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Characterizing the Quality of Evidence-based Prescribing for Hospitalized Veterans

open

NIH

Significance to VA: Each year, hundreds of thousands of Veterans are hospitalized for new presentations and acute exacerbations of complex chronic conditions, such as cardiovascular, pulmonary, neurologic, and substance use disorders. For each of these conditions, there are medications with strong evidence for improving clinical outcomes when taken long-term. Use of evidence-based, long-term medications following hospitalization is often deficient, with disparities observed in prescribing by race, ethnicity, rurality, and socioeconomic status. To date, no studies have systematically assessed the quality and equity of evidence-based prescribing at hospital discharge, a critical time to initiate guideline-recommended care. The objectives of this proposal are to detect and understand determinants of quality and equity of prescribing for hospitalized Veterans and to identify evidence-based strategies to improve prescribing. This research has been developed in partnership with the National Hospital Medicine Program, Office of Health Equity, and Center for Medication Safety and aligns with HSR priorities to apply Learning Health Systems foundational methods to achieve the VA Quintuple Aims of improving outcomes and ensuring equity. Innovation and Impact: The proposal is innovative in three ways. First, this research moves beyond disease- specific silos to examine evidence-based prescribing as a cross-cutting concept for hospitalized Veterans. Second, this research evaluates prescribing quality with an explicit health equity lens and employing a novel pharmacoequity framework. Third, it will use a complementary set of rigorous health services research methods to understand the underlying mechanisms for gaps in the quality and equity of prescribing and develop strategies with stakeholders to close gaps. This proposal will provide hospital-specific metrics to frontline clinicians and administrators to guide quality improvement efforts to advance inpatient prescribing quality and equity. Specific Aims: Aim 1: To examine the association of sociodemographic factors with receipt of evidence-based medications at hospital discharge. Aim 2: To determine mechanisms by which Veterans do not receive evidence- based medications at hospital discharge. Aim 3: To identify stakeholder perceptions of hospital prescribing performance and barriers to and facilitators of discharge prescribing quality and equity. Methodology: Aim 1 will be a retrospective cohort study using electronic health record data from the VA Corporate Data Warehouse to assess national and hospital-level rates of evidence-based medication use for Veterans hospitalized from 2022 and 2024 for five common complex chronic conditions: alcohol use disorder, atrial fibrillation, cerebrovascular disease, chronic obstructive pulmonary disease, and heart failure. Aim 2 will be a chart review study of a sample of 1,000 Veterans identified in Aim 1 as not receiving evidence-based medications at hospital discharge, oversampling for sociodemographic groups with the largest disparities in care. Aim 3 will be a qualitative study of 75 semi-structured interviews with inpatient clinicians and VA hospital leaders to identify barriers to and facilitators of equitable, high-quality discharge prescribing, recruiting from VA hospitals that are high and low performing (by quality and equity metrics) based upon Aim 1 results. Path to Translation/Implementation: This project will yield critical evidence to guide research and quality improvement efforts to equitably improve care delivery for hospitalized Veterans. The sum impact of this proposal will be the foundational data needed to initiate a Learning Health System Translation-to-Policy Learning Cycle to urgently transform current prescribing practices and test the implementation of data-informed strategies to improve hospital discharge prescribing quality and equity. Findings from all aims will be synthesized and reviewed with Operations partners, Veterans, and a longitudinal Expert Stakeholder Panel of frontline hospital- based clinicians to inform the co-design of implementation strategies to increase prescribing of evidence-based therapies for hospitalized Veterans that will be studied in future QUERI and Merit proposals.

