Implementation in the Trial Versus in the Real World

In the chapter What is a Pragmatic Clinical Trial, we introduce the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) domains for PCTs, which specify criteria that make a trial more pragmatic than explanatory. For a trial to be on the pragmatic end of the spectrum, one would expect “only ordinary attention to dose setting and side effects” and “no special strategies to maintain or improve compliance are used” (Thorpe et al. 2009).

Some PCTs use existing ordinary implementation processes and some require extra monitoring and support; this has implications for post-study implementation, as described in more detail using the case example below.

Case Example: Suicide Prevention Outreach Trial (SPOT)

  • The goal of the Suicide Prevention Outreach Trial (SPOT) is to compare outcomes in patients who receive care-management or online skills training for suicide prevention versus usual care in three healthcare systems.

Care managers and skills coaches received approximately 14 hours of initial training on suicide prevention interventions conducted by videoconference and teleconference followed by weekly or bi-weekly supervision teleconferences. This training sets SPOT apart from a purely pragmatic trial according the PRECIS domains, but was necessary because of the introduction of new clinical work processes and informatics tools. The investigators did not monitor the fidelity of the intervention (e.g., reviewing the content of online messaging or phone calls); making this aspect of the trial consistent with a pragmatic design. The implications for potential implementation (if the program is proven effective) are that similar training and subsequent supervision will likely be required.

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REFERENCES

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Thorpe KE, Zwarenstein M, Oxman AD, et al. 2009. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 62:464–475. doi:10.1016/j.jclinepi.2008.12.011. PMID: 19372436.

Citation:

Zatzick D, Tuzzio L, Chambers D, et al. Dissemination and Implementation: Implementation in the Trial Versus in the Real World. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: http://rethinkingclinicaltrials.org/dissemination-implementation-top/implementation-in-the-trial-vs-implementation-in-the-real-world/. Updated August 18, 2017.