all provinces in Flanders, with a balance between psychiatric nursing homes and psychiatric hospitals. Twelve of them had not participated in the initial research phase and the professionals had various backgrounds. Data collection took place between October 2022 and March 2023. Through an iterative process, the expert panel assessed the indicators for clarity using a dichotomous answer option of \u0026lsquo;clear\u0026rsquo; or \u0026lsquo;not clear\u0026rsquo;, and the relevance of the indicator to the concept of Oyster Care was asked using a 5-point Likert scale. The first and third Delphi rounds were organized through the completion of an anonymous, digital questionnaire and the experts had the opportunity to explain their quantitative answers in a qualitative manner. The second Delphi round was conducted via a digital live meeting. The Item-Content Validity Index (I-CVI) was calculated to measure the extent to which experts reached consensus (Yusoff, 2019). Fifteen experts participated in the first round, while twelve participated in both the second and the third round. The threshold for consensus on the clarity and relevance of an indicator was set at 86.67%, slightly higher than the conventional 80%, due to the experts\u0026rsquo; consistently positive scoring on the complete questionnaire in Delphi round one. Indicators that scored 86.67% or higher were retained. Those scoring between 66.67% and 86.67% were individually reviewed by the researchers, with decisions on these indicators discussed during the second and third Delphi rounds. This also applied to new indicators introduced based on qualitative feedback to address gaps in the original set. Indicators scoring below 66.66% were removed from the monitoring tool.\u003c/p\u003e\u003cp\u003e\u003cem\u003eSurveying management perspectives on the structure of Oyster Care teams\u003c/em\u003e: Research phase 2 also explored a potential ninth theme \"team structure\" for which insufficient data had been collected in research phase 1. The aim was to address the following question: What is the ideal structure of an Oyster Care team in terms of team composition and organizational framework? To investigate this, the researchers surveyed six head nurses from various Oyster Care teams within the participating facilities via e-mail. The survey focused on mapping their current team structure and an ideal team structure (e.g., disciplines, expertise, educational background, contract hours) necessary to deliver Oyster Care in a high-quality manner. These insights led to the development of fifteen new indicators, which were presented to the experts for evaluation in the third Delphi round. However, no consensus was reached and qualitative feedback from the experts revealed too much variation. Consequently, it was decided not to retain these indicators.\u003c/p\u003e\u003cp\u003e\u003cb\u003ePhase 3: Selecting key indicators for a feasible monitoring tool\u003c/b\u003e\u003c/p\u003e\u003cp\u003eFollowing the Delphi study, approximately 160 indicators emerged as clearly described and relevant to Oyster Care. However, feedback from Delphi experts and other stakeholders suggested that this extensive set needed to be minimized to ensure its feasibility for practical implementation (Leemans et al., 2016). Consequently, the decision was made to downsize the set of indicators to make it more manageable for use in practice. This marked the third and final phase of the study, focusing on selecting the most important indicators for delivering high-quality Oyster Care. For this, experts in each of the eight overarching themes were consulted based on their specialized knowledge. For instance, a general practitioner and nurse reviewed somatic care, a psychiatrist and psychologist assessed psychological care and a head nurse and manager evaluated the care process. Each theme was reviewed independently by at least two experts who had participated in earlier phases of the study. The choices were then cross-checked with the research group, integrating both qualitative and quantitative data from the first and second research phases. Simultaneously, one of the founders of the Oyster Care model was asked to independently select the most important indicators for all themes. The selections made by the experts, a founder of the Oyster Care model and the research group were found to be consistent with one another.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eEnduring collaboration between the research team and expert consultants\u003c/strong\u003e\u003cp\u003eDuring the two-year study, regular consultations were held with the research team, consisting of individuals with expertise in various research methodologies and the development of quality monitoring tools, palliative care approaches and end-of-life care, ethical considerations within care provision, and founders of the Oyster Care model. Additional expertise was enlisted on an ad hoc basis, including ART and FACT researchers with expertise in quality management and the development of monitoring tools for similar populations. Moreover, amidst exploration of effective care modalities for people experiencing SPMI there arose a dialogue across borders. In Belgium, healthcare workers are embracing practices from Dutch partners about prioritising the integration of people experiencing SPMI into society. At the same time, Dutch partners undertake a similar effort by exploring Belgian perspectives on delivering high-quality care within residential mental health settings to their own practices. This cross-border exchange of ideas and practices highlights the dynamic interplay between community-based initiatives and the organisation of residential mental health support systems.