The number of individuals with complex, chronic neurological diseases such as multiple sclerosis (MS) will likely increase because of continuous medical progress and an increase in aging. The prevalence of people with MS increased from 0.247% in 2009 to 0.318% in 2015 in Germany (Holstiege et al., 2017). Multiple sclerosis needs are heterogeneous (Kraft & Berger, 2020) and encompassing. They range from (re)organizing one's everyday life to measures of disease-specific therapy monitoring and aspects of palliative care (Galushko et al., 2014; Strupp et al., 2015). Enabling and coordinating health care resources and services are often perceived stressful and unmanageable for patients and their caregivers (family members or closely related persons, directly involved into patients care), especially as, disability increases. Main reasons are high bureaucracy and laborious effort of organizing and coordinating adequate care and treatment (Galushko et al., 2014; Sorensen et al., 2019; Tan et al., 2010; Wynia et al., 2010). A high need for research on structurally addressing and organizing needs for individuals with severe MS as a complex and progressing neurological disease is evident (Barin et al., 2018; Dobson & Giovannoni, 2019; Galushko et al., 2014; Tan et al., 2010; Wynia et al., 2010).

Health care is a complex system. Although the underlying structures are somehow connected, every institution remains solitary. Cooperation, coordination, and transparent communication could benefit patients and the health care system as relevant structures can be tailored more economical to individual patients' needs. A cross-sectoral continuum of care and care coordination is of utmost importance due to the complexity of the chronic and complex disease. Care management aims to connect different services, care providers, and institutions to provide seamless and efficient care for unmet needs (Wendt & Löcherbach, 2020), using a structured portfolio to target the social care system economically (Ewers & Schaeffer, 2005; Neuffer, 2013; Oeseburg et al., 2009; Stergiopoulos et al., 2015).

Case management (CM) operates on an individual level with patients and caregivers. It aims to promote autonomy and self-determination and offer professional support. It acts as advocates for patients and works cross-sectoral over a long time period improving mental and physical health as well as the impact of social determinants on health, ultimately aiming for equity in health (Case Management Society of America, 2010,2016,2022).

Care management acts superordinately on an operational level managing health care services, creating new ones, and helping improve and connect with each other, as well as transferring information between HCPs, whereas CM operates on an individual level with patients and caregivers supporting and advocating patients' and caregivers' needs. Significance and differences between care and case management (CCM) are listed in Table 1.

TABLE 1 - Significance and Task of Care and Case Management Case Management Care Management “[...] is a collaborative process of assessment, planning, facilitation, care coordination, evaluation, and advocacy for options and services to meet an individual's and family's comprehensive health needs through communication and available resources to promote patient safety, quality of care, and cost effective outcomes.” (Case Management Society of America, 2010).
Case managers operate on an individual level with patients and caregivers. They promote autonomy and self-determination and offer professional support, act as advocates for patients, and work cross-sectoral over a long period of time. Refers to the overall management of health care.
Organizes a transparent and overriding transfer of information between involved health care providers and services (operational level).
Concurrently, it supports the creation of new services with the help of existing ones to improve the patients' situation superordinately (organizational level).
The aim is to work cross-sectoral on the network structure, coordination, and cooperation across all providers to identify and close gaps in patient care (Wendt & Löcherbach, 2020).

The efficacy of CM for chronic neurological or palliative care patients has been assessed only in a few studies (Aiken et al., 2006; Kuhn et al., 2012; Leary et al., 2015; Strupp et al., 2018; Wynia et al., 2010) as access to these patient groups is often impeded (Eggers et al., 2018; Wissert et al., 2009). However, these studies did not include caregivers (Aiken et al., 2006) or palliative care aspects and included only in-hospital patients (Wynia et al., 2010) without focus on patient/caregiver outcomes (Leary et al., 2015; Strupp et al., 2018).

The authors present a structured CCM manual currently applied in the ongoing “COCOS-MS” (Communication, Coordination and Security for People with Multiple Sclerosis) study; Golla et al., 2022), aiming to develop and evaluate a continuous, long-term, cross-sectoral, outreaching patient advocacy CCM.