2029-12-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Cognitively Healthy Nonagenarians in the Cross Cohort Collaboration (CCC)

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NIA - National Institute on Aging

Half of all persons who develop clinical dementia become symptomatic after age 85 years, whereas most studies of dementia have focused on younger patients in their 70s. Compared to dementia beginning at a younger age, dementia in the oldest-old has a more heterogeneous, multifactorial etiology. Although, Alzheimer disease remains important there are greater contributions from vascular brain injury, systemic disease and dysfunction that indirectly affects the brain, and recently described, poorly understood brain pathologies. Vascular and lifestyle risk factors may contribute differently to risk of dementia in the oldest-old. Conversely, it is also important to learn what resilience factors permit persons to remain alive and cognitively normal as nonagenerians. Studies that enroll persons aged 85+, often lack information from when these individuals were middle-aged. Longitudinal cohort studies that enrolled participants between ages 45 and 70 years and followed them past age 80 years, till they died or developed dementia, would be ideal study samples, but each such cohort usually has only a small number of participants surviving beyond age 80. One solution is to combine data across multiple longitudinal studies with harmonizable protocols. The Cross-Cohort Collaboration Consortium (CCC) was established in 2018, as an offshoot of the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium. The Neurology working group within the CCC (led by MPIs Seshadri, Ikram, Dufouil, Debette, Satizabal) brought together 8 cohorts (RF1 AG059421) to study late life dementia. We now request a renewal of this grant to expand and continue the collaboration. We will add 5 new cohorts reaching 13 cohorts, to study 102,285 participants, 37,803 with brain MRI, and add a new MPI in Suchy-Dicey who will bring her experience working with AD in American Indians. We propose the following aims. Aim 1: To relate various risk factors, systemic illness and MRI markers in midlife (ages 45 to 70) to (a) the risk of late life dementia, and (b) the probability of reaching age 85 (+/- 5) years, alive and dementia free (‘wellderly’). Aim 2: To assess (a) the impact of multimorbidity examining how persons with two or more chronic conditions differ in life-expectancy and dementia risk and (b) to combine various risk and resilience factors, multimorbidity and MRI measures using artificial intelligence and machine learning to create parsimonious models that predict late-onset dementia and wellderly status. Aim 3: To examine the biological pathways underlying the observed associations using pathway analyses and structural equation modeling to explore the mediating role of plasma proteins. The proteins we study will include known biomarkers of amyloid, tau and neurodegeneration (Aβ40 Aβ42, p-tau181/217, NfL, GFAP) in 37,824 individuals, as well as an array of 3000+ plasma proteins in 38,067 persons (new assays on Olink Explore 3072 + available data) so we can identify previously unsuspected biology using Mendelian randomization methods to examine causality. Aim 4: We will investigate any effect modification by sex-, age-, race-, ethnicity-, urban or rural residence, menopause, APOE genotype on findings from Aims 1-3. We hope to uncover putative drug targets to reduce risk of late life dementia.

Up to $578K
2031-01-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Collection of Traditional Ecological Knowledge Regarding Polar Bear Habitat Use in Chukotka, Russia

