- Testing the Effectiveness of the Customized Career Development Platform (CCDP): A Cluster Randomized Trial
- Training Promotoras/Community Health Workers Using Culturally and Linguistically Appropriate Research Best Practices
- Empowering the Participant Voice: Collaborative Infrastructure and Validated Tools for Collecting Participant Feedback to Improve the Clinical Research Enterprise
- Harnessing Clinical Genomic Characterization to Accelerate Translational Advances for Patients with Intellectual and Developmental Disabilities
- Collaborative Care Teams for Hospitalized Patients with Opioid Use Disorders: Translating Evidence into Practice
- SMART IACUC: A Path to Harmonized Veterinary Multi-Site Trial Review
- Boston University Center for Molecular Discovery Chemical Library Consortium: Fostering Collaborations Between Chemists and Biologists for Translational Discovery
- Feasibility and Safety of Interleukin-1 Blockade to Treat Cardiac Sarcoidosis
- Gut Microbiome and Steroid Hormones
- Gut Microbiota in the Modulation of Outcomes After Liver Transplant
- Determining the Acceptability and Feasibility of Mobile-Health Approaches to Gather Clinical Information from Patients at Home Following Hospital Discharge
- Translating Scientific Evidence into Practice Using Digital Medicine and Electronic Patient-Reported Outcomes
Testing the Effectiveness of the Customized Career Development Platform (CCDP): A Cluster Randomized Trial
University of Pittsburgh
Principal Investigator: Doris M. Rubio, Ph.D.
Grant Number: 1R21TR003094-01
Collaborating Institutions: University of Southern California; University of Pennsylvania; Indiana University
The NIH requires that all research trainees supported by NIH funds use Individualized Development Plans (IDPs) to guide their progress and productivity. IDPs enable trainees to set goals and objectives and report milestones related to their research, training and career progression. The Customized Career Development Platform (CCDP) is an online IDP that enables goal setting, tracking of career milestones and mentor-mentee interactions, and oversight by research program administrators. The cluster randomized trial aims to evaluate the effectiveness of the CCDP among programs that support NIH-funded clinical and translational science trainees across the United States.
Training Promotoras/Community Health Workers Using Culturally and Linguistically Appropriate Research Best Practices
University of Michigan
Principal Investigator: Susan L. Murphy, Ph.D.
Grant Number: 1U01TR003409-01
Collaborating Institutions: University of California, Davis; University of Florida
Community health workers (CHWs) are increasingly being incorporated into research teams for their ability to reduce barriers in translation, particularly in regard to research on health disparities. Training for CHWs in research best practices is variable, not tailored to the research role of CHWs and not designed to train individuals who work in culturally or linguistically diverse communities. This project will develop a culturally and linguistically sensitive online research best practices course to train CHW “Champions,” demonstrate training efficacy at community sites and disseminate the course throughout the CTSA consortium. The project has the following specific aims:
- Develop and evaluate a research best practices online course for CHWs.
- Demonstrate the effectiveness of research best practices training for CHWs at community sites.
- Disseminate the course throughout the CTSA consortium and beyond.
Empowering the Participant Voice: Collaborative Infrastructure and Validated Tools for Collecting Participant Feedback to Improve the Clinical Research Enterprise
The Rockefeller University
Principal Investigator: Rhonda G. Kost, M.D.
Grant Number: 1U01TR003206-01
Collaborating Institutions: Duke University; Wake Forest University; University of Rochester; Johns Hopkins University; Vanderbilt University
Partnering with research participants to understand and improve their experiences in clinical research is a high priority for research investigators, institutions and their federal sponsors. However, researchers often lack the tools, expertise and technology to easily collect the participant feedback needed to tailor studies in participant-responsive ways. The goal of this project is to develop a new, streamlined infrastructure to enable routine collection of research participants’ feedback about their research experiences using the Research Participant Perception Survey. Six Clinical and Translational Science Award (CTSA) Hubs and other stakeholders will create the infrastructure and share it with the CTSA consortium and others through the REDCap Shared Library.
Harnessing Clinical Genomic Characterization to Accelerate Translational Advances for Patients with Intellectual and Developmental Disabilities
Washington University in St. Louis
Principal Investigator: John N. Constantino, M.D.
