Purpose: Combing two successful programs of research, we developed and tested a community to clinic tailored navigation intervention using a dissemination (randomized phase) and implementation (non-randomized phase). The final outcome measured was a) clinic attendance and, b) CRC screening. We also examined the roles and responsibilities of the statistician and/or methodologist in a D&I study and how those procedures and practices differ from those in a randomized control trial. This includes the design of a study, appropriate models or theoretical frameworks, frameworks for evaluation (i.e., RE-AIM), measurement issues, concerns of fidelity and re-invention or adaptation of successful interventions and the diffusion of innovation principles.
Methods: We randomized 232 sites to General Education +Tailored Navigation and 116 General Education only. In phase one, all participants received group education on cancer screening and risk. Those in the general education group received up to 5 reminder calls, and those in the navigation group received up to 10 calls from navigators who assisted them with barriers using a tailored message bank. In phase two, all those who attended a clinic received tailored navigation from a trained study navigator, through a combination of in-person meetings and phone calls.
Results: Of the 389 people enrolled, 25% made clinic appointments and of those, 61% complete colon cancer screening. We will frame our discussion with the 5 core values for D & I proposed by the NIH: rigor and relevance, efficiency, collaboration, improved capacity, and cumulative knowledge with specific examples from the present D & I study.
Conclusions: As such we have demonstrated that community-engaged cancer screening programs in Arizona are feasibility and acceptability (Reach), are Effective, and that Adaptation is necessary for success.