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National Park Service

This funding opportunity announcement is issued to provide public notice of the National Park Service, Alaska Region intent to fund a Cooperative Agreement without competition to the Alaska Nanuuq Commission - ANC. The intended Cooperative Agreement is a continuation of an existing project that was started in 2012. The project end date is May 30, 2014. The purpose is to conduct a habitat-use study for polar bears that builds on previous studies using traditional knowledge and local observers in several villages in Chukotka, Russia. In 2012, the ANC completed a polar bear habitat use study on the Alaska portion of the shared polar bear population. In order to get a more complete picture of the changing nature of these habitats, it is essential to include the Chukotka population. Scientists and Native leaders alike recognize that the most effective management of shared Bering/Chukchi polar bears and their habitat would require active cooperation among the governments and local Native people of the United States and Russia. The ANC will work with indigenous hunters organizations in Chukotka and gather reports on environmental changes in polar bear habitats in Russian. This project will cooperatively develop a report serving to update the report Traditional Knowledge of Chukotka Native Peoples Regarding Polar Bear Habitat Use, which was conducted by ANC and the National Park Service in 2003. Updating information gathered in the `90s. The ANC study in Chukotka will benefit a large number of Chukotka Natives, agencies, organizations, and governmental entities, including the NPS. This project is mutually beneficial and the knowledge exchange is a primary objective of the project. It contributes to the larger body of knowledge on the changing habitat of polar bears on both sides of the Bering Strait, and the long-term implications for this important species. The objectives of this cooperative agreement will be: To continue work and further develop the relationship between the ANC and Native organizations in Chukotka, with the NPS facilitating the exchange of information and the process of writing international agreements. -To gather information about polar bear habitat use through the observations of indigenous people in Chukotka. The NPS will act as a liaison when needed to facilitate exchanges, enhance communication, provide translation services when necessary, assist with organizing trainings and seminars, and provide logistical support. -To assist the Native organizations in their village outreach programs of conservation education and habitat protection of polar bear. -To update the habitat use study in Chukotka through the collection of interviews, data, and TEK in Chukotka villages -To provide a written report that will be shared by the SHBP with a vast network of interested parties through the SBHP website, Facebook page, and other distribution methods including participating communities and respondents. The National Park Service agrees to: 1. Using the network of contacts in Alaska and Russia (especially in Native communities), facilitate dissemination of project results to relevant communities and organizations in Alaska and Russia. Assist with the dissemination of information; working with local park units to post information, advertise presentations, and include in interpretive programs. 2. Use the network of contacts, the program website, and the program Facebook page to share information from the final and interim reports with the participating communities and participants, public, as well as targeted audiences through the development of distribution plan for final project materials and results. 3. Assist the ANC in strengthening their relationship with Native organizations in Chukotka, with the NPS facilitating the exchange of information and the process of writing international agreements. The SBHP has experience in writing successful agreements with Russian organizations, and will provide essential support to the ANC during the negotiation and finalization of an international agreement with a Russian Native organization. 4. The NPS will assist the ANC during their process of gathering information about polar bear habitat use through the observations of indigenous people in Chukotka. The SBHP will act as a liaison when needed to facilitate exchanges, enhance communication, provide translation services when necessary, assist with organizing trainings and seminars, and provide logistical support. 5. Provide technical assistance and expertise to the project including help with travel arrangements, and safety briefings related to project and geographic location. Also will provide translation and interpretation when necessary through our network of translators, as well as bilingual staff members. 6. The NPS will also support the ANC during meetings and conferences, including inter-Commission annual gathering. By attending relevant partner meetings, the NPS will support the mission and the objectives of the project by interacting and networking with other organizations in order to strengthen the liaison role. The NPS SBHP will also support the ANC by presenting information about the project to other interested parties, as well as at the annual gathering of ANC Commissioners. 7. Connect this project with the NPS network of projects aimed at indigenous and subsistence knowledge and share how this effort is structured and the final results, to inform other preservation efforts especially those working internationally. 8. Assign Elizabeth Shea, Program Specialist for the SBHP, NPS, as the Agreements Technical Representative (ATR) for the administration of this Cooperative Agreement; and as Liaison between the NPS and the ANC for the implementation of the program(s) identified within this agreement. The Alaska Nanuuq Commission agrees to: 1. Work directly with Native organizations on the Russian side to successfully accomplish the goals outlined under this project. 2. ANC will work directly with local organizations to coordinate all overall activities for the completion of the entire study within Chukotka. 3. Authors and editors for the Final report will be selected from the local Native organizations in Chukotka by the ANC. 4. ANC will work with chosen local organizations to incorporate the project s data and results in to the greater context of the Beringia Program to show the importance of subsistence aboriginal hunting and TEK in rural and urban communities within Chukotka. 5. The designated organizations in Chukotka will work with experts on the Russian side to provide the final draft of the overall report that includes the data, surveys and interviews conducted by the local surveyors. 6. Survey team will be headed by local Russian organizations that already have contacts with local surveyors, utilizing primarily team members from the original study, wherever possible. Technical Point of Contact: Elizabeth Shea 907-644-3606.

