This announcement solicits applications for fiscal year (FY) 2013 extramural grant program, Social and Behavioral Interventions to Increase Solid Organ Donation, a grant program administered by the Division of Transplantation (DoT), Healthcare Systems Bureau (HSB), Health Resources and Services Administration
(HRSA), U. S. Department of Health and Human Services (HHS).
The overall goal of this grant program is to:
(1) reduce the gap between the demand for organ transplants and the supply of organs from deceased donors by identifying successful strategies that can serve as model interventions to increase deceased organ donation and, (2) increase the knowledge of options available through living donation among patients who may need transplants and/or individuals considering serving as a living donor.
Accordingly, this program will support sound applied research efforts to test the effectiveness of strategies that target any of the three program objectives listed below.
The first two objectives pertain to deceased donation; the third relates to living donation.
The specific objectives of this grant program are to increase, and improve understanding of how to increase:
1) individual commitment to be a deceased organ donor and documentation of that commitment; 2) consent of family (or others authorized to consent) for organ donation for a deceased relative; 3) the knowledge of the process, risks, advantages and disadvantages of deceased and living donation among patients who may need an organ and/or individuals considering serving as a living donor.
Applicants must indicate whether they wish to conduct a project focused on deceased donation or a project focused on living donation.
Projects to increase deceased donation may focus on community initiatives to increase the public's commitment to donation and/or hospital-based efforts to increase family consent for donation.
Projects focusing on living donation may test various models to educate individuals who may need transplants and/or individuals considering serving as a living donor of the opportunities to donate specific organs or organ segments while living and the process, risks, advantages and disadvantages of deceased and living donation.
However, because of the risks associated with any major surgical procedure, this grant program will not support projects that attempt to encourage living donation, increase the number of living donors or increase individuals' readiness/willingness to pursue living donation as reflected in the goals, interventions, outcome measures, and metrics.
Some examples of projects to educate about living donation include:
interventions to help potential donors, potential recipients, and their families make informed choices; interventions to reduce or eliminate barriers to education about living donation for potential donors or transplant candidates; and interventions designed to improve the education of living donors and those considering living donation in a healthcare or other relevant setting (dialysis centers, transplant programs, nephrologists' offices, community venues, etc).
All projects are encouraged to include an evaluation component, as described below.
The program will provide support for the evaluation of, or the implementation and evaluation of, highly promising strategies and approaches that can serve as model interventions for increasing commitment to deceased organ donation or knowledge about living donation as an option for some patients waiting for a transplant.
While the program focuses on solid organ donation, it is hoped that successful strategies will have a positive effect on eye and tissue donation as well.
For purposes of this program, model interventions are defined as those that are:
(1) effective in producing a verifiable and demonstrable impact on any of the three program objectives identified above; (2) replicable; (3) transferable; and (4) feasible in practice.
All projects must have rigorous methodology and quantitative evaluation components capable of ascertaining the effectiveness of the intervention(s).
While quantitative research would most strongly demonstrate effectiveness, qualitative components may add useful information.
Development of the intervention(s) may be supported by the grant but shall be limited to no more than 20 percent of total direct costs and staff time.
Applications may focus on pilot projects or replications of interventions already shown to be effective in a pilot study or other previous research.
A pilot project tests an intervention that has not before been tested for its utility and effectiveness in the donation field.
An extension project builds on results of a pilot project by adjusting or adding some new dimension to the original intervention in attempts to strengthen the intervention.
A replication project tests a strategy as it was implemented in a previous project but in a different setting(s) (such as testing in education institutions an intervention that was demonstrated to be effective in faith communities) or a different population(s) (such as a different cultural or age group or area of the country where the population demographics differ substantially from the original study).
Applications proposing replications or extensions must provide a strong rationale and justification for the proposed project.
Projects also may test the effectiveness of a purposefully and logically coordinated and synchronized set of multiple strategies for increasing donation in specified populations.
Projects that propose the use of multiple strategies are required to measure the independent effects of each strategy as well as the interactive effect of the various strategies.
Applications that propose new ideas and novel approaches to increase organ donation that are cost-effective in achieving DoT program objectives and demonstrate utility for the donation and transplantation community are encouraged.
Applicants also are encouraged to consider implementing strategies that have been successful in other public health fields and evaluating their effectiveness for use in the donation field.
Because of the disproportionately high need for kidney transplants in minority populations and the greater likelihood of finding a donor of similar blood type within the same ethnic or racial group, applications focusing on minority populations are encouraged.
All replication studies must include at least one site with a large minority population.
If the target population of the original study was a minority population, the replication study must include a different minority group for at least one site.
Applicants have considerable flexibility in proposing interventions, including:
the focus and nature of the intervention, intervention sites(s), geographic location(s), target group(s), etc.
Sound conceptual models of behavioral change must inform the intervention and various components of the methodology.
This grant program is focused solely on interventions to increase organ donation from deceased donors and the identification of successful models for educating about living donation.
Funds will not be used for other types of projects.
Examples of activities that will not be supported under this program are:
efforts to increase living donation; biomedical and clinical research; the development and/or assessment of the efficacy of new or improved methods of donor management, organ recovery, or organ preservation; fundamental research focused on new or improved evaluation tools and methodologies; interventions inconsistent with existing Federal law or statute; and interventions to increase tissue donation alone.
Proposals to evaluate clinical outcomes of donation after cardiac death (DCD) organs will not be supported.