Reducing the use of physical restraints in home care: development and feasibility testing of a multicomponent program to support the implementation of a guideline

Despite the harmful effects of restraint use on older persons, family caregivers and professional care providers, restraints are still frequently used in home care [1, 2]. A recent systematic review states that, depending on the definition used, the prevalence of restraint use in older persons in home care ranges from 5 to 24.7% [3]. Until recently, no consistent definition of physical restraints could be found in the literature. A Delphi study of Bleijlevens et al. (2016) developed an internationally accepted definition: “Any action or procedure that prevents a person’s free body movement to a position of choice and/or normal access to his/her body by the use of any method, attached or adjacent to a person’s body that he/she cannot control or remove easily” [4].

Home care in Flanders is delivered by various professional care providers such as general practitioners (GPs), registered nurses, certified nursing assistants, home health aides, occupational therapists, and physiotherapists. Each professional care provider has an essential role in providing care for people with a care need. This role is in accordance with specific law and regulations of medical and healthcare professions [5]. In Flanders the GPs have a central role in home care. GPs are often key persons in the development of an individual care plan, in close collaboration with specialists and other professional care providers. In the decision-making process for the use of restraints, family, informal caregivers and professional care providers, mainly registered nurses, are involved [1, 6‐9]. According to the current legislation, only doctors, registered nurses, certified nursing assistants (if they meet certain conditions such as working in a structured team and under direct supervision of a registered nurse) and informal caregivers (if they meet certain conditions such as training from a nurse or GP, informal caregiver certificate, …) can apply physical restraints when needed [5, 10, 11]. However, literature shows that, in practice, GPs are less involved in the decision-making process and the application of restraints [3]. Also home health nurses in Flanders stated that GPs had no clear role in deciding whether to use restraints [1].

The influence of patient-, nurse- and context related factors make the decision-making process for the use of restraints complex [12]. In particular, the prominent role of the informal caregiver is challenging. A qualitative study reveals that informal caregivers have a dominant role in the use of restraints. This can result in conflicting opinions of restraint use between professional home care providers and informal caregivers [1]. Informal caregivers are significantly less aware of the harmful effects of physical restraints (e.g. bruises, increased dependence, depression) and have a more positive perception of their use [1, 2, 13, 14]. Furthermore, a study concludes that the knowledge of care providers on alternatives for restraint use in home care is limited [6]. The occurrence of conflicting opinions, the lack of awareness of the harmful effects of physical restraint use and limited knowledge among older persons, informal caregivers and professional care providers add to the complexity of the decision-making process in the home care setting and stress the need for a clear policy on restraint use in home care [1, 2]. Therefore, Scheepmans et al. (2016, 2020) developed the first validated evidence-based guideline that aims to increase awareness, knowledge and competences to adequately deal with questions about restraint use in home care [15, 16]. The Belgian Centre of Evidence-Based Medicine (CEBAM) evaluated, validated and approved the scientific quality and reliability of the guideline [17].

However, the development and dissemination of a clinical practice guideline is not sufficient for its integration and routine use in daily practice [18]. A systematic review shows that the rates for adherence to clinical guidelines vary from approximately 20 to 80%, with a median adherence of 34% [19]. The implementation of guidelines in home care organizations entails a complex intervention [20]. Complex interventions, such as multicomponent programs, are interventions that consist of several interacting components, which need change at multiple levels [18, 20‐22]. Implementation of a complex intervention requires an exploration of the barriers and facilitators for guideline use, as well as awareness, agreement, adoption and adherence of the adopters during each step of the process [19, 21]. Evidence from residential care settings suggests that using a multicomponent approach involving policy change, leadership and education can reduce the use of physical restraints [23‐26]. Yet, the implementation of guidelines is even more challenging in home care [20]. Home care differs from residential care as a result of its particular characteristics like interorganizational structures and team compositions [20]. In home care, where professional care providers enter briefly the personal environment of the older person, they only see the patient for a short amount of time and cannot ensure 24-h coverage and supervision when a person is being restrained [3]. Thus, the specific characteristics of the home care setting make it difficult to translate existing evidence from acute and residential care to the home care setting.

To the best of our knowledge, there is no previous research concerning the implementation of a guideline that aims to reduce physical restraints in home care. Therefore, the overall aim of this study is to systematically develop and evaluate a multicomponent program for the implementation of a guideline for reducing the use of physical restraints in home care.

Intervention Mapping (IM) was used to develop a multicomponent program for supporting the implementation of the guideline for reducing the use of physical restraints in home care [27]. IM provides guidance and tools to ensure that health promotion programs are based on empirical evidence and theories [27]. This mapping approach comprises six steps: (a) producing a logic model of the problem, (b) developing a logic model of change, (c) program design, (d) program production, (e) program implementation plan and (f) developing an evaluation plan. This manuscript describes the operationalization of the first four steps of IM, the last two steps were not performed (Fig. 1) [27].

