People with severe psychiatric disability (SPD) frequently experience overwhelming symptoms, disengagement, and difficulties handling everyday life situations (1). Generally, SPD includes or results in low autonomy (2) and a sedentary lifestyle (3). Additionally, SPD is considered to involve highly stigmatizing circumstances and is profoundly discrediting within social interactions (4), exposing status loss, stereotyping, and discrimination (5) along with social as well as economic marginalization (6). A high number of staff supporting people with SPD also tend to align with the stigmatising and degrading perspectives (7). In Sweden, people with long-term SPD are entitled to live in sheltered or supported housing facilities, so called `LSS or SoL housing´ according to the Act concerning Support and Service for Persons with Certain Functional Impairments (SFS 1993:387, LSS) (8) or the Social Services Act (SFS 2001:453, SoL) (9), when the disability is causing significant difficulties in daily life and thus requires extensive support or service. Unfortunately, however, living in sheltered or supported housing facility often results in further reduced autonomy and stigmatisation due to the institutionalisation process (10).
It is mandatory to offer basic healthcare, including rehabilitation, and this is a complex process involving a multitude of factors. Collaboration between healthcare and social service, such as the case within sheltered and supported housing facilities, is even more complex due to separate legislations, secrecy rules, roles, and responsibilities. Interventions that are useful under these conditions therefore need to be developed and studied. Furthermore, intervention research design must handle all of the complexities in order to develop evidence-based knowledge. To deal with this, a manualised but individually flexible model for integrated healthcare rehabilitation in collaboration between occupational therapists (OTs), housing staff (HS), and the resident in supported or sheltered housing facilities – namely, Everyday Life Rehabilitation (ELR) – has been developed by the principal investigator (11) and tested in feasibility studies (7, 12, 13, 14, 15) aiming at personal recovery through meaningful everyday activities and participation for persons with SPD. The MRC guidelines for complex interventions (16) have been thoroughly applied in the development process, including program theory and the feasibility studies, and now evidence is needed for implementation, thus requiring randomized controlled trial (RCT) studies. Therefore, we want to expand the design and go further with a cluster RCT built on a slightly revised manual of the ELR intervention, adding clarified focus on management, the tools for collaboration, a web-based version of the education material, and a cost-effectiveness perspective.
Background and rationale {6a} - program theory for the development of the ELR intervention
Evidence base and theory behind the problem
‘Everyday occupation’, here synonymous with being occupied in `meaningful activity´, is fundamental for all people and refers to engagement in meaningful acts of doing, e.g., looking after oneself, taking care of a home, enjoying life, contributing to society, interacting with others, etc. (17, 18, 19). People with SPD living in sheltered or supported housing facilities often lead sedentary lives with an impoverished everyday life including few meaningful everyday occupations (3). They are also affected by disengagement and generally lowered volition, autonomy, and personal agency (14). Bryant et al. (2) describe avolition or lack of motivation as common symptoms or sometimes as negative secondary effects of mental illness for people suffering from psychiatric illness. Lack of motivation may add to disability, including social exclusion, and persons with high levels of psychosocial problems have more motivational problems than those with low levels of psychosocial problems (6). Subsequently, these symptoms with lack of motivation or avolition may become an obstacle to engaging in everyday life and are as such of specific importance for OTs working with persons with SPD, particularly because these persons are commonly socially and occupationally marginalized (2, 6).
Viewing the problems from a societal level, people with SPD and impaired autonomy have significantly poorer health than others in the population, while at the same time they do not always have access to health care on an equal basis (20) even though the target group has been stated to belong to the highest priority group according to the national principles for prioritisation of healthcare in Sweden (21). The high priority has been made because the target group has low autonomy and does not speak highly of themselves, or has trouble arguing for their right to health care, and further that they do not actively seek and demand health care, along with the magnitude of suffering and the impact on quality of life.
The relation between sedentary lifestyle and problems of somatic ill health, reduced global functioning, and quality of life among persons with severe mental illness is also well known and has been addressed (22). However, methods to tackle somatic ill health do not fully reach out to persons with severe mental illness because there is a problem with having the drive to change an unhealthy lifestyle, particularly for persons with negative symptoms related to schizophrenia (23). For instance, persons with schizophrenia live about 20 years shorter than the general population (24). Thus, inequity in health in the society is being sustained. Sedentary lifestyle has appeared as an independent risk factor for morbidity and mortality (25), and a high amount of sedentary time significantly increases the risk of type 2 diabetes, all-cause mortality, and the incidence as well as mortality of both cardiovascular disease and cancer according to a meta-analysis (26).
Therefore, activities performed at low to medium intensities during everyday life, such as cleaning, washing, walking, etc., are relevant because they can reduce sedentary time during large parts of the day and thus reduce the health risks (27). Additionally, because a sedentary lifestyle also has a negative impact on sense of competence, identity, roles, engagement, and self-efficacy, and thus motivation and autonomy in general (18), it is of great value to combat in relation to personal recovery and quality of life.
