Need for integrated care

Healthcare policy, research and management have aimed to improve the quality and efficiency of services while responding to patient calls for more personalised and patient-centred care, and clinicians’ calls for organisational and technological support to achieve this [1,2,3,3,4,5]. Increased healthcare demands and costs, resulting from changing life and health expectancy [6], are intensifying the demand for sufficient, sustainable, accessible care [EU 7,8] that addresses chronic illness, multi-morbidity, and complex needs in a patient-centred cost-efficient way [9]. Person-centred care requires; integration and coordination across multiple disciplines, services, and sites; and, flexibility to respond to patients’ evolving care and support needs [10,11].

There is broad agreement that integrated care results in improved safety, quality, and value [12,13]   Considerable research and investment have not achieved the needed or sustained adoption, scale-up, and spread of integrated or patient-centred models of care due to the difficulty and complexity in designing and adapting interventions so they achieve the intended outcomes when implemented [14,15].

Co-designing and implementing integrated care

Designing and implementing complex interventions, such as integrated pathways, or technology, into existing healthcare systems has a high failure rate. The local context (population needs, resources, policies, and processes) impact if and how the intervention works. Common and critical causes of failure include the: complexity in creating interventions than can meet multiple patients’ varied and complex needs; costs and limited resources; and conflict with existing organisational processes or practices [16,17]. Most complex interventions, even those evidenced as effective, require adaptation to local contexts to achieve the intended outcomes [15].

There are a number of key steps and processes to implementing integrated care, including; identifying, formally involving, and supporting the specialist medical, health, and support professionals that need to be involved in the care pathway; identifying, and making available, the health and patient information (needed by patients and health professions during the patient’s care journey); and appointing and supporting a dedicated role, ideally a nurse specialist, as a central point of contact for the patient, and to co-ordinate the care across services. The professionals, process, time, and support needed will differ in line with the population’s, the illnes’, and sites’ needs [9]. Providing integrated care at scale is resource- and time-intensive, often requiring technological innovations to make it feasible. Digital technologies can support structured communication, data collection and sharing (for improved decision-making), the provision of tailored supportive information (based on patient’s profile), and automated alert and follow-up systems to support coordination of care at scale  [18,19]. Co-design methods and Implementation Science (IS) are distinct and rapidly developing areas, with the shared aim of creating sustainable interventions that are tailored to the local needs and contexts, and that can result in real-world impact [20, Cherly et al, 2022, 21].

Co-design involves meaningful collaboration between researchers, health service users and providers, and other stakeholders, to identify, prioritise, co-design, test, implement and evaluate solutions. Co-design principles (inclusion, participation, outcome-focussed) have been widely adopted across health and social science disciplines, with extensive evidence of positive outcomes [22]. Commonly used co-design methods in healthcare include focus groups, surveys, expert groups, design workshops, user-testing and feedback, and public events [21]. While there is a significant amount of research reporting the use and outcome of co-design, and an increasing amount of research that describes in detail the data collection, analysis, synthesis methods, there is limited empirical evidence specific to the co-design of technology-supported integrated pathway which are increasingly part of healthcare reform [23,21].

Implementation Science has established evidence-based theories, models, frameworks (TMF), and strategies [21]. Increasingly these highlight the need to consider the impact of context on the intervention and its implementation [24,25]. Classic theories (such as theories on behavioural or change), process models (such as those outlining the process or phases of translation of knowledge or research into practice), determinant frameworks (outlining factors that influence implementation and adoption), and implementation theories, collectively provide a comprehensive understanding of IS. While the use of TMF, such as the classic “Theory of Diffusion” [26], the “Consolidated Framework for Implementation Research” [27], the process model “Knowledge to Action” [28], the implementation model “Organisational Readiness” [29], and the Re_AAIM Framework [30]  have grown, and resulted in improved implementation success rates. In order to facilitate replication and evaluation of methods in other contexts, research methodologies and peer-reviewers has advocated for improved and detailed reporting on how the IS or co-design method enables early, meaningful, continuous, and pre-implementation participant involvement and impact [31,32] and support practical and sustainable solutions to end-users’ needs [33].