Grant Number: 1U01TR002764-01A1
Collaborating Institutions: Harvard Medical School; University of Wisconsin–Madison, Children’s Research Institute; The University of North Carolina at Chapel Hill; University of California, Los Angeles; Albert Einstein College of Medicine; Vanderbilt University Medical Center; University of California, Davis; Baylor College of Medicine; University of Pennsylvania; Johns Hopkins University; University of Washington,
Unprecedented advances in understanding genetic susceptibility to intellectual and developmental disabilities (IDDs) have been made throughout the last decade. Rare copy number and sequence variants are now known to account for a major share of population-attributable risk for IDDs. Clinical identification of pathogenic variants has generated opportunities to accelerate discovery and improve clinical treatment, but serious knowledge gaps persist regarding how to estimate the pathogenicity of genetic abnormalities in individual patients. This project aims to achieve the following:
- Establish standards for feasible neurobehavioral characterization of IDD patients.
- Integrate phenotypic and clinical genomic characterization of patients to directly promote progress in IDD gene and variant curation.
- Establish an IDD patient registry as an extension of the NCATS Center for Data to Health Initiative.
Collaborative Care Teams for Hospitalized Patients with Opioid Use Disorders: Translating Evidence into Practice
Cedars-Sinai Medical Center (University of California, Los Angeles)
Principal Investigator: Itai Danovitch, M.D., M.B.A.
Grant Number: 1U01TR002756-01A1
Collaborating Institutions: The University of New Mexico; Tufts University; RAND Corporation (Tufts University); Baystate Medical Center/Baystate Health (University of Massachusetts Medical School)
Patients with opioid use disorder (OUD) are frequently hospitalized, and although treatment is effective, it is dramatically underutilized, leaving patients at high risk of continued misuse, future overdose and readmission. Interdisciplinary collaborative care teams (CCTs) are a new approach to address translational roadblocks in OUD treatment delivery. CCTs offer expertise that most hospital-based physicians lack, create an organized system of care and address barriers to follow-up care. A mixed- methods, multisite, randomized pragmatic trial will compare OUD patients who receive inpatient care with and without CCTs to determine whether CCTs increase translational efficiency.
The Ohio State University
Principal Investigator: Sarah A. Moore, D.V.M., M.S.
Grant Number: 1R21TR003191-01
Collaborating Institutions: Tufts University; University of Missouri; Brigham and Women’s Hospital (Harvard University)
Veterinary clinical trials using spontaneous animal models of human disease accelerate successful translation and can assist in rapidly identifying ineffective treatments before progression to human clinical trials. Institutional animal care and use committees (IACUCs) review multicenter veterinary clinical trials on a site-by-site basis. Site-specific protocols for approval and monitoring make harmonizing cross-institutional efforts challenging and create inefficiencies and inconsistencies that decrease rigor and reproducibility and increase time to trial completion. This proposal aims to design and implement SMART IACUC, a cross-network platform for single review of multicenter veterinary clinical trials. SMART IACUC will harmonize veterinary clinical trial review across three partner institutions, educating and training key stakeholders to ensure broad adoption and success of the developed platform and evaluating and refining the platform using a multi-institutional test case.
Boston University Center for Molecular Discovery Chemical Library Consortium: Fostering Collaborations Between Chemists and Biologists for Translational Discovery
Principal Investigator: John A. Porco, Ph.D.
Grant Number: 1U01TR002625-01A1
Collaborating Institutions: The University of North Carolina at Chapel Hill; University of California, Los Angeles; The University of Chicago; New York University, Vanderbilt University; University of Notre Dame (Indiana University); University of Massachusetts; NCATS
The successful translation of a bioactive small molecule into a safe, effective therapeutic involves collaboration between chemists and biologists. The Boston University Center for Molecular Discovery (BU-CMD) is a laboratory that connects chemists who make molecules with biologists who wish to test them in various diseases. The BU-CMD curates and openly distributes a small-molecule screening collection of diverse, structurally complex chemotypes through a consortium of biological screeners. This program will leverage existing BU-CMD resources across multiple CTSA hubs, establishing an expandable molecule distribution infrastructure for seeding and fostering collaborative research projects between chemists and translational scientists to advance curative research for challenging biological disease areas.
Virginia Commonwealth University
Principal Investigator: Antonio Abbate, M.D., Ph.D.
Grant Number: 1R21TR003103-01
Collaborating Institutions: University of Michigan; American Heart Association
Sarcoidosis is an inflammatory disease that can affect any organ system. Rarely, sarcoidosis can affect the heart, leading to life-threatening heart rhythm problems, heart failure and death. Interleukin-1 (IL-1) may play a role in granuloma formation in sarcoidosis and inflammasome formation in cardiac sarcoidosis. Clinical trials have shown that IL-1 blockers can improve outcomes in ischemic heart disease and heart failure. This pilot study seeks to evaluate whether IL-1 blockade with the IL-1 receptor antagonist anakinra can safely modulate systemic inflammation in patients with active cardiac sarcoidosis. The results will serve as proof-of-concept data to conceive future phase III studies involving CTSA hubs across the country. A novel targeted treatment could bring about a much-needed paradigm shift in the treatment of cardiac sarcoidosis.