Furthermore, living in sheltered housing facilities is subject to certain constraining risks per se, in addition to the psychiatric illness, and this adds to the psychiatric disability (10, 28). We found that some HS also tend to align with the stigmatising and degrading perspectives (7). Sub-institutionalisation, lack of guidance, differing and unequal healthcare/rehabilitation efforts, and challenges regarding collaboration, together with sparse evidence on interventions for this target group and context, add to the inequity for this target group.
Contextual and legislative framework - A gap between policy goals and TAU
In Sweden, and in sheltered or supported housing facilities, health care including rehabilitation must be provided and offered. These efforts are regulated by health care legislation such as the Act of Healthcare (SFS 2017:30, HSL) (29), the Patient Act (SFS 2014:821, PL) (30); the Patient Safety Act (SFS 2010:659, PSL) (31), and others, while efforts made by HS are mainly regulated by social acts such as the Act concerning Support and Service for Persons with Certain Functional Impairments (SFS 1993:387, LSS) (8) or the Social Services Act (SFS 2001:453, SoL) (9). Thus, there are two areas of responsibility where professionals, in order to meet the legal requirements, must collaborate in their work with the respective users. However, collaboration has been identified as a difficult area (32). The Swedish Parliament has established, in the underlying principles for prioritisation within health care (33), that persons with reduced autonomy should belong to highest priority group. Despite this, in some municipalities there is no rehabilitation at all, and in some municipalities there are very limited efforts for these target groups. Only a few municipalities in Sweden offer interventions in line with the legal requirements, thus reflecting unequal care and rehabilitation.
The Act of Healthcare (2017:30) (29) states, “The goal of health care is good health and care on equal terms for the entire population”. Thus, anyone with the greatest need for health care should be given priority for care. Furthermore, it states, “The management of health care must be organized so that it ensures high patient safety and good quality of care and promotes cost effectiveness” (2017:30) (29). This entails that care providers know the target group’s needs, the extent of their suffering, and the impact on their quality of life and, when the economy is limited, know which needs should be given priority.
The open model for priorities (21) intends to create increased systematics in order to ensure that health care regulated by legislation is regarded as a guaranteed resource and that relatively more resources are allocated to the use of appropriate and effective care for people with the greatest need for care, which includes medical treatment, nursing, rehabilitation, and habilitation.
Internationally, similar arguments are forwarded, for instance, the spending by the NHS in England, emphasising that extra resources should be used for services that benefit groups with poorer health. Equity is such a criterion based on fairness.
Intervention development
Given the inequity and marginalisation of the target group and the scarcity of collaborative re/habilitative methods when working within this complex context, the ELR package was designed and developed to meet these challenges and to improve and transform the re-/habilitation efforts towards person-centred, motivational, and activity and recovery-oriented resources.
Program theory of ELR
ELR was constructed as an intervention model for integrated occupational therapy in sheltered and supported housing facilities (11, 12), aiming at personal recovery and engagement in meaningful everyday occupations for persons with SPD. The mediators identified from the best evidence and combined in the ELR model were person-centredness (19); personal recovery (34); motivation; negotiation of user goal priority and expected outcome; methods for training in real-life situations; devices for close collaboration with residents and HS; support from HS on an everyday basis; and an educational package including collegial reflection and tutorials (Figure 1).
Separately, strong evidence exists in favour of a recovery approach from the 1980s onwards compared with traditional institutionalized and stepwise efforts. Also, person-centredness has clear evidence for its effectiveness compared to standardized programs for all. Furthermore, therapeutic factors such as building a therapeutic alliance, empathy, and negotiating expectations on goal attainment are grounded in a strong evidence base (35). The desired overall objectives of the intervention are based on robust paradigms for the target group´s health, wellbeing, and occupational justice ensured by enablement of engagement in meaningful everyday occupations (17, 19). The uniqueness of ELR is that it combines these ideologies and mediators in an intervention model specifically designed and developed within the context of supported and sheltered housing facilities, not focusing on symptom reduction but rather on acceptance, and instead aiming at increasing daily occupational engagement, personal recovery, and quality of life. The language and actions of professionals promote hope, self-discovery, and shared decision-making shaped in partnership with residents. The resident is also encouraged to access different resources outside of health and social care such as family, peer, and social support, out-of-housing strategies, and resources in general society.