\u003c/p\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Ethical considerations\u003c/h2\u003e\u003cp\u003e The study adhered to the Declaration of Helsinki and European General Data Protection Regulation rules, and was approved by the Medical Ethics Committee of the Vrije Universiteit Brussel (VUB) (approval no. EC-2021-322). All participants were asked to sign an informed consent form ensuring their anonymity and confidentiality\u003c/p\u003e\u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eThe aim of this study is to report on the development and validation of a monitor tool for Oyster Care to support its implementation into practice. By guiding teams on the key principles that contribute to high-quality Oyster Care, the tool can support the implementation of the care model as intended, facilitate regular reviews of their practice, provide valuable insight into areas for practice improvement, and enable thorough evaluations of both improvement efforts and outcomes. The three underlying sub-aims are: 1) to develop a quality framework for Oyster Care by mapping its key principles 2) to translate these principles into validated, operational indicators for the Oyster Care monitor and 3) to develop a feasible monitoring tool for practical application\u003c/p\u003e\u003cp\u003eAn iterative process of various methods led to the development of 79 indicators of high-quality Oyster Care. The 79 indicators were grouped into 24 subthemes, which were in turn organized under eight overarching themes. The eight overarching themes are: 1. The care process, 2. The somatic pillar, 3. The psychological pillar, 4. The social pillar, 5. The existential pillar, 6. End-of-life care, 7. Team vision, culture and development and 8. The living environment. The corresponding scale-level content validity index for these indicators shows 97% for clarity, meaning 97% of the items were found easy to understand, and 93% for relevance, meaning 93% of the items were found relevant for the concept of Oyster Care. At the end of the results sections provides Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003ea flowchart outlining the research phases and key findings.\u003c/p\u003e\u003cp\u003eEach overarching theme in the monitoring tool begins with an introduction that delineates the care needs and challenges encountered by people experiencing SPMI, their next of kin and healthcare professionals in relation to that theme. It provides the theoretical context for the indicators, ensuring a comprehensive understanding of the framework\u0026rsquo;s foundation and elucidating how adherence to these indicators supports the delivery of high-quality Oyster Care. Each overarching thema consists of one to four subthemes, for which clear guidelines are provided for interpreting and measuring the indicators associated with that subtheme, ensuring they can be applied accurately and effectively in practice. Best practices collected throughout the study are also incorporated into the descriptions of each subtheme. Although some of these practices were not directly translated into operational indicators or selected during the third research phase, they are included as supplementary examples to support the practical implementation of quality care. At the conclusion of each subtheme, teams are presented with a 4-point Likert scale to evaluate their level of implementation for that specific subtheme. This scale ranges from \u0026lsquo;not visible\u0026rsquo; to \u0026lsquo;in development,\u0026rsquo; \u0026lsquo;embedded,\u0026rsquo; and \u0026lsquo;pearl\u0026rsquo;. The latter draws upon the shell metaphor, which serves as the central metaphor of the Oyster Care model. \u0026lsquo;Pearl\u0026rsquo; can be interpreted as \u0026lsquo;exemplary\u0026rsquo; or representing excellence in implementation. The subtheme is scored as a whole, with the associated indicators providing an indication of the extent to which that subtheme has been integrated into their Oyster Care practice. For illustration, see Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOverarching theme 2. Physical pillar \u0026ndash; Subtheme 5. Physical health\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"5\" nameend=\"c5\" namest=\"c1\"\u003e\u003cp\u003eSubtheme 5. Physical health\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"1\" nameend=\"c6\" namest=\"c6\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNot visible\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIn development\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eEmbedded\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePearl\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u003cp\u003eComments\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e\u003cp\u003e\u0026bull; The team timely assesses the care user's physical (pain) symptoms to understand and, if necessary, treat them\u003c/p\u003e\u003cp\u003e\u0026bull; The team acts as a liaison between the care user and practitioner, providing support to the care user during a medical examination if needed\u003c/p\u003e\u003cp\u003e\u0026bull; The team encourages care users to adopt a healthy lifestyle, provides tailored advice and support, and mediates when lifestyle choices are detrimental to health\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eA description of each overarching theme\u0026rsquo;s content is provided below. The complete monitor can be found in Appendix 1.