Development of CCM-Specific Structure and Content

Content and structure of the CCM manual are adopted from Monzer (2018),Wissert (2006a),Wissert (2006b),Wissert (2007b),Wissert (2008a),Wissert (2008b),Wissert (2009), and Wissert and Roccor (2013). A CM control loop comprises seven steps: (1) Outreaching—case finding—intaking is defined as finding suitable patients for the CM process and/or providing an accessible contact point. After a first informational meeting, the patient, caregiver and case manager mutually decide to commence the CM process (Wissert, 2006b). During the (2) assessment problems, resources, and needs are identified and evaluated with specific instruments (Wissert, 2006a). Herein, medical/physical needs, external/internal living conditions life perspective (ambitions), and life history (coping strategies, resources) are considered (Wissert, 2006a,2006b,2007a,2007b,2008a,2008b,2009; Wissert et al., 2009; Wissert & Roccor, 2013). Within (3) care planning, the case manager acts in the best interest of the patient by deciding on and designing different approaches to meet patients' goals and unmet needs while promoting their autonomy and self-determination (Wissert, 2007b). This step is followed by (4) implementation and linking. The case manager contacts all relevant authorities, HCPs, and therapists to achieve previously defined goals while closely (5) monitoring the progress. This allows for prompt adjustments of given objectives, if necessary (Wissert, 2007a). Patient empowerment is ensured by continuously engaging and involving them in the process (Wissert, 2007a). Upon completion of the action plan, the case manager and patients (6) evaluate the output and outcome. Depending on whether defined goals have been met, the case manager is either (7) relieved off his or her duty or the process needs to be reassessed and continued (Wissert, 2008a). Although follow-up assessments as a measure of sustainability have been recommended, most CM processes do not include them (Wissert, 2009).

MS-Specific

Kalb et al. (2019) showed that there is need for a coordinating advocacy CM for patients with MS. The author's advocate program showed that systematic data collection is of special importance, including the number of patient and service contacts that are satisfactory, insufficient, or lacking (Kalb et al., 2019). This aspect is taken into account in the CCM manual. In addition, missing and existing services are listed.

To design the CCM process, a semistructured manual has been developed within the scope of the COCOS-MS study by the authors of this manuscript consisting of an interdisciplinary/multiprofessional group of CCM experts, palliative care scientists, neurologists, palliative care physicians, psychologists, and social workers based on theoretical aspects and prior scientific work as explained later in more detail.

The individual domains of life the CCM manual assesses are composed of a variety of established guidelines, validated questionnaires (Bausewein et al., 2011; Bjellanda et al., 2001; Dillen et al., 2019; DIMDI, 2005; Gao et al., 2016; Gold et al., 2001; National Institute for Health and Care Excellence, 2014; Riazi et al., 2002; Sleeman & Higginson, 2013), and the results of a CM project in Germany (Institut für Praxisforschung und Evaluation an der Evangelischen Hochschule Nürnberg, 2017). The National Institute for Health and Care Excellence (NICE) clinical Guideline CG186 (National Institute for Health and Care Excellence, 2014) recommends different care options for MS patients, including physical condition, mobility, mental health, and social participation. These aspects are implemented in the CCM manual in the domains of physical health, mental health, self-sufficiency, and social situation and participation. Highly relevant problems and symptoms of MS (e.g., fatigue, depression) are mentioned in the Multiple Sclerosis Impact Scale (MSIS-29) (Riazi et al., 2002) and implemented into the CCM manual in the domains of physical health and self-sufficiency. Relevant aspects for the CCM manual of the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HALEMS) (Gold et al., 2001) are highly relevant symptoms of MS. Those are implemented in all four domains of life in the CCM manual. As MS can shorten the lifetime, aspects of the Palliative Care Outcome Scale and Palliative Care Outcome Scale/8 Item Integrated Palliative care Outcome Scale (POS/IPOS Neuro S-8) Bausewein et al., 2011; Gao et al., 2016; Sleeman & Higginson, 2013) and Hospice and Palliative Care Evaluation considering additional neurological issues (HOPE+) (Dillen et al., 2019) covering items of hospice and palliative care concerns are implemented in all domains of life in the CCM manual. The Hospital Anxiety and Depression Scale (HADS) (Bjellanda et al., 2001) questionnaire covers questions about anxiety and depression, which are implemented in the domain of mental health in the CCM manual. Aspects of the International Classification of Functioning, Disability and Health (ICF) World Health Organization (n.d.) are included into the respective assessments to guarantee a comprehensive approach. A summary can be found in Table 2.

