Expired PA-13-355: Advancing the Science of Geriatric Palliative Care (R21)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Aging (NIA) National Institute of Nursing Research (NINR) National Cancer Institute (NCI)
Funding Opportunity Title	Advancing the Science of Geriatric Palliative Care (R21)
Activity Code	R21 Exploratory/Developmental Research Grant
Announcement Type	New
Related Notices	March 20, 2017 - This PA has been reissued as PA-17-226. October 17, 2016 - Notice of Change to Expiration Date for PA-13-355. See Notice NOT-AG-16-075. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. January 2, 2014 - See Notice NOT-CA-14-017. Notice of National Cancer Institute (NCI) Participation. October 24, 2013 - See Notice NOT-NR-14-002. Notice of NINR’s Participation.
Funding Opportunity Announcement (FOA) Number	PA-13-355
Companion Funding Opportunity	PA-13-354, R01 Research Project Grant PA-13-356, R03 Small Grant Program
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.866, 93.361, 93.393
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) encourages research grant applications focused on palliative care in geriatric populations. This FOA emphasizes studies in a variety of settings including ambulatory care, hospitals (and specific sites within hospitals including specialty wards, intensive care units and emergency departments), assisted living facilities, and short- and long-term care facilities; however, hospice and end-of-life settings are not included within the scope of this FOA, as they are the subject of other NIH programs. Rather, this FOA highlights research on palliative care in settings and at time points earlier in geriatric patients' disease or disability trajectories. Types of studies may include observational, quasi-experimental, or interventional studies using primary data collection and/or secondary analyses. Leveraging on-going cohorts, intervention studies, networks, data and specimen repositories, and other existing resources and infrastructure are encouraged.

Key Dates

Posted Date	September 19, 2013
Open Date (Earliest Submission Date)	January 16, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Standard AIDS dates apply, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date	Standard dates apply
Expiration Date	New Date March 20, 2017 per issuance of PA-17-226. (Original Expiration Date: May 08, 2017)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The American population is currently experiencing unprecedented growth in numbers and in age. In 2000, there were approximately 282 million Americans, 12% of whom were age 65 or older. In 2025, the US population is expected to grow to over 350 million individuals, of whom nearly 18% will be 65 years or older. By 2050, projections place the US population at well over 400 million, 20% of whom will be age 65 years or older. Individuals 80 years and above, sometimes described as the oldest old, are the fastest growing segment of the population and are expected to comprise over 30 million Americans, or over 7% of the US population.

As the population ages, the prevalence of diseases and conditions common in aging is also expected to increase. Dementia and cognitive impairment, cardiovascular disease, cancer, and chronic lung disease will likely continue to be the greatest sources of morbidity and mortality among older adults, as well as the costliest conditions to healthcare systems; however, the development of targeted interventions for specific chronic diseases has far outpaced the development of approaches to preserve the quality of life for patients living with such diseases.

The growing recognition that disease-specific management has failed to address the total health needs of patients with serious illness underscores the necessity to advance the science of palliative care.

Palliative care is defined here as an interdisciplinary person-centered approach to treating patients with serious illnesses through relieving symptoms and improving quality of life for patients and their families. Contrary to the popular notion that palliative care and curative treatment are mutually exclusive, palliative care can, in fact, be incorporated successfully into the treatment regimen for life-threatening disease. In addition, palliative care is sometimes used synonymously with end-of-life care; however, palliative care is a broader concept involving care delivered at any stage of illness from diagnosis through the terminal stages of disease.

Despite promising outcomes from a variety of palliative care interventions, most studies have involved a focus on single diseases; however, the majority of chronic diseases do not occur in isolation, particularly in older adults. For example, individuals with 2 or more chronic conditions comprise almost 2/3 of Medicare beneficiaries and account for 95% of Medicare expenditures. Older adults with multiple chronic conditions pose a particular challenge to providers and healthcare systems aiming to provide cost-effective care with clinically desirable outcomes. Moreover, geriatric syndromes, such as mobility disability, cognitive impairment, falls, and sensory impairment involve multiple interacting risk factors and complex management approaches that fit poorly within disease-specific treatment guidelines. In light of the scientific progress in both geriatrics and palliative care in recent years, a significant opportunity now exists to extend the science of palliative care to the management of older adults with serious illnesses. Such an opportunity is a natural extension of the science of both specialties, as geriatricians and palliative care providers have traditionally focused on achieving many of the same outcomes for their patients, such as improvement or preservation of function, sustained quality of life, and special attention to patient and caregiver treatment preferences.

In January, 2013, the Claude D. Pepper Older Americans Independence Center at the Mount Sinai School of Medicine, the National Palliative Care Research Center, and the National Institute on Aging co-sponsored a meeting to address major knowledge gaps and research opportunities in geriatric palliative care. A series of papers that emerged from that meeting are slated for publication in consecutive issues of the Journal of Palliative Medicine from July to November, 2013. An introduction to this series can be found at http://online.liebertpub.com/doi/full/10.1089/jpm.2013.9499.

Scope

This Funding Opportunity Announcement (FOA) encourages research grant applications focused on palliative care in geriatric populations. This R21 announcement specifically encourages projects primarily aimed at short-term novel exploratory studies that break new ground or move existing paradigms into a new direction. Applicants interested in pilot studies, demonstration of feasibility, development of new methodology, or other goals of limited scope and short duration are encouraged to consider PA-13-356. Applicants requiring more substantial resources and who have adequate preliminary data for their proposed study are encouraged to consider PA-13-354.