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) During \u003cem\u003ethe care process\u003c/em\u003e, the focus is on promoting the well-being and quality of life of the care user. To this end, the care user, next of kin and the team work together to develop a care plan that responds to the care user's unique needs and values, and a care process marked by trial-and-error and the continual adaptation of care and treatment plans. For this, the team has an important role in interpreting verbal and nonverbal cues to understand and respect the care user's deeper desires, using the life story as a valuable guide. To provide personalized care and adapt the intensity of care to the changing needs of the care user, a balance between preparedness and flexibility is needed. Predefined strategies for care intensification help ensure a coordinated responsiveness, while pragmatism and adaptability are essential because standard protocols are not always appropriate. The care process consists of four subthemes: the acquaintance, the personal support plan, the support discussion, the upscaling and downscaling of care intensity.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) In the \u003cem\u003ephysical pillar\u003c/em\u003e, physical symptoms are detected early and assessed holistically, taking into account somatic, psychological, social and existential factors. When lifestyle choices are harmful to health, the team discusses the underlying needs of the unhealthy behavior and formulates an approach to mediate. In addition, the team focuses on restoring contact with the body, and medication policy balances between symptom relief and minimizing side effects. An indicator related to healthcare users having a voice in meal choice was considered less important by the experts. However, it was retained because this insight emerged as highly significant in qualitative interviews with people experiencing SPMI. For many, it served as a motivation to get out of bed, participate in cooking activities (due to the ability to choose what they ate, aligning with their preferences), or to venture outside as outings often concluded with a visit to a bistro (which in turn contributed to feeling connected to the broader community). The physical pillar comprises four subthemes: physical health, the eating environment, contact with the body and medication policy.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) The care relationship is a cornerstone of the \u003cem\u003epsychological pillar\u003c/em\u003e and serves as the foundation for further interventions, such as exploring, understanding and effectively treating psychiatric and psychological symptoms and behaviors. Understanding the care user's personal history and unique communication style facilitates this process, and the team explores creative ways to address these symptoms, intervening only when the care user or their environment are truly affected. Therapy and activities aim to create the right conditions for connection, relieve suffering and improve feelings of well-being by providing a measured amount of stimulation. The team recognizes early signs of overstimulation and creates an emotionally safe and structured environment by \u0026ldquo;closing the shell\u0026rdquo; to offer security. As the need for care decreases and the behavior and decisions of the care user become less harmful, \u0026ldquo;the shell reopens\u0026rdquo;. For example, a care user with chronic suicidal ideation and frequent impulsive suicide attempts experienced heightened emotional distress following the sudden death of his uncle. To ensure his safety, particularly given his impulsivity, the care team, in consultation with the care user, implemented a plan requiring him to travel only with accompaniment to reduce the risk of a suicide attempt. As his grief subsided and his social network provided strong support, the team gradually allowed him more autonomy, permitting occasional solo outings under structured agreements. Moving forward, the team will continue to evaluate his progress and collaboratively explore increasing his independence as his emotional stability improves. This approach addresses the dynamic nature of autonomy, which is influenced by the care user's often fluctuating levels of decision-making capacity. Four subthemes cover the psychological pillar, namely: the care relationship, therapy and activities, coping with symptoms and dealing with crisis and coercive measures.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) Within \u003cem\u003ethe social pillar\u003c/em\u003e, the team identifies people important to the care user from the past and investigates why contact with them was lost or broken. Together with the care user, they consider whether restoring these relationships makes sense and/or look for ways to maintain the meaning of these relationships without direct contact. In addition, the team supports care users in nurturing existing relationships and building reciprocal ties, providing the network with practical and emotional support. A tailored, predictable structure of activities and interactions supports care users in leading an active and as independent life as possible. Hereby participating together in daily social life and regular contact with volunteers helps to feel connected to the outside world. In addition, the team tackles institutionalization and stigma to help care users integrate into society and take on roles beyond those of a care user. The social pillar is structured around three subthemes: family and next of kin, activation, and social participation and inclusion.