Determine How the Problem Is Currently Being Addressed
The final consideration in the discovery phase involves determining how the problem is currently being addressed. This involves conducting systematic literature reviews to evaluate whether interventions for the problem area and targeted population exist. Here five scenarios may be possible, each of which may lead to a different subsequent developmental pathway. Figure 3.1 details these potential outcomes and their implications for how to proceed in developing an intervention along the pipelines discussed in Chapter 2.
One scenario and perhaps the most common that is discovered through a comprehensive literature review is that a theory-based intervention does not exist for the identified problem area. In this case, an intervention needs to be developed from “scratch” or from the ground up through Phase I testing, followed by the other phases along the pipeline.
A second scenario may be that there is not a proven intervention for the problem area of interest, but evidence-based protocols do exist for similar problems that could possibly be combined and applied to a new area. For example, behavioral activation is a powerful, evidence-based protocol that has been used to reduce depressive symptoms and improve self-care and medication management for distinct populations (Hopko, Lejuez, Ruggiero, & Eifert, 2003). This approach, however, might be useful in addressing the need to improve diabetes self-management. A behavioral activation protocol could be combined with perhaps another proven protocol for education or stress reduction. As each of these components has been previously shown to be feasible and acceptable for other problem areas, it might be possible to skip an initial pilot test of each of these components and move forward with either a strong pilot test of the new combination (Phase II) or efficacy testing (Phase III).
Figure 3.1 Five scenarios for intervention development.
Yet a third scenario is that one or more interventions may have been developed previously, but their evaluation resulted in poor or suboptimal outcomes. In this scenario, refinements, augmentations, and/or boosters to an existing intervention may be needed. If so, it may be possible to skip a few pilot test phases and evaluate the modified or augmented intervention in a Phase III (efficacy) or Phase IV (effectiveness) study. However, if developing a new intervention is warranted, it would require moving through all development and testing phases.
A fourth scenario may be that one or more interventions do exist and are effective for the targeted problem area and population. In this case, developing a new intervention is not necessary. However, it may be important to conduct a replication study or to compare two or more of these existing interventions to determine which one is more cost-efficient and beneficial.
Finally, an intervention may exist and found to be effective but not for the targeted population or context of interest. In this scenario, a new intervention or an adaptation to a proven intervention might be warranted and pilot testing occur. There is increasing interest in this scenario as it is unclear as to whether and how to adapt an existing proven intervention to enhance its fit to individuals who are from different cultural, linguistic, and/or socioeconomic backgrounds from those included in the original test of the intervention. Debated is whether it is possible to adapt an intervention to better fit a cultural context and still preserve the fidelity of the original intervention or whether a new intervention needs to be developed. Emerging conceptual models for adapting existing interventions support an adaptive approach (Bernal, Jimenez-Chafey, & Domenech Rodriguez, 2009). An example of such an approach is the Harvest Health Program, which was a cultural adaptation for older African Americans of the Chronic Disease Self-Management Program (CDSMP), an evidence-based program to improve self-management of chronic illness (Gitlin et al., 2008; Lorig, Sobel, Ritter, Laurent, & Hobbs, 2001). Harvest Health maintained the essential components of CDSMP, yet modifications included a name change to reflect a cultural meaningful symbol (e.g., one reaps what one sows); an additional introductory session to build trust and a working relationship; and course augmentations involving culturally relevant foods, stress reduction techniques, and communicating with racially/ethnically diverse physicians. Harvest Health was tested as a translational/implementation study (Chapter 2, Phase V) and shown to have benefits for this population.
In the case of the ABLE Program, at the time of its development, no other interventions or proven protocols were identified (see scenario one discussed above). Thus, the ABLE Program was developed from the ground up. This involved conducting a series of pilot studies to evaluate the acceptability and feasibility of its treatment components (e.g., whether energy conservation techniques, home modification and home safety protocol, and fall risk protocols were acceptable and used in a home environment) and identify potential outcome measures related to functional difficulties (main primary outcome), self-efficacy (secondary outcome), and quality of life (distal outcome).
As these five basic scenarios suggest, the considerations examined in this discovery prephase will yield critical knowledge that can inform how best to proceed with intervention development and the type of evaluation that will be needed.