Given that people with long-term SPD will continue to be frequent users of health and social care resources and will continue to suffer from complex disabilities as well as harsh living conditions, it is highly relevant to expand studies on understanding the hindering and promoting factors needed to offer cost-effective interventions and to mobilize knowledge and strategies for equity. A model for manualised but person-centred rehabilitation in close collaboration with HS, such as the ELR, which is distinct from other interventions by being ‘integrated’ into existing municipal health care and social services, can deliver benefits in various important ways:
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health care rehabilitation through outreach efforts directly to residents
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applying a preparation, change, and anchoring phase (maintenance after goal attainment)
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building a therapeutic alliance with the resident and enhancing motivation for change
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getting straight to understanding the resident’s challenges and goals as defined by the person, thus making more efficient and meaningful use of existing healthcare interactions
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reduce dependency on ’deficit models’ or standardised routines in which the problems are defined by the HS, and instead use the ELR model with its overall ideology of personal and social recovery and its solutions that are built on negotiated and shared decisions between residents, OTs, and HS
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exploration and training in real-life situations
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offering high quality methods to residents with hope, positive risk-taking, and change towards a meaningful and enrichening everyday life
The progress on ELR is based on previous years of development and research with feasibility studies, and it has shown significant impacts on residents’ everyday functioning and health as well as on the practices of professionals.
Previous results from our feasibility studies of ELR prior to the RCT
A feasibility project with qualitative and quantitative studies was conducted (7, 12, 13, 14, 15) to evaluate perspectives of participants and professionals, indicating very promising tendencies, such as successful rehabilitation with goal-attainment, health, and re-engagement in home-based as well as social occupations, as described below.
One study (13) evaluated outcomes of the ELR intervention for residents (n = 17). Pre, post, and follow-up differences on goal attainment, occupation, and health-related factors indicated that important progress was made. We also carried out interviews and field observations (n = 16) after completing the ELR (14), thus disclosing residents’ stories of ‘rediscovering agency’, referring to occupational and identity transformations, and the mechanisms of the intervention, i.e., hope, extended value of reaching goals, re-entering general society, and the transparency of the process.
Focus group interviews with 21 HS (7) illuminated their views on residents, rehabilitation, and their own role along with organisational conditions and different outlooks influencing their responsiveness or resistance to the intervention. Importantly, HS are a key resource in the facility context, but their roles and their views in facilitating or inhibiting rehabilitative opportunities for residents varied a lot.
Narrative analysis of OTs’ stories (15) revealed ‘personalised occupational transformations’ describing significant interactive events based on each resident’s wishes.
Our intervention studies on ELR demonstrate its value for participants and indicate that a person-centred recovery approach applying ELR can promote a shared framework among residents, HS, and OTs while facilitating ‘agent-supported rehabilitation’ and ‘out-of-housing strategies’. The project provides promising support for the use of ELR and proposes continued research. Minor adaptations have been made to the ELR model based on these feasibility studies (36), including clarified structure and tools for collaboration between OTs and HS and clarified structure for leadership guidance and follow ups, thus adopting a practice-based leadership; a web-based version of the staff training; and a thorough clarification of the focus on promoting personal agency and identity.
In the feasibility project, the length of the intervention was individually set, with a mean of 6.4 months. ELR is guided by an OT in close collaboration with HS and the social environment, and thus it is hypothetically perfectly suited for use within the sheltered and supported housing facility structure and context.
Theory of change processes
Low autonomous motivation has been identified in persons with SPD and negative symptoms (2, 23). Because motivation is not only about inner will, autonomy, and agency, but also is greatly affected by the environment, that is, the people and conditions one is surrounded by, strategies in ELR are to a great extent about involving the social environment, that is, HS and OTs, in supporting the person at a certain level of motivation and goal-ambitions with specific strategies and exploring enriching activities in order to gradually strengthen the inner will and desire for goal attainment. In order to obtain personalised occupational transformations (15), the OTs need to be individually flexible and tentative, and yet structured and transparent according to the goals and methods used. Because shared decision-making is an important method that facilitates motivation in person-centred care (37), and because individual goal setting is a useful tool to support motivation and overall rehabilitation (38) and because the recovery approach is based on personal preferences (39), these strategies add to one another positively. Overall, ELR is centred on enabling engagement in meaningful and enriching everyday activities to induce personal recovery through a collaborative, person-centred, motivational, and activity and recovery-oriented intervention.
To describe and support implementation of the present intervention package, a checklist for implementation has been used (40) to identify some crucial factors for this context based on the literature and on the feasibility studies. These include the difficult process of active acquisition of knowledge among leaders and personnel, attitudinal changes, capacity building, health care delivery and approach, the praxis of collaboration between OTs, HS, and participants, highly loaded HMs/distanced management, the importance of involving leaders in regular coaching and follow-ups of adherence, stigma, sub-institutionalization, patient status, professional status, low motivation, and the differentiation among persons with psychiatric disabilities.