IM is characterized by the involvement of different stakeholders during each step of the process [27]. An expert group of stakeholders was composed and met six times during the development process (June 2017 – May 2019). It included eleven participants: a GP, a self-employed registered nurse, a registered nurse of a home care nursing organization, two staff members of a home care nursing organization (organization of certified nursing assistants and registered nurses), a staff member of a home care organization (organization of home health aides), a staff member of an organization that represents family caregivers, an occupational therapist, a director of a centre of expertise on dementia, a researcher and a senior academic staff member with expertise in behavioral change theories.

This study developed and evaluated a complex intervention to support the implementation of a guideline for reducing the use of physical restraints in home care. Modeling, active learning, guided practice, belief selection and resistance to social pressure are the evidence-based methods used to select the eight practical applications. The developed multicomponent program has three main objectives: to disseminate and make the guideline more accessible, to increase awareness and knowledge of the problem of physical restraint use and to work towards sustained implementation. This multicomponent program consists of eight practical components (website, social media, promo video, flyer, summary of the guideline, physical restraints checklist, tutorials and ambassador restraint-free home care). The guideline for reducing the use of physical restraints in home care is not openly accessible and therefore it is not part of the developed multicomponent program [15, 16]. It could be assumed that this might form a barrier to using the guideline. For this reason, a summary of the guideline was developed. This summary contains the key points of the guideline and it also consists of the flowchart that guides professional home care providers through the decision-making process. In addition, the content of the guideline was extensively explained and discussed in the training to become an ambassador for restraint-free home care. The ambassadors for restraint-free home care received a free copy of the guideline.

The results show that the multicomponent program is useful for implementing the guideline in home care. The ambassadors positively received, experienced and evaluated various components of the program. Components that were recognizable, compact, brief and concise, such as the physical restraints checklist, tutorials and flyer, were best evaluated. The ambassadors indicated that due to the combination of the different components of the program their knowledge, skills and awareness of the problem of physical restraint use in home care had increased. Especially the tutorials and the training to become an ambassador restraint-free home care, including peer coaching sessions and telephone follow-up, are considered essential for the program. The website and promo video are valuable, but are not the essential components of the program. In the focus group interviews the ambassadors did not put as much emphasis on the website and the promo video in comparison to the key components. Optional components of the multicomponent program are the social media pages and the summary of the guideline. The ambassadors thought the social media pages were less appealing and saw the summary of the guideline, more in particular the flowchart, as too complex.

This study also highlights barriers to the implementation of the guideline. First, the term ‘physical restraints’ is interpreted too narrowly. For this reason, it forms a barrier to fully exploiting the added value of the multicomponent program for the implementation of the guideline. Some ambassadors indicated that professional home care providers were not aware of the broad definition of physical restraints as used in the guideline [15, 16]. Only the extremes, such as belts and ropes, were taken into consideration, resulting in a limited recognition of the problem. From a literature search, Bleijlevens et al. (2016) identified 34 different definitions of physical restraints [4]. The ambiguity about the term ‘physical restraints’ is well known [37, 38]. The results from our study further emphasize the need to search for a uniform term that describes the full scope. Second, the fragmented approach in home care is also a challenge. A lack of common vision, general agreements and uniform documents impedes the implementation process. A systematic review of reviews reveals that collaboration and good coordination between the different stakeholders and organizations is important for implementation. Shared decision-making, non-hierarchical relationships, mutual respect, trust and open communication are essential characteristics of good collaboration [20]. Another important barrier is the lack of involvement and support of managers. Literature also underlines that support and commitment from managers who reaffirm the importance of change are important facilitators for successful implementation in home care [20, 39‐43]. In addition, the ambassadors felt that they did not have the organizational power to carry out this change project within their organization. Earlier studies show that the absence of staff with the right competences or expertise impedes implementation [20, 39, 40, 42‐48]. For this reason, the research group formulated desirable competences (e.g. coaching skills, leadership). The participating organizations selected suitable candidates for becoming an ambassador for restraint-free home care. However, we did not verify if the candidates actually had these competences and organizational power to carry out this change project. It is possible that not all of the selected candidates had the right competences (e.g. leadership, coaching skills) to facilitate the implementation of the guideline. Another barrier is the lack of time for facilitating the implementation of the guideline. Due to the relatively short implementation period, the ambassadors felt they could only raise awareness of the problem of physical restraint use in home care. Indeed, literature shows that a lack of time for planning and implementing new interventions or procedures is a barrier. The organizational readiness (e.g. staff, training, strategic planning, resources) and the extent to which a new intervention fits in the current workflow influence the implementation process [20, 37, 42, 43]. Lastly, various ambassadors perceived the current legislation regarding the use of physical restraints in home care as an important barrier. Currently, the legislation regarding physical restraints use in Belgium is not clear. In Belgium, not all professional care providers can apply physical restraints when needed. The problem is that the current legislation regarding physical restraints is restrictive. For example, when a person is restrained and a professional home care provider, who is not allowed to apply restrains, is taking care of this person, the professional home care provider needs to contact a doctor or a registered nurse to reapply the restrains when needed. However, in home care a doctor or a registered nurse is not always available, which could mean that the use of restraints is either discontinued or that restraints are applied by persons who are neither authorized nor prepared for this. Therefore, the current legislation makes it difficult to perform integrated care and for this reason, it is complex to cooperate with different professional home care providers [5, 10, 11]. Literature reveals that the presence of an appropriate legislative framework is a powerful activator; while a lack of clarity about roles, responsibilities and tasks within the implementation process acts as important barrier. In addition, concerns about less autonomy, trust and independence impede the implementation of change [20, 37].

