Coproduction of knowledge is a “process whereby professionals and those traditionally on the receiving end of their ‘expertise’ (eg, patients/service users/marginalized citizens) can collaborate with the goal of achieving outcomes that arguably cannot be achieved otherwise” [1]. This requires a shift in power [2,3] from the narrow profession of academia to the broader public, underpinned by an epistemological shift that values knowledge derived from experience as much as knowledge derived through research [1,3]. This “epistemic pluralism” is internationally espoused in the United Nations Educational, Scientific and Cultural Organization (UNESCO) Recommendation on Open Science [4] and underpins this study of the implementation of digital health interventions for adults with acquired brain injury (ABI) and their communication partners (eg, family and friends). To reflect this pluralism, this study protocol uses a nontraditional writing style in which the direct comments of coauthors with living experience of ABI, and of communicating with or clinically supporting someone with ABI, have been interleaved with traditional academic writing. This approach allows for the sharing of collective insights into research methods and conveys the equal importance of both experiential and academic knowledge.

Additionally, this protocol refers to the “living experience” of stakeholders, quoted in the present tense, as an equally valued commentary on the research methods. As author CR explains from their living experience of ABI:

ABI, such as stroke or traumatic brain injury (TBI), commonly causes cognitive communication disorders, in which impairments in underlying cognitive skills lead to difficulties with communication [5]. These communication disorders can introduce challenges for a person’s social participation and relationships [6], employment [7,8], and mental health [9], while the ABI remains a “hidden” or “invisible” disability [10]. Author BM describes from their living experience:

Communities and close others of people with ABI also experience psychosocial, health, and economic burdens as a result of ABI [11-13]. The communication styles and skills of these close others can positively or negatively affect the communication skills of people with ABI [14-16]. Author BT observes from their living experience as a communication partner of someone with ABI:

Therefore, communication partner training (CPT) to assist individuals interacting with people with ABI is considered best practice in the management of communication disorders following ABI [17-19].

The current and future need for CPT exceeds global health care capacity to provide communication rehabilitation through qualified speech-language pathologists [20,21]. More than 135 million people worldwide currently live with an ABI [20], and this number is projected to grow continually [20,22]. To address this challenge of scale and equity in health care access, a novel suite of digital health interventions known as the “Social Brain Toolkit” [23] has been designed to enable adults with ABI, their close others and communities to access web-based communication training. The Social Brain Toolkit is being developed in Australia and will be available internationally.

The Social Brain Toolkit contains 3 interventions which leverage digital health functionalities and encompass established principles of CPT. First, “convers-ABI-lity” offers a web-based conversation skills training program for adults with ABI and their familiar communication partners (eg, family, partners, and friends). convers-ABI-lity converts the existing efficacious CPT programs of TBI Express [24] and TBIconneCT [25,26] into a bespoke all-in-one platform of self-directed web-based training and telehealth sessions with a speech-language pathologist. Second, “interact-ABI-lity” offers self-directed web-based CPT for individuals interacting with people with ABI, including paid support workers and the public. Finally, “social-ABI-lity” provides self-directed web-based social media training for people with ABI, to increase social connections for individuals who may have limited opportunity for interactions with communication partners. It aims to enhance social participation, social communication skills, and a sense of self or identity postinjury [27].

Digital health interventions such as the Social Brain Toolkit face many implementation challenges, including technological adaptability and complexity [28], cost [28,29], workflow impact [30], and long-term sustainability [29,31]. Addressing these complexities requires dialogue with potential end users early in the process of intervention design [32,33]. In addition, there is an ethical imperative for stakeholder involvement in the conduct of health care research [34,35]. The inclusion of “societal actors” in the research process has been enshrined internationally in the UNESCO Recommendation on Open Science [4] and the national Statement for Community and Consumer Involvement in Health Care Research in Australia [36]. The coproduction of research may facilitate research translation [36] and reduce research waste by ensuring that the research undertaken generates meaningful results for end users [37,38]. However, research systems and processes may be ill-equipped to support such collaboration [1,3,39]. Coproducing knowledge within these structures can be an extremely resource-intensive and politically and ethically fraught task [3,40], even without the additional complexity introduced by cognitive or communication impairments, such as those associated with ABI. Therefore, sharing of methodological knowledge and guidance on how to undertake this endeavor most effectively [37,38] is important to support future coproduction of research with people with ABI, their communication partners, and clinicians.

