Challenges inevitably arise during any protocol implementation process [2, 4], but researchers implementing multi-component interventions aimed at system change are likely to face both a greater number and more nuanced challenges than those implementing individual-focused interventions. When challenges arise, managing the tension between intervention fidelity and real life feasibility plays a key role in assessing challenges and developing solution strategies.
Although fidelity between the study protocol and implementation is necessary [20–22], systems level interventions must be developed with an awareness of the need for some flexibility in their delivery. Jordan et al. suggest that linear implementation and inflexible fidelity protocols do not fit very well when implementing system change interventions, which by definition are shaped by nonlinear interaction, self-organization, and co-evolution of the complex adaptive system. Accordingly, it may be more useful to consider research implementation more fluidly, utilizing a sense-making lens . A sense-making perspective provides a means to address challenges that emerge during research implementation in complex settings—an approach that allows for adaptation to the research setting while maintaining fidelity of the intervention . McDaniel et al. [2, p. 193] state that ‘research design is not a prescription that defines what to do when but rather is the development of tentative guides for action.’ Instead of a rigid design, Beinhocker  proposes it is better to consider the spectrum of possibilities that may occur . During the implementation of the CONNECT study, our research team learned that a systematic application of a sense-making perspective effectively guided our research team discussions to identify and implement appropriate solutions, and embodied Beinhocker’s (2006) guidance to move away from rigid research design.
The TECH provides a standard process with key questions to consider when challenges emerge—it focuses on sense-making as a process as opposed to a single decision event . It is also best suited for research teams that embrace communication strategies such as trust, responsiveness, listening, paying attention, suspending assumptions, and ability to deal with misunderstandings, because these enhance sense-making . The challenges encountered may be unexpected, but this protocol provides a systematic process for handling emergent challenges across varied research settings.
In any healthcare or non-healthcare setting, the leaders of the research team are key to successfully using the TECH tool by empowering all team members and encouraging open exchange of ideas. When the leaders value the voices of all of the research team members, it allows for emergence of richer information for interpreting the issues and forming solutions. Useful information might come from anyone on the team or it might emerge when processing divergent views to create a new idea not originally held by any team member. Specific to implementation challenges, it is imperative that all team members feel their voices are valued; if not, they may not share their implementation concerns with the team, potentially resulting in a negative impact to overall research integrity. Without team empowerment, members of the field team may implement emergent solutions without dialogue with the team, leading to protocol fidelity problems and potential negative impacts on overall findings. Alternatively, non-empowered team members may choose not to bring implementation issues to the team and instead continue to implement a flawed protocol. Thus, a team environment that encourages empowerment, open dialogue, creativity, and group problem-solving using the TECH will potentially strengthen both the protocol and research findings.
Another issue to consider when using the TECH is that each research team can adapt it to include or exclude relevant questions for their own research endeavors. The processes proposed in TECH can be incorporated into a research design, to ensure scientific rigor, flexibility, and adaptation to complex research settings. By using a standardized process for assessing research challenges within the team setting, the evolution of a study throughout an implementation period can be consistently documented. A standardized process, such as TECH, is also helpful when engaging a large research team—members are able to more effectively contribute feedback in a group setting or via distance by providing input within the framework provided by TECH. Lastly, as encouraged by scholars [2, 3, 24], this approach promotes the continuous improvement and evolution of the research process throughout the duration of the study.
The TECH is applicable across the research spectrum, from clinical trials to community based participatory research. At one extreme, clinical trials implemented without any adaptation for fear of contaminating the process may result in research outcomes that yield no real world applicability (e.g., poor feasibility, inadequate delivery). These trials would benefit from the TECH because it provides a mechanism for maintaining fidelity of the intervention and study design, allowing for the development of more robust and feasible interventions in a live setting. At the other end of the continuum, community-based research may incorporate more stakeholders throughout the process allowing for better anticipation of potential challenges; however, because these are complex adaptive systems, it is not possible to anticipate all challenges occurring across diverse sites and over time, and the TECH provides a method for addressing additional unexpected challenges that arise.
Limitations to the TECH approach should be considered. As previously stated, this TECH may not work well in an environment where all team members do not feel empowered to participate fully; when faced with this issue, we encourage research teams to focus on building a core implementation team at a minimum and work to develop a culture of trust within that team. As with any protocol that provides rules and guidelines, there is a risk that creativity might be hindered; however, we argue that the sense-making evaluation protocol allows for responsible creativity, which balances the need for intervention fidelity and flexibility. Use of TECH may extend timelines because some solution strategies may also require additional IRB review. However, we believe that in the long run this may reduce time wasted by implementing protocols that are not functioning in the field.
Aspects of validity and reliability of the TECH were assessed during implementation of our pilot study; however, further testing is warranted. The pilot study implementation was successful, and thus the protocol exhibited face validity, helping us to successfully overcome implementation challenges in the field throughout the two pilot studies (VA and community studies). Other indicators of TECH reliability include that we met all deliverables in the study timelines, met recruitment goals, were able to consistently apply the same process of change to two studies, and retained the same research interventionist across the two pilot studies and the large extension study. Focus groups conducted following the interventions in both studies indicated that the interventions were well received; indirectly, this might indicate that we made appropriate adaptations to keep the intervention feasible and acceptable to the target audience. Overall, the TECH process both proved useful and was generally well received; members of the research team believe it facilitated useful adjustments to study implementation. We secured funding for a large extension study, and TECH has been helpful in addressing issues in an additional 16 nursing homes. We have observed, however, that because of the refinements to the study implementation protocols made using the TECH during the pilots, fewer adjustments have been required in the extension study, further supporting the TECH as a valid process.
We suggest, therefore, that the TECH tool is especially helpful in pilot studies in which the goal is to identify implementation challenges and refine intervention protocols for full-scale implementation. We believe, however, that it remains useful in subsequent research that uses the same intervention protocol because each research site is unique and will present new implementation challenges. Clinical practice changes over time, which can affect the research protocol implementation. New regulations impacting research might be enacted. Because these settings are complex adaptive systems means that study challenges inevitably arise in clinical research despite careful pilot work.