$47K
rolling
Environmentalsustainability

Free to search & build · $99 one-time to unlock the application pack · No subscription

Community Connect Grant Program

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Rural Utilities Service

The Community Connect Grant Program provides financial assistance to eligible applicants that will provide service at or above the Broadband Grant Speed (100 Mbps down and 20 Mbps up) to all premises in rural, economically-challenged communities where broadband service (10 Mbps down and 1 Mbps up) does not exist. The deployment of broadband services on a community-oriented connectivity basis stimulates economic development and provides enhanced educational and health care opportunities in rural areas. RUS will give priority to rural areas that demonstrate the greatest need for broadband services, based on the criteria contained in the regulation and Application Guide.The regulation for the Community Connect Grant Program can be found at 7 CFR part 1739.All applicants should carefully review and prepare their applications according to instructions in the FY 2026 Community Connect Grant Program Application Guide (Application Guide) and program resources. This Application Guide can be found at https://www.rd.usda.gov/community-connect. Expenses incurred in developing applications will be at the applicant s own risk. Applications will be submitted through the online application system available on the program web site. The application system will open for accepting Community Connect applications on May 13, 2026. Applications must submitted by no later than 11:59 a.m. Eastern Time, June 29, 2026. Late or incomplete applications will not be accepted.

$100K – $5M
2026-06-29
business developmentcommerce

Free to search & build · $99 one-time to unlock the application pack · No subscription

Community Economic Development Projects

upcoming

Administration for Children and Families - OCS

<p>The Office of Community Services (OCS) will award approximately $18.57 million in Community Economic Development (CED) discretionary funds to Community Development Corporations (CDC) to enhance job creation and business development for individuals with low income. Projects should be well-planned, financially viable, and innovative. CED awards will be made as part of a broader strategy to address objectives such as decreasing dependency on federal programs, chronic unemployment, and community deterioration in urban and rural areas. CED projects are expected to actively recruit individuals with low incomes to fill the positions created by CED-funded development activities, to assist those individuals in successfully maintaining employment, and to ensure that the businesses and jobs created remain viable for at least one year after the project period. CED projects can be non-construction or construction projects. In states with current projects, OCS encourages applicants to target rural and underserved areas.<br><br>Furthermore, OCS encourages potential applicants to explore how proposed projects can be aligned and/or integrated with other OCS-funded programs and priorities to more comprehensively address the needs of rural and urban communities with high rates of poverty, unemployment, and substance-use disorder, as well as communities experiencing persistent poverty, as identified by US Department of Agriculture's Economic Research Service.</p>

$100K – $800K
2026-07-17
income_security_and_social_services

Free to search & build · $99 one-time to unlock the application pack · No subscription

Community Economic Development Projects

upcoming

Administration for Children and Families - OCS

The Office of Community Services (OCS) will award approximately $18.57 million in Community Economic Development (CED) discretionary funds to Community Development Corporations (CDC) to enhance job creation and business development for individuals with low income. Projects should be well-planned, financially viable, and innovative. CED awards will be made as part of a broader strategy to address objectives such as decreasing dependency on federal programs, chronic unemployment, and community deterioration in urban and rural areas. CED projects are expected to actively recruit individuals with low incomes to fill the positions created by CED-funded development activities, to assist those individuals in successfully maintaining employment, and to ensure that the businesses and jobs created remain viable for at least one year after the project period. CED projects can be non-construction or construction projects. In states with current projects, OCS encourages applicants to target rural and underserved areas.Furthermore, OCS encourages potential applicants to explore how proposed projects can be aligned and/or integrated with other OCS-funded programs and priorities to more comprehensively address the needs of rural and urban communities with high rates of poverty, unemployment, and substance-use disorder, as well as communities experiencing persistent poverty, as identified by US Department of Agriculture's Economic Research Service.

$100K – $800K
2026-07-17
social services

Free to search & build · $99 one-time to unlock the application pack · No subscription

Components of emergency department pediatric readiness associated with short-and long-term survival among injured children: a mixed method evaluation

