Competitive Revision Applications for Research on Complementary Approaches to Symptom Management in Military and Veteran Populations (R01)
PA-13-075
This Funding Opportunity Announcement (FOA) seeks competitive revision applications (formerly called competitive supplement applications). Specifically, NCCAM is encouraging competitive revision applications to augment currently active NCCAM R01 grants. NCCAM-funded researchers are encouraged to collaborate with Veteran Health Administration (VHA) or Department of Defense (DoD) clinicians or researchers to conduct research on complementary approaches for symptom management and health in military or VA populations. The research proposed should be focused on complementary approaches to pain and symptom management or improving health in U.S. military personnel, veterans and their families.
This Funding Opportunity Announcement (FOA) seeks competitive revision applications (formerly called competitive supplement applications). Specifically, NCCAM is encouraging competitive revision applications to augment currently active NCCAM R01 grants. NCCAM-funded researchers are encouraged to collaborate with VA or DoD clinicians or researchers to conduct research on complementary approaches for symptom management and health in military or VA populations. The research proposed should be focused on complementary approaches to pain and symptom management or improving health among U.S. military personnel, veterans and their families. Research related to all branches of the military (e.g., Army, Navy, Marines, Air Force, Coast Guard, U.S. Military Reserves, National Guard) and veterans are of interest.
With U.S. military forces serving in Iraq and Afghanistan, there have been approximately 2 million troops deployed and approximately 3 million deployments. As a result of these military operations, 202,281 cases of traumatic brain injury (TBI) have been recorded between 2000-2010 (dcoe.health.mil); rates of post-traumatic stress disorder (PTSD) vary, typically ranging from 5% to 20% among previously deployed personnel not seeking treatment with prevalence estimates higher in those seeking treatment (Ramchand, 2010); and high co-morbidity rates are reported among the following psychiatric conditions: PTSD, TBI, substance use disorder (SUD), and Depression (Seal, et. al., 2011). Furthermore, studies show nearly 50% of veterans report that they experience pain on a regular basis (Otis, et. al., 2009; Kerns, et. al., 2003) and there is significant overlap between chronic pain, PTSD, and persistent post-concussive symptoms (Lew, et. al., 2009).
The Office of The Army Surgeon General's Pain Management Task Force released their Final Report in May 2010, "Providing a Standardized DoD and VHA Vision and Approach to Pain Management to Optimize the Care for Warriors and their Families", and have launched a Comprehensive Pain Management Campaign Plan. One of the objectives specified in the final report is to incorporate complementary and integrative therapeutic modalities into patient centered plans of care (http://www.amedd.army.mil/reports/Pain_Management_Task_Force.pdf).
Many complementary approaches do not have a substantial evidence base to support their use, yet many of these approaches are used for pain and symptom management by the American public. The current health care needs of military personnel and veterans and the substantial interest by veteran and military entities in incorporating complementary approaches to pain and symptom management is an opportunity to study utilization, mechanisms, efficacy, and effectiveness of promising complementary approaches. Military health care systems have large patient populations and have the capability to yield large datasets. Researchers with expertise in researching intervention efficacy or expertise in complementary modalities are encouraged to explore collaborative relationships with VA sites or other sites with military populations. Revision applications that leverage existing relationships between academic institutions and DoD or VA sites are highly encouraged.
The goal of this initiative is to (1) conduct research on complementary, non-pharmacological, or integrative approaches to symptom management and health in military or VA populations, (2) leverage existing datasets and research infrastructure, and (3) foster collaborations between NCCAM-funded researchers and VA or DoD clinicians or researchers. For the purposes of this program announcement, "complementary, non-pharmacological, or integrative approaches" include mind-body interventions such as mindfulness- or meditation-based stress reduction approaches, massage, yoga, and acupuncture. "Complementary, non-pharmacological, or integrative approaches to health care" could also include multidisciplinary models of care such as pain clinics, VA hospitals, and clinical health systems that include pharmacological, psychological, and complementary treatment modalities.
Examples of the types of research partnerships include but are not limited to:
A Department of Veterans Affairs (VA) pain clinician or investigator and an NCCAM-funded health services investigator
A Department of Defense (DoD) biomarker researcher and an NCCCAM-funded complementary and integrative medicine investigator
A VA treatment outcomes investigator and an NCCAM-funded pain researcher
Clinical care providers in DoD/VA settings and clinical or basic research scientists funded by NCCAM
Research activities should involve a VA or DoD clinician or researcher and an NCCAM-funded researcher with the goal of fostering collaborations for research on complementary approaches to symptom management and health in military or VA populations. Examples of research approaches include, but are not limited to, the following:
Extending planned analyses or the approach utilized in the parent grant to a military or VA population via analysis of electronic medical record data or secondary data analysis of existing datasets to specifically look at use of complementary approaches and pain, other symptom management, daily functioning, or quality of life assessment data that may be captured in the medical record or dataset.
Extending research in the parent grant to a military or VA setting or population.
Enhancing the funded research by adding a military or VA setting or population and adding the use of PROMIS tools (http://www.nihpromis.org/) or NIH Toolbox tools (http://www.nihtoolbox.org/Pages/default.aspx) to other measures being used in the parent grant to assess pain, sleep, or other symptoms of interest in the military or VA population.
Enhancing funded studies for the development of biomarkers by collecting data in military personnel or veterans. Relevant biomarkers could serve for diagnostic purposes, assess mechanism of interventions, or predict potential intervention responders.
The description of the research project should include concrete indicators of progress and how these indicators will be used to inform the next phase of research. Appropriate indicators may include, but are not limited to, recruitment schedules and/or a timeline for administrative and scientific accomplishments. Progress indicators should be included in each annual progress report and as part of the final report for the grant.
The NCCAM will decline applications that are not considered central to the NCCAM mission and research priorities. Applicants are strongly encouraged to consult NCCAM's strategic plan (http://nccam.nih.gov/about/plans/2011), the program officer for the parent grant, and the program contact for this FOA, listed in Section VII, to discuss the relevance of their proposed work to the NCCAM mission as well as to ensure that proposed studies do not duplicate projects currently supported.
Applicants should address data sharing in the application. Data collection, data description, and management procedures should be designed and piloted with future data sharing in mind (e.g., development of data quality assurance procedures, and/or inclusion of relevant language in consent forms to allow future data sharing where appropriate).
Revisions from investigators with active NCCAM-funded R01 awards
Resubmissions of Revision applications.
Budgets for direct costs may not exceed $500,000 per year. Applicants must submit a budget using the same budget format as was used for the parent award.
The total project period for an application submitted in response to this FOA may not exceed two years. Applicants may request support for up to 2 years, but activities proposed must be completed by the end of the parent grant award period.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
For all revision applications, the Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must be the same as the PD(s)/PI(s) on the parent award. For revision applications to multiple PD(s)/PI(s) parent awards, the Contact PD/PI must be the PD/PI listed on the parent award. A revision application does not allow a change in the Multiple PD(s)/PI(s) team nor a conversion from a single PD/PI to multiple PD(s)/PI(s).
To be eligible, the parent award on which the revision application is based must be an active NCCAM R01 at the time the revision application is submitted. The project period of the revision application may not extend beyond that of the parent award. Grants that are in a no-cost extension period will not be considered for support under this program.
Research activities should include a collaboration with a DoD or VA clinician or researcher.
SF424 (R&R) Senior/Key Person Profile Expanded Component
Include the DoD or VA clinician or researchers that are collaborating on funding opportunity announcement.
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.