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Shedding light on the existential dimensions associated with experiencing SPMI \u003cem\u003ethe existential pillar\u003c/em\u003e is described. To foster a sense of connection, meaning and identity, the team (re)recognizes and understands in the care user feelings of hopeless existential suffering and grief arising from the loss of life dreams, relationships, health and self-worth. They provide an external structure within which care users can (re)discover values important to them, experience meaning in their daily functioning and reconnect with themselves, others, nature and the transcendent. These elements are covered in the sub-theme \u0026lsquo;Connection, meaning and identity\u0026rsquo;. In addition, the team recognizes and responds to care users' spiritual and religious needs by creating an open and respectful environment for such questions. They collaborate with experts to ensure that care users\u0026rsquo; spiritual and religious concerns are addressed. This focus on the journey towards reclaiming their humanity and sense of self is captured in the subtheme \u0026lsquo;Spirituality, worldview and religion\u0026rsquo;.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) Due to the prolonged stay of people experiencing SPMI in Oyster Care units, these facilities are equipped to accommodate the possibility of reaching the end stage of life. High quality \u003cem\u003eend-of-life care\u003c/em\u003e for care users in the last phase of life requires a careful and coordinated team approach so that efforts can be made to maintain and/or improve quality of life, quality of care and autonomy. To implement this, the theme of end-of-life care outlines indicators that can be divided into three subthemes, namely advance care planning, end-of-life care and post-death care. Decisions regarding end-of-life care hinge upon regular discussions held with the person and next of kin regarding their needs and preferences. Providing palliative care requires a lot from a team. Ethical consultation can help increase a team's ability to provide care and assist in end-of-life decisions. The team should have the opportunity to employ additional staff for one-on-one care when needed. Continual training in palliative care and the addition of a specialist or collaboration with a palliative home care service improve the quality of care.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) \u003cem\u003eThe team vision, culture and development\u003c/em\u003e theme focuses on the importance of a shared mission and values within a healthcare team, the importance of a positive team culture and how continuous growth and collaboration improve the quality of care. A number of key competencies are essential for an Oyster care team, these include demonstrating flexibility and creativity, being respectful and understanding of each other and of care users, and having sufficient professional knowledge. Providing Oyster Care can place significant demands on caregivers, therefore it is essential to create an environment of resilience, self-care and mutual support. The seventh domain is divided into three subthemes, namely attitude; professionalization, innovation and quality of care; and leadership.\u003c/p\u003e\u003cp\u003e(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) The eighth and final theme \u003cem\u003ethe living environment\u003c/em\u003e focuses on creating an appropriate living and housing space and designing infrastructure that meets the needs of care users, next of kin and the care team. This theme first addresses the opportunities and challenges inherent in communal living, where the coexistence of diverse personalities and individuals with severe illnesses can present some difficulties. To mitigate these challenges, the infrastructure must meet several specific requirements: it should be age-appropriate and provide structure, feature small living units and smaller living groups, offer single rooms, and include multipurpose rooms and low-stimulation rooms. Additionally, a pleasant garden and other supportive environmental features are essential to create a therapeutic and accommodating living environment. The living environment has one subtheme: living space and environment.\u003c/p\u003e\u003cp\u003eThe analyses showed a lack of definitive answers as to how an Oyster Care team should be structured because of the different needs in different care settings. This could have constituted a potential ninth theme in the study. However, the findings underscored the crucial need for sufficient staff, especially for responding promptly to peaks in intensity of care, depending on the non-stable condition of this population, and providing one-on-one support. The importance of therapists from various professional backgrounds was also stressed. This inclusiveness ensures that every care user can access and participate in therapies and activities that appeal to them personally. Moreover, the presence of psychiatrists and psychologists was considered essential for understanding symptoms, particularly through the lens of the person's life story, which may provide insight into coping mechanisms. Collaboration with general practitioners and sufficient hours for social workers and existential care professionals were also considered necessary to meet care users' somatic, social and existential needs, enabling holistic care delivery. This need is exacerbated by the various ethical and existential dilemmas and needs (e.g., dynamics around giving autonomy and providing structure; or dealing with various loss experiences) present in this population.