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

Proposed Approach: We will use a mixed methods study design to identify the components of emergency department (ED) pediatric readiness most predictive of short- and long-term survival among children. This project will help EDs prioritize implementation of ED readiness to save pediatric lives. We will use existing research infrastructure, data science methods, the ability to follow children to one year, novel analytics, and an interdisciplinary team to address this critical public health need. Importance: Injury and acute illness are the leading causes of death in children. We have recently shown that high ED pediatric readiness in US trauma centers and general hospitals is independently associated with improved survival, but the components of ED readiness driving survival are unknown. It is also unclear whether other organizational factors or ED processes of care improve survival among children. Answers to these questions will guide EDs in prioritizing the implementation of ED readiness, especially in smaller hospitals and rural settings with limited resources and budgets. This project is designed to inform the national trauma center verification criteria, the national field triage guidelines, the National Pediatric Readiness Project, and the Emergency Medical Services for Children program. Objectives: There are three specific aims: Specific Aim 1: We will build two multi-state cohorts of children receiving emergency care and use machine learning to identify the components of ED pediatric readiness predictive of short- and long-term survival. Specific Aim 2. Empirically develop a global measure of ED pediatric readiness and compare it to the weighted Pediatric Readiness Score for predicting short- and long-term survival in children. Specific Aim 3: Use a positive deviance approach to identify ED pediatric readiness factors and processes of care associated with improved survival among children receiving emergency care. Study Design & Setting: We will build two cohorts of children using emergency services from 1/1/2018 to 12/31/2022 in 928 EDs in 11 states (ED cohort) and 678 trauma centers in 50 states (Trauma cohort). We will link state vital statistics death records to the cohorts to track outcomes to one year and assess 152 unique components of ED readiness using machine learning methods. We will also conduct 150 interviews in 30 hospitals across the US using positive deviance methods as a complement to the quantitative analyses. Participants: Injured children 0–17 years using emergency services, including 15.6 million children with ED visits, 606,810 hospitalized children, and 264,865 children admitted to US trauma centers. Outcome measures: We will evaluate in-hospital mortality (primary) and 1-year mortality (secondary) at the patient-level. We will also evaluate the observed versus expected mortality at the ED-level to facilitate the positive deviance analysis.

Up to $273K
2028-04-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Developing a Single-Session, Peer-Delivered Internalized Stigma Reduction Intervention for Individuals with Polysubstance Use in Rural Maryland

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NIDA - National Institute on Drug Abuse

Project Summary/Abstract Rural communities bear a disproportionate burden of opioid and stimulant use, yet many individuals face challenges engaging in and sustaining treatment. Stigmas surrounding substance use disorder (SUD) and medication for opioid use disorder (MOUD) pose substantial obstacles to both engagement in care and achieving optimal treatment outcomes, such as retention and sustained recovery. Internalized stigma, in particular, has been linked to a higher likelihood of overdose. Patients in rural areas describe internalized SUD and MOUD stigmas as significant obstacles to recovery and other treatment outcomes (e.g., retention, continued use, mental health) in recent qualitative work, which are often compounded by stigma related to polysubstance use. Thus, there is a clear need to develop novel solutions for decreasing internalized SUD and MOUD stigmas within under-resourced, rural communities. Peer recovery specialists (PRSs), or individuals with lived experience in SUD and recovery, may be a unique solution to shifting stigma through sharing their lived experience and normalizing the experience of living with or in recovery from a SUD. While research supports PRS-delivery of brief evidence-based interventions, recent evidence also suggests that PRS-contact through non-stigma focused interventions may not be sufficient in sustaining long-term decreases in internalized stigma. Interventions to target internalized SUD and related stigmas, such as acceptance and commitment therapy (ACT), have shown promise in decreasing internalized stigma and its associated consequences (e.g., avoidance, shame), even when delivered in brief formats. However, these interventions are often limited to high-resource settings. Given the vast resource constraints in rural contexts, a brief PRS-delivered intervention for stigma reduction may be particularly feasible in increasing access to evidence-based care and reducing internalized SUD and MOUD stigmas. Thus, this study aims to: (1) evaluate patient-perceived appropriateness and potential obstacles and facilitators in the implementation of the proposed intervention in an under-resourced, rural context using a qualitative approach with MOUD patients and staff (N = 30); (2) iteratively adapt the proposed intervention and implementation strategies with three structured co-creation sessions (N = 12), guided by ADAPT-ITT and human- centered design principles; and (3) guided by ADAPT-ITT’s theater testing approach, evaluate the feasibility and acceptability of the adapted intervention components using mixed methods (N = 15).

