Key Dates

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-260 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

PAR-21-190 - Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)

PAR-20-084 - NIBIB Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

NOT-HL-21-021 - Notice of NHLBI Participation in NOT-HD-21-027

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Mental Health (NIMH)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Purpose

Purpose

The purpose of this Notice of Special Interest (NOSI) is to encourage applications in high-priority research areas related to pediatric health care transition for youth with chronic physical/medical conditions or intellectual/developmental disabilities. Research applications that will advance our understanding of promising practices designed to facilitate successful health care transitions (HCT) from pediatric to adult care settings as well as barriers and facilitators to such transition are encouraged. The ultimate goal is to improve care quality and patient and family outcomes during and after HCT.

Background

With improved rates of survival in childhood illnesses in the United States and globally, individuals are living longer with one or more chronic conditions. Children and adolescents with chronic conditions face increased health risks that require complex multidisciplinary care. As children transition from pediatric to adult health care services, however, there are several barriers that lead to issues accessing and engaging in age-appropriate care, managing developmental needs, and supporting optimal health. Challenges include increased risk for late and long-term physical and psychosocial effects of chronic conditions and their treatments, as well as subsequent care arising from additional comorbid conditions. As such, it is critical to ensure that the transition from pediatric to adult health care services includes coordination of the complexities of care for chronic conditions.

To meet the needs of diverse populations with chronic physical/medical conditions or intellectual/developmental disabilities as they transition from pediatric to adult centric services, barriers to successful HCT, methods and measures for capturing HCT, and the identification of promising practices must be better understood. Additionally, HCT should consider the context of typical developmental processes during the transition to adulthood as well as the multiple domains of functioning that are critical to life success (e.g., schooling, work, housing). Lastly, new technologies designed to manage, monitor, provide guidance/support, or otherwise facilitate successful HCT could potentially bridge gaps in current practices.

On September 30 and October 1, 2020, NIH sponsored a Workshop, "Navigating Pediatric to Adult Health Care: Lost in Transition . Efforts from this workshop and identified common themes highlighted shared research gaps and opportunities that can complement ongoing disease-specific work across NIH and collaborating organizations, and further defined research needs of youth with chronic physical/medical conditions or intellectual/developmental disabilities in the context of the health care transition (https://web.cvent.com/event/1861c38c-e953-4ffa-a0f1-1688840fb295/summary).

Research Objectives

This NOSI invites research applications that investigate approaches to meeting needs of youth with chronic physical/medical conditions or intellectual/developmental disabilities with the goal of improving care quality and patient and family outcomes during HCT.

Examples of research projects include, though are not limited to, the following:

• Studies that utilize community and social network resources, such as peers or families, to strengthen or facilitate successful transition by enhancing patient independence and self-efficacy as emerging adult patients transition between pediatric and adult care providers and health care settings.
• Studies that examine the developmental, clinical, individual, family, structural and/or health system factors that may predict a successful transition for youth with chronic conditions or intellectual/developmental disabilities to adult care. Studies that examine the interaction of these factors are encouraged.
• Studies that develop, pilot and/or validate novel measures or methods to assess successful health care transition outcomes across a range of domains of functioning. Such innovations may incorporate the use of mobile or digital devices when appropriate.
• Studies evaluating the integration of HCT processes (e.g., record transfer) and outcomes (e.g., transition completion) with electronic health records or other patient data (such as patient registries, data warehouses, billing data, pharmacy records, administrative records) at the point of care, including effective data sharing and care coordination.
• Studies to improve and coordinate information exchanges between pediatric and adult care settings and/or providers regarding treatment and payment plans, care coordination and integration. In the context of HCT, this may include specialty care coordination (from pediatric primary care or specialty care to adult primary care or specialty care or some combination), programs for mental health and/or substance use disorders, or insurance and other benefits when applicable.
• Studies to improve and facilitate communication, information exchange, and care coordination between health care providers, families and youth in order to facilitate successful transition(s). Such studies could include a focus on health literacy when appropriate.
• Studies that evaluate transition interventions that seek to improve disease relevant clinical outcomes as well as relevant behavioral, social (e.g., stigma), economic, educational, and service-related outcomes. Such studies could include the development and testing of new interventions and/or the evaluation of existing programs that follow written policies, practices, and/or guidelines. Hybrid effectiveness/implementation designs that incorporate implementation science approaches or outcomes (e.g., fidelity, adaptation), where appropriate, are particularly encouraged.
• Studies examining the impact of health disparities, including the impact of health care-related stigma, discrimination, harassment, and/or refusal of care on seeking transition-related health care as well as studies that develop and/or pilot interventions to address such barriers.
• Studies to determine the training, support, and other needs of clinical staff in order to facilitate effective transition. This could include the use of implementation science approaches to examine a broad range of implementation strategies to support transition.
• Studies with a focus on social support and other family, group, or system level interventions to improve health care transition outcomes by engaging patients, family caregivers, community partners and/or peers as appropriate.
• Studies to identify the range of relevant factors (e.g., age, developmental stage, environmental setting, cost) to be considered in determining when transition planning should begin, including the use of clinical tools or strategies, such as shared decision making, that could inform such processes.
• Studies on issues of evolving adolescent autonomy, decisional capacity, consent, assent and parental permission and related ethical issues across a wide range of developmental stages and cognitive abilities, with respect to health care transition processes.
• Research to develop technologies to bridge the gap in addressing needs of youth with chronic physical/medical conditions or intellectual/developmental disabilities with the goal of improving care quality and patient and family outcomes during HCT.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.