Current co-design research outputs demonstrate; methodological strength in the identification, selection, inclusion, and representation of the diverse cohorts of relevant stakeholders [22,34,35,21,36,37]. They also demonstrate philosophical alignment between co-design principles and data collection, analysis, and synthesis methods. Co-design method commonly use a combination of survey, focus or working groups, and/ or product testing to co-design the product or interventions. As co-design methods are increasingly used and developed, researchers and end-users are calling for evidence of continuous (in addition to early) stakeholder involvement across design iterations, and an increased level of detail on the methods [34,22], as failure to maintain stakeholders’ engagement can result in late-stage design changes, delays, or failure at the pilot or implementation stages [22,38,39]. From an IS perspective, a co-design method that facilitates early, continuous, and cross-stakeholder engagement provides a rich and robust dataset to identify and document end-users’ needs and contexts, enabling evaluation against a meaningful baseline. It also enables identification of areas needing further exploration to support and inform implementation [40,15]. Co-designing an intervention, with the involvement of the necessary broad base of stakeholders working in busy healthcare systems, requires a robust, but pragmatic, iterative way to collect, analyse, and synthesise data to design and refine the intervention so that it meets the end-users needs and context [16,40]. Detailed reporting of methods supports peer-review and scientific development and refinement of methods in addition to support replication of studies and research efficiency [41,42,43–45].

Co-designing an integrated technology-supported care pathway as part of the GERONTE project

As part of the GERONTE study, the project team identified a need for an empirically-based, practical, and replicable method to co-design (and later adapt) the GERONTE intervention (to support widespread uptake).

GERONTE combined Focus Group (FG) and Participatory Rapid Appraisal (PRA), in a structured way (three design cycles of data collection, analysis, feedback and design) as its co-design method.

Each design cycle involved collection and analysis of semi-structured data from multidisciplinary stakeholders in Focus Groups. This was followed by ‘rapid analysis’ of the collected data to produce a summary of end-users’ needs and wants. The summary was checked by the FG participants for accuracy and comprehensiveness. Once approved, the summary was sent to the design team. This ensured the early and continuous involvement of the end-users in the intervention design and refinement.

Reporting on the GERONTE co-design method

This manuscript aims to contribute by sharing for review, and/ or adaptation and use, the development, application, and steps in the GERONTE Participatory Rapid Appraisal and Focus Groups in combination to co-design technology-supported integrated care. Table 1 provides an overview of the type of information presented in this manuscript and how it is structured.

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Table 1. Overview and structure of the information presented in this manuscript.

https://doi.org/10.1371/journal.pone.0299411.t001

Developing, applying, and refining the Co-design method in GERONTE

The Material and Method section identifies the process used to develop, apply, and refine Participatory Rapid Appraisal and Focus Groups to Co-design Integrated Care in the GERONTE Project*. The GERONTE clinicians and management (oncologists and geriatricians, nurse specialist and the multidisciplinary team, patient representatives, and implementation team):

1. co-designed the GERONTE care pathway
2. collaborated with technologists to develop and adapt technology to support that care pathway.

The implementation team researched, recorded, and reported the GERONTE co-design process.

The Participatory Rapid Appraisal and Focus Groups to Co-design Integrated Care was developed in four stages, which is described briefly below and in more detail in S1 Appendix (Supplementary Material). These were:

1. 1) Collaboration between the GERONTE stakeholders to identify the project’s co-design aims and needs (the timelines, stakeholders involved, and the resources needed and available) and a rapid literature review to identify a suitable co-design method
2. 2) Stakeholder meetings to develop the method and ‘GERONTE co-design protocol (S2 Appendix)’
3. 3) Apply, test, refine, and report the co-design method in the GERONTE project
4. 4) Continued evaluation of the method.

*An EU-funded GERONTE project (GA945218) which aims to co-design, test, and prepare for EU-wide deployment an integrated technology-supported care pathway for older adults with cancer and other morbidities.

First stage: Identify the co-design needs and a suitable method

The first stage (Fig 1), involved collaborative meetings to identify the project’s co-design aims and needs. This was followed by a review of the literature to identify a suitable co-design method. S1 Appendix (Supplementary Materials) provides a detailed overview of the first stage.

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Fig 1. Overview of the process used to identify a suitable co-design method.

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Second stage: Developing the method and protocol

The second stage (Fig 2), was a sequence of multi-stakeholders meeting (between clinicians, research methodologists, patient representative groups, and managers) to:

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Fig 2. Overview of the process used to develop the PRA and FG co-design method and protocol.

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• consider the suitability, strengths, and weaknesses of the proposed, and other, methods
• develop the ‘co-design protocol’ to be used in the GERONTE’s project.

