Expired PAR-13-289: Building Evidence: Effective Palliative/End of Life Care Interventions (R01)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Nursing Research (NINR)
Funding Opportunity Title	Building Evidence: Effective Palliative/End of Life Care Interventions (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	May 10, 2016 - This PA has been reissued as PAR-16-250. 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. October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	PAR-13-289
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.361
Funding Opportunity Purpose	This funding opportunity announcement (FOA) seeks to stimulate research that develops and tests optimal palliative and end-of-life care interventions (models of care) based on measurable outcomes. Palliative Care and End-of-Life (PCEOL) interventions are increasingly needed for all individuals with Life Limiting Illnesses (LLI's) in some form or other, including those who are culturally diverse or aging. Adverse impacts have been shown to extend to the caregivers and families of patients with LLI s. Many individuals with LLI's also may concurrently be suffering from multiple complex comorbidities (MCC's), placing an increasing burden on health, health systems and costs. Few prospective interventions/models of care, especially those utilizing a randomized trial design, are testing the effectiveness of palliative and end-of-life care interventions. A wide variability exists among interventions delivered under the umbrella of palliative or end-of-life care . In addition, a variety of outcomes are being (or have been) assessed by different studies, when increasingly, the scientific need in this area is to examine and test a finite number of key outcomes (i.e., health, morbidity, quality of life, satisfaction with care) that are comparable across trials, studies, and programs.

Key Dates

Posted Date	July 26, 2013
Open Date (Earliest Submission Date)	September 8, 2013
Letter of Intent Due Date(s)	30 days prior to the application due date
Application Due Date(s)	(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 8, 2013, June 9, 2014, October 8, 2014, June 9, 2015, October 8, 2015, June 9, 2016, 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)	(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 8, 2013, June 9, 2014, October 8, 2014, June 9, 2015, October 8, 2015, June 9, 2016, 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	February/March 2014, October 2015, February/March 2015, October 2016, February/March 2016, October 2017.
Advisory Council Review	May 2014, January 2015, May 2015, January 2016, May 2016, January 2017
Earliest Start Date	July 2014, April 2015, July 2015, April 2016, July 2016, April 2017
Expiration Date	New Date May 10, 2016 per issuance of PAR-16-250. (Original Expiration Date: June 10, 2016)
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

Purpose

This funding opportunity announcement (FOA) seeks to stimulate research that develops and tests optimal palliative care and end-of-life (PCEOL) interventions/models of care that are based on measurable outcomes. It is an urgent need for all with Life Limiting Illnesses (LLI's), including those who are culturally diverse or belong to older age groups, to develop PCEOL interventions and models of care for efficacy and effectiveness. Many individuals with LLI's also may concurrently be dealing with Multiple Complex Co-morbidities (MCC's), which place an increasing burden on health, health systems and costs.

With the aging of society globally, a growing population of individuals are suffering from LLl’s that require palliative and end-of-life care, often in the setting of concurrent co-morbidities. The impact on caregivers and families is often profound and needs to be examined and addressed with respect to their health and care needs. These adverse outcomes and issues are placing increasing burdens on health systems and costs. PCEOL research, especially relating to models of care, is complex, inter- and multi- disciplinary, and a critically important focus of research expansion. Yet, it continues to be fragmented, and PCEOL interventions to-date have still not tested key outcomes defined by leading researchers and reviews of the science.

The purpose of this FOA is to (a) stimulate research on optimal palliative care and end-of-life interventions and care models based on measurable outcomes and (b) standardize such interventions across outcomes, programs and settings in order to achieve synchrony and the ability to pool data as needed for subsequent analyses that can substantiate the directions and domains of scientific growth in this area.

The August 2011 Summit entitled The Science of Compassion: Future Directions in End-of-Life and Palliative Care, led by the NINR and partnering NIH Institutes, Centers and Offices, called for substantial research efforts that develop and test effective and optimal PCEOL models of care and interventions.

Background

Only a few care interventions, utilizing a randomized trial design, are testing the effectiveness of palliative and end-of-life models of care. A wide variability exists among interventions delivered under the umbrella of palliative care . In addition, a variety of outcomes are being (or have been) assessed by different studies, when the field needs a finite number of key outcomes (e.g., health, morbidity, quality of life, satisfaction) that are comparable across trials, studies, and programs. Increasingly, the stimulation and support of this important, growing, and time sensitive focus of research is an imperative that needs to be responded to.

