In this version of the pipeline, all previous phases discussed above are essentially similar. However, it recognizes a new Phase V that refers to a translation and/or implementation phase. As most interventions are tested outside of or independent of a particular setting in which it could eventually be implemented, its performance within a particular context is unknown. Thus, typically, a set of activities is necessary to “translate” the intervention from its testing phase for its implementation into a real setting. Also referred to as T3 research in the NIH environment, this translational phase seeks to interpret, convert, and adapt a proven intervention for consistent delivery “. . . to all patients in all settings of care and improve the health of individuals and populations” (Dougherty & Conway, 2008, p. 2319).
The issues related to Phase V are discussed in more detail in Chapters 19 and 20. Briefly, there is no consensus as to the specific steps involved in a translational phase, whether it is necessary in all cases when moving interventions forward, or whether it is a separate phase needed prior to an implementation study. Clearly, however, findings from implementation science are critical for informing Phase V.
It appears that when an intervention is tested external to a particular context in which it might be embedded, certain translational activities may be necessary prior to an implementation study (Gitlin, Jacobs, & Earland, 2010). Among these activities are: identifying immutable and mutable aspects of an intervention to refine efficiencies in its delivery and afford a better fit with a particular context (see our previous discussion above on this point as well); advancing manuals that standardize all aspects of delivery for use by agencies and interventionists; developing systematic training programs for instruction in the delivery of the intervention; identifying and evaluating referral mechanisms that enhance outreach to targeted populations; identifying the barriers and supports within a practice environment that support its implementation; identifying the resources and costs needed for implementation; and serving as a pilot test prior to scaling up for full implementation (Glasgow, 2010; Gitlin, Marx, Stanley, & Hodgson, 2015). Critical to this phase is ensuring that the active ingredient(s) identified as core to the effectiveness of an intervention remain intact and are not modified. These translational activities often serve as a pilot test prior to a full implementation study that evaluates, for example, the relative merits of different strategies for implementing an intervention or the rate of adoption by interventionists and participants. These activities may also compose what others
Case Example: As an example, the ABLE (Advancing Better Living for Elders) intervention was designed to help older adults (>70 years of age) carry out everyday activities of living with less functional challenges. Its essential active ingredient is that it is client-centered and client-directed. That is, ABLE addresses the areas of daily functioning that older adult participants themselves identify as most problematic to them (versus those identified by a health professional). In five home sessions, interventionists (occupational therapists) provide instruction in strategies such as using energy conservation techniques, assistive devices, and home modifications to support performance in those activities of value to a participant. A physical therapist also provided one visit to instruct in safe fall techniques and balance exercises (Gitlin et al., 2006). In its translation for delivery in a traditional home care agency, the intervention had to be simplified. The level of coordination between occupational therapy and physical therapy visits that was obtained in the efficacy trial proved challenging for a home care agency to replicate. Thus, the intervention was modified such that, during an occupational therapy session, an evaluation of fall risk was conducted with a future referral to physical therapy provided for those participants scoring in a range indicating fall risk. Also, certain home modifications (e.g., stair glides; improved lighting) were not possible to provide as they were too expensive or not available through the home care agency. Thus, referral was made to other programs for obtaining recommended home modifications. Finally, therapists had difficulty following a person-directed approach in which the functional areas addressed in the intervention were those identified by older adults themselves. Translating this intervention thus required creating a training program that reinforced its client-directed approach and evaluating whether such an approach had added value to a traditional functional assessment approach within the context of a busy home care practice (Gitlin, Earland, & Piersol, 2010). These modifications were identified in a small feasibility study to translate the intervention for delivery by therapists in home care practices.
have referred to as “pilot testing prior to implementation testing.” Here, our earlier discussion of pilot tests and their definition and level of rigor would apply.