The methodological toolkit for implementation science research is large. Potential trial designs may involve randomization or quasi-experimental methods. Endpoints may focus on clinical effectiveness, implementation, or both. The unit of randomization is often a key decision point. Newer methods may aim to develop adaptive treatment strategies. This session will review these designs and ask the class to offer alternative designs to address implementation of a common evidence-based practice.
Required readings:
Bernstein SL, Dziura J, Weiss J, Miller T, Vickerman KA, Grau LE, Pantalon MV, Abroms L, Collins LM, Toll B. (2018). Tobacco Dependence Treatment in the Emergency Department: A Randomized Trial Using the Multiphase Optimization Strategy. Contemp Clinical Trials. 66: 1-8. https://doi.org/10.1016/j.cct.2017.12.016
Edelman EJ, Porter E, Dziura J, Yager J, Sigel K, Bernstein SL. (2021). A SMART approach to treating tobacco use disorder in persons with HIV (SMARTTT): Rationale and design for a hybrid type 1 effectiveness-implementation study. Contemp Clinical Trials. 110:106379. https://doi.org/10.1016/j.cct.2021.106379
Optional readings:
Brown et al. (2017). An overview of research and evaluation designs for dissemination and implementation research. Annual Review of Public Health. 38: 1-22. https://doi.org/10.1146/annurev-publhealth-031816-044215
Collins LM, Nahum-Shani I, Almirall D. (2014). Optimization of behavioral dynamic treatment regimens based on the Sequential, Multiple Assignment, Randomized Trial (SMART). Clinical Trials 11:426–34. https://doi.org/10.1177%2F1740774514536795
Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. (2012). A “SMART” design for building individualized treatment sequences. Annual Review Clinical Psychology 8:21–48. https://doi.org/10.1146/annurev-clinpsy-032511-143152
Murphy SA, Lynch KG, Oslin D, McKay JR, TenHave T. (2007). Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. May, 88(Suppl 2): S24-S30. https://doi.org/10.1016/j.drugalcdep.2006.09.008