In this study, researchers, together with people with ABI, their communication partners, and clinicians, as well as individuals with living experience of digital health implementation, aim to coproduce an understanding of the implementation of the Social Brain Toolkit, to enable these interventions to reach their intended users and meet stakeholder needs in a feasible, scalable, sustainable, and acceptable manner. Specifically, this study has the following aims: (1) to obtain stakeholder prioritization of theoretically based implementation targets for the Social Brain Toolkit, (2) to understand stakeholder perspectives of these priorities, and (3) to collaborate with stakeholders to identify implementation strategies targeting these priorities.

This research was ethically approved by the University of Technology Sydney (UTS) Health and Medical Research Ethics Committee (ETH20-5466) on December 15, 2020. Recruitment flyers included an invitation to email the researcher to express interest in the project. Communication partners, clinicians and industry or research experts were emailed a link to complete electronic participant information and consent forms. Participants with ABI were invited to provide informed written consent using accessible, plain English participant information and consent forms that were adapted to incorporate visual supports and explained via video call by a qualified speech-language pathologist using supported communication strategies [41]. Screening for the capacity to consent is described in the inclusion criteria (the screening protocol is also included as Multimedia Appendix 1) [42]. Participant demographic information is reported as an aggregate to preserve participant anonymity.

People with ABI and communication partners were reimbursed for their participation at the annual hourly rate recommended by Health Consumers New South Wales (NSW) [43]. To support the implementation of the Social Brain Toolkit, its developers sought to learn from the expert living experience of people with ABI, their communication partners and clinicians, as well as those who have implemented digital health interventions. From this paradigm, the individual experiential knowledge of these health care stakeholders is seen as valuable for the implementation of digital health interventions and can be valued by respecting, seeking, recording, and sharing it in academic publications, acknowledging this contribution publicly and personally, and financially reimbursing those who otherwise may not receive payment for this knowledge [38]. This reimbursement also aimed to minimize any undue burden of research participation. Potential participants were advised of this arrangement in the participant information form to facilitate decision-making around any potential economic burden of participation. This financial reimbursement was optional, and in some cases declined, with reasons including altruism and potential ineligibility for benefit schemes if any payment was received. The researchers respected these wishes. Of interest, there were procedural barriers to providing participants with direct payment via the university payroll, which would have granted institutional affiliation as equals. These barriers included a lack of precedence, university requirements for participants to complete several modules of mandatory web-based induction training as staff, and taxation requirements. Therefore, researchers were requested to provide payment via electronic gift cards and could only maximize participant autonomy with their payments by providing a choice of retailer for the gift card. This may be seen as another example of a systemic structure within academia that is not readily suited to research coproduction. Author CR reflects from their living experience of both ABI and research participation that:

Finally, all participants received a certificate of appreciation for their participation, and for some participants, this was anecdotally expressed as the most meaningful acknowledgment.

As part of the ethical considerations of the study, participants were advised of the risks of emotional distress during participation and had opportunities to take breaks or seek support from the researchers or other psychological services. Emotional support was required by one participant, requiring vigilance and counseling skills within the small group format, which was aided by the clinical background of the facilitators. Author BM highlights that a focus group may be a participant’s first encounter with another person with ABI. Individuals with living experience may therefore feel a range of emotions associated with their participation. For example, BM recalls it was “sad to see the variety of different stories of so many different people” who had this “shared devastation.” However, BM believes this was also inversely “decentralizing” in a positive way, as such a group “provokes a feeling of unity” that we were “all here for the same thing.”

The coproduction of implementation knowledge in this study is part of a broader effort to involve stakeholders throughout the development of the Social Brain Toolkit (Figure 1). The development of the Social Brain Toolkit is led by author LT, a speech-language pathologist, clinical researcher, and Director of the Acquired Brain Injury Communication Lab [23] in Sydney, Australia, together with research team members, speech-language pathologists and authors EP, RR, MB, and MM, in collaboration with the technology vendor Changineers [44]. The project was jointly conceived and reviewed by stakeholders including people with ABI and their communication partners, community partners such as Brain Injury Australia, and funding partner icare NSW. This was a requirement for funding at project inception, and subsequent funding for this study and related studies [45]. These stakeholders have continued to participate in advisory and steering committees for the project, provided feedback on early prototypes, and will provide ongoing formative feedback on the interventions and their implementation [45]. Clinicians delivering convers-ABI-lity were included as associate investigators in the project. People with living experience of ABI, of being a communication partner, or of clinically supporting someone with ABI, are coauthors of this study protocol and will be included in the coauthorship of its results.

