FUNDING MECHANISMS ALONG THE ELONGATED PIPELINE
As developing, evaluating and translating, and implementing and disseminating interventions occur incrementally and over time, funds are needed for each phase along the pipeline. Figure 23.1 summarizes key funding sources organized by phase of the elongated pipeline (see Chapter 2) for systematically building a behavioral intervention. In the United States, federal agencies are the primary funders of intervention development and evaluation work, whereas foundations are more likely to fund pilot studies, translation, implementation, and dissemination efforts. As noted, some research-intensive institutions also provide funds for the early phases (developing and pilot testing) of an intervention, and more recently, there has been a funding appetite for translational efforts, although few dedicated funds are still available for this research activity.
When developing a proposal involving an intervention, first consider the level of development of the intervention, what is needed to advance the intervention, and the amount of funds required to conduct the proposed project activities. As to the latter, for example, funding requirements to support research activity will vary widely; efficacy trials (Phase III) will require greater funds to execute than Phase I pilot studies.
Figure 23.1 Key funding opportunities in the United States along the intervention development pipeline.
Another consideration is the level of experience of the investigator and investigative team. Investigators new to behavioral intervention research will have to prove their ability to conduct this complex form of research by demonstrating a previous record of funding, publications, and developmental work in the area. In this case, it is usually helpful to include more seasoned investigators as part of the research team even if this is for a minimum level of effort of 3% to 5%. As noted earlier, novice investigators should not typically start by submitting an efficacy trial; furthermore, an efficacy trial should not be proposed without sufficient evidence from previous developmental steps and preliminary testing of the intervention that supports moving forward with further evaluation.
As shown in Figure 23.1, funds to pursue the discovery phase of intervention development are primarily garnered from mechanisms that are internal to an academic institution. Research-intensive organizations in particular offer a range of pilot funding opportunities at the department, college, and university levels. As this phase customarily entails concept development, identifying population needs, and examining a theory base, modest funds may be needed to support the conduct of comprehensive literature reviews and publication development, needs assessments or focus groups with stakeholders and end users, or to form community or stakeholder partnerships. Small grants may vary vastly in funding levels—anywhere from a $1,000 stipend to $100,000 grant or more (or less) for up to a 1- to 2-year effort, with most pilot funding being in the range of $10,000 to $50,000. In general, it is difficult to obtain federal funding for these types of activities unless they are proposed as part of larger funded center or training grants.
For Phase I intervention development activities in which feasibility is the primary focus, a few additional funding outlets are available. In the United States and at the NIH, these include the R03 mechanism, which can be used to support pilot work to advance aspects of intervention protocol development, or the R34 and R21 mechanisms, which can be used to support the testing of different elements of an intervention protocol and development of a treatment manual. These mechanisms provide support for 2 to 3 years and can be very useful. However, unfortunately, not every institute at the NIH supports these mechanisms nor at the same level of funding. Another source of funding support is through the NIH center grant mechanism referred to as the P30. Center grants are typically designed to advance science in a focused area (e.g., sleep, frailty) by supporting pilot studies by investigators from the institution that has received this type of grant. These center grants provide core supports in the form of small funds to carry out the pilot, statistical, and methodological consultation and, occasionally, coordination of outreach and recruitment. However, the NIH is not the only funding source, and other agencies and foundations should be pursued. The new initiatives from PCORI, for example, or the Centers for Medicare and Medicaid Innovations initiatives offer unique opportunities to advance intervention work. Finally, many professional organizations, such as the Alzheimer’s Association, the American Occupational Therapy Foundation, or the American Cancer Association, to name just a few, offer funding opportunities to support this phase of intervention development in the United States.
As is true for any type of proposal or testing phase, proposals for pilot studies or manual development must be novel and propose a systematic methodology to be competitive. It is not sufficient to simply ask for funds to develop an intervention or its manual without proposing a specific methodology for doing so. For example, one could propose to test an initial protocol in an open label trial with 10 participants from which needed modifications to the protocol are subsequently documented and used to inform refinements to a treatment manual or the components of an intervention. The refined treatment manual or a modified treatment component may then be tested with another 10 participants and so forth using a coding system and theory base to understand adaptations (Stirman, Miller, Toder, & Calloway, 2012).
For Phase II intervention activities, in addition to the funding mechanisms thus far mentioned earlier, the NIH R21 mechanism can potentially be a good fit to evaluate intervention safety, preliminary effect sizes, and other design elements such as use of different control groups, spacing of testing occasions, or underlying explanatory mechanisms.
There are more funding opportunities to support Phase III efficacy trials or Phase IV effectiveness trials. In the United States, the primary source of funding, however, remains through the NIH and its R01 Research Project Grant mechanism. As mentioned earlier, consideration should also be given to PCORI whose mission, in part, is to fund comparative effectiveness trials. This is an excellent source of funding if the desire is to compare two or more clinical interventions that have been shown to be efficacious previously.
Although funding levels in general for intervention development and testing are sparse, as mentioned earlier, there is even less funding available for the implementation phases (Phase V—translation/implementation; Phase VI—dissemination; and Phase VII—sustainability/maintenance). Only a few institutes of the NIH (e.g., see the Dissemination and Implementation division of the National Institute of Mental Health or the National Cancer Institute) specifically allocate resources, albeit limited, to these phases. The NIH also continues to support a multimillion- dollar initiative to universities; the CTSA in turn offers a range of research services to investigators of awarded institutions including pilot funding for translational research studies. Additionally, special funding opportunities such as one-time requests for applications (RFA) have also been a source of funding support for translation and implementation efforts. Additionally, some agencies and foundations do target this phase in specific areas such as caregiving (Veterans Administration, Rosalynn Carter Institute on Caregiving), dementia care (Administration on Aging’s [AoA] Alzheimer’s Disease Supportive Services Program [ADSSP]), bringing evidence to geriatric care services (Hartford Change AGEnts Initiative), or translating evidence for delivery in social services and area agencies (National Institute on Aging and AoA [Translational Research to Help Older Adults Maintain Their Health and Independence in the Community]).
Finally, it is worth mentioning the Centers for Medicare and Medicaid Services Innovations Awards, which, with health care reform in the United States, has provided funding for large demonstration projects that propose to evaluate novel interventions designed to lower costs and improve care. It is unclear how long this funding mechanism will be available, but currently funded projects demonstrating improvements and cost savings may have the chance of being scaled up, diffused nationally, and be recognized as reimbursable.
It is not certain if any of the initiatives or funding sources mentioned here will continue to support any aspect of intervention work. Funding mechanisms tend to come and go. Thus, it is best to continuously investigate potential sources for supporting intervention work and, as discussed earlier, cast a wide net.