In order to meet these challenges, the ELR package is constructed to be not too heavily loaded while still focusing on an enriching everyday life for the person. This is done via a shared model for staff where both the HM, housing, and rehabilitation staff, in the form of web-training, manuals, and guidance, can take part in a framework designed especially for these contexts. The ELR package gives them access to methods and tools for optimising the person´s opportunities to recovery through increased commitment to meaningful activities and participation in life.
The ELR project as a whole
To summarise, the ERL-RCT is the next phase of research, based on the feasibility research conducted on ELR. The ELR-RCT will investigate the effects and costs of the intervention in order to generate evidence that may be transferable to similar settings.
Besides the RCT, the ELR project as a whole will, over a 4-year period (2021–2025), rigorously evaluate the essential components, process factors, and impacts of ELR at multiple levels, including participants’ experiences, HS’s experiences, OTs’ experiences, HMs’ experiences, fidelity to ELR, service outcomes (cost-effectiveness), and implementation requirements (ease of use, collaboration routines, adoption, and organisational change). By studying outcomes as well as qualitative and process aspects, the ELR project asks not only if ELR works in these contexts, but also how it works in order to clarify practical and organisational guidance on the implementation of ELR in similar settings. These studies are not included in this RCT protocol. However, in order to thoroughly define the intervention, the TIDieR checklist for the intervention has been used (41), and in order to prepare for some of the implementation aspects a checklist for implementation has been used (40). The continuing development of ELR manuals as well as its implementation will take into consideration aspects such as planning for organisational readiness, the involvement of relevant stakeholders, and allowing for modifications.
Stakeholders
Early in the development and feasibility phase, user organisations were involved in the process and contributed with input on aspects such as information materials and leaflets, content and procedures, recruitment, data collection, local advertisements, meetings, and endpoint information.
For the ELR-RCT planning, the ‘FoU-userpanel in Västerbotten’ (Service User Research Enterprise) has been involved regarding primarily outcome instruments, information sheets, and follow-up questions by HM. They will also be involved in the continuing process. For overall input regarding content and municipality anchoring, the ‘Interest group for relatives of people in LSS’ and ‘Hjärnkoll’ (Brain check) are engaged.
Especially for the municipality anchoring, R&D units are involved regionally to distribute information to key persons in the municipalities. Within the participating municipalities, they are asked to each appoint a contact person for communication between the municipality and the university. Municipality stakeholders have also been involved early on in order to meet local needs, and a detailed work plan has been drawn up.
Key uncertainties and justification for undertaking the trial
Initial evidence for the ELR model is based on positive outcomes in feasibility studies, and thus an RCT is required to establish the effectiveness of ELR along with calculations of cost-effectiveness and continued process evaluations. Because of a lack of a formal control group, no effect size has been calculated. Therefore, this study will include an internal pilot to calculate the effect size after 6 months and to decide on relevant sample sizes and any need for adaptations before continuing with the full-scale RCT.
There has been a growing amount of research on SPD over the past decades; however, both rehabilitative interventions in practice and RCTs are sparse regarding interventions for this target group living in sheltered and supported housings. Thus, it is important to develop and test new potentially useful and effective interventions. Therefore, we want to expand the design and go further with an RCT based on a slightly revised manual of the ELR intervention and a cost-effectiveness perspective.
In order to study how these health, contextual, and legal demands could be better fulfilled for people with SPD, we plan to apply a health economic perspective informed by an equity approach (42). We align with the idea that putting the main focus on cost-effectiveness criteria, such as the demands laid out in the Act of Healthcare (SFS 2017:30), will produce the most health gains from a given budget (43).
The specific research questions (RQs) are as follows:
RQ 1. What is the effectiveness of the ELR intervention on recovery, quality of life, everyday functioning, and goal attainment compared to TAU?
RQ2 What is the Incremental Cost-effectiveness Ratio (ICER) for ELR compared to TAU?
Objectives, and research questions {7}
The objectives of this RCT is therefore to investigate the effectiveness and cost-effectiveness of a person-centred, activity and recovery-oriented intervention package for people with SPD living in sheltered or supported housing facilities.
Trial design {8}
This study protocol covers the ELR-RCT, which is a pragmatic, two parallel arms, cluster RCT. The framework for present study is a superiority trial, and all statistical tests will be of null hypotheses of the two arms being equal with respect to corresponding estimand.
The study has two measurement points over 6 months, including pre and post intervention (t1 = baseline, t2 = 6-month follow-up) in two waves over two years, where the first wave serves as an internal pilot study for the full trial. Randomization will be performed separately at the two waves. The randomization will be stratified on municipalities, giving a 1:1 allocating ratio of housing facilities within each participating municipality. As the number of participants within each housing facility will vary, the allocation ratio of participants in the study will not be fully 1:1 balanced. The design includes a waiting list as the control group, meaning that they will receive the ELR intervention after the control period. The protocol adheres to the SPIRIT statement, and the study will be conducted and reported in line with the CONSORT and CHEERS guidelines.