Up to $107K
2028-04-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

DYNAMO?Diabetes in Youth and Young Adults of the Pacific Northwest

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NCCDPHP - National Center for Chronic Disease Prev and Health Promo

Project summary Type 1 and type 2 diabetes mellitus (T1D, T2D) continue to rise in youth and young adults (YYA) worldwide, with disproportionately high rates of T2D among historically underserved populations. Young people with early-onset diabetes face decades of managing a complex chronic disease and are at heightened risk of complications. Despite advancements, key knowledge gaps persist regarding trends in early onset T1D and T2D incidence, disease management, and outcomes in real-world settings, particularly for young adults, rural communities, and those receiving care outside specialty centers. The transition to adulthood, which often involves changes in residence, employment, and insurance, complicates surveillance through traditional methods. To address these challenges, we have brought together a highly collaborative, multi-institutional team of endocrinologists, biostatisticians, epidemiologists, nephrologists and informaticists with experience in diabetes surveillance and electronic health record-based research. We have established a unique regional network of five major health systems across the Pacific Northwest (PNW) to conduct comprehensive diabetes surveillance in YYA. This network includes Seattle Children’s Hospital, University of Washington Medicine, Providence Health System, Virginia Mason Franciscan Health, and the Veterans Affairs VISN 20 region, collectively serving diverse urban and rural populations across Washington, Oregon, Idaho, Montana, and Alaska. By integrating EHR, claims data, and established research infrastructure, we will conduct systematic surveillance of diabetes incidence, prevalence, clinical management, and complications in YYA. Our central hypothesis is that tracking diverse demographics, including rural and Native populations, will uncover critical disparities in the diabetes burden, healthcare delivery, and outcomes amenable to targeted interventions. Data will be harmonized across the health systems in our network. We will contribute to and implement the shared protocol developed with other funded sites in this cooperative grant mechanism. This project will deliver the first large-scale, real-world surveillance system for YYA with diabetes in the PNW, capturing underrepresented populations and addressing a pressing need for timely data on evolving trends in care and outcomes. By systematically identifying disparities in disease burden and clinical management, results will inform interventions to prevent disease progression, reduce complications, and improve long-term quality of life. The focus on rural and Native populations ensures that our approach is inclusive, contextually relevant, and poised to directly influence public health efforts in regions often overlooked by surveillance studies.

Up to $500K
2029-09-29
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Epigenetic and genetic regulation of arsenic methylation and arsenic-relatedcardiovascular disease risk

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NIEHS - National Institute of Environmental Health Sciences

SUMMARY In the United States, Native American communities face the greatest burden of chronic diseases among all ethnic groups and high rates of cardiovascular disease (CVD) incidence and mortality. Elevated disease risk may be in part attributed to arsenic in drinking water, which is a key environmental risk factor among rural households that rely on private wells. Arsenic-related CVD risk may be modified by the biomethylation of arsenic, a pathway that decreases arsenic toxicity and increases urinary excretion. Arsenic methylation efficiency varies between individuals and populations and is influenced by genetic variation. However, the role of pre- and post- transcriptional gene regulatory factors, including DNA methylation (DNAm) and microRNAs, on arsenic methylation efficiency and arsenic-induced CVD is not fully understood. This study will leverage data and biospecimens representing multiple omics layers from the Strong Heart Study (SHS) and Strong Heart Family Study (SHFS), large, prospective, well characterized cohorts of Native American adults with longitudinal data on CVD outcomes and risk biomarkers. The aims of this project are to (K00, Aim 1) determine the relationship between DNAm, arsenic methylation efficiency, and CVD to identify epigenetic biomarkers of arsenic toxicity and arsenic-related disease risk; (K99, Aim 2) determine the effect of genetic variation on DNAm associated with arsenic methylation efficiency to distinguish molecular mechanisms underlying arsenic methylation phenotypes; and (R00, Aim 3) investigate the role of microRNAs in mediating the association between arsenic exposure and methylation efficiency and CVD risk biomarkers to elucidate molecular processes underlying arsenic-related CVD. To accomplish these aims, Dr. Bozack will be receive mentorship from experts in environmental, molecular, and genetic epidemiology. In the K99 phase, Dr. Bozack will also receive training in bioinformatics and machine learning, including approaches for developing DNAm biomarkers and investigating gene-epigene interactions. In the R00 phase, she will generate circulating microRNA expression data and will further apply her training in clustering and network analyses to identify microRNA signatures linking arsenic exposure and methylation efficiency to CVD risk. The proposed training and research will enable Dr. Bozack to establish an independent research path focusing on biomarker development and applying multiple omics approaches to environmental molecular epidemiology. Furthermore, mentorship and career development activities will facilitate her transition to an independent researcher. Overall, this study will advance the understanding of gene regulatory factors involved in arsenic-related CVD risk through a multiple omics perspective, which is necessary to unravel the relationship between environmental and biological factors involved in the etiology of complex diseases. Findings will contribute the development of noninvasive biomarkers of arsenic-related CVD risk and may aid in targeting arsenic mitigation and public health interventions.

