Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities

In Sweden, people with long-term severe psychiatric disability (SPD) are entitled to live in sheltered or supported housing facilities, when the disability is causing significant difficulties in daily life and thus requires extensive support or service [1, 2]. Unfortunately, however, living in sheltered or supported housing facility often results in further reduced autonomy and stigmatisation due to the institutionalisation process [3]. It is mandatory to offer integrated basic healthcare, including rehabilitation, within the housing facilities [4], and this is a complex process involving a multitude of factors. Collaboration between healthcare and social service is even more complex due to separate legislations, secrecy rules, roles, and responsibilities [5]. 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 [6,7,8] and tested in feasibility studies [9,10,11,12] aiming at personal recovery through meaningful everyday activities and participation for persons with SPD. The MRC guidelines for complex interventions [13] have been thoroughly applied in the development process, including programme theory and the feasibility studies, and now evidence is needed for implementation, thus requiring randomised 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 leadership, the tools for collaboration, a web-based version of the education material, and a cost-effectiveness perspective.

Background and rationale —programme theory for the development of the ELR interventionEvidence 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, and interacting with others [14,15,16]. People with SPD living in sheltered or supported housing facilities often lead sedentary lives with an impoverished everyday life including few meaningful everyday occupations [17]. They are also frequently affected by overwhelming symptoms, disengagement, and difficulties handling everyday life situations [18]. SPD often includes or results in low autonomy [19], personal agency [10], and reduced motivation [20]. Additionally, SPD is considered to involve stigmatising circumstances and stands discrediting within social interactions [21], exposing status loss, stereotyping, and discrimination [22] along with social as well as economic marginalisation [23]. We found that some HS also tend to align with the stigmatising and degrading perspectives [11].

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 [22, 24]. The relation between sedentary lifestyle and problems of somatic ill health, reduced global functioning, and quality of life among persons with SPD is also well known and has been addressed [25]. However, methods to tackle somatic ill health do not fully reach out to persons with SPD because there is a problem with having the drive to change an unhealthy lifestyle, particularly for persons with negative symptoms related to schizophrenia [26]. Persons with schizophrenia live about 20 years shorter than the general population [27]. Sedentary lifestyle has appeared as an independent risk factor for morbidity and mortality [28], 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 [29]. Thus, inequity in health in the society is being sustained. Sub-institutionalisation [3, 11], lack of guidance in everyday life activities to reduce sedentary time, differing and unequal healthcare/rehabilitation efforts, and challenges regarding collaboration, together with sparse interventions for this target group and context, add to the inequity for people with SPD in Sweden.

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 [4] while efforts made by HS are mainly regulated by social acts [1, 2]. Thus, there are two areas of responsibility where professionals, in order to meet the legal requirements, must collaborate in their work with the respective residents [5]. Despite this, in some municipalities, there is no rehabilitation at all, and in some municipalities there are very limited efforts for these target groups, thus reflecting unequal care and rehabilitation. The open model for priorities [24] 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 [4]. 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, integrated re/habilitative methods when working within this complex context, the ELR package was designed and developed, based on best evidence and experiences from users, praxis, and stakeholders, to meet these challenges and to improve and transform the re-/habilitation efforts towards person-centred, motivational, and activity- and recovery-oriented resources. In order to thoroughly define the intervention, the TIDieR checklist for the intervention has been used [30].

Programme theory of ELR

ELR (Fig. 1) was constructed as an intervention model for integrated occupational therapy in sheltered and supported housing facilities [6,7,8], aiming at personal recovery through engagement in meaningful and enriching everyday activities for persons with SPD. The mediators identified from the best evidence and praxis, and combined in the ELR model, were person-centredness [16, 31, 32]; motivation strategies [33]; building a therapeutic alliance, empathy, and modulating the methods (tasks) to suit the specific person’s needs, expectations, and capacities [34, 35]; negotiation of user goal priority, planning, and expected outcome [36,37,38]; personal recovery [39,40,41,42]; engagement in meaningful activities [8, 14, 18, 43]; and methods for training in real-life activities and situations, led by OT; devices for close collaboration with residents and HS; support from HS on an everyday basis; and an educational package including tutorials, as well as collegial reflection and learning inspired by practice leadership [44].

Fig. 1figure 1

The Everyday Life Rehabilitation (ELR) model

The desired overall objectives of the intervention are based on robust paradigms for the target group’s health, wellbeing, and occupational justice ensured by personal recovery through enablement of engagement in meaningful everyday activities [14, 16, 18]. ELR is guided by an OT in close collaboration with participant, HS, and the social environment. Applying a preparation-, change-, and anchoring-phase (maintenance after goal attainment), the language and actions of professionals promote hope, self-discovery, meaning, connectedness, narrative reflection, transparent decisions shaped in partnership with residents, and exploring enriching everyday life activities.

Previous results from our feasibility studies of ELR prior to the RCT

A feasibility project with qualitative and quantitative studies was conducted [8,9,10,11,12] 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 [9] 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 [10], thus disclosing participants’ 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 [11] 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 [12] revealed ‘personalised occupational transformations’ describing complex processes and significant interactive events based on each resident’s wishes.

Theory of change processes

Low autonomous motivation has been identified in persons with SPD and negative symptoms [19, 26]. 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, social network, 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 [12], the OTs need to be individually flexible and tentative, and yet structured and transparent according to the goals and methods used. Because negotiated decision-making is an important method that facilitates motivation in person-centred care [45], and because individual goal setting is a useful tool to support motivation and overall rehabilitation [46] and because the recovery approach is based on personal preferences and sociality [40], 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 [47] 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-institutionalisation; patient status; professional status; low motivation; and the differentiation among persons with SPD. 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, and for staff and management to learn through collegiate and reflective approach, inspired by practice leadership [44].

The ELR project as a whole

To summarise, the ELR-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, service outcomes, and implementation requirements. 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, the continuing development of ELR manuals as well as its implementation will take into consideration aspects such as planning for organisational readiness, continued involvement of relevant stakeholders, and allowing for modifications.

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. 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 [48]. 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 [4], will produce the most health gains from a given budget [49].

The specific research questions (RQs) are as follows:

RQ1: 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

The objectives of this RCT is therefore to investigate the effectiveness and cost-effectiveness of a person-centred and activity- and recovery-oriented intervention package for people with SPD living in sheltered or supported housing facilities.

Trial design

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 testing the null hypotheses that the two arms are equal.

The study has two measurement points over 6 months, including pre and post intervention (t1 = baseline, t2 = 6-month follow-up) in three waves over 3 years, where the first wave serves as an internal pilot study for the full trial. Randomisation will be performed separately at the three waves. The randomisation 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 Consolidated Standards of Reporting Trials (CONSORT) and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS).

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