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eIn this study, a quality monitoring tool for Oyster Care was developed through a comprehensive literature review and qualitative research involving various stakeholders of the care model. These insights were translated into measurable indicators of high-quality Oyster Care and validated through a Delphi procedure. Following this, the most significant indicators important for high-quality Oyster Care were selected, resulting in a practical monitoring tool comprising 79 indicators across 8 overarching themes. The resulting practice monitor is designed for use in Flemish psychiatric hospitals and psychiatric nursing homes, as a tool to guide and assess the implementation of the Oyster Care model. By evaluating their practices, teams have the opportunity to gain objective insights into their own performance and identify areas for improvement.\u003c/p\u003e\u003cp\u003e In line with the Oyster Care model and an expanding body of evidence, the researchers emphasized the importance of inclusivity and meaningful engagement with people experiencing SPMI in both research endeavors and healthcare development (Carlsson et al., 2017; Dempsey et al., 2016; Kars et al., 2016). A strength of this study lies in the extensive interviews conducted with people experiencing SPMI. The interviews were conducted in accordance with established standards, albeit with a deliberate embrace of non-conventional approaches while advocating an attitude of critical, ethical reflection to reach the most vulnerable people within this population. However, over the course of the study, a critical stance toward the role of gatekeepers remained imperative, especially given the tendency to overprotect these individuals. The researchers ensured that the selection of participants was not biased in favour of those who were most articulate or had positive experiences of treatment and care. Despite using a qualitative research methodology, efforts were made to include a diverse range of voices and certainly those of the hardest-to-reach. This was facilitated by gatekeepers who were highly committed to addressing the needs of this population\u0026mdash;with all its subgroups\u0026mdash;and their recognition of the potential positive impact that inclusion in research could have on practical outcomes (Van Hoe et al., 2024).\u003c/p\u003e\u003cp\u003eThe researchers were able to interview only a limited number of next of kin, which reflects the reality that people experiencing SPMI often have a limited social network (Moonen et al., 2016; Woods et al., 2008). This limitation highlights not only the challenges posed by the individual's condition but also issues within the mental healthcare system, such as the insufficient involvement of next of kin in treatment decisions. This is unfortunate, as the family member who participated in the second phase of the study provided valuable insights that differed from those of the professional experts. Their perspectives offered important nuances that the experts had not considered, enriching the overall understanding of the care experience and, consequently, what should constitute high-quality Oyster Care for them. This highlights the importance of collaboration between the care user, their network, and professionals, aligning with the principle of \"nothing about them, without them.\"\u003c/p\u003e\u003cp\u003eThe absence of people experiencing SPMI\u0026mdash;despite efforts to include them\u0026mdash;and the underrepresentation of next of kin in the expert panel might have had an impact on the consensus scores during the second phase of the study. It could be argued that incorporating indicators scoring less than 80% might compromise the validity of the research and should be approached with extreme caution. Nonetheless, these lower scoring indicators emerged as highly important during discussions with those not present in the expert panel. For example, while the experts rated \u0026lsquo;involvement in meal choices\u0026rsquo; as only moderately relevant, it was a recurring theme in conversations with people experiencing SPMI. Similarly, family meetings that provided opportunities for peer contact among family members were rated lower by the expert panel, yet in discussions with families, these meetings were highlighted as having significant added value. This discrepancy may be a result of the underrepresentation of these stakeholders in the panel, again highlighting the need for continued dialogue with them, both in care provision and in the development of policy and research, rather than making decisions on their behalf. The inclusion of lower-scoring indicators was therefore a deliberate decision to mitigate potential bias.\u003c/p\u003e\u003cp\u003eOne of the essential resources is sufficient staffing to implement Oyster Care as it is intended, which relies on providing one-on-one care when needed, adjusting care intensity to the care user\u0026rsquo;s needs, conducting activities in small groups and delivering personalized care that meets the complex needs of the individual (Decorte et al., 2020). This need is further intensified by the ethical and existential dilemmas and needs present in this population, such as balancing autonomy with structure and addressing various loss experiences, as well as providing end-of-life care and managing its associated challenges (Li\u0026eacute;geois \u0026amp; Moureau, 2023; Moureau et al., 2023). Although this study provides some insights, future research will be required to determine the optimal team structure for implementing Oyster Care interventions effectively in practice, assisting policymakers in allocating resources efficiently and ensuring the delivery of high-quality care.