For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications. " Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

National Cancer Institute (NCI)

Children and adolescents with chronic conditions face increased health risks that require complex multidisciplinary care. As children transition from pediatric to adult healthcare services, however, there are several barriers that lead to issues accessing and engaging age-appropriate care, managing developmental needs, and supporting optimal health. This is increasingly evident for child and adolescent cancer survivors who are at increased risk for late and long-term physical and psychosocial effects of cancer and its treatment, as well as subsequent malignancies and additional comorbid conditions. As such, it is critical to ensure that the transition from pediatric to adult healthcare services includes coordination of the surveillance and management of the complexities of cancer survivorship care. NCI is particularly interested in applications focused on survivors of pediatric and adolescent and young adult (AYA) cancers.

Please note the following for studies submitted to NCI through this NOSI:

• Studies should focus on a subset of the pediatric and/or AYA cancer survivor population (age at primary diagnosis 0-39), with justification.
• Studies must focus on pediatric and/or AYA cancer survivors, however, they may also focus on additional relevant populations, including informal cancer caregivers and clinicians/healthcare providers.
• Study populations may be defined by a single diagnosis or multiple primary diagnoses, cancer treatment modalities, presence of co-morbidities, or other defining characteristics as appropriate and with justification.
• Interventions proposed for development and testing should examine or address well-known barriers to transitions in care for the target population, including geographic distance, literacy, functional deficits, and preferences to optimally engage survivors in their healthcare.
  

National Institute of Dental and Craniofacial Research (NIDCR)

The mission of the NIDCR is to improve oral, dental, and craniofacial health through research, research training, and the dissemination of health information. NIDCR supports research across the translational spectrum, from basic biological and behavioral science, to prevention and clinical approaches, to dissemination and implementation science. Relevant to this NOSI, NIDCR supports research on oral and comprehensive health programs to prevent oral disease and conditions as well as provide opportunities for dental care providers to contribute to broader public health efforts as children with chronic physical/medical conditions or intellectual/developmental disabilities transition from pediatric to adult health care.

Specific areas of interest include, but are not limited to:

• Research to characterize barriers to--and facilitators of--prevention and treatment related to oral, dental, and craniofacial health, for populations with chronic conditions or intellectual/developmental disabilities
• Research to develop/adapt and test transition programs for children with chronic physical/medical conditions or intellectual/developmental disabilities from pediatric to adult dental care settings.
• Research on the use of innovative healthcare delivery models to improve transition of pediatric to adult dental care within populations with chronic conditions or intellectual/developmental disabilities.

The NIDCR supports investigator-initiated clinical trials through the UG3/UH3 phased, milestone-driven cooperative agreement mechanism to address dental, oral, and craniofacial diseases and conditions. The NIDCR offers separate Funding Opportunity Announcements (FOAs) for clinical trials of behavioral or social interventions (PAR-21-197) and clinical trials of drugs, biologics, devices, or procedures (PAR-21-160). Investigators proposing a clinical trial should respond to one of these FOAs. Please see NOT-DE-21-004 for information about NIDCR’s clinical trials program.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the NIAMS is to support research into the causes, treatment, and prevention of rheumatic and musculoskeletal and skin diseases, and includes basic, translational, clinical, biobehavioral, dissemination and implementation science studies. Areas of interest include studies focused on the health care transitions from pediatric to adult care settings in the context of NIAMS-mission appropriate diseases and conditions, including (and not limited to) juvenile idiopathic arthritis (JIA), systemic lupus erythematosus (SLE), juvenile dermatomyositis (JDM), atopic dermatitis, acne, Duchenne muscular dystrophy (DMD), osteogenesis imperfecta (OI), orthopedic conditions and injuries that require long-term rehabilitation, and other juvenile/adolescent-onset rheumatic, dermatological, and/or musculoskeletal conditions.

Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.niams.nih.gov/grants-funding) to determine if their research fits within the NIAMS mission.

NIAMS FOAs for this NOSI include the following (or their subsequent reissued equivalents):

PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

National Institute of Mental Health (NIMH)

NIMH encourages research that closely aligns to the institute’s strategic plan goals and scientific priorities.Appropriate topics include, but are not limited to:

Intervention and Services Research

For research on the effectiveness of interventions or services, NIMH requires a study design using an experimental therapeutics approach, in which clinical trials test intervention effects on mental health outcomes as well as elucidate the intervention’s mechanism(s) of action. Therefore, applications must specify intervention target/mechanism and assess whether intervention-induced changes in the target account for the hypothesized outcome. In the case of services interventions, targets/mechanisms might involve change in service-user, family and/or provider behavior, or in organizational/system-level factors to improve access, engagement, continuity, quality, equity, and/or value of services. Studies adapting interventions for racial and ethnic minority populations (e.g., American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, and Native Hawaiians and other Pacific Islanders), sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations should provide an empirical rationale for the adaptation/augmentation target and a clear hypothesis and plan to address the target mechanism by which the adapted intervention will enhance outcomes. See the Support for Clinical Trials at NIMHweb page for additional information.

Treatment or Preventive Interventions

NIMH supports effectiveness research on preventative and therapeutic interventions with previously demonstrated efficacy, for use with a transition-age youth population or in a new practice setting. Of particular interest are studies in which there is evidence that unique therapeutic targets are indicated for this age group. Proposed interventions should be designed to engage those targets, and applications should include plans to evaluate the intervention’s impact on the hypothesized target mechanism(s) and the impact of the target(s) on the primary outcomes. All studies of treatment or preventive interventions for transition-age youth should include a mental health-related target mechanism and/or mental health-related primary outcome.

Services Interventions

NIMH supports services research focused on transition-age youth a) with or who are at risk for mental illness and/or b) with autism spectrum disorder. Priorities include research to 1) improve engagement in treatment and services through the transition to the adult healthcare system; 2) improve identification of those transition age youth at high risk of falling out of care using information gleaned from electronic health records, claims, and other administrative data sets; 3) test approaches to foster the development of age-appropriate illness self-management and other independence skills; 4) test strategies to better implement evidence based services and supports to maintain normative developmental milestones in education, employment, social skills, and progress to greater independence; 5) develop and test interventions that address factors common to this target population and that may impede transition to adulthood, including co-occurring alcohol or substance misuse, juvenile justice involvement, homelessness, unstable housing, challenges securing employment and healthcare coverage, and financial insecurities; 6) evaluate the adequacy financing mechanisms for approaches that effectively facilitate the transition from pediatric to adult healthcare settings.

HIV-Related Research

The Division of AIDS Research is interested in research that focuses on the successful transition of youth who are living with HIV from pediatric or adolescent HIV care to adult care or the re-engagement of youth who dropped out of care during the transition. Interventions targeting youth, family, health care providers, and clinics are all encouraged. NIMH is particularly interested in how stigma, discrimination, mental health, and mobility during this developmental time period impact a successful transition. Research on how to provide differentiated care to youth after they transition to adult care is also encouraged. Outcomes should include HIV-related outcomes along the HIV care continuum to be responsive to NIMH priorities.

NIMH’s FOAs for this NOSI include the following or their subsequent reissued equivalents:

Application and Submission Information

This notice applies to due dates on or after June 5, 2021 and subsequent receipt dates through January 8, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-185- NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-260 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

• PAR-21-035 - Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required)

• PAR-21-190 - Modular R01s in Cancer Control and Population Sciences (R01 Clinical Trial Optional)

• PAR-20-084 - NIBIB Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-HD-21-027 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Sonia Lee, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: [email protected]