Theoretically underpinned by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) theoretical framework for digital health implementation [46,47] in both analysis and data collection protocols, this mixed methods study gives voice to the priorities and perspectives of 2 distinct cohorts: (1) a purposive, maximum variation sample of people with ABI, communication partners, and clinicians; and (2) a purposive sample of individuals with experience implementing digital health interventions for any health condition. The use of a complexity-based theoretical framework such as the NASSS [46] enabled the consideration and integration of the needs of multiple stakeholders, including clinician end users who will implement the intervention in complex, adaptive health care systems. People with ABI, communication partners, and clinicians participated in (1) an initial prioritization survey and (2) subsequent focus groups exploring these priorities. Individuals with experience in digital health implementation responded to the prioritization survey via individual interviews. Interview methods were used due to both limited participant availability and a need to balance homogeneity and heterogeneity in the focus groups, particularly in relation to power and differences and similarity of experience [48], as participants with experience implementing digital health were not required to have clinical or research experience in ABI specifically. The results of this group were analyzed separately to understand and compare these perspectives with those of potential end users.

This protocol details stakeholder prioritization according to the REPRISE (Reporting Guideline for Priority Setting of Health Research) guidelines for reporting research priority setting [38]. All interview and focus group participants were given an opportunity to add to their original contributions verbally or in writing for inclusion as original data. All focus group transcripts will be verified against the original audio or video recordings by at least one person originally present in that focus group. All interview and focus group participants will be given an opportunity to member-check preliminary interpretations of their input. A second author will verify a random 25% of the total codes from focus groups and interviews using the aforementioned codebook. For focus group data, this verification will be conducted by a coauthor who was present in that focus group as either a researcher or participant. Any discrepancies will be resolved via consensus discussion.

Stakeholder priorities and implementation strategies are directly informing the implementation of the Social Brain Toolkit. The outcomes of the implementation strategies will be investigated in a hybrid type 2 implementation–effectiveness study [53] of all 3 interventions in the Social Brain Toolkit [45].

Stakeholders with living experience contributed to, critically reviewed, and are therefore listed as coauthors in the publication of this study protocol. They are also coauthors in the analysis, interpretation, and publication of the study results. MM conceptualized and formalized this coauthorship process in the grant proposals for this study. MM is facilitating this collaboration by email, telephone, video call, and Microsoft Word (Microsoft Corporation), according to each author’s communication preferences and accessibility requirements. In keeping with the UNESCO Recommendation on Open Science [4], researchers have obtained funding to enable both this study protocol and the forthcoming results of the contributions of participants to be available open access. Authors AS and MM highlight that journal requirements to include academic qualifications for the stakeholders coauthoring this protocol are artifacts of a system that prizes academic knowledge, which, although reported for transparency, may arguably be seen as less relevant than or even contradicting the value of living experience.

This implementation study combined (1) the experiential knowledge of people living with ABI, communicating with or clinically supporting people with ABI, and implementing digital health; with (2) academic knowledge in the form of current digital health implementation evidence and theory to (3) coproduce new implementation knowledge for 3 real-world interventions. As people with ABI, their communication partners, and clinicians are direct stakeholders in the development and implementation of digital health interventions targeting communication changes after ABI, there is an ethical imperative for their inclusion in intervention design, development, and delivery [35]. In the field of implementation science in particular, it is arguable that their input is essential for successful real-world implementation as early as intervention development [32] and while empirical data are still developing.

At the heart of this coproduction is a proactive exchange of power [2,3]. In the Social Brain Toolkit project as a whole, stakeholder involvement to date has included project conception, advisory input, feedback on prototypes, and the coproduction of implementation knowledge (Figure 1). In practice, this has required stakeholder input from multiple groups and individuals to varying degrees and at various times over the course of a multiyear program of research, commensurate with each stakeholder’s autonomy and availability. For instance, within the present implementation study, some stakeholders did not accept the offer for coauthorship, instead preferring to participate in surveys and focus groups as a one-off contribution, whereas others are investing ongoing time and effort to coauthor this study protocol and its eventual results. The power to decide one’s involvement in research can only begin when an opportunity is provided. Therefore, stakeholders can and should be given opportunities for involvement and contribution in research, which in some cases are opportunities that only researchers have the power to create or provide. For example, coauthorship of this study protocol required proactive invitation, inclusion, and facilitation by researchers, thus giving power to stakeholders to decide whether they may or may not want to be involved in this way.

