Implementation Science

NIH defines implementation science as the study of “strategies to adopt and integrate evidence-based health interventions and change practice patterns within specific settings.” It answers questions such as, “Why do evidence-based interventions lose effectiveness over time in real-world settings?” and “How do interventions need to be applied to various settings to maintain effectiveness?” When interventions shown to be efficacious in the controlled environment of clinical trials are applied to the real-world where there is greater population variability and the inability to maintain control over environment and patient response, it is important to evaluate for maintained effectiveness.

Implementation science frequently employs hybrid study designs. Hybrid designs provide a structure for the complex process of collecting two entirely different types of information: implementation (how well the intervention is taken up by the clinical sites) and effectiveness (the clinical impact of the intervention). The choice between Type I, II or III hybrid designs depends upon the amount of underlying effectiveness data. Studies of interventions with limited effectiveness data are best suited to a Type I design where primary outcomes are effectiveness and secondary outcomes focus on implementation. The reverse is true for Type III studies with Type II studies being somewhere in between. All hybrid studies have a phased study design: pre-implementation, implementation and post-implementation.  


CAGPM has developed two hybrid implementation-effectiveness trials (one on-going) that evaluate implementation and effectiveness of a web-based risk stratification tool, MeTree, within the primary care setting. We are evaluating MeTree in ethnically and geographically diverse settings to understand how changes to setting and population affect implementation efforts. Our current study is based on the RE-AIM framework and the Weiner organizational model of innovation implementation. Both qualitative and quantitative measures are used to understand both generalizable and specific barriers to implementation across clinics. At the end of the study, clinic-type templates will be developed to serve as road maps for broader implementation of similar IT tools.

CAGPM is also collaborating on a clinical trial evaluating implementation of MeTree within the Veteran Affairs Healthcare System. Primary care providers are randomized to immediate or 12-month delayed MeTree report availability. The primary outcome measured is difference in rates of identification of patients at increased risk for colorectal cancer (CRC) and differences in referral for increased risk screening and genetic counseling for CRC risk.