This study uses Intervention Mapping in line with the widely used and cited United Kingdom Medical Research Council (MRC) framework for developing and evaluating complex interventions. The MRC framework provides a useful general approach to systematically design and evaluate complex interventions. The key elements of the development and evaluation process are: development, feasibility and piloting, evaluation and implementation [18]. In addition, this study uses Intervention mapping, which provides a systematic and logic process for intervention development, implementation and evaluation in accordance to the criteria of the MRC framework [27]. Yet, intervention mapping provides researchers more detailed and specific guidance during the development of the intervention [49‐51]. Therefore, an important strength of this study is the use of Intervention Mapping in the systematic development of the multicomponent program [27]. By using this mapping approach, we applied four perspectives during all steps of the development process. With the (a) participation perspective, we intended to involve the target group and program implementers. (b) The multi-theory perspective stimulated us to approach real-life problems with multiple theories. (c) The systems perspective indicated that interventions need to be seen as part of a system, with interacting factors. (d) Finally, with the social and ecological perspective, we took the impact of the social and ecological conditions on behaviour into account. The developed multicomponent program includes clear objectives, methodologies and relates to behavioral change theories [27, 52]. Another strength of this study is that we performed a process evaluation of the multicomponent program with the intended program adopters. A process evaluation is an essential part of designing and testing a complex intervention, such as a multicomponent program for the implementation of a guideline [53]. The feasibility study is useful for getting a sense of how care providers perceived and evaluated the different components of the program [18, 21]. In addition, the process evaluation gave us more insight in the contextual factors (e.g. perceived barriers and facilitators), the implementation process (e.g. the use of the different components of the program) and the mechanisms of impact (e.g. participants’ responses to the different components) [53]. These results can be used to optimize the multicomponent program.

Nonetheless, it is important to note the limitations of this study. The first limitation is the limited involvement of management. A change requires time, resources and sufficient support. Therefore, the involvement of this group is already crucial during the development phase and should be strengthened in future efforts. Another limitation is that patients, informal caregivers and self-employed home care providers are insufficiently represented in the development phase of the study. Various initiatives were taken to involve these groups; but this proved to be difficult. A possible explanation for their absence, is that given the sensitivity of this topic and the negative connotation of the term ‘physical restraint use’, no patients, informal caregivers or self-employed home care providers were willing to participate. There are also some limitations of the feasibility study. First, the knowledge test was cautiously constructed based on the content of the guideline and evaluated by the researchers of the research group. Yet, the knowledge test was not externally validated, and therefore the results for this knowledge test need to be interpreted with some caution. Second, only two thirds of the ambassadors participated in the online survey (n = 10) and the focus groups (n = 9). Not all of the trained ambassadors evaluated the multicomponent program. A possible reason for not evaluating the multicomponent program can be the limited duration of the feasibility study (8 months). The ambassadors were still working towards increasing awareness. Not all the ambassadors had the time to use the different components of the program. It can be assumed that we performed the evaluation too early in the process. For this reason it is important to interpret the results of the process evaluation with caution. The management is also insufficiently involved in the feasibility study. This could explain why the ambassadors did not experience support from the management of the organization. Lastly, we let the participating organizations select the suitable candidates for becoming an ambassador for restraint-free home care. The findings of this study emphasize the necessity to carefully select the ambassadors based on strict competences (e.g. motivation, coaching skills, experience with change projects, leadership).

Prior to further implementation, future research needs to focus on the fifth and sixth step of IM. An integral plan for wider implementation needs to be developed (step 5 of IM – Program implementation plan). In addition, it is important to determine the effects of the multicomponent program on the attitudes, self-efficacy, knowledge and skills of the professional home care providers. Furthermore, we need to gain more insight into the implementation outcomes (reach, dose, fidelity) and the effect of the multicomponent program on the use of the guideline for physical restraint use in home care (e.g. cluster randomized controlled trial, hybrid designs) (step 6 of IM – Evaluation plan).

We can conclude that the multicomponent program shows promising results for implementing the guideline for reducing the use of restraints in home care. The multicomponent program is necessary, yet not fully sufficient to guide the full implementation of this guideline. Prior to further implementation, research is still necessary and needs to focus on larger scale implementation and evaluation of the effect of the multicomponent program. For future implementation it is important to involve all stakeholders from the beginning of the implementation process, use uniform terminology and a uniform definition for physical restraints, select competent ambassadors, assure buy-in of the management and facilitate collaboration between different home care providers.