TABLE 2 - Consideration of Guidelines and Questionnaires in the CCM Manual Guideline/Questionnaire Relevant Aspects for CCM Implementation Domain in CCM Manual NICE clinical Guideline CG18 (National Institute for Health and Care Excellence, 2014) Recommends different care options for MS patients; these recommendations cover physical condition, mobility, mental health, and social participation. Physical health
Mental health
Self-sufficiency
Social situation and participation MSIS-29 (Riazi et al., 2002) Covers symptoms and problems highly relevant in MS such as depression, fatigue, and quality of life. Physical health
Self-sufficiency HALEMS (Gold et al., 2001) Covers symptoms and problems highly relevant in MS such as depression, fatigue, social participation, and quality of life. Physical health
Mental health
Self-sufficiency
Social situation and participation POS/IPOS Neuro S-8 (Bausewein et al., 2011; Gao et al., 2016; Sleeman & Higginson, 2013)
HOPE+ (Dillen et al., 2019) MS shortens lifetime by about 10 years (Scalfari et al., 2013). Patients with progressive and/or severe MS may develop palliative and hospice care concerns and needs that are covered by the validated palliative and hospice care measurements. Furthermore, the psychological social situation is ingested. Physical health
Mental health
Self-sufficiency
Social situation and participation HADS (Bjellanda et al., 2001) A widely used validated questionnaire, covering questions about anxiety and depression. Mental health ICF (World Health Organization, n.d.) Covers all aspects of life. Included in the respective assessment

Note. CCM = care and case management; HADS = Hospital Anxiety and Depression Scale; HALEMS = Hamburg Quality of Life Questionnaire in Multiple Sclerosis; HOPE+= Hospice and Palliative Care Evaluation by neurological symptoms; ICF = International Classification of Functioning, Disability and Health; MS = multiple sclerosis; NICE = National Institute for Health and Care Excellence; POS/IPOS Neuro S-8 = Palliative Care Outcome Scale/8 Item Integrated Palliative care Outcome Scale.

Structure of the CCM Manual

The CCM manual has been designed according to Wissert's seven steps (Wissert, 2006a,2006b,2007a,2007b,2008a,2008b,2009) and adapted to six steps including (1) the collection of personal data of patient and caregiver (includes the preliminary assessment); (2) assessment of (unmet) needs, resources, and problems (patient and caregiver); (3) action planning; (4) care planning and actions; (5) process control assessments; and (6) relief of duties. A visualization is shown in Figure 1.

FIGURE 1:

Structure of the CCM manual.

Process Sequence of CCM in the COCOS-MS Study

During the initial visit with patients and caregivers, sociodemographic and medical data (e.g., type of care, medical treatment, and emergency contacts) are captured. A detailed assessment on behalf of different areas of life (physical health, mental health, self- sufficiency, social situation, and participation) allows for the development of an individual action plan. Moreover, a care plan is continuously evaluated and adapted. Monthly personal and weekly telephone contacts by means of reassessments and reevaluations (see Figure 2) ensure that current problems, achieved aims, and unmet needs are updated regularly. Meticulous documentation of identified unmet needs, fragmented care, deficits in the health care system for the individual case, and advice for possible solutions given by the CCM are documented in the manual. The case manager is in contact with HCPs and health care services to ensure coordination and monitoring of all relevant health care services necessary for each patient (e.g., monitoring of immunotherapeutics). This allows for cross-sectoral transparent communication and an integration of care. Relevant information is being reported back to HCPs. The CM process ends with a final evaluation and release of the case manager.

FIGURE 2:

CCM process in the COCOS-MS study according to the CCM manual.

Assessment

Based on the aforementioned theoretical reasoning, the assessment plan is created including four main categories that correspond to the areas of life: (1) physical health, (2) mental health, (3) self-sufficiency, and (4) social situation and participation; each with subcategories containing relevant items. Each item is assigned an individual code important for care planning and assessed using a 5-point Likert scale ranging from 0 (no problem/none/no need) to 4 (very high/very good/crisis intervention). The results are used to define an individual action plan.

In case of a crisis intervention, the assessment is terminated immediately and the CM intervention is initiated instead.

