Implementing and evaluating co-designed change in health

Stemming from a long history of participatory methodologies, co-design has increasingly been adopted to create health service change, with applications across a broad range of health settings including mental health, oncology, critical care and more. ¹ A requirement for health systems to demonstrate person-centred and values-based models of care has brought with it a surge of interest in using co-design methodology to create change proposals, alongside the integration of patient-reported measures into healthcare and service delivery evaluations.^2,3 Co-design and associated terms such as co-production, experience-based co-design and co-creation are defined as methods of design using social inquiry. In co-design, participants share, with the researchers, equal power in decision making about projects and in creating outcomes.^4,5

In healthcare, approaches such as experience-based co-design have been used predominantly to better understand an individual’s lived experience of their health conditions and/or healthcare services in order to design care processes, services or models that better meet their needs.^4,6–8 The value of co-design operates at several levels including promoting consumer perspectives, placing value on expertise through lived experiences and creating access to decision-making about healthcare change proposals that can span from decisions about individual care, to local service improvements up to system-wide reforms. ⁹ Evaluations of co-designed change are often focused on these immediate gains. Despite the identification of implementation phases within co-design frameworks, evidence of the value of co-designed interventions once implemented on improving health and care outcomes, however, is less clear.^10,11 With increasing focus on these evaluation gaps, we explore the potential contribution of implementation science frameworks to enhance implementation of co-designed change in healthcare. We further evaluate whether co-design has made a difference to health and care outcomes. We consider the role of sponsorship and leadership in ensuring co-designed change is adopted beyond a project lifecycle role and how to retain co-design members’ involvement.^12–14

Implementing co-designed change

Bringing about change to create healthcare improvement continues to be a substantial challenge due to the complexity of the context of healthcare, leading to limited realisation of benefits in terms of healthcare or service delivery improvements.^15,16 Co-design approaches that harness the experiences of those with lived experiences provide a mechanism to increase stakeholder engagement with a proposal for change. They can also enhance the suitability and relevance of the proposal and stakeholder commitment, thereby adopting the proposed change. ¹⁷ While opportunities to harness user experience to design change have been widely adopted, the use of co-design to prospectively explore implementation barriers and concerns among end users and stakeholders (including health system and service leaders and policy-makers) as a strategy to ensure co-designed change is adopted beyond a project lifecycle has received limited attention to date.

A commonly held assumption is that co-designing an intervention (that is fit for purpose and has buy-in), will, in and of itself, act to support implementation. Intentional discussions about implementation of co-designed interventions do not occur routinely, tend to be unstructured and focus on implementation barriers that are front of mind, potentially obscuring less evident but powerful factors that may influence implementation success.^18,19 Latent influences such as systemic bias, healthcare cultures and mindsets may be at odds with novel strategies, especially those developed for seldom-heard and minority populations. ²⁰ Early phases of co-design often include evidence gathering of experiential data via interview or other methods in which factors with potential to impact implementation may be identified informally. We propose that applying a structured approach, informed by implementation science theories or frameworks to guide evidence gathering in the early stages of co-design may lead to the intentional identification of issues that may ultimately impact implementation of co-designed change at the end of the project. Drawing on categories of theoretical approaches used in implementation science, we highlight how different implementation theories, frameworks and models can be utilised proactively to give greater consideration to the implementation of co-designed change. ²¹

Proactively exploring and addressing implementation

Determinant implementation science frameworks, such as the Consolidated Framework for Implementation Research, ²² Theoretical Domains Framework ²³ and PARIHS, identify a range of determinants – domains or categories of barriers and enablers – that influence implementation outcomes. ²⁴ These domains or categories may be used to develop interview schedules to capture lived experiences in the early stages of co-design, and in this way, guide comprehensive, prospective exploration of implementation issues ahead of intervention development and implementation as noted by Damschroeder et al. ²² Process models, such as the Knowledge to Action Framework, ²⁵ can be used to identify key features of successful implementation and to inform the co-design of planned implementation strategies, which may be developed to accompany the co-design on an intervention.

Sustaining and embedding implementation

How can participants who were involved in the co-design project have oversight and involvement in implementation state, or even support its success? Often people leave a co-design process and think it is the responsibility of others to implement what has been designed. ²⁶ Drawing on social science theories, such as the Theory of Diffusion, co-designed implementation strategies can proactively consider the role of leaders, change agents and gate keepers – as best understood by those involved in the co-design process. This may extend to considering the role of the members of the co-design themselves who may contribute significant value in the implementation of co-designed change as they can champion and communicate the change back to their communities and networks (consumer, health professional and other stakeholders).^27,28 The literature notes that often no feedback loops are enabled for participants involved in co-design as the work is implemented. ²⁹ Overlooked in co-design is any guidance on what role people can have to support implementation.

Implementation science frameworks tell us that those involved in the co-design process are best placed to understand and design for the context-specific nuances. For example, using the Normalisation Process Theory we can identify four determinants as necessary to ‘normalise’ or embed complex interventions in practice beyond their early implementation: coherence/sense making; engagement/cognitive participation; collective action; reflexive monitoring. ²¹ Co-designed change creates new approaches to delivering care that may be associated with requirements for behavioural change and financial or human resourcing by healthcare teams and providers. Implementation success and its sustainment may therefore be contingent upon resource and support from senior leaders for the change proposed. ²⁹ The mindset supported and nurtured by health service teams and wider organisations has an important role to play in supporting the principles of co-design, including the requirement for action to result and be sustained. ³⁰ The Normalisation Process Theory provides a structured approach to consider the role of senior healthcare leadership and their sponsorship of co-designed change efforts in implementation success. Despite the opportunities outlined, in bringing together distinct perspectives, the process of integrating implementation science techniques into the process of co-design also raises the possibility of tensions at points where theoretical underpinnings may be at odds. The process of integrating established change theory with co-designed change therefore requires consideration and warrants further development.

Evaluating co-designed change

Growing use of co-design, coupled with evidence of the potential value and unintended consequences, means that there is now a need for further guidance about how to evaluate the use of co-design and its impacts on health and care outcomes.^4,31 We propose that evaluation of co-design requires three broad components: process analysis of the co-design; evaluating intervention effects on the desired health and/or care outcomes; and a process of mapping design features to intervention elements and their impacts.

Process evaluations often use qualitative methods such as interview and observation to determine how a process has occurred, often utilised in evaluations of the implementation of complex healthcare interventions. ³² In co-design, process evaluation may be used to establish the ways in which and extent to which stakeholders contributed to the design. The resulting knowledge can be used to evaluate whether the co-design process supported depth and diversity of contribution, but also to explore the ways in which the contributions of co-design members shaped the resulting intervention or change proposal. When evaluating co-designed intervention effects on the intended health or care outcomes, the contribution of co-design specifically to the intervention outcomes is challenging to delineate but important to understand given the resource and personal investment in co-design processes. The broad ranging influences of using co-design on change proposals prohibit the delineation of direct causal links between the use of co-design and improved health or care outcomes from resulting interventions. Yet mapping activities drawing on techniques from implementation science such as implementation mapping may provide some indication of the ways in which co-design has impacted intervention components which, in turn, influenced intervention success with regard to improved health or care outcomes. Intervention mapping describes a process of connecting theory-based methods with practical strategies to develop an intervention that can then be evaluated comprehensively. ³³ Identifying the ideas that emerged from lived experiences, mapping their links with the practical strategies that were then developed and used in the intervention, and evaluating the effects of these strategies could provide some indicative information about the contributions of co-design to the interventions effects on health or care outcomes.

Conclusion

Opportunities to harness user experience to co-design healthcare change have been widely adopted from policy to practice worldwide. In order to realise the benefits of the resultant co-designed change proposals, better understanding of how to support successful implementation of co-designed change and evaluation of its impacts of health and care outcomes are needed. We identify a range of ways in which implementation science techniques may support this process. Critical to the success of co-designed change is the role of senior leaders in supporting implementation of co-design, championing the pathway from resourcing co-design activities through to implementation and evaluation. ⁷

Contributions to the literature

Current approaches to co-design in health predominantly focus on the participatory elements of change proposals.

There is limited attention given to implementation and evaluation of co-design in healthcare services.

The integration of implementation science frameworks within co-design provides a novel approach to promote successful implementation of co-designed change.

Ensuring co-designed change is adopted and embedded beyond the project lifecycle is challenging. We outline how applications of implementation science frameworks may support the implementation of co-designed change in healthcare.