\u003c/p\u003e\u003cp\u003eIn the development of a practical monitoring tool, the third phase of the study focused on reducing the number of indicators to retain only the most crucial ones for delivering Oyster Care. Although an additional Delphi round could have been conducted to finalize these selections, the experts were already heavily burdened by extensive questionnaires and had put significant effort into providing qualitative responses for each indicator. To maintain their engagement and avoid overburdening them, it was decided to select the most important items within each theme with the experts related to that theme. These choices were reviewed with all experts from the second phase of the study, and no substantial objections were received. This strategy aimed to balance the need for expert input with the practical constraints of their involvement, ensuring that their feedback remained an integral part of the entire Oyster Care development process.\u003c/p\u003e\u003cp\u003eInfluenced by discussions with FACT and ART experts, the scoring system in the monitoring tool prioritizes emphasizes the strengths of an Oyster Care team during an assessment, rather than merely checking off items (Westen et al., 2019). In this approach, the indicators for each subtheme will constitute a significant portion of the score. However, if a team applies a different, yet responsible, approach to the subtheme that deviates from the prescribed method, they can still receive a positive score for the subtheme. This allows for an emphasis on best practices while ensuring that less successful elements do not dominate the overall assessment. Consequently, the evaluation process becomes more flexible and nuanced, providing recommendations that are better tailored to the specific context and casemix of each team. This encourages innovation and creativity and empowers teams to explore what strategies work best in supporting and caring for people with SPMI within an offered quality framework that underscores Oyster Care's core principles.\u003c/p\u003e\u003cp\u003eFurthermore, quality indicators can be adapted and refined to align them with the (evolving) needs of the target population, the social context, available societal resources and new insights into factors that influence healthcare outcomes (Durlak \u0026amp; DuPre, 2008). It is recommended to carefully document what changes \u0026ndash; to adapt indicators to their specific context \u0026ndash; are made to facilitate measurement of their impact on outcomes. This need for contextual flexibility also partly explains why no definitive answer could be drawn about the team structure required to implement Oyster Care. Different settings, such as psychiatric hospitals versus psychiatric nursing homes, and varying case mixes require different resources and approaches. In future studies, efforts will be made to translate and adapt the indicators for use in other care contexts, including general nursing homes and outpatient psychiatric teams.\u003c/p\u003e\u003cp\u003eA pilot study will capture the experiences of end-users \u0026ndash; professionals who utilize the monitor \u0026ndash; and to evaluate the implementation process of Oyster Care using the monitoring tool. This would assist in refining the process based on their feedback and experiences, given the complexity and variability inherent in Oyster Care ensuring consistent implementation is challenging. The pilot study will be conducted from April 2024 to April 2025 in four mental health facilities. The primary aim of this study is to evaluate and optimize the implementation of Oyster Care through a comprehensive approach, including validating the monitor \u0026ndash; to ensure that detailed measurements are feasible \u0026ndash; developing review protocols and implementing coach-led improvement processes (Meyers et al., 2012). In parallel, another study will be conducted to assess the effects of Oyster Care on health outcomes. These measurements can provide insight into health changes, inform treatment decisions and are crucial for evaluating cost-effectiveness and improving resource allocation (Gayes et al., 2015).\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003e During a three-phase study, a quality monitoring tool was developed to ensure high-quality Oyster Care for people experiencing severe and persistent mental illness was developed. The tool is both theoretically sound and practically based, adapted to the specific imperatives of Oyster Care and applicable in the real context of mental health hospitals and psychiatric nursing homes in Flanders. It offers a structured framework that enables teams to implement the model as intended, engage in ongoing reflection and improvement of their practices, and inform resource allocation and treatment decisions.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eThis work was supported by Onderzoeksfonds KU Leuven (BOF) (grantnumber: ebc7b31d-c18d-4d94-9639-cfdb561abcdf) and Congregation of the Sisters of Bermhertigheid Jesu\u003c/p\u003e\u003cp\u003eThe authors have no competing interests to declare that are relevant to the content of this article.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eCVH, LM, KL, ID, YV and KC contributed to the study conception and design. CVH and LB conducted the data collection and data analysis with input from all authors. All authors contributed to the content of this article, derived from discussions held in various meetings. KC and LM supervised the project and provided guidance throughout the study. CVH wrote the first draft of the manuscript. CVH, LM, KL, KC, AL, LB and YV critically revised the manuscript. All authors approved the final version.