Assessment of Patients

During all (re-)assessments, every subitem of each category as shown in Table 3 is rated. During the short assessments, only the superordinate items of the respective areas of life are checked. The domain of physical health includes the superordinate items and focuses on MS, other physical illnesses, and medication of the patient. The psychological situation is assessed as a superordinate item in the domain of mental health. The domain of self-sufficiency covers more detailed superordinate items including the self-care abilities of the patient, medical, therapeutic and nursing care, mobility, housing, ability to work, and the financial and social legal situation. The domain of social situation and participation covers the superordinate items of communication, social integration, pursuing hobbies/leisure time activities, cultural/social/political participation, and spiritual/pastoral care. All superordinate items and subitems are shown in Table 3.

TABLE 3 - CCM Assessment Patient Physical health MS Spasticity, paralysis, numbness, hypesthesia, etc. Pain Coordination and fine motor skills Status of swallowing, speech, and/or language disturbance Vision/hearing/smelling/tasting Progress of MS Respiratory problems Skin condition Urogenital (e.g., incontinence) and gastrointestinal tract (e.g., nausea) Other physical illness Other internal diseases (e.g., cardiovascular) Weight Access to routine health screenings Medication Management of immune modulatory therapy Medication Mental health Psychological situation Dealing with stressful situations Concentration, cognition, disorientation Personality change Fatigue, depression, depressive mood, suicidal thoughts Anxiety/internal restlessness, panic attack Grief Ability to express feelings Break in biography Autonomy Smoking, alcohol and drug use Self-sufficiency Self-care patient: nursing, household, and organization Satisfaction with external appearance Washing the upper and lower body Incontinence care Showering/bathing; dental care; hair/nail care; putting on clothes Cleaning the apartment Eating/drinking independently, preparing food, shopping Preparing and procuring medications Organizing their own daily structure, coordinating appointments Medical, nursing, therapeutic care General practitioner care Neurological care, other specialist care Nursing service Physiotherapy, ergo therapy, speech therapy, psychotherapy Information about MS (course, therapy, self-help offers) Mobility Walking inside/outside the house, climbing stairs Standing safely Access to/use of individual transportation (e.g., car) Access/use to public transportation Housing Place and type of residence, access to residence Accessibility of living and sleeping rooms, bathroom, kitchen, and other rooms, balcony/terrace/garden Work and employment (e.g., voluntary work) Professional ability, work ability, organization of the workplace Meaningful activity (e.g., voluntary work) Financial and social legal situation Financial security of livelihood and care Financing of housing adaptations, aids Social insurance carriers (e.g., health insurance) Debts Old-age security Being able to represent legal interests oneself Recognition of (severe) disability Other sociolegal needs (e.g., custody) Social situation and participation Communication Use of mobile/phone/computer/tablet Access to information media (e.g., internet) Reading, listening, writing Social integration, family and friendship involvement, role as, e.g., partner, child, parent, friend Feeling a sense of belonging, caring for family/relatives, maintaining friendships, participating in events Being, e.g., a parent, daughter, friend, partner Love/sex life, family planning, access to contraceptives Pursuing hobbies/interests, leisure time activities Sufficient free time, pursuing hobbies/interests Exercising Attending cultural events (movies, theater, concerts) Going on vacation Cultural/social/political participation Participation in neighborhood/club life Access to educational opportunities (e.g., VHS) Political participation (e.g., voting rights) Spiritual/pastoral care, religion Possibility of living out/finding contact with one's religion/spirituality Contact with spiritual/pastoral care

Note. MS = multiple sclerosis; VHS = Volkshochschule.

Assessment Caregiver

The patient and caregiver form a unit of care; previous studies have shown that caregivers experience high levels of stress and burden when caring for patients with long-term neurological conditions such as MS (Golla et al., 2015). Therefore, their concerns are also taken into account in form of the superordinate items. Physical health includes physical illnesses and stress due to care. Mental health assesses mental burden as a caregiver and mental illnesses. Management of household, organization, mobility, living, work, and financial security is covered in the domain of self-sufficiency. Social integration and participation includes family involvement, maintaining friendships, and the role as, for example, partner, parent, and friend. All of these items are listed in Table 4.

TABLE 4 - Care and Case Management Assessment Caregiver Physical health caregiver Physical illnesses Physical stress due to care/provision Mental health caregiver Mental burden as caregiver Mental illnesses Self-sufficiency caregiver Household management (shopping, cleaning, etc.) Organization (e.g., of appointments) Mobility Living Work Financial security Social integration and participation caregiver Family involvement Maintaining friendships Role as, e.g., partner, child, parent, friend Pursue hobbies/interests Cultural/social/political participation Spiritual/pastoral support
CM (Individual Level)

The structured CCM manual helps identify and measure patients' and caregivers' problems, resources, and unmet needs, which allows for the development of a resource-orientated action plan with clear goals. The standardization of the CCM manual aids in assessing, documenting, and evaluating these aspects in a comprehensive, structured, and systematic manner.