Up to $249K
2029-05-31
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

Examining a Digital Perinatal Smoking-Cessation Intervention

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NIDA - National Institute on Drug Abuse

PROJECT SUMMARY Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S., contributing to serious adverse events ranging from catastrophic pregnancy outcomes to later-in-life metabolic syndrome. Perinatal smoking has a disproportionate adverse impact on populations with constrained access to healthcare (e.g., rural residents). We developed a clinic-based financial-incentives (FI) intervention for perinatal smoking cessation that has been shown to be efficacious and cost-effective in randomized controlled trials (RCTs) and meta-analyses. Indeed, in 2024 the United Kingdom announced national implementation of clinic-based FI for perinatal smoking delivered by National Health Service tobacco interventionists. Unfortunately, scaling clinic- based versions in the U.S. is difficult as many prenatal-care clinics and hospitals fail to provide smoking- cessation services, especially in rural regions where many obstetrical services or entire hospitals are closing. Hence, we developed a digital FI intervention in collaboration with DynamiCare Health Inc. In a Phase 2 RCT that we conducted with 90 pregnant participants recruited across 33 U.S. states, adding this digital FI intervention to best practices (BP+FI) increased odds of cessation 4-fold above BP alone. Maximum FI earnings possible in that trial were $1,620 across the approximately 9-month intervention, with a mean [SD] incentive payout of $331 [446] per women treated. This smartphone-based digital FI intervention previously received Food and Drug Administration (FDA) Breakthrough Device Designation. We are submitting this UG3/UH3 application to conduct Phase 2 (UG3) and Phase 3 (UH3) RCTs in collaboration with FDA with the overarching aim of having this digital FI intervention authorized as an FDA Approved Digital Therapeutic. The UG3 Phase 2 RCT will address a January 2025 Substance Abuse and Mental Health Services Administration advisory that caps maximum potential earnings in FI for treating substance use disorders at $750 when using federal funds. Because federal funds will be essential to successful U.S. implementation of this digital FI intervention, we propose to conduct a UG3 Phase 2 RCT (N=137) examining the efficacy of BP+FI with $750 maximum earnings versus BP alone. Based on prior FI RCTs and meta-analyses, we hypothesize that BP+FI will remain efficacious with a $750 maximum although with a smaller effect size than at the $1,620 value which is why we are proposing a larger sample size in the UG3 than our prior Phase 2 RCT. Go/no-go criteria for the UG3 phase are: (1) complete an FDA Q-submission and (2) the UG3 trial results support the efficacy of BP+FI at $750 maximum earnings for increasing antepartum smoking abstinence significantly above BP alone. If these benchmarks are met , we propose to conduct a UH3 effectiveness trial (N to be informed by UG3 results and FDA recommendations) examining overall smoking abstinence, birth outcomes, treatment acceptability, and cost-effectiveness. Overall, this digital FI intervention has potential to bring sorely needed and effective perinatal smoking-cessation services to U.S. women including rural residents and others with constrained access to healthcare.

Up to $732K
2028-04-30
health research

Free to search & build · $99 one-time to unlock the application pack · No subscription

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