Third stage: Applying and refining the method (in GERONTE)

The third stage involved applying and refining the method in GERONTE. It was an iterative process (Fig 3A and 3B), which is described briefly below, and presented in full detail in S1 Appendix.

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Fig 3. A. Overview of the process used to apply and refine the PRA and FG co-design method.

B. Detailed view of the steps in applying and refining the PRA and FG co-design method.

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The PRA and FG co-design method itself involved three design cycles consisting of an ‘ideation, early testing, and validation cycle’ (Fig 4).

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Fig 4. Overview of the process used to test PRA and FG co-design method following its use in GERONTE’s co-design.

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The PRA and FG co-design method was tested and refined by using it in the GERONTE project. As such, we used each design cycle to gain feedback on the GERONTE PRA and FG Co-design method (Fig 3B).

Number and type of participants and the nature of feedback to refine the method.

We had a total of 38 focus groups across 3 countries (Ireland, France, and Italy) with a total of 79 participants including clinicians, patient representatives, and managers (Table 2). We sought feedback on; whether the method achieved its aim overall, and within each design cycle; and, whether or not it was user-friendly. These feedback questions are presented in S1 Appendix.

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Table 2. Summary of the number and categories of participants who gave feedback on the co-design method.

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The participants were experienced practitioners and service users who were considered able to identify if the co-design method was providing them with the opportunity to engage meaningfully and impact the intervention’s design. The number and experience of participants was; considered practical within the scope of the Randomised Controlled Trial of a complex intervention; and, met the FG and co-design methods literature recommendations (to ensure the number of participants per FG, involved multiple end-users, and enabled diverse discussion followed by consensus). The feedback, on the co-design method itself, from:

• the FG participants, was collected at the end of the FG or in a follow-up interview
• the research team, was collected during later GERONTE team meetings and/ or in written (email) format.

Evaluation and feedback used to refine the individual design cycles and the co-design method.

The FG participant and researcher feedback identified that the PRA and FG co-design method achieved the intended aims:

• to design and refine an integrated technology-supported care pathway
• while enabling continuous and meaningful engagement of different types of stakeholders in multiple locations.

We also sought feedback to identify if the individual design cycles achieved their intended aims. This feedback on the outcome of individual design cycles is identified in Table 3.

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Table 3. Details of the feedback gained from each of GERONTE’s design cycles.

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Fourth stage: Reporting and continued testing

The GERONTE clinical trial is ongoing. This co-design method will continue to be evaluated on its ability to co-design a ‘fit for purpose’ intervention (an integrated technology-supported care pathway) that meets end-users needs and context as part of a Randomised Controlled Trial. This co-design method will also be tested in other sites for its ability to co-design and/ or adapt an integrated technology-supported care pathway to different contexts.

As the level of detail and regulation in policy- and industry-standards have progressed since this Project’s started, the fourth stage will also involve the development of an additional set of FG questions designed to gain end-users’ feedback on industry standardised measures of quality and user-friendliness

Once the GERONTE project is complete and this method’s success or otherwise is known, this will be reported and submitted for further peer review and feedback.

Three cycles of participatory rapid appraisal and focus Group to co-design integrated technology-supported care

The structure of the Participatory Rapid Appraisal and Focus Group method is 3 cycles of design, namely an: ideation, user-testing, and design validation cycle. Fig 5A and Table 4 below provides an overview of each design cycle and thier aims. Fig 5B provides a detailed overview of the steps in the PRA and FG co-design method.

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Fig 5. A: Overview of the 3 design cycles in the PRA and FG co-design method (and their aims).

B: Detailed view of the steps and processes in PRA and FG to co-design integrated care. *Note: Defining the care pathway includes, identification and detailing of: which professionals need to be involved. what are the important times, events, and touchpoints along the patient's care journey (referral consultation, diagnostic testing, diagnosis consultation, treatment decision-making, treatment-specific milestones (such as 6 weeks post chemotherapy to assess tumour response). what information is needed, and when, by the health professional and patients.

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Table 4. Overview of the aims of each of the design cycles.

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Each of the 3 design cycles involves:

1. A. A number of multistakeholder focus groups from different sites to collect data on end-users’ individual and collective needs and priorities
2. B. rapid analysis (appraisal), and feedback to the FG participants for sense-checking, of the FG findings (which sought end-user feedback on the design needs and priorities)
3. C. the creation or refinement of a design (for the care pathway and/ or technology).

