Abstract
BackgroundLittle research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies’ effectiveness in the community health center setting.Methods/designThis cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics’ ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the “how” and “why” underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in “real-world” practices.DiscussionHaving a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers. Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers.Trial registrationClinicalTrials.gov, NCT02325531
Highlights
Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers
Having a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers
Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers
Summary
While substantial research has identified interventions that improve care quality, little is known about how to implement such interventions most effectively and efficiently in diverse care settings. Given that the field of D&I science is nascent, SPREAD-NET may serve as a model for future trials interested in identifying methods for encouraging uptake of EHR-based decision support, by clearly differentiating between the intervention and the methods used to implement it This trial’s mixed methods design is important, as it will allow us to understand not just how often clinics acted on the targeted practice change and why certain approaches did or did not work well in clinics with different characteristics. The SPREAD-NET trial described here is an empirical example of the research that is needed to allow us to accelerate implementation timelines and reduce disparities in health care and health outcomes, especially in CHCs. It has the potential to contribute much-needed knowledge to the field of implementation science and to serve as a model for future research on how to implement effective interventions in diverse care settings.
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