There continues to be a paucity of data regarding (a) optimal providers, setting, or content of palliative or end-of-life care; (b) the impact of PCEOL interventions that introduce care early (defined as care interventions that begin close to the point of diagnosis with a LLI, or are administered concurrently with acute disease related care); and (c) care interventions based on a core set of key outcomes and goals that are measurable, acceptable, and effective across gender or ethno-cultural perspectives. Most care intervention or models of care studies conducted either focus on the palliative care or end-of-life phases of the PCEOL trajectory, and fail to take note of or acknowledge that end-of-life care is part of the palliative care trajectory. Further, the impact of multiple chronic conditions and their care on palliative care is an important issue of increasing importance that has not been examined. Also virtually unexamined are caregiver health issues and their impact on the receipt of palliative care. Future studies need to address these important nuances and knowledge gaps. Finally, patients with some LLI’s such as heart failure may move back and forth between the extremes of care over the course of their illness. The nature and impact of transitions across the diagnostic trajectory thus need to be assessed, and models of care developed that are cognizant of transitions and decrease the chance of missing windows of opportunity that allow early ( upstream ) introduction of palliative care. Ways to effectively decrease care fragmentation, increase care continuity and coordination, and strategies to enhance the quality of care for life limiting illnesses need to be examined.

Among outcomes examined, models of care interventions have focused on quality of life, physical and psychological symptoms, family caregiver outcomes, satisfaction with care, health-services utilization, and end-of-life outcomes. However, there continue to be important questions regarding the most appropriate outcomes that should be included in PCEOL care models and are comparable across studies. Noted in the literature are 7 categories from which representative outcomes may be examined in models of care. These include: (i) physical and psychosocial symptoms; (ii) quality of life; (iii) function; (iv) satisfaction with the quality of care provided, ways to increase satisfaction, ascertainment of optimal communication, and advance care planning; (v) distress (e.g, family, physical and psychosocial); (vi) minimization of aggressive care at the end of life including location of death, and pre and post bereavement issues; and (vii) costs of care. Interventions supported as a result of this FOA should address the limitations of prior work; develop and test care interventions utilizing a limited and core set of outcomes such as those mentioned in i through vii; and fund a group of comparable studies that lead to the development of standards for care interventions, outcomes, and programs, and optimal models of care for life limiting illnesses across the diagnostic trajectory.

Research Objectives

Overarching areas of interest include, but are not limited to research that:

(a) Develops and tests care interventions and models of palliative and end-of-life care that take into account ethnoculturally diverse and medically underserved groups, are gender-sensitive, and improve the management of life limiting illnesses; and

(b) Expands the body of knowledge regarding methodologically rigorous and evidence based PCEOL interventions that are effective in decreasing care fragmentation; comparable; introduced earlier in the course of disease or concurrently with acute treatment for advanced disease, and enhance the quality of care.

Specific Research Objectives include but are not limited to studies that:

Develop and test models of care interventions that include a finite number of comparable outcomes such as: (i) physical and psychosocial symptoms; (ii) quality of life; (iii) function; (iv) satisfaction with the quality of care provided and ways to increase satisfaction (e.g., optimal communication and advance care planning); (v) distress (e.g, family, physical and psychosocial); (vi) minimization of aggressive care at the end of life including location of death and pre and post bereavement issues; and (vii) costs of care
Examine ways to enhance comparability across interventions
Establish standards for palliative care programs, interventions, and outcomes that are acceptable and effective especially across gender and ethno culturally diverse settings
Gather empirical evidence regarding characteristics of quality of palliative and end-of-life care
Test models of care that incorporate features of quality care such as: interdisciplinary teams; comprehensive symptom assessments encompassing physical, psychosocial, and spiritual domains; optimal communication across providers, patients and families to enhance coordinated care and advance care planning
Test integrated models of care, including those that span the palliative and end-of-life care spectrum, or are introduced early in the course of a life limiting disease or concurrently with disease related care, and those which address the impact of multiple or complex comorbidities on palliative care
Assess models of care that include caregiver health or the impact of caregiver health issues (such as depression and bereavement) on palliative care

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 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	Application budgets are not limited, but need to reflect the actual needs of the proposed project.
Award Project Period	The scope of the proposed project should determine the project period. The maximum project period is 5 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Yujing Liu, Chief, Office of Review
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 451-5152
Email: [email protected]

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