This FOA emphasizes studies in a variety of settings including ambulatory care, hospitals (and specific sites within hospitals including specialty wards, intensive care units and emergency departments), assisted living facilities, and short- and long-term care facilities; however, hospice and end-of-life settings are not included within the scope of this FOA, as they are the subject of other NIH programs. Rather, this FOA highlights research on palliative care in settings and at time points earlier in geriatric patients' disease or disability trajectories. Types of studies may include observational, quasi-experimental, or limited interventional studies using primary data collection and/or secondary analyses. Leveraging on-going cohorts, intervention studies, networks, data and specimen repositories, and other existing resources and infrastructure are encouraged. Topics of interest include, but are not limited to:

Development and evaluation of management approaches that improve quality of life, preserve or enhance function, or otherwise promote clinically meaningful outcomes, both within care settings and across care transitions, in seriously ill older adults.
Development, evaluation, and implementation of assessment tools in older adults with complex care needs; e.g., multiple disabilities, frailty, cognitive impairment.
Evaluation of treatment algorithms or clinical decision support tools optimizing across multiple parameters including functional status, patient and family preferences, clinical outcomes, and healthcare resources.
Evaluation of specialized management strategies for older adults with multiple chronic conditions.
Evaluation of discontinuing treatments hypothesized to be unnecessary in specific populations of older adults or in specific settings, and barriers to such discontinuation among patients and caregivers.
Development of intervention strategies to relieve non-pain symptoms in older patients, such as fatigue, dyspnea, nausea, constipation, anorexia, sleep disturbance, delirium, and pruritis. (See Additional Guidance below for further information about proposals focused on pain).
Understanding gender, ethnic, geographic, and socioeconomic disparities in access, delivery, and outcomes of palliative care for older adults.
Development and evaluation of novel strategies to improve advance care planning and/or articulation of treatment preferences among older adults.
Development and evaluation of innovative decision aids for seriously ill older patients and/or their proxy decision-makers, such as prognosis calculators and communication of prognosis.
Evaluation of new technologies for acquiring data about symptoms, quality of life, treatment preferences, and other variables not routinely captured as specific data elements in studies of older adults.
Addressing systemic challenges in conducting research studies of palliative care in older adults, such as barriers to care, high rates of disability and mortality, and compliance among patients, caregivers/family members, and providers.
Analysis of the effects of coverage policies of Medicare and other care funders on timely access to appropriate palliative care, and of the effects of care coordination, payment bundling, or other organizational and financing innovations on timely access to appropriate palliative care.
Development and evaluation of enhanced analytic methods for quasi-experimental and observational studies of palliative care strategies in older adults that, for example, address time-dependency, multimodal treatment, or matching of control subjects.

Additional Guidance

Applicants are encouraged to enroll subjects who represent accurately the broad range of age, gender, race, ethnicity, health, and functional level in the geriatric population. Applicants are discouraged from excluding subjects with cognitive impairment, frailty, or other age-related complicating conditions without reasonable scientific justification. Consideration of social factors is particularly encouraged in clinical studies, as inattention to such issues as socioeconomic status, built environment barriers, and attitudes and behaviors may likely threaten external validity.

Intervention studies may include traditional randomized controlled designs or more innovative approaches, such as adaptive designs. Low-cost pragmatic trials are particularly encouraged as they approximate more closely real-world practice. Studies that evaluate the effects of an intervention should define its specific parameters such that other investigators or providers may accurately replicate the intervention. For example, addition of expertise (e.g., academic detail, consultation, informal caregiver) or diagnostic method (e.g., geriatric assessment) should also include information about what specifically will be done and how subsequent management decisions will be informed. For any intervention study, applicants are encouraged to include patient-centered outcomes and, when possible, cost-effectiveness analyses. Applicants are encouraged to consider using NIH PROMIS measures for patient-reported outcomes. A full list of available measures and support tools for incorporating these measures into clinical studies are available at http://www.nihpromis.org. Investigators may also refer to recent efforts on identifying appropriate outcome measures for older adults with multiple chronic conditions, published in the Journal of the American Geriatrics Society 2012; 60: 2333-2341.

Applicants interested in submitting an application specifically on pain in older adults are encouraged to respond to PA-13-058 (R01), PA-13-059 (R21), or PA-13-060 (R03). A recent summary of research opportunities related to pain in older adults is published in Pain Medicine 2011; 12: 1336-1357. Applicants interested in studies on fatigue are encouraged to see PA-12-227 (R01), PA-12-225 (R21), and PA-12-226 (R03).

The Claude D. Pepper Older Americans Independence Centers, Alzheimer's Disease Research Centers, and Resource Centers for Minority Aging Research are NIA-supported centers that may be particularly useful for accessing recruitment resources, analytic capabilities, specimens, specialized expertise, and other aging-related research resources. Applicants interested in conducting ancillary investigations or secondary analyses of aging-relevant population studies can search or browse the NIA Population Studies Database.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	The combined budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. Applicants may request direct costs in $25,000 modules.
Award Project Period	The total project period may not exceed two years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover