Within the context of PCTs and embedded research, where clinical research is performed as part of routine care, a researcher should consider the causal pathway from trial results to the initiation of a sustainable intervention in the design phase of a trial. Effectiveness research and implementation research may, in fact, produce stronger impacts when they are done together as opposed to separately (Glasgow et al. 2012), although this is rarely done (Curran et al. 2012; Brownson et al. 2013), and there is considerable room for improvement when it comes to designing a trial with dissemination in mind (Brownson et al. 2013).
In PCTs and comparative effectiveness research “designs rely on controlling/ensuring delivery of the clinical intervention, albeit in a less restrictive setting, with little attention to implementation processes likely to be of relevance to transitioning the intervention to general practice settings.” (Curran et al. 2012).
Expanding on the notion that uptake and implementation in routine care could be studied in conjunction with clinical effectiveness in a PCT, dissemination and implementation could be considered in the early stages of research design—even as part of research topic selection (Curran et al. 2012; Slutsky 2015). Potential issues related to dissemination and implementation could be considered at the design phase as they can be anticipated at many levels: from the patient, the clinicians and organizations delivering the interventions, the financial and political environment, and the broader social context (Glasgow et al. 2012). However, if the intervention is not effective, then there is a need to either pursue the development and testing of an alternative intervention or ensure that the existing intervention does not get taken up in practice; increased attention on “de-implementation” of ineffective practices has occurred as a result of the “Choosing Wisely” campaign and other efforts to reduce use.
Investigators conduct the trial to get information about the effectiveness of an intervention. If no consideration is given to implementation of an intervention at the design stage, then it may be unclear as to whether the intervention can be integrated into various practice settings in its current form. An implementation study, which would seek to understand how to get the practice to be used in healthcare delivery systems, may be necessary if the results are positive. Conversely, in a stepped wedge trial, where the intervention is turned on at all sites over time, if the results are negative, de-implementation may be necessary. One resource that may be useful in gauging the likelihood that the intervention is designed for dissemination and implementation is the PRECIS-2 tool (Loudon et al. 2015; Johnson et al. 2016) This measure assesses, along nine dimensions, the relationship of the intervention, setting and study design with the clinical practice environment where the intervention may be delivered in the future. Researchers may benefit from designing their trials with these criteria in mind.
Brownson RC, Jacobs JA, Tabak RG, Hoehner CM, Stamatakis KA. 2013. Designing for dissemination among public health researchers: findings from a national survey in the United States. Am J Public Health. 103:1693–1699. doi:10.2105/AJPH.2012.301165. PMID: 23865659.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. 2012. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 50:217–226. doi:10.1097/MLR.0b013e3182408812. PMID: 22310560.
Glasgow RE, Vinson C, Chambers D, et al. 2012. National Institutes of Health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 102:1274–1281. doi:10.2105/AJPH.2012.300755. PMID: 22594758.
Johnson KE, Neta G, Dember LM, et al. 2016. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 17. doi:10.1186/s13063-016-1158-y.
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. 2015. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 350:h2147. PMID: 25956159.
Slutsky J. 2015. PCORI Snapshot. Presented at: Patient-Centered Outcomes Research Institute Meeting; Washington, DC.