Structures and steps in the co-design cycle and method

The overall structure and sequence of the Participatory Rapid Appraisal and Focus Group method is outlined in Fig 5A and 5B. This is supported with a worked example in S2 Appendix (the GERONTE Co-design Protocol) which is provided in the Supplementary Materials. Fig 5A and 5B outline and describe:

• the preparation and starting point for the PRA and FG method
• the broad 3 steps in the PRA and FG method
• the data collection, analysis, checked (participant sense-checking), and synthesis within each step/ cycle
• how end-user feedback is used to design and refine the final intervention (integrated technology-supported care).

S2 Appendix (the GERONTE Co-design Protocol) provides a worked example of:

• the co-design aims
• PRA and FG method’s data collection, analysis, and synthesis methods
• FG participant inclusion and exclusion criteria
• The FG questions used in GERONTE (for the care pathway and FG)
• and detailed description of the role and responsibilities
• the timelines for the FG
• resources needed for the FG
• identification of factors that impact the time needed for the 3 design cycles

Adapting the co-design method to suit your needs

Current literature

Over the last three decades, there is a large body of co-design, IS, and related theoretical and empirical literature on their respective principles, practices, and definitions [Peters, 2024,33]. This has resulted in a comprehensive set of theoretical and practical guides for those undertaking co-design research [21,52,53]. The many local and national co-designed interventions that have succeeded when implemented demonstrate the utility and value of co-design principles and methods [54–60,61,62].

Most of these studies focus on the intervention (research output) or its impact. Many describe their co-design method, but, in line with the need to prioritise focus on research impact, the focus has been on the output, leaving lessspace to provide detailed description the method’s development, testing and refinement. Individually each of these studies have invested a lot of effort and time in developing a co-design method [57,63]. There are many methodological similarities across these methods, as they draw from the well-established co-design, and/ or IS, knowledge base [64]. The presence of a detailed robust and replicable method support research efficiency.

In real-world and time- and money-limited settings it is helpful to have a well-developed, structured and flexible, co-design method that maps onto the data collection, analysis, synthesis, and reporting processes [65,66]. The GERONTE project aimed to contribute to this gap, by developing and reporting a co-design method based in the existing evidence but applied to current healthcare needs (to implement integrated care).This co-design method provides a practical, replicable, evidenced-based approach which can be adapted to meet research needs and setting [67,68].

This project aimed to develop, test, and report in detail on a method that mapped PRA and FG onto the research process. In reporting this method, we considered the ease and accuracy with which this method could be re-used and how best to ensure it was connected in a clear way to its evidence base (PRA and FG) to enable users to easily recognise and draw from this base. We endeavoured to provide sufficient detail to make the method readily re-usable or adaptable by providing a full guide in the Appendices [69,70]. We also worked to situate this method within the existing literature by using existing common co-design and IS terminology [71,72,73].

A method that aims to contribute to healthcare need

The current healthcare capacity, quality, efficiency, and policies identify the need for integrated care and services. A practical and efficient co-design method is needed to design the complex and interdependent changes needed to achieve integrated care.. The FG and PRA developed in GERONTE is presented as an evidenced-based, practical, flexible, affordable, replicable way to to identify and make change needed. Appreciably, there are limits, and consequently choices to what can be achieved within budget, time, or project limits, and we propose that PRA and FG can facilitates the collective discussion and agreement of these needs and priorities.. Consequently, while it is critical to have a co-design process giving meaningful inclusion and power-sharing [74], it is also necessary to have project leadership with relevant knowledge, alert to, balancing, identifying and developing all stakeholders priorities and needs within the co-design work [24].

The method’s current place and further growth

Much co-design research is locally driven and time and cost-restrained [24,75], and as such there is benefit to having a defined, structured, evidenced-based method, that uses established discipline terminology, to co-design interventions. The FG and PRA method has drawn from and added to the incremental development of empirically-based replicable co-design method, by grounding its methods in the literature while aiming to address the practical need to have defined and detailed structures and processes that can be applied in other projects.

The use of PRA and FG in a structure way has been used with success in the GERONTE project, and while its ability to co-design an intervention (integrated technology-supported care pathway) that works as intended in the real world setting can only be determined at the completion and evaluation of the GERONTE RCT, the end-user feedback during the project has indicated:

• the intervention meets their needs
• the co-design PRA FG method enabled meaningful engagement across different end-users, locations, and designs and was user-friendly.