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eThe authors would like to thank Dr. Verfaillie for the insightful discussions on the concept of Oyster Care, which greatly contributed to the conceptual strengthening of this study. We would like to acknowledge our Dutch partners from the ART and FACT team, especially Lieke Zomer and Koen Westen, for their inspiration and critically important perspective that enriched our project. Thanks also to Palliative Care Flanders and the Congregation of the Sisters of Bermhertigheid Jesu for their support of this project. Special thanks are extended to Manon Strumane and Juliette Van Ryssel who collected and analyzed data as part of their master's theses. The authors appreciate all mental health and other care facilities that facilitated recruitment, interviews and aftercare phases. Deepest gratitude is expressed to the people experiencing SPMI and their families who participated in the interview studies.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBellg, A. J., Borrelli, B., Resnick, B., Hecht, J., Minicucci, D. S., Ory, M., Ogedegbe, G., Orwig, D., \u0026amp; Czajkowski, S. (2004). 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Defining Severe and Persistent Mental Illness \u0026ndash; A Pragmatic Utility Concept Analysis. \u003cem\u003eFrontiers in Psychiatry\u003c/em\u003e, \u003cem\u003e11\u003c/em\u003e, 648. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3389/fpsyt.2020.00648\u003c/span\u003e\u003cspan address=\"10.3389/fpsyt.2020.00648\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"severe and persistent mental illness, palliative psychiatry, palliative care approach, long-term mental health care, quality improvement","lastPublishedDoi":"10.21203/rs.3.rs-7545849/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7545849/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction:\u003c/h2\u003e\u003cp\u003eOyster Care is an innovative care model designed to meet the needs of people experiencing severe and persistent mental illness\u0026mdash;a population often overlooked by the healthcare system and at heightened risk due to caregivers either persisting with ineffective therapeutic interventions or discontinue care altogether. The model encourages caregivers to engage in creative, out-of-the-box thinking, enabling them to move beyond conventional protocol to improve the person\u0026rsquo;s sense of meaning, well-being and quality of life. In recent years, the adoption of Oyster Care\u0026rsquo;s principles has gained momentum within Flemish mental healthcare. Consequently, there is an increasing recognition of the need for an evidence-based tool that can translate the conceptual framework of Oyster Care into practice, providing caregivers with clear, actionable guidance on its core principles.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA mixed methods study was conducted from 2021 to 2023. The first research phase involved a literature review and a qualitative study aimed at understanding the models\u0026rsquo; principles. The second phase focused on translating these principles into validated, operational indicators through a Delphi expert consensus process. In the final phase, experts were tasked with selecting the most relevant validated indicators for Oyster Care.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003e79 indicators of high-quality Oyster Care were developed. These indicators were grouped into 24 sub-themes, which were organized under eight overarching themes: The care process; The somatic pillar; The psychological pillar; The social pillar; The existential pillar; End-of-life care; Team vision, culture, and development; The living environment. The SCV-I demonstrated 97% for clarity and 93% for relevance.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e\u003cp\u003eThe monitoring tool is designed for use in Flemish mental health hospitals and psychiatric nursing homes. A pilot study is currently underway to evaluate the practical use of the tool. The monitor has the potential to support future research measuring the impact of Oyster Care on health outcomes.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eA practical monitoring tool was developed to support the implementation of Oyster Care within mental health services in Flanders. The tool offers a structured framework that enables teams to implement the model as intended, engage in ongoing reflection and improvement of their practices, and inform resource allocation and treatment decisions.\u003c/p\u003e","manuscriptTitle":"Ensuring high quality Oyster Care for people experiencing severe and persistent mental illness – A three-phase development of a quality monitoring tool","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-14 10:32:11","doi":"10.21203/rs.3.rs-7545849/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"111cc381-fbea-4f8d-9a6c-1d80038f613c","owner":[],"postedDate":"October 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-09T16:04:32+00:00","versionOfRecord":{"articleIdentity":"rs-7545849","link":"https://doi.org/10.1007/s10597-026-01596-8","journal":{"identity":"community-mental-health-journal","isVorOnly":false,"title":"Community Mental Health Journal"},"publishedOn":"2026-03-07 15:58:03","publishedOnDateReadable":"March 7th, 2026"},"versionCreatedAt":"2025-10-14 10:32:11","video":"","vorDoi":"10.1007/s10597-026-01596-8","vorDoiUrl":"https://doi.org/10.1007/s10597-026-01596-8","workflowStages":[]},"version":"v1","identity":"rs-7545849","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7545849","identity":"rs-7545849","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}