Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses

Kenny et al. propose that ‘relational persons develop and deploy their values within the social worlds they inhabit, conditioned by the opportunities and obstacles that shape their lives according to the socially salient features of their embodied lives (for example, their gender, race, class, age, disability status, ethnicity)’ [39]. Adopting a relational ethics approach means that socially salient features need to be considered to assess the webs of relationships that target populations live within to determine how decisions might be made about taking part in a study [40]. In turn, this acknowledges the relationally constituted nature of existence and the importance of identity in fostering stronger, committed and mutually flowing relationships.

In Sartre’s notion of existential engagement [35], existence is [viewed as] a social virtue that entails obligations to others. Engagement instructs us to care about the civic conditions through which our identities are shaped and sustained [35]. Engagement rests on three main conditions: awareness (being aware of, reflecting on and disclosing injustice); responsibility (encouraging others to act and be responsible through disclosure); and respect (both for the audience to whom one is disclosing and those experiencing suffering). Combining the relational theoretical approaches with the principles of participatory action research meant that we could invoke a commitment to giving voice, collaboration and empowerment to people who may be on the margins or experience exclusion. The values of the participatory paradigm enabled a closer matching of the needs of all stakeholders and fitted well with local context dynamics, available resources and constraints [41]. The participatory approach provided a space for dialogue and joint action, which fosters an environment conducive to knowledge translation [42]. Taken together, the application of these two theories provided the framework to develop an ethics of engagement based on the strategies illustrated in Fig. 4.

Figure 4 highlights some but not all of the strategies for engagement that were developed across the trial continuum. This ethics of engagement is premised on the lived and relational worlds of study participants and the importance of participatory values underpinning research approaches. Within each stage we have illustrated how the Sartrean conditions for engagement were considered by highlighting the injustices (awareness), the goals (taking responsibility) and actions (embodying respect). Our study began from the premise that stigma exists for people living with mental illness and, despite a rhetoric of service user participation, many people remain excluded from meaningful involvement in service planning and re-design. From this awareness we identified the need for a co-design intervention in services that could enable this to occur and work from the basis of empowerment.

From the early design stage our strategies for breaking down stigma and empowering people with lived experience included enlisting people with lived experience in the development of recruitment postcards by using their artwork to capture key messages for participation. We returned to staff within services with recruitment strategy ideas and refined approaches based on their feedback and input. This aspect encouraged staff to buy-in into the study aims and goals and laid the foundation for ensuring their support for recruitment phases. In addition the team sought to disrupt stigma and views of people with lived experience of mental illness by incorporating the Stand Up for Mental Health comedians into study information and recruitment days. We also offered annual engagement events based on comedy and public lectures on new initiatives in reading and writing for well-being that staff in the services were invited to attend. Flexible participation options were embedded into the trial design so that participants could complete one-off surveys or longitudinal follow-up depending on remaining with a service or their ability to participate depending on wellness. We trained peer workers recruited from our partner peak agency VMIAC to be research support workers on the recruitment and information days so that people could talk about the study aims and the requirements for participation in a supportive environment. Where possible, we did recruit people with lived experience to complete telephone interviews with participants, and where it was not possible, we provided training to research staff to foster shared understanding of experience and empathic approaches in data collection. A proportion of funds was allocated to reimbursing participants for their participation in the intervention and to support travel to and from meetings to ensure the best possible opportunities for participation. We had a dedicated logistical coordinator who liaised with service users and carers to provide information about venues, attendance and what to expect during the intervention. Partner agencies and researchers with lived experience delivered the intervention with support from the trained university research team, and they participate in the development of co-produced policy briefs to ensure translation of research findings into practices.

Developing a theoretically informed engagement model that can enact an ethics of engagement is essential for creating the conditions for knowledge translation to take place [43‐45]. The theory-based model of translation practices (Clavier et al. [38]) was identified as important for structuring some of the engagement activities within the continuous facet further. Clavier et al. [38] suggest that there are three essential translational practices: cognitive, strategic and logistic practices. The cognitive practices refer to the need to circulate knowledge. Here we made efforts to raise awareness amongst partners about the study through face-to-face meetings, study updates, community reports and a dedicated study blog. Specific goals of these practices were to build a common understanding of the research program and study design and to engage people in a way that assisted in developing the research questions. The strategic practices refer to the activities, tools and competencies used to raise and maintain interest of research participants across the lifespan of the study. They aim to facilitate the research process and balance power relationships amongst partners (valuing one’s own interests while also promoting others’, balancing interests for shared power). Here we enlisted staff in the recruitment process and co-developed recruitment strategies with them; we also identified an ambassador in each site to be responsible for sharing study updates and coordinating between the research team and the sites on the ground. Logistic practices correspond to the coordination tasks that create the actual conditions for the engagement. They generally operate with the specific goals of ensuring effective trial management, maintaining partnerships over time, enhancing the recruitment process and facilitating implementation of the research in local settings. Our deployment of a logistical coordinator was part of the endeavour to ensure that effective trial management occurred.

These translational practices combined with systems thinking also allowed for in-depth consideration of the linkages, relationships and interactions amongst the elements that comprise a complex system—that is, one that self-organises, adapts and evolves [46]. The system in which the research is structured, implemented and transformed is referred to here as complex: an interconnected network of actors (experiences, knowledge and values), activities, intentions and projects, as well as environments in perpetual transformation [47]. Systems thinking encourages multifaceted approaches to engagement that are well integrated in local context, involving sustained action and engagement across multiple levels, from the early stages of the research until the knowledge translation phase [37]. It promotes the dynamic engagement of multiple stakeholders and aims to inspire system-wide learning, planning and evaluation. It emphasises the synergies between people-intervention-context and research-practice which are essential to better understand changes that occur over time and emerging outcomes along the way. The engagement strategies we developed sought to grasp the full spectrum of factors at play (e.g. structural, technological, political, cultural, educational, emotional, ethical) [48]. Systems and translational theories were used to evoke knowledge mobilisation whereby knowledge was mobilised in a dynamic flow between researchers, participants and the wider community. Table 3 details where the engagement strategies fit within the translational practices. The higher order goal was for the study to become an active process that not only generated data and evidence but contributed to social change.

The CORE study is registered as a trial with the Australian and New Zealand Clinical Trial Registry, trial ID: ACTRN12614000457640, registration title: The CORE Study: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting. The date registered was 01 May 2014; the start date was 30 June 2014; enrolment of participants was 01 October 2014.