When researchers seek to redress the imbalance of power in research, it can empower stakeholders. As author AS reflects, his involvement “provided me with the opportunity to make a contribution to a worthwhile project, and improve my self-esteem.” Author MRW reflects that:

Author MRW also reflects that “the encouragement that we got from [the researchers] and even other people with ABI and their communication partners was extremely encouraging.” Author BM says:

This protocol outlines the resource-intensive and politically and ethically challenging task of research coproduction [3,40] and how the consideration of cognitive or communication impairments, such as those associated with ABI, increased the complexity of the task. In this study, the facilitation of stakeholder involvement required proactive, premeditated support, including the investment of significant and ongoing time and effort to (1) guide stakeholders through the research process; (2) scaffold requests for input visually, verbally and in writing, according to individual communication preferences and accessibility requirements; (3) pilot and prepare resources in accessible, plain English with visual supports and supported communication techniques; and (4) secure grant funding in advance to reimburse participants for their expertise. The provision of these supports was necessary to affirm stakeholders’ value and potential for input at each stage of an otherwise unfamiliar research process. Although MM, EP, RR, MB, and LT’s backgrounds as speech-language pathologists and MM’s background training in accessibility aided the development of accessible supports for participants, the aforementioned interest, encouragement, support, and respect that was appreciated by stakeholders are arguably universal hallmarks of effective and respectful communication and collaboration, achievable by, and expected of [36], all researchers. Likewise, the additional time, effort, and funding invested are not unique to the speech-language pathology profession. This time-cost may be counterbalanced by the way that stakeholder prioritization enables the reduction of research waste [37], in this case by enabling a focus on implementation domains that were of most importance to potential end users.

In this study, there were numerous time points and methods by which stakeholders contributed to the implementation of the Social Brain Toolkit. In addition to prioritizing implementation research targets, stakeholders were involved in the development of targeted implementation strategies to address these priorities. A subgroup is currently involved in the interpretation of these findings for publication as coauthors. Additional opportunities for dialogue among stakeholders, and between stakeholders and researchers, were created by using collectively surveyed stakeholder priorities to inform focus groups, and cumulatively sharing each focus group’s data in subsequent focus groups and interviews. This collaborative dynamic was important to foster not only for successful focus groups [48] but moreover because the purpose of the research was to coproduce implementation knowledge. Researcher MM reflects that although common goals were initially outlined in individual surveys and interviews, this could also have been reiterated in subsequent focus groups. Although plenary discussions naturally led to discussions regarding the collaborative purpose of the focus groups, author BM recommends that researchers proactively facilitate a collaborative dynamic by (1) prefacing focus group discussion with a concise and jargon-free explanation of “this is what we’re doing, this is what your role is, and this why we’re doing it,” and (2) reminding participants “that the academic research goals are strictly aligned with the needs of TBI sufferers and their families, in that the research and collaboration is to build pathways that reduce problems and pain for TBI sufferers.”

This collaboration toward a common goal is at the core of research coproduction. However, in author MM’s experience, the time-limited nature of academic systems directly hinders research coproduction at every stage of research [1,3,39], as it inherently conflicts with the space and time required for the intensive and relational nature of effective collaboration. Yet stakeholder suggestions for the opportunity to build familiarity with other participants, and the need for researchers and clinical end users to discuss common goals clearly attest to this relational need.

This study demonstrates potential methods of engaging stakeholders throughout the implementation research process, from prioritization to authorship. In particular, we share how to retain theoretical rigor in implementation science while capturing the highly nuanced and complex reality of implementation from multiple stakeholder perspectives. However, there are several limitations to this study in relation to stakeholder representation. First, there was a minority representation of stakeholders outside Australia. Although the inclusion of English-speaking users in Australia reflects the initial development context of the Social Brain Toolkit, future studies may seek to explore international and CALD perspectives. In addition, although this study included similar numbers of communication partners as people with ABI, author MM observed that communication partners were most reticent to participate, and therefore underrepresented, in the publication stages of research. A particularly proactive effort was and may be required to give voice to this population specifically. Finally, although we sought to recruit clinicians, managers, and policy makers, clinical participation was solely comprised of speech-language pathologists. Although they are conceivably the most likely clinician to recommend, deliver, or support the implementation of the Social Brain Toolkit, the perspective of other clinical professions, as well as health care managers and policy makers, could have contributed to a more multifaceted understanding of implementation from a clinical perspective.

By making implementation theory directly accessible to multiple stakeholders and proactively facilitating a dialogue between stakeholder experience and implementation theory, we were able to coproduce new implementation knowledge to support the implementation of 3 real-world interventions, including targeted implementation strategies [45]. Author MW observes the following from a clinician perspective:

To our knowledge, this is the first published coauthorship of implementation research with people with living experience of ABI, of being a communication partner of someone with ABI, and of clinically supporting adults with ABI. As a person with living experience of ABI, author CR believes:

Author CR concludes as follows: