Large randomized controlled trials (RCTs) are preferred; robust observational studies will also be considered if an RCT is not possible, and the proposed approach appropriately controls for confounding. Thoughtful use of new study designs, such as hybrid designs (Curran, et al., 2012), also are encouraged and could speed the translation of research findings into routine practice, identify more effective implementation strategies, and provide more useful information for stakeholders. For this funding announcement, one of the primary aims must be focused on a comparative clinical effectiveness question, so hybrid type 1 and hybrid type 2 designs may be appropriate. Hybrid type 3 designs, for which the primary aim is implementation research, will not be considered responsive.
Reference: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–226.