Applying implementation frameworks to the clinical trial context

Abstract

Background Clinical trials advance science, benefit society, and provide optimal care to individuals with some conditions, such as cancer. However, clinical trials often fail to reach their endpoints, and low participant enrollment remains a critical problem with trial conduct. In these ways, clinical trials can be considered beneficial evidence-based practices suffering from poor implementation. Prior approaches to improving trials have had difficulties with reproducibility and limited impact, perhaps due to the lack of an underlying trial improvement framework. For these reasons, we propose adapting implementation science frameworks to the clinical trial context to improve the implementation of clinical trials. Main text We adapted an outcomes framework (Proctor’s Implementation Outcomes Framework) and a determinants framework (the Consolidated Framework for Implementation Research) to the trial context. We linked these frameworks to ERIC-based improvement strategies and present an inferential process model for identifying and selecting trial improvement strategies based on the Implementation Research Logic Model. We describe example applications of the framework components to the trial context and present a worked example of our model applied to a trial with poor enrollment. We then consider the implications of this approach on improving existing trials, the design of future trials, and assessing trial improvement interventions. Additionally, we consider the use of implementation science in the clinical trial context, and how clinical trials can be “test cases” for implementation research. Conclusions Clinical trials can be considered beneficial evidence-based interventions suffering from poor implementation. Adapting implementation science approaches to the clinical trial context can provide frameworks for contextual assessment, outcome measurement, targeted interventions, and a shared vocabulary for clinical trial improvement. Additionally, exploring implementation frameworks in the trial context can advance the science of implementation through both “test cases” and providing fertile ground for implementation intervention design and testing.

Healing Right Way randomised control trial enhancing rehabilitation services for Aboriginal people with brain injury in Western Australia: translation principles and activities

“…It is important to note, however, that the team did not start Healing Right Way with an implementation plan, although it is evident from the implementation journey described below that many elements of authentic and culturally secure translation and knowledge exchange were embedded in the implementation practices of the trial team. The brief introduction to the principles and practices of knowledge translation below outlines some of the key issues and challenges and culminates with the set of principles that guided the KTE process (Beidas et al 2022;Stensland et al 2022). The trial team was committed to principled practice as outlined below.…”

“…Zhang et al (2022) emphasises knowledge exchange as 'knowledge bridging' (p. 531). In clinical trials, knowledge exchange and implementation efforts pose particular challenges and have often suffered from poor implementation practices (Stensland et al 2022). Damschroder et al (2022a) also lamented that context often conspires against evidence-based innovations and that our efforts at knowledge exchange must grapple with both describing and analysing the context within which we are attempting to enact knowledge exchange activities.…”

“…In planning for Healing Right Way we were concerned with the processes for ensuring that the learnings and outcomes from the trial were adopted and embedded in the everyday practice in complex health settings. In addition to the outcomes of the trial itself (which was in and of itself a knowledge exchange opportunity as suggested by Stensland et al 2022), as noted above, the research process itself was a social, cultural, political and economic practice that offered opportunities (and threats) for more expansive knowledge exchange. McGrath (2012) said that in the field of health this is a 'process concerned with ensuring that information gained from research is made readily available to policy makers, service providers, and consumers in a user-friendly way that maximises the practical application of the findings' (p. 163).…”

Using Implementation Science to Improve Patient Care

“…Implementation science provides scientific backbone to systematically improve the conduct, efficiency, and equity of clinical trials, and aid in tailoring trials to succeed. Better understanding the context for trial implementation (eg, competing studies, degree of buy-in, funding source), developing targeted improvement strategies to overcome barriers, and measuring trial implementation outcomes could greatly enhance trial success in urology, 6 for example, identifying areas where prostate cancer incidence is high but there are no trial sites available, ie, scientifically underserved areas, where prostate cancer trials may be needed. 7 Adapting implementation of clinical trials to context will help identify where other trial improvement interventions may be helpful, optimizing resources to more efficiently increase our evidence base.…”

Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis

“…The dynamic contextual determinants within ICUs are highly likely to impact the FSI uptake and delivery [ 12 – 14 ] and could consequently influence the degree of effectiveness [ 15 – 18 ]. To ensure successful implementation of complex interventions, tailoring of implementation strategies to the local context is considered a key factor [ 17 , 19 , 20 ].…”