Rush University Medical Center
Principal Investigator: Ece A. Mutlu, M.D., M.S., M.B.A.
Grant Number: 1R21TR003105-01A1
Collaborating Institutions: Northwestern University
The gastrointestinal tract (GIT) microbiome plays a significant role in the bioavailability and physiological effects of steroid hormones (e.g., estrogens, progestogens, androgens) that are extensively metabolized in the GI tract. Exposure to high estrogen levels is a risk factor for breast cancer (BC), but it is not known if BC patients have alterations in GIT bacterial taxa. This translational proposal aims to characterize fecal bacterial taxa and steroid hormone levels in BC patients and to identify bacterial taxa and their candidate genes that contribute to the metabolism of steroid hormones within the GIT. Understanding which bacterial taxa play a role in GIT steroid hormone metabolism and identification of bacterial taxa and genes that are involved in steroid metabolism can potentially be used to design individualized microbiome-based therapies directed at these organisms.
Virginia Commonwealth University
Principal Investigator: Jasmohan S. Bajaj, M.D., M.S.
Grant Number: 1R21TR003095-01A1
Collaborating Institutions: Columbia University
Cirrhosis is a major cause of morbidity and mortality, and the only reliable cure is liver transplant (LT). However, a sizable proportion of post-LT patients develop multidrug-resistant organisms (MDROs), cognitive impairment and metabolic syndrome, which can be life threatening and result in long-term disability or incomplete recovery of pre-LT function. Some evidence indicates that altered gut microbiota play a role in post-LT complications. This proposal represents the first step toward using pre-LT microbial modulation in preventing post-LT complications, with the central hypothesis that gut microbial composition and function before LT can successfully predict post-LT outcomes. The study aims to determine the role of pre-LT gut microbial composition and function in the prediction of post-LT infections through MDRO colonization, in the development of post-LT metabolic syndrome and in cognitive recovery after LT.
Determining the Acceptability and Feasibility of Mobile-Health Approaches to Gather Clinical Information from Patients at Home Following Hospital Discharge
The University of Iowa
Principal Investigator: Philip M. Polgreen, M.D., M.P.H.
Grant Number: 1R21TR003410-01
Collaborating Institutions: Washington University in St. Louis
The emerging ubiquity of personal computing devices provides new opportunities to collect health-related data outside traditional clinical environments. The promise of collecting meaningful data increases if survey questions can be paired with “objective” information collected from sensors capable of collecting health-related data. The CTSA hub at The University of Iowa has designed, tested and deployed custom m-Health software to aggregate information from subjects using SMS, web-based tools and mobile apps. We also have integrated information directly from sensors (e.g., step counters, blood pressure cuffs, scales, thermometers) into our custom software so that we can remotely collect objective health-related data from research participants. In this proposal, we will use our m-Health platform to gather clinical data from patients in their homes following discharge from the hospital on outpatient parenteral antimicrobial therapy (OPAT). The study will achieve the following:
- Assess the feasibility of using a mobile health approach to gather clinical data from patients in their homes following discharge from the hospital on OPAT.
- Determine patient and researcher perspectives regarding the utility of our approach.
- Estimate the sample size necessary to power a study to determine the utility of remotely collected patient-reported data for predicting hospital readmissions among patients discharged on OPAT.
Translating Scientific Evidence into Practice Using Digital Medicine and Electronic Patient-Reported Outcomes
Icahn School of Medicine at Mount Sinai
Principal Investigator: Ashish Atreja, M.D., M.P.H.
Grant Number: 1U01TR002997-01A1
Collaborating Institutions: Northwestern University; Cleveland Clinic Lerner College of Medicine (Case Western Reserve University)
Delivery of health care traditionally has been limited to in-person office visits or hospitalizations, although patients spend the majority of their time at home or work. Digital medicine (e.g., apps, remote monitoring, telemedicine, patient-reported outcomes) has the potential to bridge this gap, but it is unclear how to implement it as a mainstream clinical practice that can lead to high-level patient and provider adoption. Through the creation of a Digital Transformation Network for inflammatory bowel disease, we plan to reduce digital disparities and scientifically address the evidence gap of digital health interventions across populations and communities. We hope that this study will help us build an evidence-based approach to determine whether digital medicine can engage a diverse group of patients and improve outcomes and, if it can, how it can be reproduced and replicated across different settings to address the T3 and T4 translational gaps.