Goal Detection, Action Plan, Monitoring, and Care Planning

As a result of the first assessment, objectives are mutually set and an individual action plan is created, which is being reviewed at the end of the CCM (see Figure 2).

The case manager also develops a care plan. During the monthly assessments, goals and actions are monitored to determine whether goals have been met or new ones have to be added, using a Likert scale ranging from 0 (not achieved) to 4 (more than achieved). Each action and goal are coded and documented. Further monitoring takes place during the weekly telephone contacts. Care and case management services fulfilled (e.g., consulting, coordination) are recorded.

Cooperation Partners Plan

Contacted cooperation partners (e.g., HCPs) are listed with information on suitability.

Evaluation of Participation

As one main aim of the CCM actions is to improve patients' self-efficacy and empowerment, the degree of patients' participation is evaluated at 3, 6, 8, 11, and at the end of 12 months. The evaluation contains nine statements about having a say, the level of support, choosing the actions and service providers, realizing wishes, feeling relieved, and structuring life in a self-determined way (see Table 5).

TABLE 5 - Evaluation of Social Participation 0 (Very Little) 1 2 3 4 (Very Much) My wishes are realized. I choose the service providers. I felt relieved during the implementation of the actions. I choose the actions. I have a say. My values and ideas are taken into account. The level of support I receive is appropriate. I structure my life in a self-determined way. I feel relieved.
Relief of Duty and Evaluation

After the CM process has ended, CCM and patients/caregivers evaluate the process and then dismiss the CCM from his or her duties. This final evaluation encompasses a detailed assessment, evaluation of social participation, and review of set goals. If a set goal is not reached throughout the CCM process, this must be recorded with good reason (see Table 6).

TABLE 6 - Possible Reasons for Not Reaching a Goal Health status changed/reduced Individual action not well delivered Cooperation problems with partners Funding problems Individual action not available Individual action not accepted Care and case management consultation discontinued Care and case management competencies insufficient Other (text entry) Not specified
Care Management (Superordinate Level)

Within care management, a systematic portfolio of sociomedical support services tailored to severely affected MS patients is developed. If these services cannot be found or established, they are being documented as “gaps in care.” In this case, the CCM contacts and connects existing structures to arrange new services. If successful, a new service is listed in the portfolio; otherwise, it is documented as failure in the health care system that has to be addressed in the future.

Discussion

Based on previous literature and well-established questionnaires (Bausewein et al., 2011; Bjellanda et al., 2001; Dillen et al., 2019; DIMDI, 2005; Gao et al., 2016; Gold et al., 2001; National Institute for Health and Care Excellence, 2014; Riazi et al., 2002; Sleeman & Higginson, 2013) following theoretical aspects and prior scientific work, we have developed the CCM manual. It covers four individual domains of life of patients with MS and their caregivers and herein identifies complex symptoms, problems, needs, and resources on an individual level. Working with the CCM manual should empower patients and caregivers to reduce problems and strengthen resources on an individual level for more than 12 months. Moreover, it helps detect “gaps in care” and tries to establish new services on the superordinate level of care management. This CCM manual complements the previous study by Kalb et al. (2019) adding points of long-term intervention and improvement of surrounding structures discussed there. In addition, it involves caregivers according to Golla et al. (2012) and Golla et al. (2015).

Within the COCOS-MS study, the outcome assessment meticulously tests in standardized assessments the feasibility of the CCM manual within the intervention group receiving CCM for 12 months in addition to standard care (Golla et al., 2022). At the end of the intervention period, it will be analyzed statistically and qualitatively. Consequently, conclusions can be drawn as to whether the CCM manual is feasible or has to be adapted for use in standard care after analyzation.

Implications for CM

The CCM manual serves as a tool for the continuous, long-term, cross-sectoral care for patients suffering from severe MS and their caregivers. The manual provides guidance in adequately addressing patient's complex symptoms, problems, and needs, as well as assessing existing resources both at the individual patient level and at a superordinate level. To ensure holistic care, the four areas of life: (1) physical health, (2) mental health, (3) self-sufficiency, and (4) social situation and participation are assessed regularly by the case manager.

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